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From Clinical Need to Market: How Medical Devices Are Built w/ Stuart Broyles of MDM2 - AZ TRT S07 EP06 (288) 3-29-2026
From Clinical Need to Market: How Medical Devices Are Built w/ Stuart Broyles of MDM2 - AZ TRT S07 EP06 (288) 3-29-2026       What We Learned This Week:  Medical devices can take a decade to reach patients Bringing a medical device to market isn’t quick. Phoenix is quietly becoming a major MedTech hub The Valley has a growing cluster of medical technology companies including: The biggest risk in medical innovation is building something doctors don’t need One of the most common failures in MedTech is creating technology without validating the clinical problem first. Universities often invent the technology—but companies bring it to life Many medical device ideas originate in research labs. The future of healthcare innovation depends on collaboration Successful medical device innovation requires an ecosystem     Guest: Stuart Broyles, PhD LKIN: https://www.linkedin.com/in/stuart-broyles-phd/   Stuart builds connections that move ideas forward—from university research to real-world MedTech solutions. He was at WL Gore & Assoc. for nearly 3 decades working in MedTech at various levels and helped bring 13 devices to market. Also includes, university advisory roles, early-stage venture coaching, and innovation ecosystem development. Organization: MDM2 (Medical Device Manufacturing Multiplier)   Summary:  Medical devices can take a decade to reach patients Bringing a medical device to market isn’t quick. While some devices can launch in six months to a year, many take five to ten years once clinical trials and regulatory approvals are involved. That’s why early testing and feedback are critical. Phoenix is quietly becoming a major MedTech hub The Valley has a growing cluster of medical technology companies including: ·         Medtronic ·         Abbott Laboratories ·         Dexcom ·         West Pharmaceutical Services Add in research from Arizona State University and University of Arizona and the region is building a strong bioscience ecosystem. The biggest risk in medical innovation is building something doctors don’t need One of the most common failures in MedTech is creating technology without validating the clinical problem first. Organizations like MDM2 (Medical Device Manufacturing Multiplier) are working to connect startups directly with clinicians early in the process so companies can refine their products before investing millions. Universities often invent the technology—but companies bring it to life Many medical device ideas originate in research labs. Universities typically own the patents and license the technology to startups or companies that can develop and commercialize the product. Programs like the ASU Skysong Innovation Center and Tech Launch Arizona help bridge the gap between research and business. The future of healthcare innovation depends on collaboration Successful medical device innovation requires an ecosystem: • clinicians who identify real problems • engineers who build solutions • investors who fund development • manufacturers who scale production Arizona is building that ecosystem through groups like MDM2 (Medical Device Manufacturing Multiplier) and the Phoenix Bioscience Core.       Podcast Show Notes Guest: Stuart Broyles, PhD LKIN: https://www.linkedin.com/in/stuart-broyles-phd/   Stuart builds connections that move ideas forward—from university research to real-world MedTech solutions. He was at WL Gore & Assoc. for nearly 3 decades working in MedTech at various levels and helped bring 13 devices to market. Also includes, university advisory roles, early-stage venture coaching, and innovation ecosystem development. Organization: MDM2 (Medical Device Manufacturing Multiplier) Episode Topic: How Medical Devices Move from Clinical Need to Market   Interview recorded: March 2026 Segment 1 – The Medical Device Industry What Are Medical Devices? Medical devices include a wide range of technologies used to diagnose, monitor, or treat patients. Common examples include: ·         Coronary stents used to treat blocked arteries in the heart ·         Artificial limbs and prosthetics ·         Implantable devices used in cardiology ·         Monitoring technologies such as glucose sensors A well-known example is the glucose monitoring technology produced by Dexcom, which operates in the Mesa, Arizona area. Medical devices also include technologies used to treat circulation issues in arms and legs, along with remote monitoring tools used in modern healthcare. History of the Industry Medical devices began emerging in the 1950s, but the real acceleration occurred between the late 1970s and the 1980s. This era introduced breakthroughs such as: ·         Coronary stents ·         Artificial hearts ·         Prosthetic limbs Over time, the technologies have become: ·         safer ·         more durable ·         more precise Phoenix as a MedTech Hub The Phoenix metro area has developed into a significant medical device and bioscience ecosystem. Major companies with a presence in the region include: ·         Medtronic ·         Abbott Laboratories ·         Dexcom ·         West Pharmaceutical Services This sector is particularly important in the Phoenix Valley, which has a rapidly aging population, increasing demand for medical technology and healthcare innovation. Importance of Clinical Partnerships Successful medical device development requires close collaboration with clinicians and hospitals. In the Phoenix ecosystem, companies often partner with: ·         HonorHealth ·         Mayo Clinic Universities also play a major role in research and collaboration, including: ·         Arizona State University ·         University of Arizona Clinicians provide feedback during development, helping companies ensure devices actually solve real-world clinical problems. How Long It Takes to Bring a Device to Market Development timelines vary widely: Typical timelines: ·         6 months – fastest case observed ·         1 year – simple device pathways ·         Up to 10 years – complex devices requiring clinical trials Segment 2 – Stuart Broyles’ Career Stuart Broyles spent nearly 30 years at W. L. Gore & Associates (1995–2024). During that time he worked on multiple divisions developing cardiovascular and medical technologies. Key accomplishments include: ·         Participating in the commercialization of 13 medical devices ·         Working at the team member and leadership levels ·         Bringing complex devices through development and into the market Transition to Mentoring and Innovation After retiring in 2024, Broyles: ·         Did consulting and investing ·         Returned to the startup ecosystem ·         Became an Entrepreneur-in-Residence at Arizona State University He now works with startups through MDM2 (Medical Device Manufacturing Multiplier) helping early-stage companies navigate the development and commercialization process. Many of the companies he works with range from: ·         very early-stage startups ·         teams of just two or three founders ·         companies developing new medical manufacturing technologies MDM2 also partners with HonorHealth to help startups engage with clinical partners. Phoenix Innovation Infrastructure Several organizations contribute to the Valley’s health technology ecosystem: Research and innovation hubs ·         Phoenix Bioscience Core ·         Flinn Foundation Startup programs ·         WearTech Center ·         ASU Skysong Innovation Center Medical device and engineering companies ·         PADT (3D printing and product development) ·         BD (Becton Dickinson) Wearable Technology Innovation The WearTech Center in central Phoenix supports startups building wearable medical technologies. Examples include companies such as: ·         Gravitrex ·         Hemasense One demonstration project includes a mock apartment designed to test monitoring systems for independent living seniors, helping companies validate technology in real-world environments. WearTech also hosts quarterly demo days where startups present their technologies to investors and industry partners. Segment 3 – Clinical Trials and Product Development The Need for a “Clinical Innovation Sandbox” A major challenge for startups is access to clinicians who can provide meaningful feedback during early development. MDM2 is working to create a system where: ·         startups can regularly meet clinicians ·         products can be demonstrated in person ·         real clinical feedback is gathered early This helps companies determine whether a product actually solves a meaningful healthcare problem. Continuing Medical Education (CME) Forums MDM2 is developing CME forums that allow clinicians to: ·         learn about emerging medical technologies ·         discuss product concepts ·         provide guidance during early development These sessions also create opportunities for honest feedback before expensive trials begin. One of the first sessions included collaboration with: ·         HonorHealth ·         Hemasense Clinical Trials Outside the United States Clinical trials in the U.S. can be complex and slow due to regulatory requirements. As a result: ·         many companies run trials in Europe or Asia ·         approval processes may be faster ·         testing costs may be lower Improving regulatory efficiency in the U.S. remains a challenge for medical device innovators. Intellectual Property and Universities Many medical technologies originate in universities. In these cases: ·         the university typically owns the intellectual property ·         companies license the technology to commercialize it Technology transfer organizations help bridge the gap between research and commercialization. Programs supporting this in Arizona include: ·         ASU Skysong Innovation Center ·         Tech Launch Arizona These programs help connect professors with entrepreneurs who have experience bringing products to market. Segment 4 – The Future of Medical Device Innovation in Phoenix Phoenix and Arizona are increasingly positioned as a national hub for bioscience and medical device innovation. Key advantages include: ·         strong manufacturing capabilities across the state ·         major university research centers ·         growing healthcare systems ·         startup accelerators and incubators New startups frequently spin out of larger companies like: ·         W. L. Gore & Associates ·         Medtronic These larger companies sometimes help fund and mentor new ventures. Building a Strong Innovation Ecosystem A successful innovation ecosystem requires collaboration among: ·         universities ·         hospitals ·         manufacturers ·         investors ·         startups Arizona is actively building this network to support long-term growth in the medical technology sector. Advice for Entrepreneurs For founders looking to build a medical device startup: 1.    Work with clinicians early in development 2.    Validate the problem you are solving 3.    Understand the regulatory pathway 4.    Build partnerships with universities and hospitals 5.    De-risk the concept before large investments Ultimately, success depends on proving value to three key stakeholders: ·         clinicians ·         investors ·         patients Organizations Mentioned Medical Device Manufacturing Multiplier MDM2 (Medical Device Manufacturing Multiplier)https://www.mdm2.org/ MDM2 works to strengthen Arizona’s medical device manufacturing ecosystem through partnerships with universities, hospitals, and startups. WearTech Center WearTech Centerhttps://www.azweartech.org/projects Focus areas include: ·         wearable health technologies ·         remote monitoring systems ·         aging-in-place innovations   If you want to learn more about the growing medical device ecosystem in Arizona, visit the website for the MDM2 (Medical Device Manufacturing Multiplier) and explore how they’re helping startups move innovations from the lab to the patient.     Tech Topic: https://brt-show.libsyn.com/category/Tech-Startup-VC-Cybersecurity-Energy-Science  Best of Tech: https://brt-show.libsyn.com/size/5/?search=best+of+tech   ‘Best Of’ Topic: https://brt-show.libsyn.com/category/Best+of+BRT      Thanks for Listening. Please Subscribe to the AZ TRT Podcast.     AZ Tech Roundtable 2.0 with Matt Battaglia The show where Entrepreneurs, Top Executives, Founders, and Investors come to share insights about the future of business.  AZ TRT 2.0 looks at the new trends in business, & how classic industries are evolving.  Common Topics Discussed: Startups, Founders, Funds & Venture Capital, Business, Entrepreneurship, Biotech, Blockchain / Crypto, Executive Comp, Investing, Stocks, Real Estate + Alternative Investments, and more…    AZ TRT Podcast Home Page: http://aztrtshow.com/ ‘Best Of’ AZ TRT Podcast: Click Here Podcast on Google: Click Here Podcast on Spotify: Click Here                    More Info: https://www.economicknight.com/azpodcast/ KFNX Info: https://1100kfnx.com/weekend-featured-shows/  
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