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You have now identified what your intellectual property strategy would look like, how to integrate it with your regulatory strategy and the technical development of your device. Your project development phase is progressing well and you have started the prototyping phase of your device. How can you now facilitate the transition from R&D phase to its clinical adoption and make sure your device will ultimately be used in the clinics? Our experts in residence from Odelle Technology, Deborah Rizzi, Dr Steven Haken and Claire Edwards have provided key principles that you can implement in the development phase to eliminate roadblocks to facilitate the clinical adoption of your device.

Clinical adoption and market access

By Odelle Technologies

What type of company do you want to be?

  • Reactive?
  • Tactical?
  • Transactional?
  • Price Driven?
  • Insights Driven?
  • Value-Driven?

Market access strategy is about:

  • Seeing the bigger picture
  • Determining the end goal and working backwards
  • Thinking like a payer – “what’s in it for me?”
  • Making choices and trade-offs based on deep insight
  • Ensuring strong cross-functional alignment with Medical, Commercial, etc.

Key market access principles:

  • Start early (ideally up to 3-4 years before anticipated launch).
  • Define and articulate the true unmet need from the payers’ perspective.
  • Understand payer evidence requirements clearly.
  • Develop a value strategy that is realistic and justifiable.
  • Build an evidence package that addresses payer requirements (or mitigates for gaps)       Appreciate that gaps and uncertainty will be compensated for with lower price or restrictions.
  • Design a pricing and payment model that is transparent, logical and aligned to the payer agenda.

Market access process:

Purpose

  • Why are we here?
  • Where are we playing?
  • What does our product do?
  • Consider: burden of disease, Product clinical benefit, patient population, market and competitor events, product economic benefit, current treatment benefit

Vision

  • Where do we want to be?
  • By when?

Implementation

  • How will we get there?

Market Access Plan

  • Target patient population
  • Position in treatment algorithm
  • Anticipated Standard of Care (SoC) and price comparator
  • Unmet need from payer perspective.
  • Incremental benefit vs SoC
  • Pricing strategy
  • Economic justification
  • Policy change goals