How to Ensure Clinical Adoption and Market Access

Clinical Rationale Review

Clinical rationale is the scholarly justification for the development of a new product based on original research, position statements from stakeholder groups, policies, clinical care standards scientific studies. Published literature provides the backbone for the acceptance of a medical product or treatment. A review of this established literature helps gather current supporting evidence for the new technology and build strong rationale that will help to get buy-in from key stakeholders and opinion leaders. The review typically includes:

  • Review of relevant clinical practice guidelines, rules and regulations
  • Collection of evidence required by stakeholders
  • Comparative effectiveness assessments
  • Return on investment analysis
  • Case Studies/user testimonials
  • Comparison of evidence for standard treatment and competitive solutions

The collection of this body of evidence establishes the importance of the problem to the people who will use, buy, pay for, or in other ways influence the adoption of the new product. The purpose is to create a clear and well-supported case for innovation.

Clinical need

Ultimately, the goal of the clinical rationale process is to answer the following questions: 

  • Is the clinical need is aligned with the market opportunity?
  •  Is the product a feasible solution to the clinical need?
  •  Do potential customers want to buy and use the product?
  • Are there any major roadblocks that would prevent the product from being commercialized? 

A strong clinical rationale increases the likelihood of adoption, purchase and reimbursement by policy makers. It is tailored to a particular purpose and intended audience, such as a grant application, business plan, or marketing materials. The process of establishing clinical rationale prepares the innovator to understand where the new product will fit within the context of the clinical ecosystem, moving toward the goal of successful sales, clinical adoption, and implementation, and gaining an understanding of the value and utility the product will have for patients, providers, and other stakeholders involved in the delivery of healthcare.

Clinical Workflow Assessment

A clinical workflow assessment involves mapping the patient care pathway to identify the strengths, weaknesses, opportunities, and threats to determine where the product fits within the clinical pathway. The delivery of healthcare in the United States is a complex ecosystem that can be difficult to navigate. Our goal is to help the innovator, understand the product’s place in this ecosystem.  

The process begins by creating a layout of the current patient care experience and comparing and contrasting this with a scenario including the new product. Will the new product adapt to the current clinical workflow, or will it disrupt the process completely? In order to complete this assessment, the following factors must be considered:

  • The current best practice
  • Clinical best practice guidelines
  • Rules and regulations
  • Stakeholder opinions and experiences
  • Pain-points and key influences
  • Trends, changes and innovation influencing clinical practice
  • Context and setting information
  • Areas of research and policy emphasis

Innovators with a mission to introduce and sell a new product into the healthcare system must understand how the new product is positioned to deliver high value within the healthcare delivery system. 

One useful framework for assessing value is the Triple Aim (developed by Institute for Healthcare Improvement). In order to do this, we consider how the new product will demonstrate each of the three dimensions of the Triple Aim:

Triple Aim

Innovators must be equipped to express the value of the new product to those who will be using it on a regular basis. This is best accomplished through being transparent in the capabilities of the product. Although there may be great positive value, it is also important to address any negatives. Consider any direct or indirect costs associated with the implementation of the new product. For example: is there training required for the clinician prior to using the product that will be costly or will pull them away from clinical duties for a significant amount of time?

Regulatory Strategy

A Regulatory Strategy describes the plan and approach which will be used to meet regulatory and industrial standards and third-party insurance payment for the product. For medical devices this means a plan for achieving US Food and Drug Administration (FDA) clearance and determining who will pay for this product, whether it can be reimbursed by public or private payers, or if it must be paid for out of pocket. The Regulatory Plan outlines key steps to move the device forward in a strategically appropriate manner for the business, while following required guidelines.

Our approach typically includes:

  • Background on the regulatory process
  • Classification/code/submission pathway
  • Applicable FDA guidance documents
  • Links and summary
  • Applicable industrial standards
  • Description and summary
  • Potential predicates (if following 510k)
  • Links to k summaries, labeling, tech features
  • Referral list for submission or pre-submission process, international

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Reimbursement Strategy

At its most basic level, a reimbursement strategy answers the question: Who is going to pay for this product? Traditionally, medical products are paid for through the patient’s health insurance, but others are purchased as capital equipment or medical supplies in a healthcare setting and some medical products will be bought “out of pocket” by the customer. Understanding which of these categories a new product fits into is the first step in establishing a reimbursement strategy. 

A health insurance-based reimbursement strategy seeks to identify any existing coverage policies applicable to the target customer, as well as to assess applicable product or procedural billing codes and determine payment levels. If no existing coverage, coding or payment pathways are available, the reimbursement strategy can outline a plan to establish new mechanism or consider alternative paths such as pursuing value-based payment and bundled payment systems.

Our process typically includes: 

  • An overview of insurance reimbursement for the specific condition/topic
  • Background on the topic
  • History and coverage trends
  • Stakeholder opinions and experiences
  • Details on the coding, payment and coverage policies for public and private companies.
  • Review of coverage determination documents, counts of service provided
  • Comparison of innovation to current standard practice
Image of Claim Form

Reimbursement strategy should be established early in the development process and revisited multiple times during the product development cycle. During the Need and Opportunity Analysis, product viability may be determined to hinge on health insurance coverage if potential customers cannot or will not pay for a healthcare product out-of-pocket. In these cases, the ability for the customer to obtain reimbursement from an insurer is a critical element of the business model and key to achieving revenue streams that sustain product development and allow the business to grow. 

innovators can avoid spending precious capital on designing, developing, and testing features for which insurers will not pay by including insurers early in market research. Their input will provide an early opportunity for the team to pivot, or make changes to the product before development begins. Reimbursement considerations not only affect the product design, but also impact clinical testing and the strategy to obtain evidence required to support payment from an insurer. Waiting to consider reimbursement until the regulatory and product evaluation development stages will increase the risk for the product post FDA clearance. Careful consideration of these topics will result in a sound reimbursement strategy and provide project risk mitigation.

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