Project Medtech

In this episode, Amy and I discuss Pain Care Labs, her apperance on shark tank, why the adoption of new medical technology takes so long, hurdles when taking a product to market, and more.  

Dr. Amy Baxter Bio: As Founder and CEO of Pain Care Labs Pain Relief, Dr. Amy Baxter’s mission is to eliminate unnecessary pain.

She invented and patented VibraCool® Vibrating Cryotherapy to treat tendinitis and decrease opioid use, and her Buzzy® device has been used to control needle pain for over 32 million needle procedures. She has been named a Healthcare GameChanger, Healthcare Transformer, Wall Street Journal “Idea Person”, Most Innovative CEO of the Year by GA Bio, a Top 10 Disruptors in Medical Tech, and “Top Women in Tech to Watch” by Inc. She is currently developing a wearable VibraCool Low Back pain reliever to accompany VibraCool Knee Pain and VibraCool Elbow Tendinitis Relief, and exploring regenerative implications of thermal and vibratory energy.

After graduating from Yale University and Emory School of Medicine, she completed pediatrics residency and child abuse and emergency pediatrics fellowships. Prior to becoming a full-time CEO, double-boarded pediatric emergency physician Dr. Baxter founded and directed PEMA Emergency Research, Scottish Rite, Children’s Healthcare of Atlanta.

Federally funded for her work in needle pain management, she has published multiple first author papers and textbook chapters and lectures nationally and internationally on sedation, procedural pain management, and the incidence, cause and consequences of needle phobia. To develop her neuromodulation pain reduction platform, Dr. Baxter was awarded a 1.1MM Fast-Track SBIR by the NIH. She wrote the patents for cooling and vibration utilization to decrease pain, and prepared and filed the FDA 510K submission for medical devices, securing the FDA expansion of the utilization to include muscle pain and cosmetic injection pain control.

A founding Board Member of the Society for Pediatric Sedation, additional experience includes the Standish board for hospital pain relief, Trustee of the Robert A. Heinlein Butler Library, Editorial Boards of Medscape and Elsevier Pediatrics, and Board Member of the International Women’s Forum Georgia Chapter. She has been named a Fellow of the American Academy of Pediatrics and the American College of Emergency Physicians. Dr. Baxter reviews for multiple scholarly journals, conferences, and national and international grant boards.

Speaking venues include Exponential Medicine, Bloomberg, Converge, AARP Life at 50+, TEDx and TEDMED. Dr. Baxter is known for creating and validating the BARF nausea scale for children with cancer. She is also known for turning down Mark Cuban, Robert, and Mr. Wonderful on Shark Tank.

In this episode, Jon and I discuss Greenlight Guru, how he founded the company, thinking about quality early, advice for start-up companies, and why he loves the medical device industry.  

Jon Speer Bio: Jon is the founder and VP of QA/RA at Greenlight Guru (quality management software exclusively for medical device companies) & a medical device guru with nearly 20 years industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.

In this episode, Kevin, Neil and I discuss how to think about intellectual property as a medical device company, when to think about it, and how IP fits into the overall company strategy.

Neil Thompson Bio: Neil is a patent agent who worked for years in the medical device industry as a product development engineer. He became a patent agent while working as an engineer to lessen the load of outside counsel drafting patent applications. Working at both startups and larger companies, Neil has been involved with the patenting process in both environments.

In addition to drafting and prosecuting patent applications, Neil has led workshops in IP for SCORE and IP webinars for Orthopedic Research Society and the Society for Biomaterials. He currently hosts a meetup group for patent practitioners. Right before joining Torrey Pines Law Group, he worked as a freelance patent agent. He also uses his medical device background to advise small companies on packaging design and development.

Neil is also passionate about public speaking for those in STEM. He created a course, Teach the Geek to Speak, to help engineers and scientists with their public speaking, especially when presenting in front of decision makers and those outside of STEM. He is also the author of a children's book, “Ask Uncle Neil: why is my hair curly?” The story focuses on Neil’s nephew asking him why his hair is the way it is, and Neil uses science to answer the question.

Neil received a Bachelor of Science degree in Materials Engineering from the University of Toronto, and graduate degrees in Bioengineering and Biomedical Engineering from Clemson University and Columbia University, respectively. He is also a Professional Engineer.

Kevin Buckley Bio: I am first, and foremost, a patent attorney. There are currently about 30,000 of us worldwide, and I am proud to be a part of this group. As a *biotech* patent attorney, however, I focus on helping our clients protect and bring lifesaving technologies to the world.

This certainly involves international patent law, but also involves international commercial competition, government regulations, litigation, medical device/drug/biological regulatory approvals, product branding, R&D strategy, and business strategy.

I am a biochemist by training but spent the past 20+ years as a patent attorney helping our clients commercialize their innovations. I was previously:

· a partner in a large US law firm where I led the Life Sciences Practice,

· Chief Legal Officer to the Research Foundation of the largest US university, and

· in-house counsel to a variety of startup companies where I developed complex legal strategies for commercializing artificial intelligence (AI) implemented technologies.

Technical fields in which I specialize include medical device, biotechnology, pharmaceutical, diagnostics, and AI technologies.

In this episode, Henry and I discuss the important collboration between engineering and marketing/sales during product development, the younger generation of medtech professionals entering the field, and much more. 

Henry Peck is part of the Clinical Innovation Team at Johnson & Johnson Robotic & Digital Solutions 

In this episode, Hitesh, Peter and I discuss Nutromics, the problem they see in healthcare, lessons learned so far, and advice for medtech start-up companies. 

Peter Vranes bio:

Peter Vranes is a Chemical Engineer and serial entrepreneur. Peter is the co-founder of Nutromics, an Australian MedTech company revolutionising healthcare through continuous real time molecular monitoring. The company’s innovative Smart Patch biosensor platform will solve some of the biggest healthcare challenges we face today in the fields of chronic disease prevention, chronic disease management, acute diseases and Therapeutic Drug Monitoring.

Hitesh Mehta bio:

Hitesh is Co-Founder and Co-CEO at Nutromics (Nutromics.com.au) and passionate about bring innovative new wearable and AI driven health-tech products and solutions to the market for impact. Hitesh has more than 10+ years of experience consulting globally within Healthcare and previously worked at IBM Watson Health.

In this episode, Alex and I discuss Medstartr, crowdfunding in the medical device and digital health space, how to use crowdfunding to validate your product and raise money, and more.  

Alex Fair is the Founder and CEO of MedStartr.  He originally trained as a scientist, working in physics, then cancer and finally in heart disease research. In the 90s he had an idea for a company that took off so he finished off his last paper and came into the world of business. MedStartr is his 7th startup and his favorite so far. Other creations include Expert-Med, Scanbuy.com, FairCareMD.com, MPADS.com, Dr1st.org and the Pinnacle Consulting Group as well as dozens of corporate entities and products for clients and employers over the years. Alex Lives in Long Island, New York and is the proud dad of two wonderful kids.

In this episode, Bhavana, Mike and I discuss PCI Ventures, healthtech in the Philidelphia, advice for start-up companies and more.

Mike Dishowitz Bio: Dr. Dishowitz manages a portfolio of PCI Ventures startup companies,   focusing on life science sector, including therapeutics, medical devices and diagnostics. His primary responsibility is to build businesses that   commercialize Penn intellectual property by recruiting management, developing   business strategies, fundraising, board management, supporting company   operations, and executing deals.

Prior to joining PCI Ventures, Mike was a member of PriceSpective, a   boutique consulting agency, where he specialized in determining asset   valuation and pricing & market access potential of emerging life science   technologies. Before entering industry, Mike spent several years in academic   research, studying the impact of cell signaling pathways on orthopedic   tissue and repair. He was also co-founder of a startup company based on his   thesis research that uses a combination drug-device to promote bone formation   and regeneration.

Mike graduated with a B.S. in Mathematics from the University of Florida   and a Ph.D. in Bioengineering from the University of Pennsylvania. Dr. Mohanraj is a portfolio manager at   PCIV, working alongside Penn founders and entrepreneurs to create and grow   life sciences start-ups developing innovative medical device and diagnostic   systems, digital health tools, and therapeutics.

Bhavana Mohanraj Bio: Bhavana developed an interest in entrepreneurship during graduate school, wanting to understand how to translate research discoveries into commercial products. Initially focused on orthopaedic technologies, she co-founded a start-up company based on her research on a mechanically-activated drug delivery platform. After graduate school, Bhavana joined a medical device company, Biorez, developing regenerative implants to improve tendon and ligament healing. Now having returned to Penn, Bhavana joined the PCIV team, where she sits at the interface between academic research and company formation to help commercialize innovative technologies.

Bhavana graduated with a B.S and M.S. in Biomedical Engineering from   Rensselaer Polytechnic Institute and a Ph.D. in Bioengineering from the   University of Pennsylvania.

In this episode, Jeremy and I discuss healthcare innovation, the rise of surgical robotics, and the role Freehand plans to play in it.  

In this episode, Angelina and I discuss her incredible journey, quality management systems, MDR, and more.   

Angelina Hakim Bio: Angelina Hakim is the founder, Co-Owner and CEO of QUNIQUE GmbH. She developed her experience through the different stations of her career at global medical devices manufacturers as well as consulting organizations. At Olympus Winter & Ibe, Institut Straumann and Schiller AG she was exposed to medical devices from classes I to III and was responsible for documenting and establishing procedures, work instructions and compiling the technical documentation in compliance with applicable international standards and regulations. Thanks to her detailed knowledge of MDR 2017/745, IVDR 2017/746, Medical Devices Single Audit Program (MDSAP) and ISO 13485 requirements, Angelina is able to combine her past experience with the new requirements to train and support many customers around the world to adapt their quality systems and update their product technical documentation.