Date(s) - 04/25/2019
1:00 pm - 5:30 pm PT
Baker McKenzie, LLP
NAMSA’s complimentary Start-Up Summit provides a unique opportunity for early-stage medical device organizations to learn directly from NAMSA’s teams of medical device testing experts. This small, intimate gathering will offer attendees with limited medical device knowledge to draw upon NAMSA’s 50+ years’ experience with efficient, cost-effective product development. Presenters will draw upon real-world global development efforts to share recommendations, best practices and resources that are critical to successful market introduction and commercialization, including:
- Design and development
- Medical device testing
- Clinical research
- Regulatory strategy
Highlighted during the event will be the following presentations:
Product Development Process
Presented by Brian Doughty, MBA, MPA; Entrepreneur in Residence (NAGLREITER)
Times have changed for the medical device industry. Any new or innovative medical device concepts now days are rarely enough to gain investor interest or commitment, even when supported with unique or novel IP. Development professionals within the field not only need to understand why this ‘truth’ has evolved so dramatically, but also how it will drive change for future development efforts. Only then will device organizations truly recognize how to operate effectively within the new paradigm to become, and remain, competitive.
This presentation will:
- Explain how and why investment in novel medical device technology has quickly evolved;
- Formulate expectations related to paradigm shifts and understand their impact to the new product development operating environment;
- Identify necessary activities in order for start-ups to remain competitive in medical device innovation and development efforts;
- Identify the various development options that exist, and their key differences; and
- Understand the benefits of NAMSA’s MRO® approach, a process that accelerates development, reduces costs and drives value.
FDA Trends & Guidance for Industry
Presented by Jason Krzeszak; Director, Product Development Strategy (NAMSA)
The old adage that “the only constant in life is change” directly applies to the medical device landscape, and even more so to the U.S. Food & Drug Administration (FDA).
With a new Medical Device User Fee Act in its fourth iteration, a series of changes from the FDA are expected over the next five years. Likely shifts include shorter approval decision times, more patient involvement and increased utilization of real-world evidence. Broader trends in government, technology and society will also directly drive new requirements within the medical device industry. Staying abreast of these trends and understanding practical aspects of FDA roll-out is key to accelerating development of innovative technologies and creating successful product introductions.
This presentation will:
- Provide an understanding of current FDA regulatory trends;
- Allow an understanding of how to navigate the ever-evolving U.S. regulatory landscape; and
- Examine proven, time-tested strategies and frameworks that lead to accelerated regulatory approvals for any device type.
Regulatory Hurdles to Marketing Authorization: Is It Really That Complicated?
Presented by Jur Strobos, MD; Partner (Baker McKenzie, LLC)
This presentation will cover some of the legal challenges an early-stage medical device manufacturer can face when bringing a product to market. This presentation will:
- Identify what pathway to market provides the best Return on Investment for your product
- Discuss the do’s and don’ts in approaching the FDA
- Help prepare for the FDA-EU Medical Device Cabal
Start-Up Summit Panel Discussion
– Brian Doughty, MBA, MPA; Entrepreneur in Residence (NAGLREITER)
– Jason Krzeszak; Director, Product Development Strategy (NAMSA)
– Jur Strobos, MD; Partner (Baker McKenzie, LLC)
– Meredith Brown-Tuttle, RAC, FRAPS; Vice President-Regulatory Affairs (Regulatorium)
This panel discussion will allow attendees to interact with presenters from the day’s sessions and ask in-depth questions surrounding regulatory and product development strategies.
MEET THE SPEAKERS
Meredith Brown-Tuttle, RAC, FRAPS
Meredith has 26 years of industry experience from bench to clinic and approval of both drugs and devices. She has written and coordinated numerous drug and biologic submissions to U.S. and international regulatory agencies, developed global regulatory strategies and conducted worldwide regulatory intelligence. She owns and contributes to the much sought-after strategy/intelligence consultancy, Regulatorium. Meredith has written, managed and led over 30 successful domestic and international IND and NDA submissions. She is a founding instructor at UC-Santa Cruz Regulatory Certificate Program and author of two books: “IND Submissions: A Primer” and “Regulatory Intelligence 101.” Meredith graduated with a BA in biological psychology (neuroscience) from San Jose State University.
Brian Doughty, MBA, MPA
Brian brings over 19 years of healthcare company commercialization acting as a senior advisor to the executive team at Naglreiter. His expertise in understanding products, markets, reimbursement and sales processes has enabled him to drive product development and commercialization success in both Fortune 500 companies as well as start-ups. Prior to joining Naglreiter, he served as VP of Commercial Operations at Cardiovascular Systems, Inc. He has also served as the Marketing Director for EKOS Inc. and was the National Marketing Manager for Fox Hollow Technologies. Brian holds a Bachelor of Science in Public Administration, an MPA from Oakland University, an MBA from Michigan State University and an MA from Oakland University in Psychology.
Jason Krzeszak has 15 years of experience in product development of medical devices and joined NAMSA in 2018. Jason has led activities focusing on preclinical and clinical research of devices through the feasibility, premarket and post-market phases. Notably, Jason has held leadership positions within clinical affairs for both large and start-up companies, which also included cross-functional leadership responsibilities. He has clinical experience in vascular (cardiac, aortic and peripheral vascular), cervical spine and urinary stones, in addition to numerous applications of medical technology in the preclinical environment.
Jur Strobos, M.D.
Dr. Jur Strobos is a partner in the Washington, DC office at Baker McKenzie and provides legal, regulatory and policy advice to life science companies regulated by the U.S. Food and Drug Administration (FDA). He was a regulatory and policy official for FDA’s Commissioner and a credentialed federal law enforcement officer. During his prior practice, he had the opportunity to serve part-time as a senior executive managing legal, regulatory and product development at five start-ups and full-time as VP Clinical and Regulatory Affairs at a NYSE-traded company. His work resulted in approval of five new drugs, two premarket-approved medical devices, a cell therapy and a biological product. His work included strategic policy and evaluation of in-licensing or sale of products including acquisition and merger. From 2010 to 2017, Dr. Strobos taught a graduate level course on drug development at the University of California Berkeley. He has numerous publications on drug development, clinical trial design, statistics and pharmacovigilance.
Dr. Strobos has practiced FDA law (food, cosmetics, drugs, biological products, drugs, controlled substances, alcohol and tobacco) for 20 years before joining Baker McKenzie in 2016. He supports mergers and acquisitions, licensing, recalls and compliance to creative solutions to regulatory impediments that could delay marketing authorization on both a U.S. and EU basis. He assists with inspectional readiness, compliance agreements, delegation subcontracts with clinical sites, research and manufacturing organizations, Sunshine Act, False Claims Act, promotion and food safety, among others.