Pre Market Access

A solid pre-market strategy ensures that future evidence development efforts are aligned with key stakeholder needs.  Aligning activities to proactively address regulator and payor expectations quickens the time to market and steepens the revenue curve after launch.

Comprehensive Regulatory & Reimbursement Strategy
RCRI’s senior consultants integrate global reimbursement and regulatory strategies so that our clients fully understand the available pathways to approval and payment.  It is vital that manufacturers understand both components early in the product development life-cycle and before conducting clinical studies.  This maximizes the impact of research dollars and helps avoid costly delays years down the road when evidence is determined to be insufficient.

Health Economic Model Development
Developing the health economic models that will be populated and analyzed post-data collection is a crucial early step.  Models help stakeholders visualize where and when efficiencies can be gained with the new therapy if the evidence unfolds as expected. These models are a key input to the Pre-Market Access strategies and serve as a cross check on the final selection of information to be gathered.

Robust Study Design to Address Needs of Payors and Regulators
With diverse stakeholder needs, it is becoming increasingly difficult to have a single trial address every need.  That said it is critical to design comprehensive research plans that make the best use of available information.  RCRI statisticians, epidemiologists, and clinical experts collaborate to create efficient study designs and budgets.  Alternative designs and adaptive/Bayesian methods are used where applicable to shorten time to market.

Publication Planning and Management
A comprehensive publication plan defines at the outset how and where study findings will be presented, including peer-reviewed (e.g. journals, posters) and other mediums (e.g. sales tools, white papers).  The plan provides transparency to study investigators and aligns internal stakeholders in preparation for the typical flurry associated with product launch.   RCRI works closely with our clients to fully define and ensure the proper timing of all publication activities.

Post Market Evidence Development

Evidence-Based Market Development
There is increasing pressure on medical device manufacturers to provide robust, real-world evidence of their product’s performance in the marketplace.  In the era of Accountable Care Organizations, pay-for-performance, and other capped payment methodologies, medical devices need to produce repeatable, predictable, and measureable efficiencies for the health care system.

Every product faces stakeholder scrutiny in every geography.  Patients, providers, and payors influence the adoption and acceptance of technologies and are often driven by differing and sometimes incongruent incentives.  Understanding their distinct needs within the context of what can reasonably be demonstrated by a technology is the key to maximizing the potential market impact of evidence development initiatives.

Finding the ‘Next Best Dollar Spent”
RCRI consultants can synthesize existing evidence from disparate data sources and prioritize and manage future initiatives.  Our goal is to provide you with a cost-efficient and powerful scientific base to help drive market adoption.   Our approach includes:

  • Stakeholder and market assessment of the types and level of evidence required to effectively compete.  Assessments include mapping of prospective and retrospective study methods and budgets to key stakeholder requirements.
  • Review of available data sets, current publications, and other marketing tools to ensure current evidence is being maximized.
  • Turnkey post-marketing studies with rapid activation.
  • Market impact measurement and return on investment modeling.
  • Rank ordering of evidence development initiatives across product portfolios to determine the “next best dollar spent.”

A Note on Study Design
RCRI understands that prospective randomized controlled trials (PRCTs) are not always the best option for our clients seeking to enhance their evidence base.  While generally accepted as the gold standard in clinical research, PRCTs are performed to isolate treatment effects against a specific control.  They are typically inefficient for measuring product performance across a range of patient subgroups or for developing a comprehensive safety profile.  A variety of study alternatives can be more informative in these settings.  Our goal is to match the most efficient design to meet your stakeholder requirements to maximize the return on your research investment dollar.

Sales Team Support
Even the best study results can be overlooked by key stakeholders when the messaging is not razor sharp.  RCRI consultants manage the development and publication of study results to ensure they reach their intended audience.  We also develop sales team training and targeted sales tools to ensure that our clients’ commercial teams are fully prepared to capitalize on the evidence development efforts.

Contact us today for an appointment and consultation.

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Regulatory and Clinical Research Institute

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