Darlene Ebeling, former senior director, Clinical Operations at PneumRx, Inc., talks medical devices, and warns how a lack of investment in new technology could stifle innovation within the industry.

CTA: What are the biggest challenges facing industry regarding medical devices?

Darlene Ebeling: For small start-up device companies, money is becoming less available for innovative technology development. As a result, in those companies, there are fewer people to do much of the work and still remain on task with timelines. This is the challenge and the risk is that quality may be impacted and repeat testing may be required. The other challenge is that the qualified individuals are seeking positions either in different industries that are evolving in the healthcare segment or these individuals are moving into the larger company infrastructure environment.

The perception of the small start-up company is that the innovative technology is being driven by fast development and execution in order to get noticed by a larger company who may be interested in aligning their own product portfolio. As a result, emphasis on training and quality may not be as engrained as in more structured and larger organizations.

CTA: What are the best solutions to remedy the situation?

DE: From a regulatory perspective, the medical device industry is already coming more in line with the pharmaceutical industry, i.e., adhering to universal GCP/ICH rules and guidance. More and more companies are establishing independent clinical quality oversight of the clinical operations segment of the business. This may support the need for qualified resources necessary to drive the timelines and improve the quality overall.

CTA: What are other challenges?

DE: The device regulatory pathway is different in that there is no traditional phase I to IV approach to clinical trial design, rather, depending upon the risk of the device will determine if a clinical trial is needed and if needed, the type of clinical design chosen.

CTA: What advice would you give smaller medical device companies looking to overcome these regulatory hurdles?

  • Do not sacrifice the resources early enough on to achieve a solid quality foundation.
  • Establish an independent clinical quality assessment of clinical operations and put into place prior to the initiation of a pivotal clinical trial.
  • Regular GCP and ICH training in addition to study-specific training is not an option but a necessity.
  • Hire resources of strong quality and professional background and experience.

CTA: In your experience, what would say are the best practices in developing medical devices?

DE: Establishing a robust Quality System which includes clinical operations, obtain the best regulatory advice on the most appropriate filing pathway to follow for the innovative technology being addressed, and if a clinical trial is needed engage the highest quality of professional resources available to support the full breath of the study from study start-up through final endpoint analysis and filing.

CTA: Where do you see the future of medical devices?

DE: As stated earlier, I think the funding for medical devices is depleting, at least on the west coast of the US, especially for small start-up medical device companies. As a result, some innovative technology may be directed toward the larger companies. Large technology industries are starting to create healthcare divisions within their organizations. This may be the next generation of investment activities to fund the innovative projects with the unmet need to broaden the resources and foster good clinical research leading to more patient care options.