Strategy & Commercialization

The Customer Speaks: Healthcare's Unmet Needs and the Next Generation of Medical Technologies

What clinical and operational challenges remain unsolved - and where are the greatest opportunities for innovation? Leaders from the healthcare innovation ecosystem will explore unmet medical needs, technology gaps, and emerging trends that are shaping the future of patient care. Drawing on perspectives from innovation, investment, commercialization, and, where appropriate, clinical practice, the discussion will examine where the greatest opportunities exist for the next generation of medical technologies.

Moderator:
Niki Kennedy, MD, CEO, ArborHive

Panelists:
Daniel Ehrmann, MD, MS, Pediatric Cardiologist and Intensivist, Assistant Professor of Pediatrics, University of Michigan Medical School
Vic Estrada, Innovative Portfolio Associate, Henry Ford Health Innovations
Tom Shehab, MD, MMM, Managing Partner, Arboretum Ventures

Technology & Manufacturing

Building Strategic Partnerships with CMOs, CDMOs and Suppliers

Successful medical device companies engage manufacturing and supply chain partners well before production begins. This session explores how startups, OEMs, contract manufacturers, and suppliers collaborate throughout product realization - from design for manufacturability and supplier qualification to design transfer, quality system alignment, manufacturing scale-up, and long-term strategic partnerships.

Moderator:
Maya Dbaibo, Medical Application Engineering Manager, Materialise

Panelists:
Hugh Davies, Former President, Medbio
Jeff McMartin, President, Pliant Medical
Chris Martin, Vice President, OEM Partnerships & New Technologies, Thompson Retractor

Strategy & Commercialization

Commercialization Playbook: From Regulatory Clearance to Market Success

Regulatory clearance is a major milestone - but it is only the beginning of commercialization. Industry leaders will discuss the strategies required to successfully launch and scale medical technologies, including commercialization planning, market positioning, pricing strategy, customer engagement, distribution, commercialization execution, and operational growth.

Moderator:
Lindsay Klee, Founder and CEO, Intent Venture Management

Panelists:
George Malinoff, Founder & President, Built North, LLC
Matthew Pelto, Senior Marketing Manager, Global Strategic Marketing, DePuy Synthes
Ashlea Souffrou, Vice President, SxanPro

Technology & Manufacturing

Beyond the Device: Essential Technical Services for Market Readiness

Successfully bringing a medical device to market requires far more than product design and manufacturing. Companies must navigate a broad range of specialized technical services - from sterilization and packaging validation to microbiology testing, biocompatibility, electrical safety certification, labeling, environmental testing, and other regulatory compliance activities. This session will explore how these specialized services fit into the product development process, when they should be incorporated, and how early planning can reduce risk, avoid costly delays, and support successful commercialization.

Moderator:
Jenn Goff, Chief Commercial Officer, Packaging Compliance Labs

Panelists:
Megan Frost, PhD, Founder & CTO, Sterile State
Mike Hafner, Packaging Engineer, Viant Medical
Haley Schrauben, Director, Global Product Strategy, Oliver Healthcare Packaging

Strategy & Commercialization

Reimbursement Roadmap: Coding, Coverage and Payment Strategies for Medtech

Reimbursement planning should begin long before product launch. This session examines how medical device companies develop successful coding, coverage, and payment strategies, generate clinical and economic evidence, and navigate CMS and commercial payer requirements to support adoption and long-term commercial success.

Moderator:
Randel Richner, Founder & President, Richner Consultants

Panelists:
Victoria Wallace, Partner, Hogan Lovells Cadwalader
Cara Santillo, Senior Vice President, Market Access & Reimbursement, Heartflow

Technology & Manufacturing

Cybersecurity in Medtech: Protecting Products, Patients and Companies

Cybersecurity is no longer just an IT issue - it is a product development, quality, regulatory, and business imperative. As cyber threats continue to evolve, and regulatory expectations become more rigorous, medical device companies must strengthen cybersecurity throughout the product lifecycle. This session will examine current FDA cybersecurity requirements, emerging global regulations, vulnerability management, incident response, and lessons learned from recent cybersecurity events.

Presenters:
Michelle Jump, CEO, MedSec
Matt Hazelett, COO/CQO, MedSec