The medical device industry in the United States is world's largest with an expected market size of over $200bn by 2023. For US companies, early market access planning is crucial and, while it might not be the first target market for companies from other countries, its size means it can’t be ignored. However, there are many challenges and hurdles in accessing the market beyond just gaining regulatory clearance and careful planning is required to achieve success.


In this session, led by MCRA's Tonya Dowd, we will explore how, and in what ways, planning of your market access strategy is a critical consideration for medical device companies and how early planning is vital, not optional.

This webinar will present a new narrative for medtech innovators: a reimbursement and market access strategy that is developed early in the product lifecycle is as important as your regulatory strategy, and by not having a plan in place, you compromise your ability to raise capital, and put your technology at risk of not achieving optimal market adoption upon launch.

Working backwards from the goal of achieving successful market adoption, the reimbursement and market access strategy must consider the three key fundamentals to reimbursement- coding, payment and coverage and the interrelation of these factors and requirements to achieve all three, especially for new and emerging technology. Accruing the necessary data and garnering the support for successful reimbursement starts early in the product lifecycle, ideally in parallel with the reimbursement and clinical strategies.

This session will:

  • Identify key stakeholders and oversight bodies in the reimbursement process and their role in establishing coding, coverage and payment
  • Review the requirements and considerations for achieving coding, coverage and payment
  • The financial crunch and effect on clinical study design; thinking creatively with to reduce cost, timing, and burden
  • Presentation of two case studies: a “challenging reimbursement case” and a “best practice case” resulting from early reimbursement planning

Expert Speaker


Tonya Dowd, MPH, Vice President, Reimbursement, Health Economics & Market Access, MCRA

Tonya Dowd, MPH, Vice President, Reimbursement, Health Economics & Market Access, MCRA 300x
  • 30+ years of reimbursement, health economics & market access experience
  • Former Global Franchise Director of Healthcare Economics and Market Access within Johnson & Johnson's medical device division
  • Healthcare company experience includes Biosense Webster, HeartFlow, & iRhythm
  • Expert in upstream product plan development and downstream execution of reimbursement strategies
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