Podcasts about intended use

In a world inundated with quick-fix solutions and miracle cures, it's easy to get lost in the noise. When it comes to our health, informed decisions are paramount. Today, we're diving deep into a topic that's been making waves in the healthcare industry: GLP-1 medications. Are you considering or have been prescribed a GLP-1 medication like Ozempic or Wegovy? Do you wonder about their long-term effects and potential side effects? Join us as we explore the science behind these medications, uncover the potential risks, and discuss healthier, sustainable approaches to weight management. Our special guest, Marcelle Pick, certified as an OB/GYN Nurse Practitioner and a Pediatric Nurse Practitioner and a renowned expert in women's health with a focus on integrative medicine and functional medicine, will shed light on the complexities of GLP-1 medications and provide valuable insights. Together, we'll navigate the hype and uncover the truth." Key Takeaways: [01:17] Introduction to GLP-1 Medications: Originally used for diabetic patients to control blood sugar. [03:57] High Discontinuation Rates: Many users stop due to side effects [04:56] Weight Regain Risks: Over two-thirds of people regain the lost weight [05:13] Intended Use for Specific Groups: The medications may be beneficial [08:28] Need for Root-Cause Approaches: Addressing underlying health issues  [10:27] Telehealth and Quality Concerns: GLP-1 medications are sometimes prescribed without thorough assessments [12:02] Pharmaceutical Influence on GLP-1 Drugs: Big pharma actively promotes GLP-1 medications [13:22] Complex Biochemical Pathways: Weight and overall health involve numerous interconnected biochemical pathways [14:09] Reported Adverse Effects: Significant adverse effects, including deaths and serious health events [16:05] Personalized Diet and Lifestyle Importance: Tailored diet plans (e.g., Mediterranean, low-fat) [17:08] Alternatives to Weight-Loss Drugs: A structured, homeopathic program [20:09] Whole-Food Diet for Long-Term Health: A diet rich in vegetables and fruits, avoiding processed foods [20:28] Conversations around dieting: Many people feel that their eating habits are "unusual" [21:12] Side Effects of GLP-1: A patient who stopped GLP-1 lost weight but then rapidly regained it [22:07] Enjoying Healthy Meals: Emphasis on finding joy in healthy eating [23:18] Homeopathy Overview: Explanation of homeopathic remedies [26:06] Sustainable Weight Loss Habits: The importance of finding methods that align with long-term lifestyle changes [29:00] Oral Health's Link to Overall Health: Importance of dental health for systemic well-being, highlighting biological dentistry. [31:51] GLP-1 as a Last Resort: Recommendation that GLP-1 medications should only be considered for those with high BMI or diabetic conditions. [32:07] Potential Long-Term Impacts: Concerns about the effects of high levels of GLP-1 [33:19] Quick-Fix Approaches vs. Long-Term Health: Warning against quick-fix solutions   Marcelle Pick, OB/GYN, NP, is passionate about transforming the way women experience healthcare through an integrative approach. She co-founded the Women to Women Clinic in 1983 to support women in pro-actively making healthier choices to prevent disease. She is among the first certified Functional Medicine Practitioners and holds a BS in Nursing, a BA in Psychology from the University of New Hampshire, and an MS in Nursing from Boston College-Harvard Medical School. She is certified as both an OB/GYN Nurse Practitioner and a Pediatric Nurse Practitioner and is a member of the American Nurses Association and the American Nurse Practitioner Association.   For more details about Marcelle Pick, visit her here: Website: marcellepick.com Facebook YouTube Topic References: YouTube Video on Long-Term Risks of Ozempic and Weight Loss Drugs - A powerful, in-depth look at the potential long-term risks associated with popular weight loss drugs.   What did you learn about today's topic? Let us know by leaving a review! Visit these links to learn more: https://www.drchristianson.com/ Dr. Christianson on Facebook Dr. Christianson on Instagram Subscribe for more Medical Myths, Legends, & Fairytales: Apple Podcasts Spotify YouTube   "Our bodies are amazing at telling us what they need-- we just need to learn to listen." - Marcelle Pick

This week, Lisa and Amy are joined by Jack Young to talk about some important terms in USPAP!

370: Erin has the hilarious voice actor, comedian, and personal trainer Connett Croghan in the weight room! We talk his journey to becoming a personal trainer, crazy things (and people) we've seen in the gym, and picking your childhood sports based on your favorite movies!See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA's Intended Use rule and how it impacts device labeling. It is also revealed how labeling can be used by medical device OEMs as a competitive advantage. Specifically, the following questions are addressed:Could you please explain exactly what we mean by labeling, and further, clarify the difference between high level and low level labeling?How can labeling, both high level and low level, be used as a strategic advantage?Could you please explain the difference between intended use and indications for use?What is this intended use rule and why is it important to medical device manufacturers?What is meant by manufacturer's objective intent?Do you have examples you can provide?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see how Intended Use affects your device labeling. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

On this episode of the podcast we had Karandeep Singh Badwal. Karandeep and I discuss: Why QA/RA is the place to be (if you're so inclined) Intended Use, Indications and Use cases Where software startups struggle Eudamed Cybersecurity Artificial Intelligence in Medical Devices SaMD and Digital Health Considerations related to the MDR Impact of Brexit on existing and future products within the EU and UK Robert Green and his books His Podcast: The Med Tech Podcast ------------------------------------------------------------ Karandeep is a QA/RA consultant and host of The MedTech Podcast with a mission to help you understand the Quality, Regulatory Affairs and Compliance of Medical Devices, Digital Health and Biotech. Karandeep can be found at: Linkedin Profile The MedTech Podcast: Podcast Link

This week Amy and Lisa do a deep dive on intended use and why it matters to an appraiser.

On this episode of The King's Healing Room Podcast, Dr. Lacey demonstrate to us why we should allow GOD purpose to lead our life. To give today: Givelify: Search: The King's Healing Room Pay Pal TKHROFFICE1@gmail.com TKHR now offers Text to Give... Here's how it works: 5 Steps... 1. Text - "give " to 1 (844) 981-2759 which is unique to TKHR 2. You will receive a text with instructions 3. Follow the instructions to set up a giving account 4. Text the amount you want to give and the designation (eg. tithe, offering, general fund) 5. You will receive a receipt via email confirming your gift I did it and it works! If you want to listen to the sermon on audio podcast here are the links below Apple Podcast https://podcasts.apple.com/us/podcast/the-kings-healing-room-podcast/id1494591065?uo=4 Breaker https://www.breaker.audio/the-kings-healing-room-podcast Google Podcast https://www.google.com/podcasts?feed=aHR0cHM6Ly9hbmNob3IuZm0vcy8xMjJjOWQ4OC9wb2RjYXN0L3Jzcw== Overcast https://overcast.fm/itunes1494591065/the-kings-healing-room-podcast Pocket Cast https://pca.st/bv1ufvf7 Radio Public https://radiopublic.com/the-kings-healing-room-podcast-WJ2LL1 Spotify https://open.spotify.com/show/4LDhQ58s0Ysk6PYJ9vKMbo --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/TKHRChurch/message

This edition of Ropes & Gray's podcast series, Non-binding Guidance, focuses on one of the most fundamental concepts in FDA regulatory law: intended use. On August 2, FDA issued a final rule amending its drug and medical device regulations describing the types of evidence the Agency considers relevant to determining a product's “intended use.” The new regulations just took effect on September 1. Join Kellie Combs, a partner in Ropes & Gray's life sciences regulatory and compliance practice, Doug Hallward-Driemeier, a partner in the litigation & enforcement practice and head of the firm's appellate & Supreme Court practice, and Josh Oyster, a senior associate in the life sciences regulatory and compliance practice group, as they discuss this final rule and what its implementation means for the drug and medical device industry.

There are three types of lies......Lies, Damned Lies and Statistics - Benjamin D'IsraeliWe've been lied to. We've been lied about. We're going to talk about that, and the TRUTH is finally coming out. Is it too little too late? Can we take advantage of this and help ourselves and our friends?Pfizer expands recall on carcinogenic meds to save people from cancer causing cigarettes.https://www.msn.com/.../pfizer-expands.../ar-AANiwkG...RI prohibitionistshttps://www.providencejournal.com/.../stat.../8134976002/...Who got blocked on twitter this week for pointing out a COPD Doctor hates vaping because it gets smokers off of cigarettes? This guy did!How do you get Skip Murray out of her funk? We will show you how.Do flavor bans actually help? Nope.https://academic.oup.com/.../10.1093/ntr/ntab154/6332852...Flavors are important, here's some #science.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7275248/The worst study we've seen all year.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311841/...RightToVape(dot)com Blocked by FB. Why?Kevin found a link about "Intended Use".https://www.lexology.com/library/detail.aspx...The Great Vape Debatehttps://medium.com/.../why-do-opponents-of-vaping-want-to...Stanton Glans Tainthttps://rodutobaccotruth.blogspot.com/.../stanton-glantzs...Your Genes and Nicotinehttps://blog.23andme.com/23an.../data-on-e-cigarette-use/...Prohibitionists called out for their BShttps://ajph.aphapublications.org/.../AJPH.2021.306416...&https://filtermag.org/tobacco-control-vaping-e.../...CHARLES ROCKS!https://www.youtube.com/watch?v=Ns9xosXZxmshttps://www.youtube.com/watch?v=7cxF1eIRM2gTweets to look at.....https://twitter.com/nachtnoir/status/1428476681048797184https://twitter.com/nachtnoir/status/1428157835393835010https://twitter.com/Vapingit/status/1428461486469419013https://twitter.com/Vapingit/status/1428379618944376837

On this week's podcast we discuss the US agency's final regulation on the intended use of products, which device makers must follow beginning on 1 September. Medtech Insight articles addressing topics discussed in this episode: • FDA Widens Scope In Considering Evidence For Off-Label Use

FDA published a final rule, which goes into effect the first of September, to amend its “intended use” regulations.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the implications of FDA's final rule on intended use, manufacturer's objective intent, and the role that it has with labeling.Some of the highlights of this episode include:When Mike and Jon refer to labeling, they are talking about the content of the label - the words used and claims made.High-level labeling describes intended use, indications for use, and label claims. Low-level labeling includes directions for use and package inserts. A claim is a claim whether put in high- or low-level labeling.High- and low-level labeling can be leveraged as a strategic, competitive advantage to minimize or streamline regulatory burden, which means how much effort and evidence is needed to go through the FDA and put on the market.Intended use focuses on a device (what it does, how it works, and what is its mechanism of action). Indications for use focuses on the patient (what illness, injury, disease, or condition is the device intended to prevent, diagnose, or treat).Why do we need a new rule about intended use? The intended use rule is important for medical device manufacturers because labeling is not limited to what they say or print.The root cause for the rule relates to manufacturers' saying or claiming one thing, but inferring and implying another thing. FDA does not regulate, at least not yet, the names of medical devices.Manufacturer's Objective Intent: If manufacturer knows or has knowledge of facts that product, device, or drug would be used for conditions or purposes other than what is advertised/claimed, manufacturer may need to provide adequate labeling.Manufacturers also need to consider product liability and reimbursement implications of a device being used for purposes other than what's on the label.Memorable quotes from this episode:“When we refer to labeling, at least when I refer to it, I'm not talking about the sticky piece of paper that we stick on a package or in a box that a medical device comes in, nor am I talking about the graphics that go onto that label.” Mike Drues“There have been numerous and continues to be numerous warning letters, recalls, etc, etc, etc, that are strictly related to content or lack thereof or misinformation that's on labeling.” Jon Speer“FDA does not regulate, at least not yet, the names of medical devices. So, you can embed a claim in the name of your device without it being subject, at least directly, to FDA regulation.” Mike Drues“Don't just focus on what you say in your labeling, also consider what you don't say and how you don't say it.” Mike DruesLinks:FDA finalizes long-awaited intended use ruleFDA Delays Implementing Parts of 'Intended Use' RuleFederal Register's Regulations Regarding “Intended Uses”FDA - Center for Devices and Radiological Health (CDRH)Mike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Blockstack PBC's Head of Growth, Patrick Stanley, is joined by Dr. Uri Klarman, Founder & CEO at Bloxroute for deep dive on the intricacies of blockchain scalability that proves interesting for technical and non-technical folks alike. The conversation covers staples like Bitcoin, Ethereum, and others, taking a look at how the specific problems each blockchain generally intends to solve impacts its approach to scalability. See omnystudio.com/listener for privacy information.

When designing a building, the most important factor is the intended use of the building rather than its outward appearance. Do you agree or disagree?   perform its intended function/functions fulfill its purpose its fitness for purpose functionality   external appearance aesthetically pleasing visually impressive   exterior   user satisfaction   is the foundation of is the key to   have difficulty doing something   readily available   financial rewards financial returns   an aquatic center an Olympic-size pool go bankrupt

It's time to break down the how and why of intended use and indications of use statements for your new medical device. On this episode of the Global Medical Device podcast we'll explain the differences between these two statements and how you can design your labels around them. Mike Drues, Ph.D. is our guest today giving some great examples of these use statements and successful label designs. He's the President of Vascular Science, consulting for medical devices and regulatory bodies like FDA, and he travels the globe to set everyone straight on medical device regulations. Your intended use and indications of use statements are integral to getting your medical device to market. These statements help insure your device meets regulation when used properly. If you want to bypass any hiccups in your marketing plan, you need to understand the key differences between these two statements: First, intended use is EXACTLY what your product is used for. Don't focus on what it COULD be used for. Rather, define exactly what it is in as few words as possible. Second, your indication of use statement are the precise situations and reasons where and why you would use this device. Again, being very clear and definitive here is extremely important. “They think they understand what intended use means, but they really don't…Intended use is all about what we say this device is to be used for, and indications for use is under what circumstances or under what conditions you would use that particular product.” – Mike Drues Mike Drues goes into what he calls “high level labeling” with tips on how to get your label to market with as few words as possible. Little words do matter, and sometimes it may take you 6 different use statements before you find the right ones that work for your device. Breaking down examples, using clear-cut definitions, and using a trick Mike calls “label expansion” are all ways you can use your intended use and indication of use statements to your advantage. “The single most important thing that people should remember is to apply the same concepts and philosophies that we learned as engineers to product design [and] apply that same kind of thinking to label design…and indication of use statements.” – Mike Drues Mike also discusses the reimbursement pathway and how it is often overlooked in the beginning of our development processes. Changing up when you approach regulation can really make it easier to design and write the right kinds of use statements, and focusing on regulation this early on will often make it easier for marketing further down the road. Tune in now to hear how these tips can be applied to you, your team, and your medical device. To get in touch with Mike Drues, find him on LinkedIn.

Podcast: Industrial IoT SpotlightEpisode: EP038 - Security and Trustworthiness in IoT Deployments - An Interview with Sven Schrecker of IntelPub date: 2018-10-04*This episode of the Industrial IoT Spotlight Podcast is sponsored by the Industrial Internet Consortium What are the differences between Greenfield and Brownfield IoT deployment environments in terms of security? How does security relate to trustworthiness? What are the best practices for IoT deployments? Sven Schrecker explains to us the IIC view on system security and why the trustworthiness of a system matters. Sven Schrecker is the chief architect of IoT security solutions at Intel. Sven is also the co-chair of the IIC Security Working Group, co-chair of the IIC JTG5 Security Team and a member of the Industrial Internet Consortium Steering Committee.   Links mentioned: IIC Security framework: https://www.iiconsortium.org/IISF.htm IIC Security Maturity model: https://www.iiconsortium.org/pdf/SMM_Description_and_Intended_Use_2018-04-09.pdf IIC Journal of Innovation on Trustworthiness: https://www.iiconsortium.org/journal-of-innovation.htm   IoT ONE is an online platform devoted to accelerating adoption of Industrial Internet solutions. We are mapping the global ecosystem of IoT vendors, use cases, case studies, and technologies. We leverage this data to help companies source technology, research competitors, and enter new markets. https://www.iotone.comThe podcast and artwork embedded on this page are from Erik Walenza: CEO, IoT ONE | Chair, IIC Smart Factory Task Group | Director, Startup Grind, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.

intro CFP for Bsides Barcelona is open! https://bsides.barcelona Aaron Guzman: @scriptingxss https://www.computerweekly.com/news/252443777/Global-IoT-security-standard-remains-elusive https://www.owasp.org/index.php/IoT_Attack_Surface_Areas https://scriptingxss.gitbooks.io/embedded-appsec-best-practices//executive_summary/9_usage_of_data_collection_and_storage_-_privacy.html OWASP SLACK: https://owasp.slack.com/ https://www.owasp.org/images/7/79/OWASP_2018_IoT_Top10_Final.jpg Team of 10 or so… list of “do’s and don’ts” Sub-projects? Embedded systems, car hacking Embedded applications best practices? *potential show* Standards: https://xkcd.com/927/ CCPA:  https://en.wikipedia.org/wiki/California_Consumer_Privacy_Act California SB-327: https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201720180SB327 How did you decide on the initial criteria? Weak, Guessable, or Hardcoded passwords Insecure Network Services Insecure Ecosystem interfaces Lack of Secure Update mechanism Use of insecure or outdated components Insufficient Privacy Mechanisms Insecure data transfer and storage Lack of device management Insecure default settings Lack of physical hardening 2014 OWASP IoT list: https://www.owasp.org/index.php/Top_10_IoT_Vulnerabilities_(2014) 2014 list: I1 Insecure Web Interface I2 Insufficient Authentication/Authorization I3 Insecure Network Services I4 Lack of Transport Encryption I5 Privacy Concerns I6 Insecure Cloud Interface I7 Insecure Mobile Interface I8 Insufficient Security Configurability I9 Insecure Software/Firmware I10 Poor Physical Security BrakeSec Episode on ASVS http://traffic.libsyn.com/brakeingsecurity/2015-046_ASVS_with_Bill_Sempf.mp3 OWASP SLACK: https://owasp.slack.com/ What didn’t make the list? How do we get Devs onboard with these? How does someone interested get involved with OWASP Iot working group? https://docs.microsoft.com/en-us/azure/iot-fundamentals/iot-security-best-practices https://www.iiconsortium.org/pdf/SMM_Description_and_Intended_Use_2018-04-09.pdf https://www.dhs.gov/sites/default/files/publications/Strategic_Principles_for_Securing_the_Internet_of_Things-2016-1115-FINAL_v2-dg11.pdf https://api.ctia.org/wp-content/uploads/2018/08/CTIA-IoT-Cybersecurity-Certification-Test-Plan-V1_0.pdf https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/747977/Mapping_of_IoT__Security_Recommendations_Guidance_and_Standards_to_CoP_Oct_2018.pdf   https://www.mocana.com/news/mocana-xilinx-avnet-infineon-and-microsoft-join-forces-to-secure-industrial-control-and-iot-devices   https://www.microsoft.com/en-us/research/wp-content/uploads/2017/03/SevenPropertiesofHighlySecureDevices.pdf   Check out our Store on Teepub! https://brakesec.com/store Join us on our #Slack Channel! Send a request to @brakesec on Twitter or email bds.podcast@gmail.com #Brakesec Store!:https://www.teepublic.com/user/bdspodcast #Spotify: https://brakesec.com/spotifyBDS #RSS: https://brakesec.com/BrakesecRSS #Youtube Channel:  http://www.youtube.com/c/BDSPodcast #iTunes Store Link: https://brakesec.com/BDSiTunes #Google Play Store: https://brakesec.com/BDS-GooglePlay Our main site:  https://brakesec.com/bdswebsite #iHeartRadio App:  https://brakesec.com/iHeartBrakesec #SoundCloud: https://brakesec.com/SoundcloudBrakesec Comments, Questions, Feedback: bds.podcast@gmail.com Support Brakeing Down Security Podcast by using our #Paypal: https://brakesec.com/PaypalBDS OR our #Patreon https://brakesec.com/BDSPatreon #Twitter: @brakesec @boettcherpwned @bryanbrake @infosystir #Player.FM : https://brakesec.com/BDS-PlayerFM #Stitcher Network: https://brakesec.com/BrakeSecStitcher #TuneIn Radio App: https://brakesec.com/TuneInBrakesec  

Aaron Guzman: @scriptingxss https://www.computerweekly.com/news/252443777/Global-IoT-security-standard-remains-elusive https://www.owasp.org/index.php/IoT_Attack_Surface_Areas https://scriptingxss.gitbooks.io/embedded-appsec-best-practices//executive_summary/9_usage_of_data_collection_and_storage_-_privacy.html OWASP SLACK: https://owasp.slack.com/ https://www.owasp.org/images/7/79/OWASP_2018_IoT_Top10_Final.jpg Team of 10 or so… list of “do’s and don’ts” Sub-projects? Embedded systems, car hacking Embedded applications best practices? *potential show* Standards: https://xkcd.com/927/ CCPA:  https://en.wikipedia.org/wiki/California_Consumer_Privacy_Act California SB-327: https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201720180SB327 How did you decide on the initial criteria? Weak, Guessable, or Hardcoded passwords Insecure Network Services Insecure Ecosystem interfaces Lack of Secure Update mechanism Use of insecure or outdated components Insufficient Privacy Mechanisms Insecure data transfer and storage Lack of device management Insecure default settings Lack of physical hardening 2014 OWASP IoT list: https://www.owasp.org/index.php/Top_10_IoT_Vulnerabilities_(2014) 2014 list: I1 Insecure Web Interface I2 Insufficient Authentication/Authorization I3 Insecure Network Services I4 Lack of Transport Encryption I5 Privacy Concerns I6 Insecure Cloud Interface I7 Insecure Mobile Interface I8 Insufficient Security Configurability I9 Insecure Software/Firmware I10 Poor Physical Security BrakeSec Episode on ASVS http://traffic.libsyn.com/brakeingsecurity/2015-046_ASVS_with_Bill_Sempf.mp3 OWASP SLACK: https://owasp.slack.com/ What didn’t make the list? How do we get Devs onboard with these? How does someone interested get involved with OWASP Iot working group? https://docs.microsoft.com/en-us/azure/iot-fundamentals/iot-security-best-practices https://www.iiconsortium.org/pdf/SMM_Description_and_Intended_Use_2018-04-09.pdf https://www.dhs.gov/sites/default/files/publications/Strategic_Principles_for_Securing_the_Internet_of_Things-2016-1115-FINAL_v2-dg11.pdf https://api.ctia.org/wp-content/uploads/2018/08/CTIA-IoT-Cybersecurity-Certification-Test-Plan-V1_0.pdf https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/747977/Mapping_of_IoT__Security_Recommendations_Guidance_and_Standards_to_CoP_Oct_2018.pdf   https://www.mocana.com/news/mocana-xilinx-avnet-infineon-and-microsoft-join-forces-to-secure-industrial-control-and-iot-devices   https://www.microsoft.com/en-us/research/wp-content/uploads/2017/03/SevenPropertiesofHighlySecureDevices.pdf

*This episode of the Industrial IoT Spotlight Podcast is sponsored by the Industrial Internet Consortium What are the differences between Greenfield and Brownfield IoT deployment environments in terms of security? How does security relate to trustworthiness? What are the best practices for IoT deployments? Sven Schrecker explains to us the IIC view on system security and why the trustworthiness of a system matters. Sven Schrecker is the chief architect of IoT security solutions at Intel. Sven is also the co-chair of the IIC Security Working Group, co-chair of the IIC JTG5 Security Team and a member of the Industrial Internet Consortium Steering Committee.   Links mentioned: IIC Security framework: https://www.iiconsortium.org/IISF.htm IIC Security Maturity model: https://www.iiconsortium.org/pdf/SMM_Description_and_Intended_Use_2018-04-09.pdf IIC Journal of Innovation on Trustworthiness: https://www.iiconsortium.org/journal-of-innovation.htm   IoT ONE is an online platform devoted to accelerating adoption of Industrial Internet solutions. We are mapping the global ecosystem of IoT vendors, use cases, case studies, and technologies. We leverage this data to help companies source technology, research competitors, and enter new markets. https://www.iotone.com

It’s time to break down the how and why of intended use and indications of use statements for your new medical device. On this episode of the Global Medical Device podcast we’ll explain the differences between these two statements and how you can design your labels around them. Mike Drues, Ph.D. is our guest today giving some great examples of these use statements and successful label designs. He’s the President of Vascular Science, consulting for medical devices and regulatory bodies like FDA, and he travels the globe to set everyone straight on medical device regulations. Your intended use and indications of use statements are integral to getting your medical device to market. These statements help insure your device meets regulation when used properly. If you want to bypass any hiccups in your marketing plan, you need to understand the key differences between these two statements: First, intended use is EXACTLY what your product is used for. Don’t focus on what it COULD be used for. Rather, define exactly what it is in as few words as possible. Second, your indication of use statement are the precise situations and reasons where and why you would use this device. Again, being very clear and definitive here is extremely important. “They think they understand what intended use means, but they really don’t…Intended use is all about what we say this device is to be used for, and indications for use is under what circumstances or under what conditions you would use that particular product.” – Mike Drues Mike Drues goes into what he calls “high level labeling” with tips on how to get your label to market with as few words as possible. Little words do matter, and sometimes it may take you 6 different use statements before you find the right ones that work for your device. Breaking down examples, using clear-cut definitions, and using a trick Mike calls “label expansion” are all ways you can use your intended use and indication of use statements to your advantage. “The single most important thing that people should remember is to apply the same concepts and philosophies that we learned as engineers to product design [and] apply that same kind of thinking to label design…and indication of use statements.” – Mike Drues Mike also discusses the reimbursement pathway and how it is often overlooked in the beginning of our development processes. Changing up when you approach regulation can really make it easier to design and write the right kinds of use statements, and focusing on regulation this early on will often make it easier for marketing further down the road. Tune in now to hear how these tips can be applied to you, your team, and your medical device. To get in touch with Mike Drues, find him on LinkedIn.

By Paul Cole, July 12, 2015