The first major component of a medical product Development Plan is the background research supporting the business strategy for commercialization such as an evaluation of the competitive landscape for the putative product, the potential for reimbursement based upon CMS cpt coding, a marketing approach, and the manufacturing and distribution chains. A critical feature of a commercialization plan is identification of realistic milestones and funding mechanisms to keep each project moving forward.
Technology development by small firms is often limited to prototyping or small scale production needed for studies in animal models or human beings. As such, the Institute provides guidance on “Quality by Design." As needed, firms gain advice on the compilation of data needed for regulatory agencies. The Institute will help sponsors utilize industry accepted modeling and simulation tools that inform device design. It will do this in partnerships with other organizations and institutes, such as the Center for Medical Technology Policy, which focuses on reimbursement strategies for early stage companies.
As devices undergo iteration during development, the Institute and its partners are able to guide sponsors on the assembly of information needed to leverage clinical study data from earliest prototype to final finished form of the commercial product. When industry standards and regulatory guidance documents have been published, the Institute will help sponsors meet safety expectations for patient exposure. As an invention matures toward becoming a commercial product, the Institute will work with sponsors to address engineering issues associated with manufacturing, reliability testing and service management over the entire product life cycle. Clinical information gathering is embedded with all stages of medical device development. For example, an invention that has been fully developed can still fail to return on initial investments if the final product does not adequately address an unmet clinical need or if use of the product does not reduce cost or substantially improve access to care.
Another aspect of clinical development is the identification of the appropriate pathway for regulation by FDA, CMS and State licensing of medical practitioners. Forward development of a medical product must be geared to meeting the requirements of the correct regulatory pathway for the medical product to be marketed.
The Institute will offer services in clinical study design. For example, first-in-man studies of therapeutic medical devices identify potential risks and benefits associated with the treatment effect in a low risk population such as healthy volunteers. Next, “feasibility studies” identify a possible primary effectiveness endpoint, the appropriate patient population, the best dose, human factors issues, and broad categories of adverse events. Only after this preliminary work can a scientifically designed clinical study for “pivotal” decision making in a regulatory setting for medical devices be expected to be successful.