UNMET NEED

David Cash is the Founder and Managing Director of Medvest Capital. On this episode, Dave encourages entrepreneurs to have a clear mission & strategy to stay focused. Medvest’s product is growth capital but views VC as a service business and seeks to partner with Founders navigating the process of company building. Dave shares his early career experience as an entrepreneur and how it lead to medtech investing and eventually raising his first venture fund.

Providence Medical Technology co-founder and Unmet Need Podcast host, Jeff Smith, discusses the overwhelming results of PMT's FUSE Clinical Study which highlights the importance of posterior cervical fusion in combination and addition to anterior cervical decompression & fusion. Jeff also discusses what this means for patients, surgeons, and the spine community moving forward.

Roxanne Dubois has represented medical device companies as the primary liaison with the FDA and Notified Bodies for over 25 years. Roxanne forms collaborative working relationships with representatives of regulatory agencies to obtain clearance/approval for 510(k)s, IDEs, PMAs, and Design Dossiers for new medical devices and device modifications. Roxanne has hands-on experience writing regulatory applications (including three Original PMAs), responding to Agency questions and meeting in-person and by teleconference with FDA representatives. Roxanne’s experience also includes initiation of Quality Systems for start-ups, approval of new manufacturing facilities and facilitating on-site inspections by Regulatory Agencies (QSR, BIMO, pre-PMA, new facility and inspections by Notified Bodies and a Competent Authority). While mostly focused on Regulatory and Quality, she also has experience with Clinical Affairs and combination products.
Roxanne has served as the VP of Regulatory Affairs and Quality at SI-BONE, VP of Regulatory Affairs at Tenaxis Medical, VP Regulatory Affairs and Quality Assurance at Carbylan BioSurgery, Inc., VP Regulatory Affairs, Clinical Research and QA at ReGen Biologics and also as the Director of Regulatory Affairs at several mid-sized companies including Kyphon, Collagen Corporation and Cohesion Technologies. She has also consulted for medical device companies in a variety of fields such as orthopedic, gastroenterology, women’s health, dental and cosmetic surgery. Roxanne has a Bachelor of Science in Biochemistry from Cal Poly, San Luis Obispo.
Roxanne's Contact information:
m: 408-828-5019
e: [email protected]

Ariel Katz is the Co-founder and CEO of H1 Insight, a network dedicated to connecting healthcare professionals and companies with the aims of being the "Linkedin for healthcare."
Founded in 2017, H1 now has over 8 million HCP profiles in 16,000 institutions in 70-plus countries. Its clients, which encompass over 35 pharmaceutical companies, including seven of the top 10, use the platform to do things like find doctors to work on a clinical trial for a given biotech, find hospitals where they can do their clinical and find the thought leading healthcare professional to lead a CME session. H1 saw its revenue grew 350 percent year-to-year in 2019.
The company, which graduated from Y Combinator, recently raised it first institutional funding round, a $12.9 million Series A led by Menlo Ventures, along with Novartis dRx, Y Combinator, Baron Davis Enterprises, ClearPoint Investment Partners, Jeff Hammerbacher, Liquid 2 Ventures, and Underscore VC.

The response from "Episode #10 Winning The Patent Wars w/ David Shaw" was incredible. It was clear from the messages we received the Unmet Need community has more questions about IP litigation. David was kind enough to deliver an encore and on Episode #11 shares his 4 key concepts for litigation strategy.
David Shaw was Intuitive Surgical's Vice President, Legal Affairs and Chief Patent & Corporate Counsel (1999-2003) during the nascent stage of robotic surgery. His expertise in patent strategy, prosecution, and litigation helped Intuitive overcome early IP missteps to become the market leader with a present market capitalization of $80 billion.
David played a similar role at Kyphon (2003-2007) as Vice President, Legal Affairs General Counsel & Secretary where he helped the company defend the balloon kyphoplasty market it created and ultimately be acquired by Medtronic for $4 billion.
David received his B.S. in Chemical Engineering from North Carolina State University, earned his J.D. from Duke University School of Law, and served two years as a Law Clerk to Federal Judge Raymond C. Clevenger, III on the U.S. Court of Appeals For The Federal Circuit.
David currently consults with private medical device companies on patent strategy and helps entrepreneurs patent and defend the breakthrough innovations transforming the practice of medicine.
David Shaw
[email protected]
408-390-8329