Medical Device Data and Evidence: An Integrated Approach

One of the most formidable challenges in bringing a medical device to market is generating clinical and commercial evidence for a diverse group of stakeholders, such as the FDA, insurance payers and healthcare providers. It’s a complicated process where any misstep can lead to costly delays and a loss of profits. 

Join Orthogonal for a webinar bringing together distinguished MedTech leaders to share insights, case studies and best practices for developing effective evidence gathering strategies. These pioneers will speak to shifts in the regulatory and reimbursement landscape related to integrated data strategy, including Total Product Life Cycle (TPLC), Predetermined Change Protocol Plans (PCCP), CMS’s TCET pathway and FDA/CMS Parallel Review. They’ll also discuss a new industry collaborative from the Digital Medicine Society (DiME) working on an Integrated Evidence Plan for Digital Health Products.

You’ll leave this webinar with actionable advice to achieve success in obtaining evidence needed to satisfy stakeholders and set you up to successfully bring a medical device to market.

Agenda:

11:00am CT | Opening remarks

11:05am CT | Main program

12:30pm CT | Virtual networking with the speakers

1:00pm CT | Program concludes

ABOUT THE SPEAKERS

Kwame Ulmer

Managing Partner, MedTech Impact Partners

Kwame Ulmer is a med tech executive with over two decades of experience leading and advising public and private sector organizations to improve compliance, interpret FDA policies, conduct M&A due diligence and build impactful DE&I organizations.

Kwame currently serves as managing partner of MedTech Impact Partners, a regulatory strategy consulting firm, where he has grown the company by 89% CAGR and guided over fifty med tech companies through FDA approval and improved their enterprise value. Kwame also serves as venture partner of Wavemaker Three-Sixty Health, an early-stage venture capital firm with $84M AUM. Kwame leads the team in sourcing, diligence and support of med tech and diagnostic companies.

He is a member of the board of Essenvia, Inc, the Lincoln University Foundation, California Life Sciences Board and the University of Virginia Licensing & Ventures Group, where he also served on the search committee for its executive director. Kwame is a board observer of Strados Labs, Inc.

Bernhard Kappe

CEO & Founder, Orthogonal

Bernhard Kappe is the founder and CEO of Orthogonal. For over a decade, Bernhard has provided thought leadership and innovation in the fields of software as a medical device (SaMD), digital therapeutics (DTx) and connected medical device systems. As a leader in the med tech industry, Bernhard has a passion for launching successful medical device software that makes a difference for providers and patients, as well as helping companies deliver more from their innovation pipelines.

He’s the author of the eBook “Agile in an FDA Regulated Environment” and a co-author of the AAMI Consensus Report on cloud computing for medical devices. Bernhard was the founder of the Chicago Product Management Association (ChiPMA) and the Chicago Lean Startup Challenge. He earned a Bachelor’s and Masters in Mathematics from the University of Pennsylvania, and a Bachelor’s of Science and Economics from the Wharton School of Business.

Christian Johnson

Founder & CEO, ScoutMedix

Christian Jonson is a purpose-driven entrepreneur, startup advisor and strategy consultant dedicated towards the advancement and commercialization of breakthrough medical technologies, diagnostics and artificial intelligence enabled solutions. Over the last decade, Christian has led or supported market research, strategy, scouting, diligence, investment or commercialization activities for over 250 medical devices, health technologies and sustainability technologies worldwide.

Currently, Christian is founder and CEO of ScoutMedix, a med tech strategy, market research and go-to-market advisory firm. He also serves in strategic development at Essenvia – an innovative med tech regulatory (RIM) platform – is an advisor at the Lundquist Institute for Biomedical Innovation, is an advisor at Saving Hearts Foundation and is co-founder and board director at Seed Consulting Group.

Prior, Christian served as global vice president of product for a multinational in vitro diagnostic (IVD) company. He also was a senior fellow at the UCLA Biodesign Hub where he co-led the landmark industry study “Interstates and Autobahns: Global MedTech Regulation in the Digital Age”, in partnership with Boston Consulting Group. Before, Christian served in global strategy and marketing at Edwards Lifesciences. Finally, he’s a member of Forbes Councils, a TEDx speaker and recipient of “Best and Brightest” MBAs by Poets & Quants.

Jennifer McCaney

Co-Executive Director of UCLA Biodesign

Jennifer McCaney holds a dual appointment at UCLA Anderson School of Management and the UCLA David Geffen School of Medicine’s Department of Medicine in the Division of Pulmonology and Critical Care. She is the co-executive director of UCLA Biodesign, a new joint interdisciplinary initiative led by UCLA Health, David Geffen School of Medicine and Anderson that promotes leadership and entrepreneurship in health care technology.

Jennifer specializes in early-stage company formation and technology development in the healthcare sector, bringing her experience as an entrepreneur, advisor and operator to the classroom. Her interests are related to the disruption of the healthcare industry across digital health, medical devices, diagnostics and care delivery transformation. As the founding director of the MedTech Innovator Accelerator, McCaney has worked extensively with startup companies in the healthtech sector, as well as with business development executives from leading manufacturers, including Johnson & Johnson, Amgen, Baxter, BD, Olympus and others.

She is an associate director of the UCLA Clinical and Translational Science Institute (CTSI), a research partnership of UCLA, Cedars-Sinai Medical Center, Charles R. Drew University of Medicine and Science and Harbor-UCLA Medical Center/Lundquist Institute for Biomedical Innovation. As part of a broader CTSI network of 50 research hubs, Jennifer is active in supporting the institute’s mission to support the translation of biomedical innovations that address the health needs of Los Angeles — one of the most ethnically and economically diverse counties in the U.S. — through the UCLA Biodesign training program.

As the co-lead of UCLA Biodesign, she works across clinical service lines at UCLA Health, ranked No. 1 hospital in California and No. 4 in the nation. At the core of the UCLA Biodesign program is a one-year fellowship for business, engineering, design and medical professionals that draws on the clinical resources of UCLA Health’s four hospitals and 190 patient clinics. UCLA Biodesign has a dedicated fellowship track for Anderson Fully Employed MBA students, and Jennifer also serves as a faculty advisor to Anderson student teams that focus on the life science sector through the UCLA Biodesign Business Creation Option (BCO) track.

ABOUT THE MODERATOR

Randy Horton

Chief Solutions Officer, Orthogonal

Randy Horton is chief solutions officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping med tech firms accelerate their development pipelines for software as a medical device, digital therapeutics and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., agile, lean startup, user-centered design and systems thinking) with the regulated focus on device safety and effectiveness that is at the heart of med tech.