In spite of the economic downturn, opportunities exist to continue product development activities while avoiding significant capital expenditures. There are numerous regulatory and clinical activities that companies may undertake that do not necessarily require large outlays of capital to complete.
With respect to regulatory tasks, firms may want to consider conducting a pre-IDE meeting with CDRH. For fiscal year 2009, there are no user fees for such meetings, which provide an opportunity to meet informally with FDA to gain a better understanding of the regulatory pathway for a particular device. The process usually results in having a better grasp of the preclinical and clinical testing required to support the FDA review process, and will allow a company to describe the regulatory pathway with more clarity to potential investors.
This is also a good time to put incremental efforts into building an infrastructure for quality systems and documentation processes, which are critically important to maintain compliance with Quality System Regulations once the device is marketed. At the early stages of development, it is prudent to put in place a design control process to document the key design decisions and risk evaluation that will drive the preclinical testing and clinical testing strategies. These documentation activities have the added value of organizing and structuring key design assumptions, early verification testing results, and other development activities so that they are easily retrievable and accessible to those considering investment in the new device.
While multicenter, randomized, controlled investigations remain the gold standard for Class III devices, they are quite expensive to conduct. As an alternative, a firm may consider running smaller pilot or feasibility studies, which would require less expenditure, and would afford the opportunity to gain early insight into the appropriate intended uses or patient populations for which the device is best suited. Pilot studies provide early evidence of safety and establish preliminary data on effectiveness; positive results help build the case for pivotal study investment.
The strategies and activities described here are just a few opportunities a firm should consider to add value to an emerging medical technology. Doing so now will ensure that your company is well-positioned and more attractive for significant investment in pivotal clinical trials and regulatory approval efforts as the economic outlook improves.
Ronald S. Warren is a principal consultant in the regulatory services group at MDCI, a full-service CRO and regulatory consulting firm focused on the medical device industry. He has more than 22 years of regulatory and clinical affairs experience, with specific expertise in IVD products, human-derived tissue-engineered products, and cardiovascular devices. He has coordinated and led multiple pre-IDE meetings and been involved in the submission and preparation of PMAs, 510(k)s, PMA supplements, and IDEs for various clinical indications.
Michael L. Feldstein, PhD, serves as vice president and principal biostatistician at MDCI. He has more than 30 years of experience in the design and analysis of medical device clinical trials and provides high-level strategic guidance to clients in the areas of study design and biostatistics.