DeviceAlliance: MedTech Radio

In an ideal world, no one would have a catheter, but the reality is that 100M patients worldwide rely on an indwelling urinary catheter.  Catheterized patients often experience problems, such as catheter-associated urinary tract infections (CAUTI), catheter blockages, leaking and bladder spasms.  FLUME estimates the healthcare burden of Foley catheter complications to be equivalent to $80 on average, for each of the 28m placed annually in the US - a total burden of around $2.2bn - and close to $60 even for short term placement. Join Co-Founder & Chief Executive at The Flume Catheter Company Limited Roger Holmes, and DeviceAlliance MedTech Radio Host Scott Johnson as they discuss....   - The catheter problem impacting 100M people - The 2.2B burden in the U.S. - Flume Catheter's goal to impact millions for a philanthropic purpose - Roger's life lessons in entrepreneurship

It's been almost a year since Anthony Klotz, a psychologist and professor of business administration at Texas A&M University, coined a famous phrase when he said “the great resignation is coming” in an interview with Bloomberg Businessweek.  The popular phrase refers to the elevated level in early 2022 coming off a year in which almost 48 million people quit their jobs, an annual record.  As one can imagine, this revolution of sorts has caused quite a stir amongst the HR Community, with experts scrambling to understand the "why" behind this mass exodus…and work out what it is that employees actually want.   Join us as we discuss the misconceptions of the Great Resignation from the employee and employer perspective, the mistakes that companies are making to address employee engagement, best shared practices adapting to our new norms, and the strategic considerations for small to large scale MedTech companies building their workforce.

Today we speak with CEO of Diality, Osman Khawar.  Diality is a privately held medical device company currently in development of a versatile hemodialysis machine useable at home or in a variety of care settings, including nursing homes, hospitals, transitional care facilities and dialysis centers*. Committed to helping build a future where all patients and partners can control kidney disease, Diality is focused on developing solutions that help care providers improve the care and lives of patients with kidney disease while giving physicians the flexibility to prescribe personalized dialysis treatments regardless of delivery setting.   Join us as we discuss the current status of dialysis treatment, the burdens of treatments, the evolution toward consumer centric dialysis, and how the opportunity for innovation can improve the distinct needs of dialysis providers across all segments of the market.

Ramin Mousavi is the CEO, President, and Board of Directors for Cathworks; a medical technology company focused on applying its advanced computational science platform to optimize Coronary Artery Disease (CAD) therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians.   Ramin has executive leadership and operational experience in general management, marketing, strategy, product development, and commercialization across multiple market segments and was responsible for developing the clinical and commercial strategy for CathWorks.  He helped with the regulatory clearance of the product in Europe, United States and Japan.  He also led the company's Global Health Economic & Reimbursement strategy where the company was successful in receiving reimbursements in the US and Japan. He is leading the way in building an innovative and community-based organization with a mission to provide clinicians with objective data, so they can make the best decisions for their patients. Join us as we discuss the unmet clinical needs for coronary artery disease, Cathworks journey to understanding the physician perspective, Ramin's personal leadership journey, the advancement of computational science, the economic benefits for patients and payers, the evolution of innovation, and much more!

Your Medtech brand is not something an agency gives to you. Nor is it something you buy. Your brand is defined by the relationship you have with your customers, and it's shaped by the messages you send and the response those messages elicit.  Getting the attention of busy physicians and hospital executives is more challenging than ever for medical device manufacturers across the globe. Doctors are busier and have less time to see patients, let alone talk to a sales representative. Successful medical device marketers have learned how to harness the power of digital to achieve their key objectives. In this episode of DeviceAlliance's Medtech Radio, we speak with Chief Operating Officer of TMG360 Media, Kristy Kennedy. TMG360 Media is a Medtech media company focusing on exclusive editorial coverage to influence mainstream media, policymakers, emerging companies, strategics, investors, payers and providers, clinicians, and consumers. Join us as we discuss -  The biggest changes medical device companies must consider for their marketing strategies -  The new outlook on social media -  How the empowered patient will impact consumerization of Medtech -  Adding value beyond the device -  How upstream and downstream marketing has impacted sales   And much more!

Irvine is home to over 15,000 businesses, and life sciences and medical device companies constitute one of the fastest-growing sectors.  With a global focus on the Medtech industry, the need to build an infrastructure that can support the explosive forecasted growth is more crucial than ever.   A well-educated, job-ready workforce, world-renowned R&D facilities and community initiatives all conspire to make Irvine a magnet for Medtech success.  So how is Irvine executing on their 50-year plan coming out of the pandemic, to ensure our medical device community is not only a hub of talent and innovation for California, but for the world? In this episode of DeviceAlliance's Medtech Radio, we speak with the President and CEO at Greater Irvine Chamber of Commerce, Destination Irvine and Irvine Economic Development, Bryan Starr.  Join us as we discuss the efforts the Irvine Chamber is making to support the medical device community, their initiatives to attract foreign medical device companies to relocate to Irvine, as how we as a community can engage in local efforts to ensure the thriving success of medical device industry.

You've got a great idea for a medical device! Now what? Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is absolutely crucial for clinical trial success.   With the explosion of Medtech opportunities for startups, what are the current best standards for ensuring the success of your design and clinical trials? Join us for this Live-Recorded Podcast Event "Proving Your Device Works in The Real World" as we discuss...   - Consideration for the problem you are trying to solve - Big Questions to answer for Clinical Literature, IP Landscape, Stakeholder and Value Proposition, What is relevant today - Pre-clinical / Clinical Testing Feasibility - Planning the Clinical Trial Design – Tactical and Strategic Considerations  - Regulatory Pathway & Business Strategy - Design Approach and policy level considerations - The External Environment  (Legislative, Healthcare Economics, Orange County Talent, Reimbursement and Market Adoption   Expert Panelists Include:   Dr.  Michael Drues - President of Vascular Sciences & FDA Consultant Jeremy Koehler - Director Of Engineering at NXT Biomedical Vinny Podichetty - VP Clinical & Medical Affairs at JenaValve Technology, Inc.   Anand S. Patel, MD - Chief of Interventional Radiology at Providence Little Company of Mary, Torrance     Free Opinion Disclaimer The views and opinions expressed at this event are those of the panelists and do not necessarily reflect the official policy or position of their respective organizations.   Any content provided by our panelists are of their opinion and are not intended to malign any organization, company, individual or any entity.

What is leadership, anyway? Such a simple question, and yet it continues to vex popular consultants and laypeople alike.  Leadership is a process of social influence, which maximizes the efforts of others, towards the achievement of a goal.   In this episode of DeviceAlliance's Medtech Radio, we speak with the President of Bioplatte, Thomas Hopson.  Thomas Hopson is an accomplished business executive with over 30 years of experience in the medical device industry. Thomas has provided leadership to multi-million-dollar business enterprises in Europe, Asia, and the United States, and he has successfully transformed multiple struggling organizations into healthy and thriving businesses. He joined Bioplate as President in 2018, bringing with him an extensive background in sales, business development, organizational learning, and product commercialization. Before joining Bioplate, Thomas served as the Director, Global Talent Management & Learning at Edwards Life Sciences. Prior to Edwards, Thomas held various leadership positions at St. Jude Medical.   Join us as we discuss his life's journey into leadership, his most valuables mistakes, keeping teams motivated in times of crisis, how to handle making unpopular decisions, and key trends in key trends in the global craniofacial fixation market.

What are Contract Research Organizations?   For any Medtech company, working with CRO’s allow them to outsource work that would otherwise require significant capital to do internally.   CRO's let you avoid buying expensive equipment and hiring or training staff for a short-term project.  Having independent oversight is critical to ensuring compliance, keeping your clinical research trial on track and bringing your device to market faster.   For this reason, many companies hire a clinical research organization (CRO) to monitor, audit, and even manage their trial.  Medical device trials in particular bring complex compliance challenges, so having a CRO with specific expertise in this area can be tremendously beneficial.  How can you be sure you hire a medical device CRO that is committed to ensuring compliance and is as invested in your success as you are?    In this episode of DeviceAlliance’s Medtech Radio, we speak with the Director of Regulatory Affairs at Inari Medical, Sarah Boundy Wong and Vice President Clinical Affairs & Market Dev. at JenaValve Technology, Inc., Vinny Podichetty.  Join us as we discuss the best-shared practices and methodologies for selecting a medical device CRO, where does one find CROs, the biggest selection considerations, and lessons learned from both of their professional experiences.  

COVID-19 has put the MedTech industry at center stage with unparalleled demand for diagnostic tests, personal protective equipment (PPE), ventilators, and other critical medical supplies.  In addition to the extraordinary measures underway to rapidly ramp up manufacturing capacity and capabilities, MedTtech companies are also looking outside their normal sector boundaries to explore creative solutions to strategize how they will supplement capacity, open-source equipment design, and address deployment of medically trained employees to support public-health needs.  Forward-thinking firms will need data to respond with new products, services, and operating models that can optimize the shifting landscape of healthcare and Medtech development.   Join us as talk with the CEO & Founder of LSI, Scott Pantel.  In this episode, we discuss the challenges of living in an era of an overabundance of MedTech data and how unique market insights remain an industry challenge. We explore why it's more important than ever for startups and large corporations to make their key strategic decisions based on unique and timely insights.   Learn about covid's impact permanently changing the MedTech landscape, and the new considerations the industry must face to address unmet clinical needs.

For medical device companies, the consumerization of Medtech represents a new paradigm. In the past, medical devices were more targeted toward healthcare providers and payers – now there is a demand for direct-to-consumer products.  People are demanding to have more control over their healthcare and they want the ability to proactively manage it.  The connected health and wellness devices market is expected to reach $612 billion by 2024, according to a report by Grand View Research Inc. and the wearable medical device market alone is projected to reach $14.41 billion by 2022, according to Markets&Markets Inc.  As Medtech explores opportunities within this business model, this consumerization will forever change how healthcare is delivered and medical device evolve.     In this episode of DeviceAlliance’s Medtech Radio, we speak with the FDA Consultant and President of Vascular Sciences, Dr. Michael Drues.  Join us as we discuss the consumerization of Medtech, defining what is a medical device vs. wellness device with respect to regulation,  the "essence" of these distinctions, interpretation of words, and one's ability to defend them in regulation, "Class 0" devices, and wellness devices impact on the evolution of medical devices.

Before one begins any new project, it’s important to understand where you fit into the grand scheme of things.  While you may be the person who had the brilliant idea in the first place, that doesn’t mean you know how to lead a company, or build a team, or build a prototype.  You can’t be all things to all people.  One needs to know what you’re good at, and then you need to know how to hire the best people to fill the positions that you can’t cover. The very first question you should ask is, am I the person who should lead my new company, or do I need to hire a leader who can take my idea and run with it? In this episode of DeviceAlliance’s Medtech Radio, we speak with the Chief Technology Officer at Balt, Dave Ferrera. He also serves as a member of the Board of Advisors to Spinal Singularity, a member of Sage Executive Group, and Chair Orange County American Heart Association Heart & Stroke Ball 2020. Join us as we discuss his upcoming book Innovation in Translation, the critical lessons learned through his early startups, and what it takes to build a team of "A players". Follow the great work Dave and team are doing at Quantum Fund OC. Connect with Dave on LinkedIn Dave's Book Recommendation - Iacocca: An Autobiography by Lee Iacocca Thanks for listening! Please share our podcast on LinkedIn, Twitter, and Facebook, and stay tuned for our next episode!

Medical device marketing teams are facing unprecedented times as we close out in 2020.    As companies emerge from COVID-19 constraints, marketing teams are struggling to refocus their respective work roles and manage the transition back to the workplace.  The challenges that marketing teams are facing are more daunting this year than ever. Product launches have been delayed, sales have been lost, and trade shows have been canceled.  We’re coming into business planning time and marketing teams will be forced to reckon with the usual “do more with less while at the same time achieving exponential growth” pressures.  Only this year, there’s more pressure than ever as teams look at how they can make up for lost time and dollars while managing supplier and manufacturing issues and other critical gaps in infrastructure.   Medical device companies have an opportunity to play a role in helping the hospitals solve these challenges that are bigger than the price of the device. By providing needed value-added services and support for hospitals that help address challenges such as infection control, patient throughput, and emergency room wait times, medical device companies can position themselves as indispensable partners. In this episode of DeviceAlliance’s Medtech Radio, we speak with the Founder of Bloom Creative, Svetla Kibota.  Svetla has more than twenty years of experience in the pharmaceutical, medical device, and medical technology sectors. She's managed a breadth of medical brands and spearheaded numerous product launches.  Prior to founding Bloom Creative, she led the marketing and client services teams at Lathian Health, an interactive medical marketing and medical education agency where she helped recruit clinicians to various digital campaigns. Before that, she worked across Europe and the U.S. for Gilead Sciences and Applied Medical Devices, in both marketing and sales roles.  Join us as we discuss... - Essential marketing strategize for Medtech companies - Pivoting from volume to value - The empowered patient model of marketing - Branding for 2021 and beyond - The impact of stories over facts - Optimizing digital communication tools

Deerfield Management and Stan Rowe created a therapeutic device incubator, NXT Biomedical.  NXT Biomedical expects to invest up to $25 million in cutting edge technologies over the next 5 years.  Deerfield has allotted up to an additional $250 million for the formation and development of five to eight startup companies that emerge from the incubator.  NXT Biomedical provides an exciting new pathway for exceptional science to be incubated with the world-renowned leadership while continuing to address major unmet needs with next-generation medical technologies. In this episode of DeviceAlliance’s Medtech Radio, we speak with the Co-Founder & CEO of NXT Biomedical, Stan Rowe.  Stan recently retired from Edwards Lifesciences where he was Chief Scientific Officer since 2008 and also served as Corporate Vice President, Advanced Technology.  He joined in 2004 when Edwards acquired Percutaneous Valve Technologies, a company he helped to found in 1999 and served as President and CEO.  Join us as we discuss Stan's life lessons learned in the Medtech industry, including... - What are the biggest mistakes R&D makes - Growing a company in his bedroom to being acquired - Biggest strategic considerations for innovation - Different types of accelerators - Addressing the future of unmet clinical needs

In January of 2020, Axonics Modulation Technologies, Inc. announced FDA approval of an enhanced, second-generation Programmer for its r-SNM® System under a premarket approval application supplement.  This medtech company has developed and is commercializing novel implantable rechargeable Sacral Neuromodulation (SNM) devices for the treatment of bladder and bowel dysfunction.  Axonics has received industry recognition for its technology, including one of FierceMedTech’s Fierce 15 Companies in 2017, 2018 Winner of a Medtech Insight Award: Best Technological Innovation, and a 2019 Finalist for a Medical Design Excellence Award.    In this episode of DeviceAlliance’s Medtech Radio, we speak with the CEO of Axonics, Raymond W. Cohen.  Raymond is an accredited public company director with over 35 years of experience in leading medical-device companies and serving as a board member at a number of private and publicly traded life science companies.  Join us as we discuss his personal journey through medtech leadership as he shares his valuable insights into what it takes to successfully identify market opportunities, create clinical and regulatory strategy, develop viable commercial products, and execute high level strategic planning. 

Accurate medical device labeling is a critical component to any quality control system. Often though, labeling is only considered at the end of the packaging process, which in itself, is often at the end of medical device design and production. Typically, product engineers develop a device, and only then start to think about how they are going to package and sterilize it. And, then after all that work is done, and typically only after that, do OEMs (original equipment manufacturers) and their contract packaging partners consider the labeling requirements.  Yet, many downstream quality issues are the result of incorrect labeling and/or ill-conceived quality controls that do not provide the proper monitoring at each stage. These can result in drastic consequences from the US and/or EU regulatory bodies, and more importantly to the health of the patient. If the wrong components are incorrectly labeled or not labeled at all, the negative downstream effects can be considerable.   In this episode of DeviceAlliance’s Medtech Radio, we speak with CEO of Pro-Tech Design and Manufacturing, Pam McMaster, and her son Aaron Swanson President of Pro-Tech Design & manufacturing.  PRO-TECH is a family-owned, full-service FDA and ISO 13485 registered medical device contract manufacturer who specializes in medical device assembly and packaging, laboratory services and custom sewn products.  Join us as we discuss what most medical device companies forget about, defining and optimizing work flow, the importance of your sterilization method to materials selection, how to navigate an audit during a pandemic, and what opportunities have arisen in this new Medtech environment.

With the flurry of activity that has been happening in the Medtech industry, having a proper strategy for conducting interviews virtually and in-person is more important than ever.  All professionals have engaged in the interview process.  However, there is an astonishing lack of effort given to systematic attempts at building improvements into this age-old process.  Interviewing remains one of those activities which we think we know all about merely because we have been doing it so long; we have been lulled by habit.  It seems apparent that a modest effort aimed at an analysis of our resume writing and interviewing techniques would yield generous returns.  Even though most jobs don't require smooth-talking skills, getting through the interview often does. In this episode of DeviceAlliance’s Medtech Radio, we speak with SVP of Recruiting and Development for McDermott & Bull Executive Search, Denae Bluthemann.  With 20 years of recruiting experience, she has seen recruiting from all perspectives.  She holds an advisory board role for Project Activate, which is an organization that helps individuals at all levels create a path to their dream job. Join us as we discuss the winning techniques for resume writing and job interviews.  Topics include... -  The most important considerations for virtual interviewing -  Addressing resume job and skill gaps effectively -  Creating a resume with directional focus and results -  Addressing resume job and skill gaps effectively -  Why the first five minutes of an interview is absolutely critical -  How to best position your "selling points" -  The S.T.A.R. method for ensuring interview success -  How to close every interview

ScaleHealth is an innovation ecosystem focused on connecting great innovators in the health/wellness space, with the strategic resources and partnerships with the goal to impact communities in need.  On April 7th ScaleLA formally announced that it will be renamed ScaleHealth, a move which coincides with the announcement to open a 2nd location in Orange County.  This location will be launched in partnership with The Innovation Institute, a nationwide leader in healthcare provider innovation, and will be housed at the Innovation Lab in Newport Beach.   In this episode of DeviceAlliance’s Medtech Radio, we speak with CEO of ScaleHealth Taylor McPartland.  Join us as we discuss his unique background into entrepreneurship, ScaleHealth's mission to build a global health innovation ecosystem, why Orange County was the perfect next step for their strategic growth, and much more!

To celebrate our 4th Annual Woman in OC Medtech Event, we will be doing a interview with event panelist Marinela Gombosev.  Marinela is CEO of Evoke Neuroscience, a data and diagnostics company focused on reducing the number of people living with treatable cognitive impairment.  After immigrating into the United States as a war refugee from Bosnia at the age of 14, she went on to complete her undergraduate studies in Electrical Engineering at the University of California, Irvine and received an MBA from Pepperdine University where she was recognized as a “Top 40 under 40” alumna.  In 2015, Marinela was inducted into the University of California, Irvine School of Engineering Hall of Fame as the youngest recipient of this award.  She has spent her entire 15 year career in regulated industries, the most recent 10 of which have been in medical devices.   In this episode of DeviceAlliance’s Medtech Radio, we discuss her experience coming to the US, the importance of why soft skills in leadership are essential in these times, the impact of Alzhimers's Disease and Evoke Neuroscience's solution for cognitive impairment, what women can do to prepare themselves for success during these times, and much more!

In November of 2019, DeviceAlliance celebrated its 10th year anniversary.  This was a huge milestone for the organization given that data from the National Center on Charitable Statistics reveals that approximately 30% of nonprofits fail to exist after 10 years.  According to Forbes, over half of all nonprofits that are chartered are destined to fail or stall within a few years due to leadership issues, driving community engagement, and the lack of a strategic plan, among other traits.  One of the most common traits of nonprofits that have longevity is having “Servant Leaders” who are passionate for their organization's mission. In this episode of DeviceAlliance’s Medtech Radio, we speak with Senior Advisor, Finance Chair, and Past President of DeviceAlliance, Kevin McNerney.  Join us as we discuss his involvement starting DeviceAlliance, the critical lessons learned in running a nonprofit, and the essential traits an organization needs to mobilize and inspire others.

Orange County-based medical diagnostic company Fluxergy has taken the next step toward getting a high-speed test for COVID-19 available for use.  Fluxergy submitted an emergency use authorization request to the U.S. Food and Drug Administration Center For Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company’s test system as a COVID-19 diagnostic at the point-of-care. Advanced rapid point-of-care tests for COVID-19 may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing. Fluxergy’s on-site sample- to-answer test for COVID-19 requires a very small sample, typically a nasal swab, which is mixed with a reagent solution, loaded onto a card and inserted into the analyzer in a two-step procedure.   In this episode of DeviceAlliance’s Medtech Radio we with speak CCO of Fluxergy, Dr. Ali Tinazli.  He also serves as Business Partner & Strategy Advisor with Immunaccel, and is a Member of the Strategic Advisory Board of InnVentis Ltd.  Join us as we discuss Fluxergy's goal to make laboratory testing accessible everywhere, the challenges facing current labs, and how our current environment is acting as a catalyst for the next generation of medical device innovation.

Before one begins any new project, it’s important to understand where you fit into the grand scheme of things.  While you may be the person who had the brilliant idea in the first place, that doesn’t mean you know how to lead a company, or build a team, or build a prototype.  You can’t be all things to all people.  One needs to know what you’re good at, and then you need to know how to hire the best people to fill the positions that you can’t cover. The very first question you should ask is, am I the person who should lead my new company, or do I need to hire a leader who can take my idea and run with it?   In this episode of DeviceAlliance’s Medtech Radio, we speak with the Chief Technology Officer at Balt, Dave Ferrera.  He also serves as a member of the Board of Advisors to Spinal Singularity, a member of Sage Executive Group, and Chair Orange County American Heart Association Heart & Stroke Ball 2020.  Join us as we discuss his upcoming book Innovation in Translation, the critical lessons learned through his early startups, and what it takes to build a team of "A players".

After giving birth to her second child in 2011, Jill Bigelow was frustrated that her hospital’s solution for her pelvic discomfort was ice in a rubber glove, gauze underwear and pain medication.  After scouring both the medical and maternity markets, Bigelow was surprised to discover there was no singular product that truly addressed all her physical ailments as a new mom.  With her entrepreneurial spirit, she set out to design a product for modern mamas that helped them heal their bodies from the physical damage of pregnancy and childbirth.  In 2013, her prototype was classified by the FDA and in 2014, she celebrated the launch of her company PELV-ICE™ and its first medical device of many, the Mama Strut™. In this episode of DeviceAlliance’s Medtech Radio, we speak with the Founder of PELV-ICE LLC, Jill Bigelow.  Join us as we discuss her journey as a medtech founder and how she identified a huge gap in women’s health care, the importance of marketing/brand awareness, and lessons learned through her entrepreneurial challenges.

n recent years, research on light therapy has moved from the fringes of scientific discovery to something closer to the mainstream.  Its commercial uses are now following the same path, as these devices, once available only in spas, gyms, or dermatologists’ offices, become increasingly affordable for consumers.  Meanwhile, the research is only getting more ecstatic.   BioPhotas Inc. is providing unique devices founded on NASA-developed technology and backed by clinical studies, that conveniently treat a variety of skin, muscle and joint conditions.  By the end of 2019, Celluma received the Innovative Product of the Year Award from The Aesthetics Journal in the United Kingdom.   Celluma has already received another three Product of the Year awards from U.S.-based skin care journals, including Dermascope Magazine’s award for Best Full Body LED device, for the company’s innovative Celluma DELUX.   In this episode of DeviceAlliance’s Medtech Radio, we speak with the President & Chief Executive Officer at Celluma by BioPhotas, Patrick Johnson.   Join us as we discuss his journey as a medtech founder while sharing his insights on how his philanthropic passions drove his purpose, lessons in leadership, and his role of ringing to market safe, effective and affordable devices that unlock the clinical power of low-level light therapy.

LensGen is a clinical stage company headquartered in Irvine, California focused on restoring youthful vision to millions of cataract and presbyopia patients. With its innovative Juvene™ modular fluid optic intraocular lens the company aims to treat vision correction errors and provide spectacle independence to patients affected by cataracts and/or presbyopia.  Their leader is a serial entrepreneur with 25 years of experience in the ophthalmic pharmaceutical and device industry.  What are some of the key strategic insights to scaling a startup to a large scale medtech organization? In this episode of DeviceAlliance’s Medtech Radio, we speak with the CEO of Lensgen, Inc., Ramgopal Rao. Ram is the Inventor, Founder, and Chief Executive Officer of LensGen, Inc., a clinical-stage medical device company that is developing a novel intraocular lens for presbyopia. Currently, he is also Chairman of the Board of 2C Tech Corporation, Inc., an emerging medical device company that is developing a novel nanotechnology application for preservation of vision for patients with degenerative retinal diseases.  Join us as we discuss his journey as a medtech founder as he shares his insights on understanding the long game, the role of clinical innovators & investors, the difference between money and smart money, and embracing your entrepreneurial passion.

Podcast Recap – looking back on our 1st year with Device Alliance Medtech Radio, we’re thrilled to have built such a healthy following with 7,000+ listens to date. One of our favorite episodes was with Mike Mussallem, CEO of Edwards Lifesciences. Mike’s perspective on what’s needed in OC to keep the medtech engine going was both insightful and refreshing. If you missed this episode when it first aired in August of 2019 you’ll want to make sure to listen in now.

Medtech entrepreneurship is on the rise, and for good reason.  The continual growth that’s seen within the life sciences industry in Orange County has been attracting an increasing number of international investors and VC firms.  Venture capital firms have set their sights on the Southern California life sciences industry, which is displayed by the fact that the amount of VC investment for 2018 was around $7.6 billion for biotech and medical devices.  It's a good time to be involved in the startup scene.  Yet entering the world of medtech startups is complex and rife with unique challenges.  When 90% of startups fail, what does one need to know about the 10% that don't?  What are the best practices to cover blind spots one may have when launching a medtech startup? In this episode of DeviceAlliance’s Medtech Radio, we speak with the Director of LaunchPad & Investor Relations at OCTANe OC, J.C. Ruffalo.  Join us as we discuss how to properly launch your startup medtech company, creating a cohesive business plan, and amplify your capital funding strategy.  Learn insight from over 600 successful LaunchPad Alumni since 2010, and discover why LaunchPad ranks in the top 5 out of over 900 SBDCs in the United States. 

Last September of 2019, Foldax, Inc. announced its first-in-human use of the Tria heart valve under its FDA Early Feasibility Study (EFS) for the treatment of aortic valve disease.Tria heart valves combine LifePolymer™, an advanced biopolymer material, and a patented design to create a valve with the potential lowering the cost of medical care given the increasing costs of using animal tissue valves and the associated durability and calcification concerns.  The proprietary biopolymer material and design of the Tria heart valves also allows for high volume manufacturing. The valves are robotically manufactured to provide the highest level of quality and precision and allow for future patient customization, while eliminating the variability of human production.  In this episode of DeviceAlliance’s Medtech Radio, we speak with the Executive Chairman of Foldax Inc., and Exec Chairman Chief Strategy Officer of Compellon Inc. Ken Charhut.  Join us as we discuss how this ground breaking technology was created, what major milestone this represents for heart valve patients worldwide, and how the progress toward mitral and transcatheter versions of the valves next year have the potential to revolutionize the heart valve industry. 

Strokes are the number one cause of disability in the world, and the second cause of death globally.  In addressing this challenge, Medtronic grew to become the largest medical device company in the world.  With key strategic acquisitions, Medtronic experienced unparalleled growth.  In such a business environment, how does a professional adapt the change agility to scale themselves at the same rate as the business? In this episode of DeviceAlliance’s Medtech Radio, we speak with the Vice President and General Manager Neurovascular with Medtronic, Stacey Pugh.  With over 16 years in medical device, Stacey has served several key leadership roles, including Vice President, Global Medical Affairs, Neurovascular with Covidien and Sr. Director, Global Clinical Development with Kinetic Concepts.    Join us as Stacey shares her personally journey from her background as a nurse at the patient's bedside, to becoming a key leader of the fast growing business division of Medtronic.

The City of Hope will invest $1 billion in a new hospital and research center in Irvine that will enhance the way cancer care is delivered in the region.  The large-scale facility will include a hospital and a research facility conducting clinical trials of new drugs and medical devices.  The cancer incidence rate in Orange County is projected to increase by 18% over the next decade, as cancer risk increases with age and the county’s population is aging faster than the U.S. average. In this episode of DeviceAlliance’s Medtech Radio, we speak with the President, City of Hope Orange County, Annette Walker.  She served as president of strategy for Providence St. Joseph Health and chief executive of St. Joseph Health.  In 2017 she was named one of the top 25 women in U.S. healthcare by Modern Healthcare magazine.  Join us as we discuss her professional journey in health care, the challenges fighting cancer today, and how the medical device community can help in that fight.

How does one take a medical device idea on a napkin to a 510k approval to market release as efficiently as possible?  How does one manage risk to drive the safety and quality of products and processes, while striving to be first in a innovative market?  How does one change their company’s focus from simply meeting regulations to building quality into their processes as a differentiator? How does one understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers? In this episode of DeviceAlliance’s Medtech Radio, we speak with Founder of Greenlight Guru, Jon Speer.  Join us as he shares his deep insights in the differences that help medical devices get to market faster with less risk. Greenlight Guru is the only quality management software platform designed specifically for medical devices companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more.

Did you know that 50% of concussions go unreported or undetected.  If you or a loved one had a concussion, what signs would you look for?  What should you do if you think you or your child has had a concussion?  How can clinicians collect objective data to make better-informed decisions about the nature of impairment, and the corresponding treatment needed to optimize recovery?  In this episode of DeviceAlliance’s Medtech Radio, we speak with Chief Clinical Officer of SyncThink, Inc. and Medical Observer for the NFL, Scott Anderson.  Join us as he shares his clinical expertise on what exactly a concussion is, signs of recognizing a concussion in yourself and others, and how SyncThink is assisting medical professionals in assessing brain health, monitoring health, and optimizing performance.  Scott also shares his experience with working at NFL games for the past seven years, and how the culture of concussion diagnosis and care has changed.

The medical device sector is one of the largest and fastest growing industries in Irvine.  As such, The Greater Irvine Chamber of Commerce is creating task forces to attract and engage talent from the community to meet tomorrow's challenges head on.  How can you be a part of strengthening Irvine's international profile and medtech ecosystem?    In this episode of DeviceAlliance’s Medtech Radio, we speak with the Executive Vice President of the Greater Irvine Chamber of Commerce, Linda DiMario.  Linda has over thirty years of sales, marketing and leadership experience in the tourism industry and economic development sphere.  Join us as she shares the the Chamber's action plans to bring global medical device companies to Irvine by leveraging its diversity, innovative prowess, and collaborative strength!

In this episode of DeviceAlliance’s Medtech Radio, we interview Chairman and CEO of Edwards Lifesciences, Michael Mussallem.  Join us as we speak with Mike about how Edwards plans to support Orange County's medical device community, and what we can do to drive collaboration, innovation, and career development for all device professionals in Southern California.

Eradicating the enduring social stigma related to mental health conditions is uniquely challenging.  The nature of mental health services can make it difficult to develop medical device technology that successfully intervenes in human behavior and actually creates measurable, positive outcomes. Many times the most difficult task is to simply have the conversation. One inspiring woman is, and she is the recipient of our first DeviceAlliance Woman STEM Scholarship Award.    In this episode of DeviceAlliance’s Medtech Radio, we interview Joanne Ly.  She serves as Multimedia Director and Associate Editor at GPS-Biomed and is a doctoral student at UCI. 

When people talk about having a purpose in your professional or personal life, they often sound like a self-help book. However, having a purpose in your work and life can help you become more motivated and push you to go above and beyond. When we talk about ‘finding your purpose’, we’re referring to an overarching goal that drives you.  This can be anything, such as reaching the top of your company or even raising a family. Whatever your goal may be, the idea is that having something to aim for will help you put your best foot forward day after day.  In this episode of DeviceAlliance’s Medtech Radio, we interview Jeff Blanton of the Blanton Group. The Blanton Group focuses on transforming the potential of a business by discovering and implementing the combination of business and personal purpose. Join us for an in depth discussion on the keys to success, and how to marry one's desires, strengths, and passions with the collective goal of the business.

In this episode of DeviceAlliance’s Medtech Radio, we interview Jörg Lorscheider, Director Of Sales & Marketing at Omnica along with Earl Robinson, President at Omnica.  Join us for a in depth discussion on the unique challenges of medical device product development, the difference between products that "go big" and those that struggle, and the perils of being first in a ever fast paced market of innovation.