Medical Device Link.

Originally Published MX September/October 2003

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

The scope and shape of a clinical research program should match the medtech company’s goals and objectives. The following five key aspects of business strategy should be taken into account in drafting program plans, particularly in the areas of staffing, scheduling, budgeting, and regulatory preparedness.

Funding. One key factor is the extent to which clinical program funding is driven by milestones.
Milestone-driven funding might call for tightened timelines and therefore necessitate strategic rethinking. Ways to accelerate a clinical trial include outsourcing in order to expedite certain processes or—to focus on the end rather than the means—switching to a more narrowly targeted indicated use of the device.

Core Interests. Another consideration is the company’s intention to establish or expand core competencies in clinical product development—or lack of same. Some early-stage companies decide to outsource clinical functions to expert contract research organizations and consultants. Others choose to handle some aspects of their clinical trials in-house, increasing their capabilities over time. The latter course can be cost-effective for companies planning to have multiple products in the pipeline, and allows for maximum control over program functions.

Marketing Support. Companies should also consider the manner in which clinical study data are used to support product marketing. The proposed product labeling and intended patient population will influence the magnitude of the clinical research effort and the resources needed to support it. The clinical study objective (efficacy, safety, or equivalence), the type of study designed (pilot, pivotal, or controlled), the number of patients enrolled, the study end points, and the length of follow-up all are factors in determining the cost and complexity of the clinical program, and all are affected by the company’s strategy for presenting the product to the market.

Self-Marketing. Whether or not the trial sponsor will ultimately market the product itself is another key business consideration. Any company that does not intend to position its product for purchase by another company subsequent to regulatory approval or clearance must include planning for postmarketing surveillance in its clinical program.

Foreign Involvement. A final business consideration is whether the company has an intention to clinically study and market the product outside the United States. Companies sometimes choose to conduct clinical studies abroad in an effort to control clinical research costs. If foreign clinical data are going to be used to support a U.S. regulatory submission, overseers of the clinical program must ensure that the rigor of the study design and characteristics of the study population and end points are sufficient to support an FDA submission. On the other hand, the often less rigorous regulatory approval processes prevalent in Europe and elsewhere may afford companies an opportunity to begin generating income from a device relatively quickly. Those revenues can in turn be used to support clinical investigations of the product in the United States.

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