Podcasts about Aami

Facilities in many parts of the country are feeling the staffing crunch for Sterile Processing (SP) professionals. Our roles demand a high degree of technical knowledge, and some places do not have access to academic programs or training courses that prepare students for working in a Sterile Processing department (SPD). In episode 154, host Casey Czarnowski speaks with DeMango Griffin Sr. and James Johnson of BJC HealthCare in St. Louis. The guests discuss the diverse pathways to a career in the SPD. Griffin describes the challenges he has found in staffing his department and shares methods that have worked at his facility to find interested candidates. The conversation stresses the importance of advocating for the SPD with healthcare administration and supporting employees in their journeys toward certification. It's time to stop waiting for vacancies and start recruiting proactively and building talent internally. ABOUT OUR GUESTS DeMango Griffin Sr. Senior Clinical Program Manager BJC HealthCare DeMango Griffin Sr., BS, MHA, CRCST, CHL, CER, CIS, is a healthcare leader with more than 25 years of experience in sterile processing and perioperative support services. He currently serves in a senior leadership role, overseeing multiple Central Sterile departments within BJC HealthCare with operational responsibility across high-volume acute-care facilities. Griffin earned his master's degree while working full time and has built a reputation for driving operational improvement, regulatory compliance, staff development, and patient safety initiatives. His expertise includes SP/CS operations, Joint Commission readiness, AAMI standards implementation, workforce development, productivity management, capital planning, and multi-site leadership. Griffin is passionate about mentoring the next generation of SP professionals and strengthening local workforce pipelines through education and certification support. James Johnson Sterile Processing Supervisor BJC HealthCare James Johnson has more than 20 years of leadership experience in logistics, inventory management, transportation, and operational oversight. In his current supervisory role, Johnson focuses on patient safety, operational efficiency, and team development. He is committed to ensuring regulatory compliance, improving workflows, and maintaining the highest standards in instrument processing and infection prevention. Known for his strategic mindset and hands-on leadership style, James excels at building high-performing teams and fostering a culture of accountability and continuous improvement. His diverse background enables him to effectively streamline processes, optimize resources, and support healthcare teams in delivering safe, high-quality patient care. The code required for CE credit will be mentioned during the podcast.  Please make note of the code when you hear it to complete the quiz at the end for CE credit. Earn CE Now

Don’t let the AI wave crush you. Subscribe to our Newsletter: https://theultimatepartner.com/ebook-subscribe/ Check Out UPX: https://theultimatepartner.com/experience/ Dive into the seismic shifts happening within the AWS Marketplace and discover how AI, self-service product-led growth (PLG), and advanced co-selling strategies are redefining partner success. Matt Yanchyshyn, VP of Marketplace at AWS breaks down the recent announcements from the summit, illustrating how agility and adaptation are crucial to surviving the new agentic future. From lowering professional services fees to the explosion of business applications like ServiceNow, this conversation reveals the hidden mechanics of modern cloud procurement and how you can position your organization to capture massive enterprise opportunities before your competitors do. https://youtu.be/gaWxU1kgCLk Key Takeaways Adapting to the new agentic future requires agility rather than fighting the influx of AI tools. Lowering the listing fee for professional services from 2.5% to 0.5% drastically improves partner economics. Organizations without a self-service or PLG motion on the marketplace are literally leaving money on the table. Millennial buyers increasingly initiate complex enterprise procurements through self-service and AI-driven research. New AI-powered opportunity scoring empowers partners to prove their value internally and to AWS. Marketplace success hinges on optimizing metadata for AI agents, not just traditional SEO. If you're ready to lead through change, elevate your business, and achieve extraordinary outcomes through the power of partnership—this is your community. At Ultimate Partner® we want leaders like you to join us in the Ultimate Partner Experience – where transformation begins. Key Tags: AWS Marketplace, agentic workflow, med pick scoring, phoenix.ai, Cara Cloud, branded storefronts, product-led growth strategy, intrinsic value boost, SaaS evolution, self-service motion, Databricks credit model, Trend Micro companion app, MCP servers, opportunity score tracking, PPA drawdown, concurrent agreements, AAMI structural debt, CXML procurement Transcript: Matt Y Audio Podcast [00:00:00] Matt Y: The ability to adapt with change and kind of roll with punches. ’cause a lot of people are saying like, agents are gonna destroy everything. And, and the opposite has been true. [00:00:08] Vince Menzione: You can feel it happening. The ecosystem is shifting beneath us, the way hyperscalers are partnering, how AI is remaking the channel and what it means to win in 2026. [00:00:19] Vince Menzione: Welcome to the Ultimate Partner Podcast. I’m Vince Menzi, own your host. And each week I sit down with leaders at the intersection of technology, partnerships and outcomes. The voices shaping how ecosystems actually work. We talk about what’s real, what’s changing, and what it takes to lead in this era where the partner channel isn’t just part of the strategy. [00:00:42] Vince Menzione: It is the strategy because being in the room changes everything. [00:00:46] Matt Y: Let’s start. [00:00:50] Vince Menzione: And now on to the really important stuff. So, Matt, I don’t wanna butcher it ’cause I, a couple people have told me how to pronounce your last name and they said use the word magician and you’ll get close to it. But I’m just gonna introduce you as Matt Wy and I’m gonna ask you to pronounce your name on stage, but I want to have you join us. [00:01:08] Vince Menzione: So excited to have Matt wy. After a super busy day and night last night, come over from Brooklyn and join us today. Matt, so great to have you. Thanks. Thank you so much. Thank you so much. Alright, so pronounce your name for us. [00:01:23] Matt Y: Anyone wanna guess? Ian’s? It’s like magician. [00:01:27] Vince Menzione: It’s not that hard, [00:01:28] Matt Y: it’s not that [00:01:28] bad, [00:01:28] Vince Menzione: but I don’t wanna butcher. [00:01:29] Vince Menzione: I wanted to let you do it. Good. [00:01:30] Matt Y: What calls me Matt White. [00:01:31] Vince Menzione: That’s great. [00:01:32] Matt Y: Yeah. [00:01:32] Vince Menzione: So 13 years. [00:01:34] Matt Y: Four coming up on 14 next month. Yeah. [00:01:36] Vince Menzione: Wow. Congratulations. Yeah. So you’ve been there, you’ve been there since the early days. And we, we had a conversation. I had some Microsoft, former Microsoft colleagues. Uh, Theresa Carlson, for those of you who knew the public sector business. [00:01:48] Vince Menzione: Yeah. Who started, I mean, Andy came out, it was so funny because I was there and she was hosting Andy for a dinner and with all the CIOs of the federal government. [00:01:57] Matt Y: Yeah. [00:01:58] Vince Menzione: And she was still at Microsoft and it was actually kind of an interesting time. And she came over and did a lot of great things for a number of years. [00:02:04] Matt Y: Yeah. She [00:02:05] Vince Menzione: and a lot of great [00:02:05] Matt Y: business. [00:02:06] Vince Menzione: Yeah. She really like, it went from employee number one to 7,000. [00:02:09] Matt Y: Yeah. [00:02:09] Vince Menzione: And you, you were, you’ve been there all that whole time. Pretty much. [00:02:12] Matt Y: Yeah, I guess when I started in New York, just down the road, we were, uh, in a Regis facility. There were like 11 of us in, uh, just sitting around a table and we had to speak quietly sometimes because there was a, um. [00:02:21] Matt Y: Some type of a financial services organization down the hall and they’d listen to try and get stock tips on Amazon. Yeah, [00:02:28] Vince Menzione: I love it. [00:02:29] Matt Y: Never leaked. That’s [00:02:29] Vince Menzione: good. I love it. [00:02:30] Matt Y: Yeah, [00:02:30] Vince Menzione: you probably got some great stories and, um, we won’t have time for today ’cause I wanna leave some room for conversations on marketplace end questions. [00:02:38] Matt Y: Yeah. [00:02:38] Vince Menzione: But I would love to invite you back for a real, like, in-depth podcast and I would love to get the whole genesis story. [00:02:44] Matt Y: Let’s do it. [00:02:45] Vince Menzione: We’ll do it. Okay, so let’s talk about, let’s talk about yesterday for you. Uh, some, some really big announcements as well. I thought maybe you could recap a little bit of what’s been going on in the marketplace business and it’s an, it’s been an exciting time. [00:02:58] Matt Y: Yeah. Yeah. You know what’s, I think what was really nice yesterday is it was sort of the combination of bringing, uh, our partner services like Partner Central and all those other services together closer to marketplace. We’ve been doing that over, over several years. So Marketplace has some of its own. [00:03:12] Matt Y: Big announcements, like, uh, we have a, we formalized our list and sell initiative. For example. We have a new, so it we essentially reducing the cost, uh, to list on marketplace through a partner program. [00:03:22] Vince Menzione: Yep. [00:03:22] Matt Y: And incentives associated with that. We have a new AI powered listing experience, which I think is particularly important ’cause I think many of you are like me and watching your SEO numbers go down and watching your agent traffic go up. [00:03:33] Matt Y: And so having, uh, an AI assistance in marketplace to optimize your listings for not just to, you know, retain what you can of your SEO, but prepare for the newent future and improve your GEO as we’re calling it. So that, [00:03:45] Vince Menzione: so it’s GEO now? [00:03:46] Matt Y: Yeah. You know, there’s a little debate right now in the acronym Moral A A EO versus GO I’m going, I’m on the G team, so, yeah. [00:03:52] Vince Menzione: Alright. GEO [00:03:54] Matt Y: It’s like the, the, yeah, they’re gonna win. They’re like the Knicks, but the, um, [00:03:57] Vince Menzione: yeah, yeah, exactly. [00:03:57] Matt Y: But yeah, so AI assisted, uh, I mean, making. The most of, like, essentially marketplace is an excellent conversion engine. And so using AI to help improve that conversion engine in the form of your PDPs for both humans and agents. [00:04:08] Matt Y: So that was an exciting launch. Um, I got the most applause when I announced that. We lowered, we made the economics better for, uh, consulting offers professional services, nice to marketplace. We lowered the listing fee from 2.5 to, to 0.5% and wow, it goes even lower in certain circumstances. So just improving the economics. [00:04:24] Matt Y: I’m really excited to. Really partner with a lot of you to reinvent services through, through the marketplace like we did with SAS and other areas. Uh, and we’re doing with agents right now. So that was a big one. And then a whole series of announcements around, um, how we’re making it easier and more cost effective and more efficient to partner with AWS. [00:04:41] Matt Y: So using AI to, uh, using med pick scoring to automatically progress opportunities so you don’t have to kind of wait on a human. To, to click and progress, you know, that that can take days. And, uh, if you, if you wanna have an opportunity and have that be cos sold with AWS, that can be through a mix of agents for the long tail and with humans in the, in the sort of top end and more complex. [00:05:00] Matt Y: And allowing AI to help all the partners improve their opportunity quality so that we can better co-sell together. So. Yeah, I said AI a lot intentionally. Um, [00:05:09] Audience Guest: yeah, [00:05:10] Matt Y: AI sort of in the whole cycle for buyers, for sellers, uh, for operational efficiency, cost of sales. So a lot of announcements. I think I hit the big ones, so yeah. [00:05:18] Matt Y: I’m Might have missed something there. There we go. [00:05:21] Vince Menzione: George. [00:05:21] Matt Y: Oh, and storefront. Yeah. Thanks George. See, I look at George to see what I missed. Uh, we, we acquired a great company called phoenix.ai late last year. Okay. And you, you actually were said Caresoft and Yeah. Be down. Uh, [00:05:30] Vince Menzione: yeah. [00:05:30] Matt Y: So if you’re familiar with Cara Cloud, they have a procurement portal. [00:05:33] Matt Y: It’s heavy use by the US government, and they, um. Uh, we, we acquired them, uh, the really great growth company. They have over 70 logos now, and they help you build a branded storefront on marketplace, which obviously is important in the government space. If you’re procuring on a certain contract with a certain reseller, um, you know, there’s a certain set of products you’re allowed to buy. [00:05:51] Matt Y: But what we’re finding is even down on Wall Street, you hear, um, enterprises are, are using storefronts for internal procurement and they wanna have a curated collection of, of partner products and, and your own ecosystems internally. So we’re selling to both customers. And also to channel partners to build custom storefronts, branded storefronts for, and [00:06:07] Vince Menzione: it makes total sense, right? [00:06:08] Vince Menzione: Yeah, because you wanna li you wanna limit the, the viewing and, uh, and get, because I mean, how many different listings do we have? Like over 30,000? [00:06:16] Matt Y: Yeah. Yeah. There’s, I think the official numbers over th we have over 36,000. I was checking from over 6,000 vendors. Um, it’s a lot. And, and that’s gonna explode with the AI powered, uh, listing, uh, experience that we launched. [00:06:26] Matt Y: We’re gonna make it easier. And I guess what I’ve been telling partners is. You know, customers aren’t clicking through categories anymore. They’re using AI to search. And so it doesn’t matter how big our catalog is, what matters is being found. And what matters is converting that buyer. So if you have a. [00:06:39] Matt Y: If you’re running a demand gen campaign for say, like, you know, life sciences in, in Jersey and there’s a specific buyer at j and j, you wanna capture, that person doesn’t wanna be just dropped onto a generic marketplace, 30,000 listings. They wanna be dropped in a very specific place where they’re seeing like life sciences offers from Accenture, for example, coupled with a life sciences power thing with Elastic, you know, like, but a solution. [00:07:00] Matt Y: And that they want to land in a curated place where that highly intention buyer can be converted effectively. So that, that’s what we’re doing with all this. [00:07:06] Vince Menzione: And that’s where the GEO comes in because [00:07:09] Matt Y: Yeah. ’cause that buyer might be an agent That’s right. With, and that agent has is even more fickle, honestly. [00:07:14] Matt Y: And you know, what used to be milliseconds for the human before they kind of click away is, is now perhaps microseconds. Yeah. And so, uh, you know, having the right metadata and, and the right positioning, uh, the right story that an agent or a human can pick up to ultimately. Uh, complete their product research and choose your product is, is critical. [00:07:30] Vince Menzione: Very cool. Very cool. So before I, I, I’ve been asked to ask you this because I, I’ve had this con, people have brought come to me and said, you gotta ask Matt about music. He’s a big music guy. And, uh, so what are your favorite bands? [00:07:49] Matt Y: So, I mean, the, the real answer is, uh. I, I go to about a show about every week. [00:07:54] Matt Y: As, as Mike Trill knows, uh, we heard a show last night. Um, we were, uh, just a few hours ago, really? And, uh, um, favorite band, uh, well, I’ll tell, I’ll tell a story. I, I had a side hustle with MTV for years. Um, I used to run a music website. Um, oh, that’s cool. I didn’t know that. It got, it got kind of popular. It got sponsored by, if, if anyone’s into like early hip hop. [00:08:16] Matt Y: It got sponsored by a group called Jurassic Five. ’cause he, one of them reached out to me and said, nice. Hey, uh, you know, I’ve been, I like your website. And he ended up paying for a web, hosting a Dream host, if you remember, of cost back then. [00:08:26] Vince Menzione: Oh, Jesus. [00:08:26] Matt Y: Because I was broke and couldn’t afford it. And then, uh, and then this band sent me like a, a single and said, Hey, you know, trying to get the word out about our little band, can you help us out? [00:08:35] Matt Y: And I put their, uh, I put their, you know, single up on my, on my website and it blew up. And that band is Vampire Weekend. So they’re kind of big now. Wow. Yeah. Um, and uh, that got picked up by like Vanity Fair and all these other guys. And then I got sponsored by MTV to essentially write. Music reviews for years on the side. [00:08:51] Matt Y: So I was working for the Associated Press, laying cable in sports and war and, and, uh, yeah. So Vampire Weekend was good to me that, that they, they kind of paved a way to go to a lot of free shows over the years and a lot of bands and see a lot of great music. But yeah. [00:09:03] Vince Menzione: That is very cool. And that, and how did that get your day? [00:09:05] Vince Menzione: WS It was just a, it was just the technology path that was like, [00:09:09] Matt Y: I mean, it’s a, it’s a, I guess it’s a bit of a long story, but, um, the. There’s many versions of this story. I’ll tell the, tell the one quickly. I was living for free in a Fulbright scholarship house in West Africa. You, we can talk about how that happened another time. [00:09:23] Matt Y: And, uh, a guy had sort of fallen down on the floor ’cause he’d had too much to drink. And I, I sort of lay down beside and be like, Hey man, are you all right? And, um, he, uh. He worked, he, he worked for the Associated Press and next day I had the job, um, being West Africa, head of technology for West Africa. [00:09:37] Matt Y: And because of that, um, and as I learned years later, the AP didn’t have dr they had no disaster recovery. Yeah. And I, I can tell you that now ’cause um, you know, 16 years since I worked there, but they, uh, I put the DR in, um, on AWS and we’re talking like, yeah, 16, 17 years ago. This is early. It was early days. [00:09:56] Matt Y: And I, I swear to God, I paid for. Uh, our AWS bill using, um, taxi receipts, fake taxi receipts that I bought in on Nigerian market, um, because there was no budget and so, you know, it was like 30 bucks. [00:10:08] Vince Menzione: I was gonna say swipe a credit card, but they didn’t [00:10:09] Matt Y: knew that this is the entire press this before. [00:10:11] Vince Menzione: This is before, yeah. [00:10:12] Matt Y: Yeah, like the entire ap. Um, and, uh, so AWS called me like, who are you? Like, why, why are you paying on like this like low limit credit card for like the ap? Like, who are you? And, uh. Next day I had the job. Well, a week later I had the job with aw WS. That so cool. So that’s the story’s [00:10:29] Vince Menzione: cool thing. [00:10:29] Matt Y: Yeah. [00:10:30] Vince Menzione: Very cool. [00:10:31] Vince Menzione: Uh, sports teams. So Knicks fan. [00:10:34] Matt Y: Yeah, I mean, I like the Knicks. Um, they’re h hockey, I’m not allowed to say anything different. No. I appreciate them. Uh, I’m a Raptors fan. I grew up in Toronto mostly. Yeah, yeah. Uh, so, and you know, when they won, uh, that was very exciting as well. So no, Nicks are great. I like the Knicks. [00:10:49] Matt Y: Nothing against the Knicks. Um. They’re fine. Yeah. [00:10:54] Vince Menzione: Hockey, hockey fan. Favorite hockey teams? [00:10:56] Matt Y: Oh yeah. Itron. Maple leaf. Maple leaf. Yeah. They’re gonna, they’re gonna win. Of course. Of course. Yeah. Um, like every year they’re actually, we [00:11:02] Vince Menzione: have some Canadians laughing in the sand. [00:11:03] Matt Y: Well, the leaf are, are, are the Knicks of hockey? [00:11:05] Matt Y: Like Yes, they are. You know, it’s 67 years out, coming up on 68 since they won, so That’s crazy. 53 is nothing. I know. Pain. So. Yeah, definitely the least. Yeah. [00:11:15] Vince Menzione: I love it. I love it. It’s so cool. Yeah. So what was the, uh, what was the, what was the last concert you went to? [00:11:22] Matt Y: Well, literally last night. Oh, it was last, [00:11:23] Vince Menzione: oh, that [00:11:24] Matt Y: was actually concert were my favorite bar in the world. [00:11:26] Matt Y: This place called Sunny’s. Uh, it’s, you know, I, I took Mike and, and Matt from, from Texas and from TGS down there to sort of see my neighborhood and they’re like, where are we? And I’m like, yeah, I live here. Uh, sort of an industrial part of Brooklyn. And, and we went to see, um, I dunno what you would call it, like. [00:11:40] Matt Y: I guess it’d be like roots music. There was a woman with an accordion and a guy with a big cowboy hat. Yeah, it was, it was fun. Yeah. [00:11:47] Vince Menzione: That is so funny. Alright, we’re gonna shift back years. Um, important time right now for partners. What, what should partners be looking out for the most? What would you say to them in terms of what’s the, what’s their real headline for them? [00:11:59] Matt Y: Well, I, I, you know, to borrow from you actually, you know, I liked, uh, the, the principles you had up there and, and with agility, um, you know, there’s a lot of fud flying around right now. You know, people. People were like, oh, it’s the demise of sis with the arrival of ai, you know, everyone’s gonna be using agents. [00:12:13] Matt Y: And then it turns out it’s been a huge boon for most, uh, you know, system integrators and consulting companies that I work with. They all have, you know, the, the good ones especially have vibrant consulting practices now, and everyone is deploying fds, uh, you know, um, the new, the new cool acronym. But it’s, it’s essentially created a huge opportunity for the consulting space. [00:12:31] Matt Y: Uh, and similarly, uh, you know, there there’s this narrative around the sa sa apocalypse, which I really hate, you know, ’cause it was, uh, premature and kind of a trigger reaction from the stock market. And, you know, just look, look what Snowflake did. And, you know, they did what a lot of SaaS companies are doing, but they, they added a nice sort of glaze of positioning and, and, you know, their stock popped and they did pretty well. [00:12:50] Matt Y: And so I think the ability to adapt with change and kind of roll with the punches. ’cause a lot of people are saying like, agents are gonna destroy everything. And, and the opposite has been true. For the more successful consulting companies and software companies who have become agentic. But SaaS hasn’t gone away, you know? [00:13:05] Matt Y: No. Look at our own marketplace. We have this agent marketplace, but people aren’t buying atomic agents at scale. They’re buying ified SaaS solutions with sort of agent sidecars, which has created new opportunities for candidly additional licenses, [00:13:16] Vince Menzione: right? [00:13:16] Matt Y: Um, as customers sort of want to consume more AI services on top of their. [00:13:20] Matt Y: On top of their SaaS solutions. So I think being agile, you know, you see like ServiceNow as part of our billionaires club. Yes. They’re not going anywhere. They’re, yeah. They’re gentrifying. You know, Salesforce has pivoted to this headless model, um, along with Asian Force and using sort of Slack as the operating system. [00:13:34] Matt Y: And, you know, you said like a lot of companies from the seventies aren’t around anymore. They’re gonna be winners and losers. Yeah. Um, but the winners are gonna win even more. And so I, I think what’s so important right now for partners is to not, not bite too hard at the, the latest trend. You know, models are changing and everyone’s like, oh, you know, philanthropics really in the world and they’re wonderful, great to work with, amazing technology. [00:13:55] Matt Y: That’s what people are saying about open AI six months ago. That’s right. And before that, you know, and it, I, I was with Fireworks AI yesterday, a great company and they have some really cool stuff with sort of, um, they believe in more cost effective, uh, open source models essentially, that you can find tune. [00:14:08] Matt Y: Maybe that’s gonna win. I don’t know. Um, is it gonna be sort of domain specific models? Is it gonna be highly capable LLMs? Are LLMs gonna level off as soon as Fable and Mythos are allowed to launch? Maybe. I, I don’t think anyone can predict the future right now. So you have to be agile and you have to kind of seize the opportunities and take a couple punches. [00:14:25] Vince Menzione: Yeah. [00:14:26] Matt Y: You know, and marketplace too, like we’re, you have to be unafraid to experiment right now. Um, you know, that’s hard if your stock’s taking a beating. Um, but this is, it’s a, it is a disruptive time, uh, but it’s creating actually enormous opportunities for growth for partners and, and we really see that, you know, in marketplace specifically within AWS. [00:14:45] Vince Menzione: It, it, it does still feel like the deer in the headlights moment. Right. Would you agree? Like you’re probably taking a lot of meetings and, and calls from ISVs specifically? [00:14:54] Matt Y: Well, [00:14:54] Vince Menzione: that are still trying to figure it out. [00:14:56] Matt Y: Yeah. But it’s everyone. Yeah. I think what’s really interesting, I had a meeting [00:14:58] Vince Menzione: with, it’s not just one. [00:14:59] Matt Y: Yeah. I, well, I had a meeting with one of the leading AI companies, like one of the biggest ones. And they, uh, they demonstrated how they work and they were really proud. They were like, you know, look at our agentic workflow. And I came out at me. I’m like, that’s it. Ours is way better. Like really like, you know, ’cause we we’re, we’re using quick desktop with MCP servers and connectors and all this, and you know, we, we have our own sort of ecosystem of partners, a mix of homegrown software and third party. [00:15:20] Matt Y: And I kinda walked out there and, and looked at, you know, my phone, which has been populated by agents this morning with all the, and I was like, I have a way better agent workflow than this world’s leading supposedly AI company. And I think, um, that really, so during, I, I would, during the headlights, you can call it deer in the headlights, I call it chaos. [00:15:36] Matt Y: And in times of chaos there are people who create. Opportunity again. And so, yeah, there are some people who are stuck and who don’t know what to do, who are over worried about token costs, um, who are not experimenting. But there are a lot of companies, uh, taking this opportunity to kind of pivot their business. [00:15:53] Matt Y: Um, I think, I think we’re in a moment and, uh, yeah, I, I candidly I see more of the latter. I see more experimenting. [00:15:59] Vince Menzione: You mentioned ServiceNow. Any other great examples of that? Organizations that really embraced it? [00:16:04] Matt Y: Uh, yeah. Well, you know, ServiceNow is part of this business applications category, as we call it, in marketplace. [00:16:09] Matt Y: That outside of AI, I think is the fastest growing category in marketplace, which is wild when you think about it. ’cause we’ve historically been an infrastructure partner marketplace with security and data and analytics and, you know, security with channel partners, et cetera. But Salesforce, ServiceNow, Workday, Adobe, you know, I could go on. [00:16:23] Matt Y: They, they are actually. You know, our fastest growing category and yeah, ServiceNow, obviously reinventing itself for ai, Salesforce, but Workday, you know, the workday’s done some, who knows if it’s gonna work, but they, they’re experimenting with essentially like a Databricks, uh, credit style model for like, units of work, uh, which I think is fascinating. [00:16:41] Matt Y: Like everyone’s talking about value-based, outcome-based pricing and meter. And, and you have companies that are ERP companies, you know, like traditional business applications, experimenting with effectively like a metered pay as you go, value based credit model. Again, like who knows if it’s gonna work. [00:16:54] Matt Y: But I think that’s really amazing to see and we need more ISVs experimenting. I, I was talking about trend ai and I know they’re, they’re, they’re one of the sponsors yesterday. You know, many of you know them as Trend Micro back in the day. They’ve successfully reinvented themselves. They built that companion app. [00:17:10] Matt Y: Um, you know, that I think we’re seeing. Just a ton of experimentation in the market across categories. Uh, I could go on and on about partners. Um, yeah, there, I I wouldn’t pick a winner right now. Yeah. [00:17:24] Vince Menzione: You, you, we’ve talked about ai. We’ve talked, talk more about the buying journey and how that’s changing, because again, it feels, it feels like that’s also [00:17:33] Matt Y: Yeah. [00:17:33] Matt Y: So, you know, one of, one of the core, uh, strategic objectives, or we’ll say like the philosophy marketplace is that. Um, financial incentives are important, you know, EDP or PPA drawdown, uh, credits. Like we need to act as an efficient and effective vehicle for allowing buyers to exercise their discounts for, and, and sort of partners to exercise their credits, et cetera. [00:17:55] Matt Y: That, that’s actually important. But what, what a lot of people over rotate on that, and we’re really, one of the things we say a lot inside at Amazon or at AWS marketplace is we want to continue to boost the intrinsic value of marketplace beyond the financial incentives. And well over a quarter of all private offers, private pricing, private, uh, custom terms, et cetera. [00:18:14] Matt Y: Um, begin with a self-service or PLG motion. And partners who don’t have a PLG or self-service motion are literally leaving money on the table. Like if you look at like a Databricks for example, and they did a good job integrating buy with a WS within their SaaS application. They have free trials, they have really strong pego and, and, uh, and PLG motion. [00:18:33] Matt Y: They’re making, I can’t share their numbers obviously, but they’re making a ton of money. On purely self-service motions. And importantly, they’re acquiring new business, new logos that they nurture, you know, really like not just leads but closed opportunities, right? That they lead, they’re growing, uh, at a reasonable conversion rate or or success rate into the next big logos. [00:18:50] Matt Y: And these are over multi-year horizons. They’re patient, you know, they bring in these new logos with PLG, and they’re also bringing banking, a lot of large enterprises. Through self-service. I, I was with data Mask. There’s this great little startup from New Zealand. They’re a New Zealand based company. Um, super nice guy. [00:19:06] Matt Y: And, and, uh, they, they got huge logos. I think they got, what was it? A DP and some huge American logos. Okay. And this like logo in, I think it was Chile, or no, it was Peru. They’ve never been to Peru. They don’t have sales in Peru. Um, and they. Buyers were discovering them self-service and they, they, I think they got something like 13 logos entirely through a self-service motion. [00:19:26] Matt Y: One password will tell you the same thing. I was just with them in Toronto and companies big and small startups and the largest are getting enterprise wins in addition to net new small logos through that PLG. Buyer motion. And that’s because you have a whole generation of CFOs, CTOs, CROs, whatever. The C is [00:19:43] Vince Menzione: millennial [00:19:43] Matt Y: who grew up on their phones. [00:19:45] Vince Menzione: Yeah. [00:19:45] Matt Y: And, and it sounds like, you know, hyperbole, but it’s true. They, they want immediate apps, immediate access. And that actually, you’re like, oh, that never translates to business applications. Turns out it does. It does. And they might not be buying on their phone, but what they are doing is researching and we see the numbers, the amount of customers who are doing their research, and then eventually landing on the page from chat, GPT. [00:20:06] Matt Y: From major financial, like Fortune 500 companies is extremely high. Yeah. Uh, you have procurement team, sourcing team, uh, developers who are starting the research increasingly, like in clawed in chat, GPT, and then, you know, building a proposal and then handing it to their enterprise procurement team. Yeah. [00:20:22] Matt Y: Which is still largely unchanged. So buyer behavior is on the front end, on the research side is really changing. So the [00:20:29] Vince Menzione: discovery is happening through PLG. [00:20:32] Matt Y: Yeah. [00:20:32] Vince Menzione: And then the backend work on private offers and things like that sometimes still happens the old way. [00:20:36] Matt Y: Yeah. Well, and so, you know, it’s [00:20:37] Vince Menzione: fax machine, [00:20:38] Matt Y: some people Yeah, sure. [00:20:39] Matt Y: They’re bringing the deal directly to Marketplace last minute. But even if that deal goes direct, sometimes they’re still beginning their research journey and increasingly using Marketplace as a research vehicle, which is why we launched Agent Mode, um, to help you sort of help you and agents do research. [00:20:51] Matt Y: But that I think if, if I have one piece of device for any partner consulting or ISV is. Don’t leave those leads and that money on the table by not having a PLG self-service strategy like you’re fooling yourself. Uh, and it’s, it’s a huge, it’s a huge, huge business for us. The, the majority of all customers by far on marketplace don’t even have a PPA, uh, and a huge percentage of even those with PPA spend beyond the p. [00:21:17] Matt Y: And so if you’re just think if you’re just using marketplaces as like BPA retirement, you are literally losing money. [00:21:22] Vince Menzione: Yeah. [00:21:22] Matt Y: Yeah. [00:21:23] Vince Menzione: We have a session with Vinod. We’re gonna talk a little bit about that right after. Great. So good. Um, so I, yeah, I think, um. We talked about, we talked about agents, we’ve talked about the millennial buyer, the change in buying behavior. [00:21:40] Vince Menzione: What other, what other areas of aspect I, I, I, I do wanna think about like opening it up though for a second. I think that maybe with maybe nine minutes left. Sure. I just want to get a read from the people in the room. People have questions for Matt that we weren’t able to ask them. Yeah, I think, I think we probably have a few of those. [00:21:57] Vince Menzione: I think that would probably be great. [00:21:58] Matt Y: I can sense the hardball coming. [00:22:00] Vince Menzione: You’ve known each other [00:22:00] Matt Y: a long time. [00:22:01] Vince Menzione: Yeah. No, no. Hardball. We have a mic back here. Okay. I’ll just, we’ll, we’ll, we’ll get you a mic as we are recording. So good. Thank you. [00:22:11] Audience Guest: Uh, Boris Geller with a, a Click PLG is near and dear to my heart. [00:22:17] Audience Guest: We’ve been doing a lot of business in marketplace and I’m still struggling to sell my vision internally on, on, uh, on PLG. Uh, I think. Ag Agent AI is gonna be one of the drivers, and we are already on, uh, agent Marketplace, but I would appreciate guidance on, uh, best practices. How do we kind of, uh, operationalize it? [00:22:41] Audience Guest: It’s, it’s on us, not on you. [00:22:43] Matt Y: Well, no, I think it’s on both of us. You know, we, uh. One thing that we’re trying to do is give you more data to, to sell to your internal stakeholders in your executive suite. The value of co-sell with AWS all up, like finally with what we launched at, uh, the summit yesterday, you now get an opportunity score. [00:23:02] Matt Y: You, you get a number. People have been asking for this for years, so, so you can say when we do this and we, when we give AWS this information. The score goes up and we have a higher propensity to be cos sold by humans or agents before you had to kind of, it was like this mystery you had to guess. And similarly with marketplace, um, we, we have new dashboards that you can use to sort of, you used to have to sit down with us and go through spreadsheets to trace sort of lead to trace the funnel to sort of a close opportunity. [00:23:28] Matt Y: And we’re gonna continue to launch more there. But you now have more data that you can show. You can be like, listen, these are our inbound leads, this how’s converting, and now we have PRM, the partner revenue measurement where we can say like, this is what it’s translating into in terms of. AWS service revenue driven by our product. [00:23:41] Matt Y: And so that being able to tie from that inbound lead from your demand gen campaign through to a converted opportunity to what you actually drive from an AWS impact perspective, so you can, and then what your opportunity score is that data you can use to sell. Not only internally, but to us as well. Yeah, to a skeptical sales team or whatever who’s not maybe, you know, hype on partners in the, in the US West. [00:24:03] Matt Y: You can be like, listen, I don’t care what you think about my business. This is what I’m gonna drive for you with your quarter retirement from an AWS perspective, and this is how the shape of your customer accounts are gonna change. And this is why you should pay attention to my opportunities. ’cause my opportunity score is, is crazy high and I’m giving you insights into business that AWS would not otherwise have. [00:24:19] Vince Menzione: That’s your brand story we’re talking about. [00:24:21] Matt Y: Yeah. [00:24:22] Vince Menzione: Building your story up with within [00:24:25] Matt Y: So it’s, it’s about the data, I guess. And, and you should, you know, you should all actually be [00:24:28] Vince Menzione: Yeah. [00:24:29] Matt Y: Asking me for more data, so, you know, and tell me like, what do you need to sell to your internal stakeholders? ’cause if I can draw a clear line. [00:24:35] Matt Y: From your demand chain campaign that lands on a marketplace, which I know is a conversion machine, it has way better than industry levels of, of conversion rates. And then you can show, hey, if we have a PLG strategy and we land those leads on marketplace, we will convert them with high efficiency, low cost of sales and, and, and have sort of a bifurcated where we can close some through self service, some through express private offers and some through private offers, depending on deal size. [00:24:57] Matt Y: Like you tell A CFO that, and they’re my number one customer now and they love it ’cause they see cost of sales going down, cost of operations going down and business going up. Um, so I think we have more data than we used to use that data. And let me know what other data do you need to make that pitch and make that pitch to the CFO go around the head of sales, all those other people. [00:25:15] Matt Y: Honestly, the CFO is where we get the best leverage. [00:25:18] Vince Menzione: Awesome. Great question. [00:25:23] Matt Y: Gonna bring your mic. [00:25:23] Vince Menzione: We’re, we’re gonna get your mic here. There you go. Oh, [00:25:25] Audience Guest: thank you. So my name’s Jody Cheval and I’m a consultant now, but I was at Workday during when they adopted AWS and it, a sales organization needs propensity to buy data. [00:25:34] Audience Guest: To really drive the sales team to realize the opportunity kind of makes them visualize it. We didn’t struggle, but it was challenging to get that data because at that time we’re getting spreadsheets. So does AWS have a vision of making that API based data that our client, my clients, can get at and bring into a tool to start building account hypothesis based on that data? [00:25:57] Audience Guest: ’cause it really is important to an enterprise sales guy to have the sense that OAWS can help me close this deal. [00:26:03] Matt Y: Yeah. I mean. Part of that. So we, we launched, we’ve been launching part of that in stages and we’re not done. There’s, there’s more coming. Um, part of that is embedded really within the new, uh, partner agent workflows. [00:26:13] Matt Y: We are giving sort of more, uh, information back to you, not just about like what funding programs you’re eligible for, but like, you know, and when, when we will co-sell this deal with you, which is effectively a signal like we, we see this as a high value opportunity, that you have a likelihood of winning internally. [00:26:28] Matt Y: We, we have this solution matching engine that we’re using and we announced. That, that that ties you the partner to a customer specific opportunity that you have a high propensity or the partner has a high propensity to assist with and ultimately win. And now we’ve tied that to our express private offers, which we announced this week. [00:26:44] Matt Y: So it’s an indirect answer to what you’re asking, but a rep can essentially say. Send a private priced offer to the customer on behalf of the partner without having to ring up the partner because they have a high propensity to win this deal with the customer. So we’re progressively launching features like that. [00:26:59] Matt Y: In addition to the propensity to buy data that we do now share. It used to be kind of, again, manual magic depending on who you knew we could share. Now we do share that programmatically, and there’s more to come specifically in that space. Uh, I’d say watch that space. In the next few months, there’s gonna be more data coming away, but we do have the APIs, we have the agent. [00:27:16] Matt Y: We have things like express private office solution matching, and we have been sort of in that space progressively launching features over the last six to 12 months. And, and you should expect to see some more there soon, not just from us or from our partners. [00:27:27] Vince Menzione: Nice. Any announcement dates? [00:27:30] Matt Y: I can’t commit to a date or else my engineers will get mad at me. [00:27:33] Vince Menzione: It looks like we Another question number. Is the mic still back there? Okay. There’s a gentleman over here [00:27:40] Audience Guest: first Go leaves. Um, it’s awesome. I’m right next to. I was right next. [00:27:46] Vince Menzione: We’ve got a lot of great plants here, so, [00:27:49] Audience Guest: um, so this may be a little bit myopic or, or a challenge that we run into, but I love a lot of the innovation that’s looking forward and all the future things that we’re doing. [00:28:00] Audience Guest: One of the things that we’re struggling with is a little bit of almost like tech or structural debt. How do you think about bringing flexibility to the core pieces that underpin all of the innovation, which is. We are self-hosted. So one of our listings is an a MI. You can’t amend an a MI, you have to cancel and start over. [00:28:18] Audience Guest: So a lot of the building blocks, when you think about PLG, if somebody wants to add to that in an a MI listing, it’s, it’s sort of broken. So how are you thinking about taking all of the, the rapidly changing buyer behavior and then looking back at the structural foundation that underpins all of those things, like offers and, and amendments and changes and all of that? [00:28:39] Matt Y: Yeah. I, I promise I didn’t seed that question, but that, that’s a great one. Um, so not to get too in the weeds, but fundamentally, marketplace was built up, um, a bit like AWS like a set, a series of services somewhat independently. And each product type was effectively its own service, SaaS, server images, ais. [00:28:59] Matt Y: Um, what we’ve done recently is now we, we have, we got rid of product types basically on the backend. You, you don’t see it, but what that means, for example, like another thing AAMIs don’t support today, future data agreements. Um, or concurrent agreements, uh, they will all be supported by amis before the end of the year. [00:29:14] Matt Y: ’cause what we’re doing, this fundamental thing that you won’t even see called product offer decoupling. Uh, and it’s a fundamental piece of things that we need to unwind. ’cause we built up, we were moving very quickly over the years. We had a distributed engineering model and we built each product type independently. [00:29:28] Matt Y: And so yeah, if you’re a seller and you’re selling containers, agents, SaaS, amies, um, we’re breaking down the silos between those so that each of them will get the same benefits. And, and by the way, we’re taking the same approach to international. Hopefully you’ve noticed now that. It’s not like a feature launches in the US only and then takes five years to launch in either public sector or another country. [00:29:48] Matt Y: We, we’ve taken a global approach to feature launch and increasingly a product type neutral approach to feature launches. Uh, that’ll be largely resolved before the year’s out. We’re working on it right now. So again, it’s, it should be transparent to you, like you shouldn’t actually see any difference in the, in the experience. [00:30:05] Matt Y: Except that all of those features will be available. So, so that is, uh, actively under work. And that’s actually something if you’d like to try, um, you’re, you’re welcome to. So, yeah, [00:30:17] Vince Menzione: we have time for maybe one more question and we we’re actually gonna have you up here with a couple partners. [00:30:24] Matt Y: Sounds [00:30:24] Vince Menzione: good. Kind of fun. [00:30:32] Audience Guest: Hey, Matt, uh, met Natasha from Dondo. Uh, quick. So great announcements. And you know, you talked about the million, multi-billion dollar, uh, club, and, uh, that’s all great. Uh, in terms of the. Propensity data. I think that’s coming at the center of a lot of things, right? You know, for enterprises, oh, there’s an investment and you tap into that investment. [00:30:53] Audience Guest: But also there’s the other side of the procurement where a lot of customers, sometimes we work with, they’re like, they still wanna go direct for whatever reason, right? So I think there’s an education piece there, but also trying to understand like how we can work together to, you know, get some of that side of the things sorted out as well. [00:31:11] Audience Guest: You know? ’cause a lot of times it’s not about. Just, you know, retiring the, uh, the, the spend comets, but also like, Hey, I’m used, I’m already used that for something else. So maybe that’s not an, uh, something that applies here. And in also in tying that the PLG motion, uh, you know, for the customers you said, you talked about, you know, if there is. [00:31:34] Audience Guest: Leads on the TA table, like where the, it’s not the enterprise, but you know, the others. Um, I feel like it’s more to do, changing the business model at some times. Like with the enterprises, you have the revenue stream coming through, say large deals, right? And all of a sudden you tap into this, you know, PayGo. [00:31:51] Audience Guest: Where it flips the whole equation with, you know, the financing and the, and the, and the revenue measurement. So I think there’s two aspects of how do you kind of cons reconcile those things in terms of, you know, the revenue measurements going forward. [00:32:05] Matt Y: Yeah. So, so two things real quick on the procurement. [00:32:07] Matt Y: Um, yeah, like, yeah, I sort of alluded to this earlier, but, uh. Procurement is a bit late to the AI ag agentic transformation. They’re trying, and there’s a lot of great new incumbents in this space. And the big leaders like, you know, Coupa and Ariba and Oracle are, are, are evolving their products, albeit a bit slowly. [00:32:26] Matt Y: Um, but the, I think, uh, it’s still the long pole in the tent. You know this. And so like, there are two reasons why deals tend to go direct, because it kind of hits a wall of. Legal, uh, you know, procurement, governance, like all that kind of after the selection’s been made, et cetera, or, or they’re, you know, we can’t change. [00:32:44] Matt Y: People are gonna optimize for, for finance, you know, they’re, they’re going to, if they’re getting big discounts. I mean, that is life. I always say it’s like sellers at the most agented company are still gonna chase quota no matter how, you know, crazy. Uh, your, your company is, and it’s the same with, um, with the chief, uh, financial officer and chief procurement officer. [00:33:01] Matt Y: They are going to, they’re literally. Paid to find discounts. And so we’re not, we’re not gonna get rid of financial engineering. That’s a, that’s a thing. What we can do is reduce the friction for procurement. So we launched, for example, like mandatory purchase orders. That was a big thing. We, we have buyer notifications, now we’re making other procure to pay enhancements. [00:33:17] Matt Y: I mean, procurement systems still use like CXML. It’s like, that was, that was cool when I worked for the ap. And like I, I have teenagers that are old, like older than, so they, I, I think, um. Procurement needs to evolve and we’re gonna help it evolve. We’re gonna push it forward and, and we need to make it more seamless for procurement teams so that we remove those objections. [00:33:38] Matt Y: Uh, I can’t remove the financial engineering objection, like, you know, that’s just life. Um, but I can make it irresponsible not to use marketplace ’cause it’s so easy to use. And, uh, that, that’s kind of the approach we’re taking on, on the front end. Uh, you, you know, I think you, you, again, I didn’t see this question. [00:33:52] Matt Y: You, you stepped into a trap. Un unwittingly, um, PLG is not just is for enterprise. And, and PLG doesn’t necessarily mean pego or self-service. Uh, doesn’t necessarily like, uh, most of our self-service efforts are actually focused on private offers. And not necessarily for pego. Uh, when, when I say self-service and, and PLG, uh, it, it can mean all kinds of things like it. [00:34:14] Matt Y: We have requested private offer, requested demo call to actions, buttons that you can put on your listing. For example, you don’t necessarily need a free trial or a metered pay as you go listing to take advantage of those inbound self-service leads. So, and those inbound self-service leads are often massive enterprise deals, like I mentioned specifically, uh, the data mask. [00:34:31] Matt Y: Those giant enterprise deals that they launched came from an enterprise like Fortune 1000 Enterprise in the US that organically discovered their solution on the marketplace using our AI search. And that was a massive enterprise. And so I, I think yes, there is the long tail, you wanna capture a new logo acquisition, but you should think of your product like growth in your self-service strategy as a way to, um, acquire all kinds of leads, including large enterprise. [00:34:54] Matt Y: And so when I say leave money on the table, I’m not just talking about things that are gonna mature over two years or tiny little deals. These could be massive deals. Uh, and, and you’ll accelerate those deals by accelerating their discovery and, and research so that I think that, so, and my advice is don’t, you don’t have to go all in if you don’t have, if you don’t have metering, if you don’t have PayGo, that’s cool. [00:35:13] Matt Y: Start with something simple. Start with a public listing, with a request to private offer like that. That is a, a huge step. That doesn’t take much, and, and it kind of blows my mind still that a lot of companies aren’t doing that yet. [00:35:25] Vince Menzione: Great answer. Well, it’s now time we’re gonna bring, we’re gonna bring, it’s time. [00:35:29] Vince Menzione: We, we’ve got some great partners coming up here, Nvidia Elastic, Accenture gonna all join us for a conversation. Great. And I’m glad that you’re gonna stay with us. And let’s, let’s, well, let’s thank Matt, by the way, for that session. [00:35:41] Matt Y: Thanks. [00:35:42] Vince Menzione: And [00:35:42] Matt Y: thanks for listening to the Ultimate [00:35:44] Vince Menzione: Partner Podcast. If today’s conversation resonated, share it with a partner leader in your network. [00:35:51] Vince Menzione: Subscribe where you listen. And head over to the ultimate partner.com. For show notes related content and the resources for this episode. And if you haven’t already, now’s the time to register for the Ultimate Partner Live Event in Reston, Virginia, October 26th through October 28th. Until next time, keep showing up in the rooms that matter because being in the room changes everything.

Sterile Processing (SP) at times suffers from poor packaging. Our departments are tucked away. Our work is behind the scenes. We as SP professionals may not view our duties in the same light as other work in the hospital, so we diminish our role in conversations or are reluctant to speak up in a group of our peers. In episode 153, host Casey Czarnowski talks with Jamelle Ross about enhancing our professional image in the healthcare community. Ross emphasizes the value and necessity of the Sterile Processing department. She discusses how to show up with intelligence, confidence and integrity and offers tools to present our viewpoints effectively. Listen to learn how to advocate for SP's role as a necessary and integral component of the perioperative team. ABOUT OUR GUEST Jamelle R. Ross Regional Director of Clinical Operations for Instrument Processing Services STERIS Jamelle R. Ross, RN, BSN, MHA, CRCST, is responsible for implementation of on-site sterile processing improvement projects, including performing work as a clinical liaison, educator and quality systems evaluator. Ross has more than 30 years of progressive, hospital-based perioperative experience and is skilled in AORN, AAMI and Joint Commission regulations. She holds a Bachelor of Science in Nursing, a Master of Health Services Administration and certifications in Perioperative Nursing, Nursing Administration, Trauma Nursing, Legal Nurse Consulting, Forensic Nursing and Sterile Processing. Earn CE Now

Kevin and Adam take a closer look at Healthmark's new AAMI Level 4 Decontamination Gown—and they're not just talking about it, they're wearing it too! The AAMI Level 4 Decontamination Gown is a full coverage gown designed specifically for the demands of sterile processing workflows, where exposure to fluids and strike-through risks are a daily concern. Tune in as they share their firsthand impressions, discuss key design features, and explore the importance of PPE that supports the daily challenges sterile processing professionals face. From comfort and mobility to fluid protection, Kevin and Adam provide practical insights into what sets this gown apart.

Melbourne Storm chief executive Justin Rodski told 3AW Breakfast hosts Ross and Russel they wanted to encourage tough conversations around mental health.See omnystudio.com/listener for privacy information.

Türkiye'nin 2026 FIFA Dünya Kupası™'nda Avustralya'ya karşı aldığı 2-0'lık yenilgi sonrası Krampon İzleri'nden Ahmet Çağın'a konuşan uzmanlar Paraguay maçının kilit önemde olduğu yönünde birleşti.ÖNE ÇIKANLARBeşiktaş Futbol Okulları Koordinatörü Ufuk Pak Türkiye'nin maç öncesinde Avustralya milli takımı Socceroos'un nasıl bir oyun oynayacağını bildiğini ancak oyuncuların bir türlü defansı aşamadığını söyledi.Maçı yerinde izleyen Savaş Sağlam Avustralya teknik direktörü Greg Popoviç'in tecrübeli isimleri geride tutup gençleri öne sürmesinin büyük cesaret estetiğini söyledi. İlk golü atan 20 yaşındaki Nestory Irankunda ve 22 yaşındaki kaleci Patrick Beach'in yıldızlaştığını belirtti.ABD milli takımının evinde çok iyi oynadığını söyleyen Muzaffer Köksal, Paraguay'a karşı millilerin galip gelmesinin şart olduğunu söyledi.Avustralya-Türkiye maçını Melbourne'daki AAMI stadında izleyen Aygül ve Harun Çöteli çifti izlenimlerini paylaştı.SBS, 1986'dan bu yana, yani kırk yıldır Avustralya'da Dünya Kupası maçlarını yayınlıyor.2026 FIFA Dünya Kupası™'nın 104 maçının tamamını SBS On Demand'de canlı ve ücretsiz olarak izleyin; turnuva boyunca maçların tam tekrarları, mini maçlar ve özetler de sunulacaktır. https://www.sbs.com.au/ondemand/fifa-world-cup-2026Beautiful Game ChangersSBS Audio'nun Beautiful Game Changers video serisinde, futbol aracılığıyla sosyal uyumu teşvik eden Avustrlaya yerlisi kahramanları kutlayın. Beautiful Game Changers portalında ve On Demand'de 12 hikâyenin tamamını şimdi izleyebilirsiniz.Words We UseWords We Use platformunda yaklaşık 25 dilde iki dilli versiyonları bulunan bu altı bölümlük sesli diziyle, saha içinde ve dışında kullanılan futbol terimlerini öğrenebilirsiniz.Route 26Olağanüstü futbol severlerin kişisel yolculuklarını ve hayatlarını şekillendiren Dünya Kupası anlarını keşfeden bir podcast olan Route 26 ile 2026 FIFA Dünya Kupası™'na giden yola katılın. Şu anda SBS Audio platformunda mevcut.SBS Türkçeyi Salı hariç hafta içi her gün dinleyebilirsiniz. Bizi ayrıca Facebook'tan takip edebilirsiniz

In part one of this episode, host Dr. Srinath Yadlapalli and guest Dr. Matthew Arduino discuss methods to assess and maintain water quality at dialysis facilities during emergencies, including following the AAMI standards.

In part one of this episode, host Dr. Srinath Yadlapalli and guest Dr. Matthew Arduino discuss methods to assess and maintain water quality at dialysis facilities during emergencies, including following the AAMI standards.

In part one of this episode, host Dr. Srinath Yadlapalli and guest Dr. Matthew Arduino discuss methods to assess and maintain water quality at dialysis facilities during emergencies, including following the AAMI standards.

In part one of this episode, host Dr. Srinath Yadlapalli and guest Dr. Matthew Arduino discuss methods to assess and maintain water quality at dialysis facilities during emergencies, including following the AAMI standards.

LinktreeMOMENTUM NEW SHOWFollow the INSTAGRAM to stay up to date with all of the great Rugby League content!! https://www.instagram.com/biglezsleague_/?hl=en Hosted on Acast. See acast.com/privacy for more information.

An action packed podcast today, tucking into the latest in the NRL, Super Rugby, the Masters and UFC 237 - it's another huge weekend of sport on the cards!With plenty happening in the NRL world - we talk through Adam Pompey's crazy suspension, preview all of the Round 6 match ups and discuss the Warriors method to victory against the Storm as we look to pull off the upset at AAMI park.Then, we dive into this weekends Super Rugby fixtures with the main focus being the game of the year so far, the Hurricanes hosting the Blues in a top of the table clash at the Cake Tin.Then we talk The Masters, Ryan Fox's chances & Carlos Ulberg taking on Jiri Prochazka for the vacant UFC Light Heavyweight Championship in the main event of UFC 327 on Sunday.Thanks as always to the TAB & Michelob Ultra for their support. Up the Wahs!

Subhi Saadeh interviews Lucas Pianegonda, founder of Grad and a plastics expert in medical technology, on how medtech companies actually choose materials—and where it goes wrong. Many teams default to “we've always used this” or rely on a molder's preferred grade, but those shortcuts can drive cost, delay timelines, and create downstream regulatory risk.Lucas breaks down a more structured, data-driven approach to material selection that balances performance, processability, regulatory compliance, cost, and sustainability. They cover how early material decisions impact total cost of goods, why late changes lead to retooling and delays, and how to think holistically across the device lifecycle.The conversation also explores common processing methods like injection molding and extrusion, key polymer categories, and emerging regulatory risks tied to additives, PFAS, and legacy materials. Subhi and Lucas discuss how GRAS and California Prop 65 are often misunderstood in medtech, and why biocompatibility is a device-level risk assessment, not a material checkbox grounded in screening, chemical characterization, and toxicological evaluation.⏱️ Timestamps 00:00 Welcome and Guest Intro00:43 Why Materials Drive Cost02:17 Common Selection Pitfalls03:35 Data-Driven Framework06:10 Early Choices Prevent Rework09:17 Processing Methods Overview10:23 Polymer Categories Explained12:58 Regulatory Risks and PFAS19:26 GRAS and Prop 65 Basics23:21 Biocompatibility Early Screening28:55 ISO 10993 Updates30:36 What Toxicologists Do33:41 Where to Find Lucas34:07 ClosingLucas Pianegonda Website: https://www.gradical.ch/Lucas on LinkedIn: https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/Lucas on YouTube: https://www.youtube.com/channel/UChPQB4eXQz3c_U2zZXAmEuQISO 10993 Overview: https://www.iso.org/standard/68936.htmlCalifornia Prop 65: https://www.p65warnings.ca.gov/GRAS Overview (FDA): https://www.fda.gov/food/generally-recognized-safe-grasLucas Pianegonda is a medical technology plastics expert and founder of Gradical, where he helps medtech companies make smarter material selection decisions. He specializes in a holistic approach that connects performance, manufacturability, regulatory risk, cost, and sustainability to prevent costly redesigns and delays later in development.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

More planes carrying Australians from the Middle East have arrived in Australia with more than 10,000 people brought home from the region since the United States and Israel went to war with Iran. A federal government move to cut the fuel excise tax in half comes into effect tomorrow but the energy minister is warning consumers won't see prices drop until at least the weekend. Socceroos, will take on Curaçao in an international friendly tonight at AAMI Park in Melbourne. - イランとの紛争が始まって以降、これまでに1万人以上のオーストラリア人が中東から帰国したことがわかりました。連邦政府が打ち出した燃料税の半減措置が、明日から実施されます。ただ、値下げが店頭価格に表れるのは、少なくとも週末以降になる見通しです。サッカーオーストラリア男子代表、サッカルーズは今夜、メルボルンのAAMIパークで、キュラソーと国際親善試合を戦います。

In this episode of Let's Combinate, Subhi Saadeh speaks with Jen Riter about analytical method validation for drug device combination products. The discussion explores how traditional drug analytical validation under ICH Q2 differs from validating functional and mechanical performance methods used for combination products. These methods often require an engineering mindset that incorporates measurement system analysis (MSA), gage R&R studies, and the use of fabricated surrogate standards when devices cannot be reused for testing.They also discuss platform test methods and how standards such as ISO 11040 and other ISO references can serve as starting points for method development. The conversation touches on the evolving alignment between ISO based device methods and pharmacopeial expectations such as USP . The episode also covers make vs buy testing decisions, when to outsource specialized testing such as CCIT and extractables and leachables, and how sponsors manage oversight of contract testing laboratories.Timestamps00:00 Welcome and Guest Introduction00:53 ICH Q2 vs MSA Mindset Shift04:37 Surrogate Standards for Mechanical Testing11:12 Platform Methods and ISO 1104015:14 ISO vs USP Verification Debate20:06 Outsourcing Analytical Testing Strategy24:07 Choosing the Right Test Lab26:20 Sponsor Oversight of Contract Labs30:09 Wrap UpAbout Jen RiterJen Riter is an analytical testing and laboratory leader with nearly three decades of experience working in pharmaceutical packaging, drug delivery systems, and combination products. She has held leadership roles at West Pharmaceutical Services and Kindeva Drug Delivery, where her work has focused on analytical method development, validation, and testing strategies for drug delivery systems and injectable combination products. She is also a contributor to the Combination Products Handbook, where she authored a chapter on analytical testing and method validation for combination products.About Subhi SaadehSubhi Saadeh is the Founder and Principal of Let's Combinate BioWorks, where he helps companies close the gaps between drug and device development, quality systems, and regulatory expectations. He is a Certified Quality Auditor and ISO 13485 Lead Auditor with leadership experience at Baxter, Pfizer, and Gilead Sciences including responsibility for management and oversight of assemble label pack sites and working with device primary, secondary and tertiary packaging suppliers. Subhi previously chaired the Combination Product Working Group for Rx-360, served as International Committee Chair for the Combination Products Coalition, and served on AAMI's Combination Products Committee. He also hosts the Let's Combinate podcast and is a writer and speaker on quality at the intersection of drugs and devices.

Continuing the ICH Q series with ICH Q5. This episode explains why Q5 exists, how to read it, and what it means for combination products. Q5 addresses quality challenges unique to biologics made in living systems where products cannot be fully characterized by physical and chemical testing alone and show inherent variability. It harmonizes expectations for viral safety, cell substrate controls including master and working cell banks, stability, and comparability after manufacturing changes. For combination products, Q5 mainly applies to the biologic drug constituent through stability and change impact rather than device requirements.00:00 Intro to ICH Q500:25 Meet the Host00:32 Why Biologics Need Q500:56 Key Risks Explained02:11 What Q5 Covers02:40 Scope and Structure03:19 Q5 A to E Breakdown04:19 How to Read Q505:05 Q5 for Combination Products05:59 Wrap Up and Next EpisodeSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

The Phantom reluctantly returns to the Lair after the shock omission of his man Will Brodie to recap every match from the pre-season AAMI Series with Five Names and Chief. With more than just a grain of salt, the crew look at which players had the best scores and — more importantly — roles on the weekend. Who’s IN, who’s OUT and which players are high on our radar for Opening Round this week?! Subscribe to the CODE Sports YouTube channel and help get us to our 23k target for an in-person Lair catchup at Gather Round! Join The Lair League: 128532 Make your team now: supercoach.com.au or via the SuperCoach app. ALL AAMI SCORES AND POINTS PER MINUTE: https://www.codesports.com.au/afl/every-preseason-supercoach-score-boom-rookie-jagga-smith-stars-against-geelong/news-story/ffb3dc4c8a1395ce10ae3bce1a5b2601 READ THE ROOKIE BIBLE: http://bit.ly/3NeM2eP?utm_campaign=EditorialSB&utm_source=supercoach&utm_medium=podcast&utm_content=rookiebible&utm_term=supercoach%2Cafl The Phantom's team reveal: https://bit.ly/4b9WQ8e CHAPTERS:FREE WILL BRODIE (00:00)The Lair League (03:30)AAMI Series Recap (04:45)Carlton v Geelong (06:45)Sydney v GWS (13:20)Brisbane v Gold Coast (18:45)Melbourne v Richmond (23:20)Western Bulldogs v Hawthorn (31:00)St Kilda v Essendon (38:30)Fremantle v Adelaide Crows (48:15)North Melbourne v Collingwood (55:15)West Coast v Port Adelaide (01:01:15) Hosts:The Phantom: @ThePhantomSC /X | @ThePhantomSC /IGDos: @HKDos /X | @dossySC /IGSimeon Thomas-Wilson: @Simeon_TW /X Produced by Haydn Kenny. Recorded on Monday, March 2, 2026. SuperCoach Plus: supercoach.com.au/sc-plus Follow SuperCoach AFL on Instagram. Follow SuperCoach AFL on TikTok. Follow SuperCoach AFL on X. Like SuperCoach AFL on Facebook. Subscribe on CODE Sports YouTube Channel. See omnystudio.com/listener for privacy information.

Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements.Timestamps00:00 Welcome and Guest Intro00:53 The Hairiest CAPA Case03:02 Human Error Root Cause04:58 Common CAPA Misconceptions06:11 Why Root Cause Fails12:16 When to Open CAPA17:26 CAPA Inputs and Triggers19:28 One Process or Two22:28 How to Investigate Properly25:09 Tools for Root Cause26:20 Problem Statement Basics27:48 Wrap Up and Where to FindGeorg Digel is the founder of Elevate CAPA and works with medical device quality leaders to make nonconformance and CAPA systems faster, stronger, and more audit-ready. He brings hands-on experience from early work on the production line through roles across consulting, startups, and larger organizations, with a focus on root cause and investigation quality. He also shares practical NC and CAPA breakdowns and training content with the MedTech community. LinkedIn: https://www.linkedin.com/in/georgdigel/Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

The dress rehearsal before the real stuff starts is upon us with the AAMI Community Series. AFL Fantasy coaches will be watching carefully and taking in the live stats (available via AFL.com.au and the AFL Live app) as they make their selections ahead of round one. Calvin, Roy and Warnie discuss what they'll be looking for and running through a player or two from each game that they'll be keeping an eye on. Head to fantasy.afl.com.au or download the app to start picking your team today. Episode guide 0:30 - Tips for what to look for in AAMI 3:30 - Carlton v Geelong 5:45 - Sydney v GWS Giants 7:30 - Brisbane v Gold Coast 9:50 - Melbourne v Richmond 12:20 - Western Bulldogs v Hawthorn 15:50 - St Kilda v Essendon 18:10 - Fremantle v Adelaide 20:45 - North Melbourne v Collingwood 24:20 - West Coast v Port Adelaide - - - - Find more from Roy, Calvin and Warnie. Head to afl.com.au/fantasy for more content from The Traders. Like AFL Fantasy on Facebook. Follow @AFLFantasy on Instagram. Follow @AFLFantasy on X.See omnystudio.com/listener for privacy information.

In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance under the NMPA.The conversation explores why Western companies often underestimate China's regulatory expectations — particularly when assuming EU or U.S. approvals, ISO standards, or FDA clearances will translate directly. Elaine explains how China requires demonstration of safety and effectiveness against applicable local standards primarily GB (national standards) and YY (medical device industry standards) including both mandatory and recommended variants (e.g., GB vs GB/T, YY vs YY/T).The episode dives into China's local type testing model and the role of Product Technical Requirements (PTRs) in defining test methods, parameters, accessories, and applicable standards for registration.Elaine also outlines how China's quality system expectations align to China Medical Device GMP rather than ISO 13485 including major GMP updates taking effect in November 2026 and discusses implications for foreign manufacturers.Additional discussion topics include China agents and authorized representatives, clinical evaluation expectations, post-market reporting requirements, and how China's device classification system can influence regulatory strategy.⏱️ Timestamps00:00 Welcome + Meet Elaine (MedTech Chopsticks)00:38 Why China Is Different: Local Standards vs EU/US Assumptions03:35 GB & YY Standards Explained (National vs Industry Standards)05:07 Local Type Testing & PTRs: Building China Product Technical Requirements06:52 China GMP Updates: Key Differences vs ISO 1348512:42 China Agent vs EU Authorized Rep: Roles & Responsibilities15:19 Choosing Local Test Labs: NMPA-Designated Testing Considerations18:42 Planning Early: Standards Gaps, Clinical Evaluation & PMS Risks24:43 China Certification & Device Classification Changes (Class I/II/III)28:38 Where to Find Elaine + ClosingSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

From the OR to SPD, those contaminated instruments are on the move, and so are pathogens! In this Season 2 premiere of "On Pathogens & PPE," host Jill Holdsworth and co-host Nicholas Day are joined by Rebecca Lauber, Kendall Ashe, Adam Okada, and Crystal Heishman to break down what really happens when soiled instruments leave the OR and make their journey to decontam. From point-of-use pre-treatment and biofilm build-up to OSHA requirements and AAMI standards, this crew digs into what it really means to move biohazards safely through your facility. Because soil transport isn't just about getting instruments from A to B -- it's about protecting everyone they pass along the way! Over the next 12 weeks, Jill and special guests from across the industry will team up to share actionable strategies for fighting pathogens while building stronger partnerships between Sterile Processing and Infection Prevention teams. Whether you're in SPD, IP, or both—this series is designed to empower you and your team with the knowledge and tools that make a real difference! New episodes of On Pathogens & PPE will release each Tuesday on all Beyond Clean & Transmission Control channels. A special thanks to our Year 2 sponsor, Healthmark, A Getinge Company, for making this series possible. #BeyondClean #TransmissionControl #Healthmark #Getinge #OnPathogensAndPPE #SterileProcessing #InfectionPrevention #Podcast *Disclaimer: The views provided by hosts and guests on this series do not represent any employer, company, or third party, and are solely that of the individuals themselves.

In this episode of the ICH Q series, Subhi Saadeh covers ICH Q4, which focuses on pharmacopeial harmonization. He explains why ICH Q4 exists, the problem it was created to solve, and how the ICH Q4 framework, Q4A, Q4B, and the Q4B annexes work together to determine when pharmacopeial test methods are considered interchangeable across ICH regions. The episode also explains the role of the Pharmacopoeial Discussion Group (PDG) in technical harmonization and walks through practical examples, including ICH Q4B Annex 3.ICH Guidelines (Quality): https://www.ich.org/page/quality-guidelinesICH Q4B Annex 3(R1) – Tests for Particulate Contamination (Subvisible Particles): https://database.ich.org/sites/default/files/Q4B%20Annex%203%28R1%29%20Guideline.pdfTimestamps00:00 Introduction to the ICHQ Series00:03 What Pharmacopeial Harmonization Means00:42 Why ICH Q4 Exists01:55 ICH Q4 Framework and Structure02:54 Understanding Q4A, Q4B, and the Annexes03:59 Practical Examples (Particulates, Disintegration)08:05 Conclusion and Next StepsSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are identified, evaluated, and controlled in drug substances and drug products.Subhi explains what impurities are, why zero impurities is unrealistic in scalable manufacturing, and how ICH Q3 establishes a risk-based framework to protect patient safety and product quality. The episode walks through the structure of Q3A through Q3E, covering impurities formed during drug substance synthesis, degradation in drug products, residual solvents, elemental (metal) impurities, and extractables and leachables highlighting where drug delivery systems and combination products explicitly come into scope under Q3E.This episode is a high-level, practical overview focused on how to read ICH Q3, how the sections fit together, and where the guideline applies and stops across the drug product lifecycle.⸻Timestamps00:00 Welcome to Let's ComBinate00:12 Introduction to ICH Q300:25 What Are Impurities and Why They Matter00:51 Sources of Impurities and Risk-Based Control02:11 Structure of ICH Q3 (Q3A–Q3E)05:30 How to Read and Use ICH Q307:22 Q3E, Extractables & Leachables, and Drug Delivery Systems09:21 Wrap-Up and Next Episode PreviewSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Biofilm is “comprised of living cells and a structure to protect them . . . that has potentially infectious material within it.” The structure creates a physical barrier between the microorganisms and their environment, providing protection from cleaning chemistries, disinfectants, antibiotics and the body's immune system. In episode 143, host Jon Wood speaks with Dr. Jon Burdach of Nanosonics. They discuss all things biofilm: what it is, how it develops and why it is so persistent. Dr. Burdach explains the difference between preventing biofilm and removing it, and he makes a compelling case for why removal is more important. He references recent studies, including those revealing that commonly used chemicals can act as fixatives and exacerbate biofilm growth. Dr. Burdach also reviews what can happen when biofilm is introduced into the body and its role in hospital-acquired infection (HAI) outbreaks over time. Lastly, the conversation turns to the particular challenge of cleaning flexible endoscope channels. Dr. Burdach introduces the cyclic-buildup biofilm (CBB) research model and shares developments in emerging lumen cleaning technologies. This episode of Process This! addresses the far-reaching implications of biofilm and what SP professionals can do to help. “If we are better armed with the right knowledge, we can do better by our patients,” said Dr. Burdach. “Processing instruments is hard . . . but the people that do it are really what makes all the difference.” ABOUT OUR GUEST Jon Burdach, PhD Vice President of Medical Affairs Nanosonics, Inc. Jon Burdach is a medical affairs executive with extensive experience in clinical research. At Nanosonics, he is responsible for developing and executing the company's medical strategy, including healthcare professional engagement, scientific communications and medical education initiatives. He also oversees clinical research and R&D activities. He has worked in medical microbiology, genetics of anti-microbial resistance, molecular biology, and medical research within infection prevention. Dr. Burdach is an international speaker, author of numerous scientific publications, and committee member for AusMedTech NSW and AAMI. He holds a PhD in Biochemistry and Molecular Genetics from the University of New South Wales. Earn CE Now

In this episode of Let's Combinate, host Subhi Saadeh breaks down the ICH Q2 guideline with a practical focus on analytical procedure validation. The discussion covers key definitions, core validation characteristics, and how ICH Q2 applies to drug delivery systems and drug-device combination products.Subhi explains how the revised ICH Q2 guideline aligns with ICH Q14 and what that alignment means for harmonizing analytical validation expectations across regions and regulatory authorities. The episode walks through key validation characteristics including accuracy, precision, specificity, linearity, and range, and clarifies the relationship between ICH Q2 and ICH Q14. Practical guidance is also provided on how to read and apply ICH Q2 efficiently, particularly for teams working with combination products.Timestamps00:00 Introduction to Let's ComBinate00:42 Purpose and importance of ICH Q203:11 Scope and product coverage06:10 Key validation characteristics08:15 Practical application and reading ICH Q210:23 Conclusion and next stepsSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate: Drugs and Devices, host Subhi Saadeh breaks down the 2025 draft update to the ICH Q1 guideline and explains what has actually changed and what has stayed the same.ICH Q1 is the core stability guideline, and with the consolidation of multiple legacy guidelines into a single document, many readers have found the draft overwhelming. In this episode, Subhi steps back from line-by-line commentary and instead focuses on how to think about ICH Q1, how to read it efficiently, and how stability decisions are expected to be made.The discussion covers why stability was one of the first topics harmonized by ICH, the fundamental stability concepts that still anchor the guideline, and how the revised structure emphasizes lifecycle management and data evaluation rather than introducing new science. Subhi also explains how ICH Q1 applies to drug-device combination products, including the role of the device as part of the container-closure system and why in-use stability often matters more than long-term storage.This episode is part of an ongoing series walking through the ICH Q guidelines and is intended to help listeners navigate regulatory expectations with clarity and confidence.Timestamps00:00 Introduction00:36 What ICH Q1 Is and Why It Exists02:59 Core Stability Concepts in ICH Q104:51 What's Changing in the 2025 Draft05:35 How to Read ICH Q107:16 ICH Q1 and Drug-Device Combination Products09:09 Closing and What's NextSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh continues the Combinating with ICH series by breaking down how the International Council for Harmonisation (ICH) guidelines are organized and why that structure matters for drug and drug-device combination products.Subhi walks through the four main ICH guideline families, Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M), and explains how each fits into the broader product lifecycle. The episode places particular emphasis on the Quality guidelines, which form the backbone of pharmaceutical development, manufacturing control strategies, and lifecycle management.Rather than a deep dive into requirements, this episode is designed to orient listeners to the full ICH landscape. It helps teams understand where different guidelines apply, who typically owns them, and how they collectively shape regulatory expectations. Future episodes in the series will explore individual Quality guidelines in detail.In this episode, you will learnWhat an ICH guideline is and how it differs from regulations and standardsWhy guidelines still matter during inspections and enforcementHow ICH organizes its guidance into Q, S, E, and M categoriesA high-level overview of the Quality Guidelines (Q1 through Q14), including:Stability (Q1)Analytical validation and development (Q2 and Q14)Impurities (Q3)Quality by Design and risk management (Q8 and Q9)Pharmaceutical Quality Systems and lifecycle management (Q10 through Q12)Continuous manufacturing (Q13)How different functional teams interact with different parts of the ICH frameworkThe next episode begins the deep dive into the Quality Guidelines, starting with ICH Q1 on Stability.Timestamps00:00 Introduction to the Series00:48 Overview of ICH Guidelines01:36 What an ICH Guideline Is and Is Not03:04 The Four ICH Guideline Categories04:08 Quality Guidelines Overview08:46 Safety Guidelines Overview09:28 Efficacy Guidelines Overview10:33 Multidisciplinary Guidelines Overview11:28 Wrap-Up and Next StepsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate: Drugs + Devices, Subhi Saadeh kicks off a new series focused on the International Council for Harmonisation (ICH) and its impact on drug and drug–device combination products.Subhi introduces what ICH is, why it was created, and how its guidelines shape global expectations for pharmaceutical quality, safety, efficacy, and lifecycle management. He walks through the historical challenges that existed before harmonization, explains how ICH guidelines are developed through the five-step process, and outlines why these standards matter—especially for teams working at the intersection of drugs and devices.The episode also sets the roadmap for the series, including upcoming deep dives into the ICH Quality guidelines (Q1–Q14) and how they apply in practice to combination products.00:00 Welcome to Let's Combinate00:37 Why ICH Matters for Drug–Device Products02:22 What Is ICH?05:21 Evolution of ICH Guidelines10:18 The Five-Step ICH Guideline Process11:38 How This Series Will Work14:09 Wrap-Up and What's NextSubhi Saadeh is a Quality Professional, Founder of Let's Combinate BioWorks and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Disruption/Interruption, host KJ sits down with Jayesh Kumar, Co-Founder at Aonami. Discover how legacy systems are being disrupted, the challenges of digital transformation, and why true innovation means building solutions that give time back to people. Four Key Takeaways: The Problem with Legacy Systems [6:10]Banks and healthcare institutions are bogged down by dozens of outdated, patchwork systems, making innovation slow and compliance difficult. Meeting Clients Where They Are [14:54]True disruption comes from understanding a client’s current state and building solutions that fit their unique needs, rather than forcing a one-size-fits-all approach. The Human Side of B2B Sales [20:03]Selling transformative technology to large organizations is about building relationships and convincing multiple teams, not just one decision-maker. The Real Goal of Technology [28:47]The ultimate aim of innovation should be to give people time back, making work more productive, creative, and compassionate. Quote of the Show (34:23):"True disruption really happens not by doing a lot of work, but by doing less in a much smarter way. You should be building systems that start giving time back to people." – Jayesh Kumar Join our Anti-PR newsletter where we’re keeping a watchful and clever eye on PR trends, PR fails, and interesting news in tech so you don't have to. You're welcome. Want PR that actually matters? Get 30 minutes of expert advice in a fast-paced, zero-nonsense session from Karla Jo Helms, a veteran Crisis PR and Anti-PR Strategist who knows how to tell your story in the best possible light and get the exposure you need to disrupt your industry. Click here to book your call: https://info.jotopr.com/free-anti-pr-eval Ways to connect with Jayesh Kumar: LinkedIn: http://www.linkedin.com/in/jayeshrout Company Website: https://aonamitech.com How to get more Disruption/Interruption: Amazon Music - https://music.amazon.com/podcasts/eccda84d-4d5b-4c52-ba54-7fd8af3cbe87/disruption-interruption Apple Podcast - https://podcasts.apple.com/us/podcast/disruption-interruption/id1581985755 Spotify - https://open.spotify.com/show/6yGSwcSp8J354awJkCmJlDSee omnystudio.com/listener for privacy information.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh is joined by Ben Locwin to break down what's changing in FDA pre-approval and pre-license inspections—and why the “inspection side” of approval is becoming a bigger conversation.They cover how PAIs and PLIs fit into the approval pathway, why Complete Response Letters (CRLs) can be driven by inspection outcomes, and what it would mean to “decouple” approval decisions from inspection timing. The conversation also explores the pros and cons of unannounced inspections, the realities of FDA capacity and scheduling, and how FDA's PreCheck program is shaping the onshoring/manufacturing-readiness narrative in the U.S. Finally, they zoom out to compare international inspection approaches and what global trends could signal for industry.What you'll learn-The difference between Pre-Approval Inspections (PAIs) and Pre-License Inspections (PLIs)-How inspection outcomes can lead to CRLs—even when the application looks strong on paper-Why industry is talking about decoupling approval from PAI timing-The idea behind FDA PreCheck and what “facility readiness” looks like-Unannounced inspections: where they help, where they create risk-How inspection expectations compare across global regulatorsChapters00:00 Introduction and Guest Welcome00:10 Understanding Pre-Approval and Pre-License Inspections01:54 Challenges and Industry Perspectives03:08 FDA Complete Response Letters (CRLs)05:23 Unannounced Inspections: Pros and Cons08:55 Economic and Regulatory Considerations12:37 Onshoring and the PreCheck Program22:51 Global Regulatory Landscape25:11 Conclusion and FarewellBen Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this short episode of Let's Combinate: Drugs + Devices, Subhi Saadeh breaks down ICH Q13 and what “continuous manufacturing” actually means. He compares batch vs. continuous, explains how a batch still exists in continuous manufacturing, and covers the essentials quality teams care about: RTD/traceability, control strategy, and disturbances/diversion plus a quick high-level note on validation, release, and lifecycle.Timestamps00:00 Intro01:00 Batch vs. continuous (and batch definition)03:00 Modes of continuous manufacturing (ICH Q13 examples)04:30 RTD & traceability06:00 Control strategy07:30 Disturbances & diversion09:00 Validation / release / lifecycle (high level)10:00 Wrap-upSubhi Saadeh is the Founder and Principal of Let's Combinate BioWorks and host of the Let's Combinate: Drugs + Devices podcast/Youtube Channel. With experience across Quality, Manufacturing Commercialization, Sustaining and R&D, Subhi has helped industrialize and launch drug delivery systems for biologics, vaccines, and generics at leading organizations such as Pfizer, Gilead, and Baxter. Subhi focuses on bridging the disconnect between drug and device development and specializes in harmonizing internal systems, aligning internal and external partners, and helping combination product teams move from siloed execution to scalable, compliant, and patient-ready solutions. He currently chairs the Rx-360 Combination Product Working Group and was the International WG Chair at the Combination Product Coalition. He has contributed to global harmonization efforts through BIO, ASTM, and AAMI. He is a certified ISO13485 Lead Auditor, CQA and CQE.For questions, inquiries, or suggestions, please reach out at letscombinate.com or on the show's LinkedIn Page.

Sterilization wrap is “not just a big blue plastic sheet.” According to Dr. Sade Brown, “It may look simple, but it is actually high-tech. Behind the scenes, there is a huge amount of science and engineering and testing that goes into it.” All of this work makes blue wrap an essential part of the sterilization system. In episode 140, host Jon Wood speaks with four members of the Kilmer Innovations in Packaging (KiiP) group: Amanda Benedict, Dr. Brown, Tanya Magaña and Tiffany Reece. Representing standards, manufacturing and healthcare end users, the panelists engage in a lively conversation about the engineering, development and proper use of sterilization wrap. They discuss ANSI/AAMI ST79, provide diverse perspectives on event-related sterility, and review educational opportunities for end users. Listen to learn more and gain strategies for how to collaborate with those outside the Sterile Processing department to protect sterility. ABOUT OUR GUESTS Kilmer Innovations in Packaging (KiiP) Inspired by a Kilmer Conference in 2019, the KiiP group works at “solving wicked problems in healthcare packaging.” Bringing together industry leaders, subject matter experts and end users, KiiP fosters collaboration with the goal of improving patient outcomes through innovations and education in healthcare packaging. Process This! episode 140 welcomes KiiP members Amanda Benedict, MA, SES-CSP, FSES, Vice President for Sterilization, AAMI; Sade Brown, PhD, R&D Engineer for Sterilization Products, O&M Halyard; Tanya Magaña, Supplier Excellence Engineering – Packaging, Solventum; and Tiffany Reece, CRCST, CIS, CHL, Clinical Assessment Specialist, Advantage Support Services, Inc. Earn CE Now

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh addresses five significant quality issues in the combination product space. This episode provides practical insights and strategies for overcoming these common hurdles to enhance quality and efficiency in developing combination products.00:00 Introduction and Host Background00:43 Overview of Development Processes01:51 Issue 1: Documentation Approach in Design Transfer04:45 Issue 2: Early Input from Manufacturing and Assembly SMEs07:26 Issue 3: Control Strategies and Sampling Plans10:23 Issue 4: Method Transfer and Control Planning12:02 Issue 5: Qualification of Supplied Components14:47 Issue 6: Monitoring Expectations in Combination Products16:55 Conclusion and SummarySubhi Saadeh is the Founder and Principal of Let's Combinate BioWorks and host of the Let's Combinate: Drugs + Devices podcast/Youtube Channel. With experience across Quality, Manufacturing Commercialization, Sustaining and R&D, Subhi has helped industrialize and launch drug delivery systems for biologics, vaccines, and generics at leading organizations such as Pfizer, Gilead, and Baxter. Subhi focuses on bridging the disconnect between drug and device development and specializes in harmonizing internal systems, aligning internal and external partners, and helping combination product teams move from siloed execution to scalable, compliant, and patient-ready solutions. He currently chairs the Rx-360 Combination Product Working Group and was the International WG Chair at the Combination Product Coalition. He has contributed to global harmonization efforts through BIO, ASTM, and AAMI. He is a certified ISO13485 Lead Auditor, CQA and CQE.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways.They discuss:- The hidden costs of regulatory failure and how to avoid them- Why early engagement with regulatory agencies is critical- Global regulatory models, including emerging markets like China and the UAE- A clear explanation of UDI and serialization- How regulatory impacts extend beyond compliance teams- The role of LinkedIn and storytelling in regulatory careers- Steven's experience running for the European Parliament and what it taught him about policyTimestamps00:00 – Introduction and Guest Welcome00:38 – The Hidden Costs of Regulatory Failure03:47 – Engaging with Regulators Early05:26 – Global Regulatory Models and Emerging Markets10:07 – Understanding UDI and Serialization15:16 – The Power of LinkedIn and Personal Stories17:11 – Running for European Parliament and Policy Insights21:18 – Conclusion and Contact InformationConnect with Steven O'RourkeWebsite: https://clarifi.fiLinkedIn: https://linkedin.com/in/sorourkdeSubscribe to Let's Combinate for more conversations exploring combination product development, quality systems, and regulatory strategy.Stephen O'Rourke is a regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. Based in Helsinki, Finland, his work spans UDI, 510(k), EU MDR, combination products, and novel ingredient safety.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, Subhi Saadeh breaks down why more engineers in pharma, medical devices, and combination products should seriously consider becoming auditors. Sparked by a question at a PDA conference: “Why don't more technical people lead audits?” This episode explores the gap between technical expertise and true audit competency.Subhi explains how engineers who combine their technical background with audit training often become the most effective auditors. They gain a system-level perspective, understand how design decisions ripple through the QMS, and can identify systemic root causes that others overlook. He also clears up common misconceptions about auditing, including the idea that it's just paperwork or checklist work, and reframes it as one of the fastest ways to build regulatory fluency, strengthen quality systems understanding, and expand career versatility across industries.The episode closes with practical steps for how engineers can get started: shadowing internal audits, learning audit frameworks and methodologies, taking formal training, and seeking mentorship from experienced auditors.Timestamps:00:00 – Why Engineers Should Consider Auditing01:10 – How Auditing Expands Technical Perspective05:26 – Misconceptions & Why Engineers Avoid Auditing11:25 – How to Start Your Audit Journey13:27 – Final Thoughts: Seeing the System, Not Just the SpecSubhi Saadeh is the Founder and Principal of Let's Combinate BioWorks and the host of Let's Combinate: Drugs + Devices. With a background spanning Quality, Manufacturing Operations, and R&D, he has supported the development and launch of hardware devices, disposable systems, and drug–device combination products across vaccines, generics, and biologics at some of the industry's largest medical device and pharma organizations.Subhi currently serves as the Working Group Chair for the Rx-360 Combination Products Working Group and previously served as the International Working Group Chair for the Combination Products Coalition (CPC). He has also contributed to ASTM Committee E55 and AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Really Interesting WomenThe podcast Ep. 161 Mandy McElhinneyMandy McElhinney is one of Australia's most respected screen and stage actors, celebrated for performances that move confidently between sharp comedy and emotionally charged drama. She has amassed an extensive list of credits across television, film, and theatre since her career began in 1994. As an actor, she became a household name not through those mediums but  as “Rhonda” in the hugely popular AAMI insurance commercials, a role that turned her into a pop‑culture icon. She went on to deliver acclaimed performances as Matron Frances Bolton in “Love Child”, mining magnate Gina Rinehart in “House of Hancock”, and Nene King in “Paper Giants: Magazine Wars”.​Alongside recent work in series such as “Wakefield” and “Home and Away”, McElhinney now stars as Eileen in “Ghosts Australia”, confirming her status as a distinctive and enduring presence in Australian storytelling.We had a great chat about her work and her journey in life. If you'd like to see her most recent work Ghosts Australia is on channel 10 and Paramount+Head to the link in my bio to have a listen to our conversation.Visit instagram @reallyinterestingwomen for further interviews and posts of interesting women in history. Follow the link to leave a review....and tell your friendshttps://podcasts.apple.com/au/podcast/really-interesting-women/id1526764849

In this episode of Let's Combinate: Drugs + Devices host Subhi Saadeh welcomes back Andy Robertson, founder of CQE Academy. Andy shares his transformative journey involving CQE certification and how it boosted his confidence and expertise in quality engineering. They explore the practical applications of Design of Experiments (DOE), including a real-life example where Andy applied DOE concepts at work. Andy also discusses the value of various ASQ certifications, including CQE, CQA, CQM/OE and Six Sigma Green Belt, emphasizing their importance for career growth. The conversation extends to non-ASQ certifications such as PMP, highlighting their relevance for leadership roles. By comparing practices from various industries, including automotive and medical devices, they underscore the importance of cross-industry learning. Andy concludes by inviting listeners to join his courses to further their own professional development.00:00 Welcome and Introduction00:48 The Impact of CQE Certification02:23 Applying DOE in Quality Engineering05:42 Top ASQ Certifications13:35 Non-ASQ Certifications and Leadership15:55 Cross-Industry Learnings18:45 Conclusion and Contact InformationAndy Robertson is the founder of CQE Academy and a leading educator in the quality profession. With a background in medical devices and years of hands-on experience as a quality engineer, he built a global audience through his practical, passionate approach to teaching CQE, Green Belt, and quality systems fundamentals. Andy's work centers on helping professionals gain confidence, accelerate their careers, and master the core tools of quality through clear, accessible education.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

For more than 50 years, the Association for the Advancement of Medical Instrumentation (AAMI) has helped healthcare professionals define best practices for employees, equipment and patients. AAMI standards are written through careful debate and consensus. They inform the way we work and are our guideposts for protecting patient safety. Staying up to date on AAMI documents is critical for all Sterile Processing professionals. In episode 138, host Casey Czarnowski speaks with Horlando Cintron and Damien Berg about AAMI's latest standards and innovations. They discuss new AAMI working groups, important standards updates, upcoming technical information reports (TIRs), and the impact of these publications on our work. Cintron and Berg also explain the AAMI process, share opportunities for participation and encourage you to get involved. ABOUT OUR GUESTS Horlando Cintron, Manager of Peri-Operative Support Services and Central Processing, Memorial Sloan Kettering Cancer Center Horlando Cintron, BS, CRCST, CHL, has 27 years of healthcare experience advancing patient safety through infection prevention, education and standards development. He co-chairs AAMI Working Group 40, leading the revision of ANSI/AAMI ST79, and received the AAMI Technical Award for co-chairing the ST58 standard recognized by the FDA. His leadership roles include Director, HSPA Foundation Board (2024–2027) and President, New Jersey Healthcare Central Service Association (2025–2026). Damien Berg, VP of Strategic Initiatives, HSPA Damien Berg, BA, BS, CRCST, AAMIF, serves as HSPA's Vice President of Strategic Initiatives and is an HSPA Past-President (2018–2019). Additionally, he works closely with regulatory bodies and standards-making groups, such as the Association for the Advancement of Medical Instrumentation (AAMI) and the International Standards Organization (ISO). Berg also serves on the Executive Committee for the World Federation For Hospital Sterilisation Sciences (WFHSS).   Earn CE Now

What happens when you go all in on a generic injectable that no one else wants, and it turns into a one hundred million dollar product in the first year?In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Usman Ahmad, former CEO of Nexus Pharmaceuticals and now CEO of Quetzal Therapeutics. Together they trace his journey from corporate finance to building a generics powerhouse with his parents, scaling a sterile injectable facility, and ultimately selling it to Eli Lilly for just under one billion dollars.They discuss the philosophy of finding the "right to win," what most companies miss about manufacturing capacity and equipment selection, how to build a team with deep industry know-how, and why Usman is now focused on bringing therapies to patients with rare diseases.This is a practical, personal, and strategic look at building something from the ground up, deciding not to sell too early, and learning how to do the hard things with intention.Topics include:-How to select the right generic molecules beyond patent expiry-Early success with isoproterenol and API sourcing-Why Nexus turned down acquisition offers-Building a commercial salesforce from scratch-Designing a facility with high speed prefilled syringe and lyo capacity-Why most other sterile sites failed-The billion dollar sale to Lilly-Launching Quetzal and developing oral arsenic for APL-The brain-eating amoeba drug and ultra rare disease strategy-Faith, confidence, and decision making under pressureTimestamps: 00:00 Introduction and Guest Welcome00:24 From Wall Street Finance to Pharma01:42 How Usman Selected Winning Generics02:58 Early Challenges Building a Generics Company05:29 Family R&D Expertise and Business Dynamics11:44 First Generic Launch and Commercial Impact16:28 Building Sterile Injectable Manufacturing Capacity18:16 Sterile Facility and Equipment Strategy22:40 Prefilled Syringe and Vial Line Capabilities23:07 Big Pharma Interest and Selling the Facility26:02 Nexus Pharma Services and the Lilly Deal27:23 Post‑Sale Reflections and New Ventures28:30 Launching Quetzal Therapeutics and Rare Disease Focus33:30 New Challenges and Confidence in Drug Development39:55 Importance of People, Teams, and Relationships41:40 Books That Shaped Usman's Thinking42:29 Where to Connect with UsmanLearn more: https://quetzaltx.comConnect with Usman: https://www.linkedin.com/in/usman-ahmed-a351b928More episodes: https://letscombinate.comUsman Ahmad is the Founder and CEO of Quetzal Therapeutics, and former CEO of Nexus Pharmaceuticals, where he led the company through explosive growth and the billion-dollar sale of its manufacturing facility to Eli Lilly. With a background in finance and a deep passion for healthcare innovation, Usman now focuses on bringing treatments to patients with rare and underserved diseases.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional who has worked with global leaders including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.Leonel shares how integrating Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) is essential to successful combination-product development. He discusses his journey from chemist to regulatory-affairs expert, uncovering common disconnects between pharma and device cultures, and the critical role of design controls, risk management, and timelines.The conversation also explores GMP and process validation, IDE vs. IND pathways, the challenges of rare-disease programs, and how understanding the cost of quality can reshape testing strategies. Leonel closes by reflecting on becoming a Lean Six Sigma Black Belt and what continuous improvement really looks like in combination-product development.⏱ Timestamps00:00 – Welcome & Introduction00:52 – Integrating GLP, GCP & GMP02:22 – Challenges in Developing Combination Products04:02 – Device-Led Combination Products07:35 – Working with Rare Diseases09:58 – GMP & Process Validation15:08 – Clinical Trials: Drug vs Device19:22 – Cost of Quality & Six Sigma25:12 – Conclusion & Contact InformationLeonel Venegas is the Founder of Precision Regulatory Consulting LLC and an expert in quality and regulatory affairs with over two decades of experience across six global pharma and medtech leaders, including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.He is certified by ASQ as a CMQ/OE, CQE, CBA, and CSSBB, and holds an M.S. in Regulatory Affairs. Leonel specializes in combination products, medical devices, and IVDs, integrating GLP, GCP, GMP, and GVP principles into complex global development programs.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh welcomes Mark Kramer, the founding director of FDA's Office of Combination Products (OCP). Mark takes us on a deep dive into the history of how combination products have been regulated in the U.S., starting with the Safe Medical Devices Act of 1990 and how the process evolved into the formation of OCP in 2002.We explore questions such as: What challenges did industry and the FDA face in the early days of combination products? How did the “Request for Designation” process come about, and how is regulatory identity determined? What is the “Primary Mode of Action” (PMOA) rule and why does it matter? How do user fees, cross-center coordination, and post-market regulations shape how combination products get to market and are monitored? Mark also highlights current regulatory gapssuch as cross-labeling and site registration issues that continue to impact developers.Whether you're working in med-tech, pharma, or regulatory affairs, this episode offers historical perspective, technical insights, and strategic take-aways for navigating the combination-product space. Tune in for a candid conversation with one of the leading figures in this field.Timestamps:00:00 Introduction & Guest Welcome00:35 Historical Background of Combination Products03:05 Creation of Office of Combination Products (OCP)04:29 Early Challenges and Developments04:54 MDUFA, PDUFA, User Fee Programs & Legislative Impact14:24 Defining Primary Mode of Action (PMOA)18:35 OCP's Role & Responsibilities26:49 Industry Adoption & Challenges38:48 Regulatory Gaps & Future Directions46:00 Conclusion & Contact InformationContact & Resources:Connect with Mark Kramer on LinkedIn or via email at Mark.Kramer@greenleafhealth.comMark Kramer is Principal of the Medical Devices & Combination Products regulatory practice at Eliquent Life Sciences (formerly Greenleaf Health). He has more than 35 years experience at FDA and in regulated industry. At FDA, he established and directed the Office of Combination Products and was a scientific reviewer and later supervisor of the premarket review of devices in a variety of medical discipline areas. Following his FDA career, he served as Regulatory Affairs Executive and Chief Regulatory Strategist at GE Healthcare and then as an independent regulatory consultant for over 10 years before joining Greenleaf. Mark served as a board member of the Regulatory Affairs Professionals Society (RAPS) and in 2021, he was awarded the RAPS Founders Award, the profession's highest honor, recognizing exemplary regulatory professionals who have shaped regulatory policy and practice and have made a positive impact on the profession.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

I get a lot of questions from students and early-career professionals about what different industry roles actually mean: what does a Quality Engineer do? What's Regulatory Affairs? How does R&D fit in?In this video, I walk through eight of the most common roles you'll find in pharma, medtech, biotech, and diagnostics companies. We'll talk about what each team does, how they connect, and how to think about which one might fit your strengths and interests.If you're trying to figure out where you belong in industry, this one's for you.Please like, share, and subscribe if you find it helpful!Timestamps00:00 Introduction and Background01:07 Overview of Industry Roles02:43 Quality Assurance06:14 Regulatory Affairs08:22 Research & Development09:46 Clinical Affairs11:07 Manufacturing & Operations12:09 Quality Control / Analytical Testing14:05 Supply Chain & Procurement15:13 Validation & Technical Services16:39 Career Path Insights and ConclusionSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, Ben Locwin and Subhi Saadeh discuss the intersection of AI, GMP, and Quality 4.0, exploring both the promise and the challenges of applying intelligent systems in regulated environments.Key topics covered:- Current applications of AI in GMP, including CAPA and deviation management- The role of validation and why algorithmic opacity poses regulatory challenges- How Process Analytical Technology (PAT) enables real-time release decisions- The importance of Design of Experiments (DOE) for process optimizationContinuous manufacturing and how yield can signal process performanceChapters00:00 Introduction to AI in Pharma00:40 Current Applications of AI in GMP02:32 Challenges and Validation in AI03:22 Process Analytical Technology (PAT)09:50 Design of Experiments (DOE) in Pharma13:27 Continuous Manufacturing Explained15:40 Yield Calculation in Manufacturing22:12 Conclusion and Contact InformationBen Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode, Jesse Gordon-Blake, PhD, delves into the intricacies of medicinal chemistry, particularly focusing on drug discovery for ALS (amyotrophic lateral sclerosis). Jesse explains the process of discovering molecules that modulate biological pathways, the difference between structure-based and phenotype-based drug design, and the role computational methods play in drug development. The conversation also explores the challenges of crossing the blood-brain barrier, the importance of validating target response, and the complexities of progressing from a theoretical compound to preclinical studies. Additionally, Jesse touches on the significance of target product profiles, CNS drug design characteristics, and the iterative nature of medicinal chemistry. He concludes by discussing his current projects at Cortex, including fundraising strategies and timelines for drug development.00:00 Introduction to Medicinal Chemistry00:37 Drug Discovery Approaches02:01 Computational Methods in Medicinal Chemistry03:21 Challenges in ALS Drug Discovery04:23 Blood-Brain Barrier and Drug Design05:29 Key Properties for CNS Drug Design08:58 Day-to-Day in Drug Discovery09:45 Early Stage Drug Development12:28 Validating Drug Targets16:15 From Theory to Animal Testing22:46 Funding and Timeline Considerations25:45 Regulatory and Manufacturing Considerations28:32 Conclusion and Contact InformationDr. Jesse Gordon-Blake is an independent biotechnology and drug discovery consultant with expertise in medicinal chemistry and neurotherapeutics. He has led efforts in small molecule and peptide therapeutic development, AI-enabled drug discovery, and biotech startup formation, and currently serves as the CSO of Cortexa Therapeutics. He earned his PhD in Medicinal Chemistry from the University of Illinois at Chicago, focusing on developing innovative small-molecule enzyme modulators for Alzheimer's disease.https://www.linkedin.com/in/jesse-gordon-blake-phd-52a26274/https://www.cortexatherapeutics.com/Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode, Subhi Saadeh sits down with Alan Stevens, CAPT, to break down the concept of five nines (99.999% reliability) in medical devices. They cover where the standard came from, why FDA introduced it in their 2020 draft guidance, and what it means for life-saving products like epinephrine and naloxone injectors.Alan explains how manufacturers can demonstrate reliability through fault tree analysis, robust process controls, and challenge testing—without needing impossible sample sizes.If you work in pharma, medtech, or quality, this episode will help you understand what “five nines” really means and how to meet FDA expectations while ensuring patient safety.Chapters00:00 – What is Five Nines Reliability?Intro to 99.999% and why it matters for medical devices.00:33 – FDA Guidance & Common Misconceptions2020 draft guidance, sample size myths, and industry confusion.01:17 – How to Demonstrate ReliabilityFeasibility, practical approaches, and FDA expectations.02:31 – High-Stakes Use CasesEpinephrine, naloxone, glucagon injectors.04:00 – Fault Tree Analysis ExplainedBreaking down failures and linking to design/manufacturing.05:25 – Why FDA Chose Five NinesBalancing feasibility, safety, and ISO 14971 influences.09:02 – Verification vs. ReliabilityDesign verification testing vs. true reliability demonstration.23:16 – Key Takeaways for IndustryClosing thoughts on meeting and maintaining reliability standards.Alan Stevens CAPT is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Artificial Intelligence is moving fast but how do you regulate it in industries where precision and risk management are everything?In this episode of Let's Combinate, Subhi Saadeh sits down with Dominick Romano, founder of Drainpipe.io, to unpack the future of AI in pharma, medtech, and drug/device regulation. The conversation goes deep into how AI could reshape dossier preparation, regulatory submissions, and quality oversight — and what strategies regulators and companies need to make sure speed doesn't come at the cost of trust.We explore:- Why pharma's unique risk profile makes AI regulation different from other industries-How ICH guidelines and process validation can be applied to AI systems-What “combinatorial problem sets” mean for pharma and AI models-The role of AI in regulatory affairs and dossier preparation-How regulators may use AI to accelerate reviews and approvals-The balance between speed, accuracy, and zero hallucinations in regulatory contexts-The future of AI in quality control, biologics, and beyondIf you work in pharma, medtech, or drug/device combination products, this episode will give you a clear look at how AI could change your world and what needs to happen before it earns the regulator's trust.Episode Chapters00:00 Introduction: Regulating AI in Pharma/MedTech01:01 Pharma's Unique Risk Profile02:14 AI in Regulatory Affairs03:44 Combinatorial Problem Sets in Pharma04:24 ICH Guidelines and AI Regulation08:22 Process Validation in AI10:20 AI in Regulatory Submissions15:54 Ensuring Accuracy and Consistency17:02 Regulatory Agencies and AI18:28 Accelerating Drug Approval with AI21:36 Time Savings in Dossier Formation25:44 AI in Quality Control for Biologics27:42 Challenges in AI Integration29:25 The Future of Pharma & MedTech with AI30:40 Where to Find Dominick RomanoDominick Romano is the founder and CEO of Drainpipe.io, focused on building trustworthy AI systems for regulated industries like pharma and medtech. A graduate of Full Sail University in video game development, his career spans game design, programmatic advertising, and voice applications before moving into AI. He was named one of Technology Innovators' Top 50 AI CEOs and has contributed to global initiatives such as the WHO/ITU AI for Health program. Today, he helps organizations explore how AI can be validated and integrated without compromising compliance or trust.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

The quality of our water varies dramatically—by location, season and source—and the presence of impurities can have a significant impact on all aspects of instrument processing. For the safety of our patients, healthcare professionals must be knowledgeable about water types and their uses. As stewards of our facility's resources, we must understand how water affects our instruments, creating spotting, rusting and staining, and how monitoring water quality prevents wasted money and time. In episode 134, host Casey Czarnowski speaks with Brian Battani of Xylem about water in the Sterile Processing department (SPD). Battani explains the importance of knowing the quality of your municipal water and how it flows through your facility. He discusses today's water quality standards and treatment processes—water softening, reverse osmosis (RO) and deionization (DI). Battani also advocates for developing a comprehensive facility-wide water management plan. Listen to learn about the science of water and its essential role in the SPD. ABOUT OUR GUEST - Brian Battani, Senior Business Development Manager, Xylem Brian Battani is the Senior National Business Development Manager for the Health Sciences team at Xylem. With 15 years in the water treatment industry, his expertise is focused on healthcare customers. Battani actively contributes to advancing industry standards as a Subcommittee Chair for the AAMI TIR119 development workgroup. He holds a master's degree in Environmental Water Resources Engineering from the University of Michigan. Based near Baltimore, MD, Battani balances his professional endeavors with enjoying quality time with his wife and three children. ABOUT OUR SPONSOR - Xylem Water quality plays a critical role in medical procedures, clinical diagnostics and medical research as well as the overall operation of healthcare facilities. Xylem offers high purity water systems, 24/7 service, and a comprehensive support network that helps medical facilities meet current AAMI and CLSI standards for water quality. Our customers are professionals in healthcare settings such as hospitals and medical centers, hemodialysis clinics and medical laboratories. Earn CE Now

Nearly two-thirds of companies believe Quality 4.0 will transform their operations in the next five years yet fewer than 20% have started, and most haven't even reached the planning stage. In this conversation, Larry Mager breaks down what Quality 4.0 really is, why life sciences lag other industries, and how to move from compliance-only thinking to a business-driving quality strategy. We cover digital twins, data continuity, culture change, and Larry's Quantum Quality Management (QQM) framework as a practical roadmap.Timestamps00:00 Introduction to Quality 4.000:20 Defining Quality 4.001:39 The Role of Quality Professionals02:50 Industry Examples & Cultural Differences04:04 Implementing Quality 4.0 (people, process, tech)08:49 The Digital Twin Concept (why legacy EQMS falls short)13:34 The Importance of a Roadmap 30:28 Quantum Quality Management (5-phase framework)35:05 Final Thoughts & Contact InformationLarry Mager is the Founder and Principal at MGMT-CTRL, where he specializes in applying strategic quality management that goes beyond mere compliance. With three decades of experience in the medical device industry, Larry has held leadership roles spanning quality systems, operations management, CAPA, supplier control, risk management, lean manufacturing, and continuous improvement. He is also the architect of the Quantum Quality Management (QQM) framework, a phased methodology that marries people, process, and technology to help organizations adopt Quality 4.0, drive operational excellence, and use quality as a strategic business advantage.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's ComBinate: Drugs + Devices, we welcome back Susan Neadle, author of The Combination Products Handbook. Susan explores the persistent and evolving challenge of terminology in combination products—a problem that continues to create confusion and regulatory risk even in 2025.Susan emphasizes the need for alignment on terminology and regulatory expectations, highlighting that true progress requires a science- and risk-based perspective. The discussion also covers how GMP requirements are interpreted differently in pharma versus medtech, the ongoing challenges of global harmonization, and why cohesive language is essential for compliance, inspection readiness, and effective product development.Episode Chapters00:00 Introduction and Welcome00:25 The Lexicon Problem in Drug-Device Combination Products01:01 Historical Efforts and Challenges02:12 Regulatory Frameworks and Definitions04:47 Industry and Regulatory Alignment Issues06:55 Science and Risk-Based Perspectives10:08 Terminology and Definitions in Practice14:05 Global Regulatory Differences17:22 Challenges in Harmonizing Standards23:13 Key Terms and Their Impact32:23 Conclusion and Contact InformationSusan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press. Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development. Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries. She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees. Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request. She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums. Susan can be reached at sneadle@combinationprod.com Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.