Regulatory Challenges of Medical Device Development
Regardless of their intended market, those developing a medical device face unique challenges. In Europe, the introduction of new regulations is raising the bar for submissions despite a shortage in the number of Notified Bodies accredited to review submissions under the new rules. On the one hand, medical devices are now held to stricter standards, while on the other there are fewer people qualified to evaluate them, creating a bottleneck on the path to market. By contrast, historically stringent FDA regulations governing the medical device approvals have undergone a change, as US authorities have become increasingly receptive to pre-submission meetings with developers. Unfortunately, with very few standardized models adequate for a wide variety of devices, it remains difficult for US developers to establish what should be the optimal design of and a safety/efficacy implantation study.
Framed by a development lifecycle that is typically shorter than a pharmaceutical’s, the stakes for today’s medical device developers are high, with tremendous pressure to move as fast as possible along the development and approval pathway. However, in the current regulatory landscape, rushing through a GLP study is ill-advised. Failure to confirm that a device is ready for implantation is costly; poorly designed efficacy studies can result in devastating in vivo results – high mortality, recorded deviations – that stay on record and put the whole program at risk. When the end goal is to develop a safe, effective device that is suitable for patients and thus attractive to venture capitalists and larger sponsors, it pays to invest time and resources in proper preliminary assessments.
Given these obstacles, the many medical device developers seek the assistance of contract research organizations for the design and conduct of study packages. But even this decision can be fraught with difficulties when the chosen CRO lacks the scientific diversity, background, and experience to design an appropriate program or the regulatory expertise to understand the current guidelines and determine what will best satisfy regulations.
Fresh off another successful FDA audit (June 2019) Charles River’s AccelLAB facility in Boisbriand, Quebec continues to demonstrate flawless performance and compliance with regulatory standards. The achievement is especially noteworthy in light of the site’s recent integration with the Charles River family, and one that emphasizes the talents of a newly harmonized team. Enhancing AccelLAB’s medical device excellence with Charles River’s comprehensive portfolio of discovery and safety services and regulatory expertise, the site continues to deliver informed, custom testing solutions for the robust assessment of medical device technologies, with even greater flexibility and capacity.
“Medical device development is complex, with unique requirements” says Boisbriand site director, Genevieve Normand. “Our clients need a true partner who can support them every step of the way. We strive to be that partner; it’s our mission, our identity reflected in the commitment of everyone on our team.” Normand praises AccelLAB’s smooth evolution as a Charles River company, noting that the organizations’ combined assets further increase the site’s ability to respond and deliver the best solutions. “Together as a team and collaboratively with clients, we work to understand the device developer’s specific needs and create sound testing strategies that comply with the regulations of the device’s intended market.”