UNMET NEED

Michael Ragan is the Executive Director at Morgan Stanley. This  episode was recorded live as part of Morgan Stanley's 19th Annual Global Healthcare Conference. Michael interviews Unmet Need's host, Jeff Smith, who is the Co-founder & CEO of Providence Medical Technology. Their discussion is centered around the unmet need Providence is addressing for high-risk cervical patients.

Providence Medical Technology
FUSE Study

Nick Desai is an accomplished and visionary entrepreneur who has started and led four venture funded start-ups over the last 18 years. Nick is the Co-Founder and former CEO of Heal, an on-demand doctor house call app available in Los Angeles, Orange County, San Francisco and San Diego. For Nick, Heal is more than a company – it’s a mission to fix the broken $3 trillion healthcare system.

Nick’s previous start-ups have been innovative leaders in technology-enabled fitness and weight loss, social media and mobile applications, and the web’s first self-updating address book.

Nick earned his BS in Electrical and Computer Engineering from UC Irvine, where he is in the Engineering Hall of Fame, and an MS in Electrical Engineering from UCLA. Nick is on the board of the UC Irvine Alumni Association and the Los Angeles Chapter of the American Heart Association.

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

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

Motivational coach and wellness guru Holly Rilinger is known for inspiring others to dig deep to make positive lifestyle changes. Nike Master Trainer, Red Bull athlete, former professional basketball player, author, founding Flywheel Instructor, star of Bravo’s Workout New York and Creator of LIFTED. Holly’s Signature LIFTED Method combines the power of movement with the peace of meditation to create a complete wellness experience. Holly is a leader and innovator in the wellness industry with over 20 years of experience. Holly uses her life experiences both as an elite athlete and coach coupled with her degree to help motivated individuals find balance and success in their lives. Her programs start with the body and mind but have a way of shaping your entire life.

Drop-in on a LIFTED class with Holly for 50% off using the Promo Code: "UNMETNEED"
Redeem your class here: https://www.holly.life/virtual-studio-single-classes

Check out Holly's book, LIFTED on Amazon: https://www.amazon.com/Lifted-Focus-Strengthen-Elevate-Spirit/dp/0738219940

Neil Oberoi is a Senior Managing Director at Guggenheim Securities. Guggenheim Securities is the investment banking and capital markets business of Guggenheim Partners, a global investment and advisory firm. Guggenheim Securities offers services that fall into four broad categories: Advisory, Financing, Sales and Trading, and Research. Guggenheim Securities is headquartered in New York, with additional offices in Chicago, Boston, Atlanta, San Francisco, and Houston.

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.

Shig Tanaka is the Vice President of Research & Development at Providence Medical Technology. He was the Co-founder of Prospect+Health and lead engineer of Kolum, Inc (acquired).   

Shig graduated from Stanford University with a degree in Product Design. His interests in mathematics, problem solving, and mechanical engineering were an ideal fit for the emerging field at a time when Computer Aided Design (CAD) was enabling rapid advancements in product development. Shig developed products for 15 years before leading Speck Design’s Medical Device practice. 

On this episode, Shig shares advice with aspiring entrepreneurs and product designers on how to advance from the idea stage to building physical prototype and ultimately commercializing healthcare innovations. As an added bonus, Shig explains how his “selfish” philosophy of working with people and selecting projects that make him happy provide the much needed motivation to overcome obstacles and persevere in the competitive healthcare field. 

Dr. Kris Siemionow is a board certified orthopaedic surgeon. He completed orthopedic surgery residency at the Cleveland Clinic Foundation and spine surgery fellowship at Rush University Medical Center. Dr. Siemionow's PhD focused on the effects of inflammation on nerve cell function.

Dr. Siemionow is the Co-founder & CEO of Holo Surgical, a company developing a proprietary neural network and algorithm to deliver the world's first-in-human digital surgery based on augmented reality and artificial intelligence.

Holo Surgical's clinical tested ARAI surgical navigation system provides real-time patient specific 3D anatomical visualization for surgical planning, intraoperative guidance, and post surgical data analytics.

Published clinical papers are available here