Overview

DBH collaborated with a pre-Series A (startup) digital pathology company that had created an AI-based SaMD, capable of predicting cancer genomic biomarkers and informing the prescription of precision therapeutics. The company was at a critical point, transitioning from an emphasis on research and development, to market access and commercialization. DBH was asked to advise the client while turning this corner, to ensure that their unique product would be well positioned in the marketplace.

Challenges Faced

Reducing risk and optimizing an access pathway. The client was unsure of the best path forward for long-term pricing and reimbursement, given the novel nature of their technology, and the lack of clear guidance from CMS and commercial payers. The client was interested in an approach that would dovetail with the more immediate need for FDA submission, and the possible requirement for a CLIA laboratory.

Understanding the perspective of HCPs and hospital purchase makers. Because of the unique features of the product, the client wanted to understand how the product might be ordered and utilized in various healthcare settings, and how decision-makers might view its ability to generate revenue for the hospital’s central laboratory.

Dream Big Health's Solution

DBH began by locating key opinion leader HCPs and purchase makers (oncologists and pathologists) with proficiency in clinical pathology, digital pathology, algorithmic (AI-based) medicine, and cancer biomarkers. Despite a limited pool of individuals with expertise across these specialties, DBH, through its network and with additional outreach to professional organizations, successfully recruited a sample of the field’s premier KOLs. Then, through a series of in-depth interviews, DBH collected and analyzed detailed quantitative and qualitative data, providing crucial detailed context to building a market access strategy. Following this market research, DBH and the client held vital discussions related to conditional ordering in the context of the Stark law (42 USC 1395nn.) and striking a balance between generating necessary lab revenue and providing valuable patient care.

From here, DBH began developing an ideal pathway forward, navigating the most critical decision points using BRAs (benefit-risk ratios) for Real Future Risk, Statistical Risk, and Projected Risk, and sharing them with the client, to ensure alignment. Key decision points included (1) FDA submission (2) CLIA laboratory buy-borrow-build (3) coding, (4) coverage, and (5) pricing & payment. Topics of discussion included the FDA pre-submission process, the appropriateness of CLIA certification and CAP accreditation for a digital tool, MolDX (CMS) evidentiary requirements, AMA Current Procedural Terminology (CPT) code criteria, and requesting ADLT status from CMS.

Ultimately, DBH created and delivered to the client a detailed 2-year strategic plan, based on the optimization of critical inflection points and alignment with client goals and resources.

Impact to Client

The market intelligence and 2-year strategic plan that DBH developed for the client were used for successful market entry. Ultimately, the client was able to effectively maneuver would-be roadblocks, allocate resources, and set pragmatic timelines, which in turn, led to accelerated fundraising.

If you need expert assistance building a market access strategy that aligns with your goals, please reach out!

One of the most common points of failure for startup companies is when they begin to shift from product development to market entry. These areas require different viewpoints and skillsets, and often, leadership struggles to translate a product’s potential value to its actualized value. Through our broad experience and expert insights, we provide the best leaders – those that know what they don’t know – the framework they need to operationalize an effective go-to-market plan.