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Gathering Medical Device Data & Evidence: Webinar

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.

Think of it like bowling, where the ball is your evidence and the pins are your stakeholders’ requirements. How do you knock down all ten pins on your first frame?

Join Orthogonal and MATTER Chicago 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 on developing an integrated evidence strategy that lines up a “strike” for your market launch.

Speakers

Kwame Ulmer Headshot 300x300

Kwame Ulmer Headshot 300x300
Kwame Ulmer, Managing Partner, MedTech Impact Partners

Kwame Ulmer is a medtech 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 MedTech 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 MedTech 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.

christian johnson headshot square

christian johnson headshot square

Christian Johnson, CEO and Founder, ScoutMedix, Strategic Development, Essenvia

Christian is a purpose-driven entrepreneur, 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 and health technologies worldwide.

Currently, Christian is founder and CEO of ScoutMedix, a MedTech strategy, market research, and go-to-market advisory firm. He also leads strategic development at Essenvia – an innovative MedTech 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.

Previously, Christian served as global vice president of product for a multinational in vitro diagnostic (IVD) company, He also was a Sr. 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, Christian is a member of Forbes Councils, a TEDx speaker, and recipient of “Best and Brightest” MBAs by Poets & Quants.

Bernhard Kappe Photo

Bernhard Kappe Photo

Bernhard Kappe, CEO and 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 MedTech 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.

Moderator

Randy Horton

Randy Horton

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 MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) 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 MedTech.

Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).