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.
Creighton ChaneyDr. Michael Dreus: The Consumerization of MedTech | Ep.37
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
Torey ConradStan Rowe: The Three Legged Stool | Ep.36
Dr. Lyon’s research interests center around the design, synthesis and application of soft (synthetic and natural polymer-based) nanomaterials in bioanalytical and regenerative medicine applications. Specific projects under investigation include the development of artificial platelet technologies, colloid-modified biopolymer scaffolds, self-healing polymer films, new bioanalytical sensors, and reconfigurable materials to direct cell proliferation and differentiation.
Creighton ChaneyAndrew Lyon: Leadership Beyond the Classroom | Ep.28
Warren Foust is the Worldwide President for Johnson & Johnson Vision surgical business. Most recently, Warren served as Worldwide President of Mentor where he also previously served as Vice President, U.S. Sales & Marketing. Under his leadership, Mentor has gained share, shown double-digit growth, and reestablished clear market leadership. Warren joined Johnson & Johnson through the acquisition of Synthes in 2011. In total, he spent 12 years in the orthopedics space in leadership roles in Trauma, Joint Reconstruction, Craniofacial, and Capital Power Equipment. Prior to that, Warren was part of sales organizations in the pharmaceutical space with Roche and Aventis. Warren has a master’s degree in Marketing and a bachelor’s degree in Public Relations with a minor in Business from the University of Alabama.
In this episode of DeviceAlliance’s Medtech Radio, we speak with Worldwide President, Johnson & Johnson Surgical Vision, Warren Foust. Join us as we discuss his experience leading through authenticity, the most important aspect of leadership during times of crisis, developing a culture that is patient-centric, and the inspiration of John Wooden in his life.
Creighton ChaneyWarren Foust: Leadership Through Authenticity | Ep.27
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 reveal 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 in starting DeviceAlliance, the critical lessons learned in running a nonprofit, and the essential traits an organization needs to mobilize and inspire others.
Creighton ChaneyKevin McNerney: Where Everyone Knows Your Name | Ep.26
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”.
Creighton ChaneyDave Ferrera: Innovation in Translation | Ep.23
In October of 2019, Modulim, a recognized leader in optical imaging solutions for noninvasive tissue assessment, announced the appointment of RichardOberreiter as its new CEO. Modulim is a pioneer in subsurface optical imaging powered by SFDI, an advanced imaging technique co-invented by founder and CTO David Cuccia, Ph.D. SFDI is a noninvasive tissue oxygen saturation technology that combines structured illumination with multiple wavelengths of light (visible and near-infrared) to allow for deeper and layer-specific assessment of tissue oxygenation and hemoglobin. Modulim’s goal is to help clinicians reduce the number and severity of diabetic foot ulcers (DFUs).
In this episode of DeviceAlliance’s Medtech Radio, we speak with the CEO of Modulim, RichardOberreiter, J.D., M.B.A. Richard has for over 20 years successfully led new ventures and orchestrated turnarounds. Join us as we discuss the life lessons learned from his time as a US Navy Officer, leading a medtech team from the front, and never giving up the ship.
Creighton ChaneyRichard Oberreiter: New Frontiers in Vascular Health | Ep. 22
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.
Creighton ChaneyRam Rao: Vision with Purpose | Ep.19
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.
Creighton ChaneyRaymond Cohen: Persevering in OC Medtech | Ep.18
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 to lower 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 allow 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 groundbreaking 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 has the potential to revolutionize the heart valve industry.
Creighton ChaneyKen Charhut: The Future of Heart Technology | Ep.16