A start-up medical device company developed a novel technology that significantly improved drug dosing capabilities in the institutional setting. The technology had broad application across a range of procedures including cardiovascular events, major trauma, transplantation and other critical care situations.
While regulatory approvals had been achieved in the U.S. and EU, the company lacked commercial experience and had established almost no in-roads into major institutions and medical centers that would benefit from this new technology. Although the company’s initial customer base had reported unanimous, and significant, success delivered by the novel technology, the client had not developed a clinical data profile sufficient to drive clinician interest and drive wider commercial adoption. With these limitations, the company’s growth prospects were extremely limited and efforts to attract interest of the critical key opinion leaders (KOLs) resulted in minimal progress.
BDF recognized the clinical value of the company’s technology and developed a comprehensive strategic plan to address the significant gaps in the clinical data story while simultaneously developing much-needed relationships with the most influential institutions and clinicians in both the U.S. and EU.
The first step in strategy development was a thorough evaluation of the current market situation to surface unmet clinical needs and competitive offerings. Evaluation steps included:
- Evaluation of the current state of unmet clinical needs and customer challenges
- Identification of data requirements necessary to drive technology adoption
- Assessment of current clinical data situation and surfacing of gaps and critical data needs
- Identification of the market influencers, including KOLs and leading institutions, whose support and guidance would drive rapid adoption and clinical endorsement
- Assessment of competitive offerings and pipelines to establish the most effective positioning for the technology
- Analysis of current pricing and reimbursement to support commercial re-launch and guide development of new sales tactics and plans
Based upon the foundational elements of the clinical and market assessment, a commercial strategy and tactical execution plan was developed to build the clinical and commercial elements required for rapid market adoption.
Key elements of the plan included:
- Development of a clinical program and publication strategy with leading critical care institutions to address gaps in the data story
- Identification of Foundation funding sources, along with a recruitment and messaging plan for attracting their involvement with the clinical program
- Development of required commercial organization and infrastructure including sales support, training, and contracting
- Identification and prioritization of target customers and segments
- Development of clearly defined value proposition and rationale for customer adoption aligning with unmet clinical needs, the competitive frame, and healthcare economics Detailed assessment of required tactical elements including timelines, budgets and financial forecasts
Implementation of the plan attracted the interest, and enthusiastic involvement, of several KOLs who joined a Scientific Advisory Board created under the plan, as well as several additional KOLs, and their associated institutions, recruited to be key sites for Data Generation Programs. Because the data generated from the programs would have significant value beyond that garnered by the client, two major foundations were recruited to provide support funding for the clinical studies. The activities associated with the studies in those key institutions generated a significant “buzz” across the relevant specialties and drove an increase in inquiries and usage at the institutions engaged in the clinical program. A new commercial organization was established and a new Head of Sales was hired based upon the recommended profile.
With these events, the client expects their technology to be well accepted in the medical community for indications that are far wider than they had originally conceived and that the business will grow to be far larger than original forecasts.