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Reducing Medical Device Product Risk: The Key Role of Clinical Trial Data in Product Development


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Webinar Notes

With increasing global regulation and reimbursement challenges faced by medical device companies, it is imperative for clinical trials to be strategically planned, well-designed, cost-effective, efficient and to be of high-quality. Safe and effective medical device products uniquely depend upon a product development process of ongoing clinical interaction and feedback from and about the user, the environment, and the patient. While human factors studies help inform design improvements early in the development process, clinical trial data and especially adverse events reporting throughout the lifecycle of a product are essential. Adverse events and related data can provide specific information on possible user errors or product issues (manufacturing or design) that can be addressed through immediate action or future product/process improvement.

This webinar will discuss the importance of thorough, accurate, and timely reporting of adverse events from feasibility studies through post-market clinical trials, as well as how medical device development teams can follow best practices in using the information in product risk management. Additionally, attendees will gain insight into the connectivity between product risk management (ISO 14971) and the clinical risk management process (ISO 14155) and the use of eClinical platforms in supporting this process.

In this webinar, you will learn about:

  • The importance of product risk management throughout the lifecycle of the medical device and how clinical trials contribute at all stages
  • How medical device product usability and design can be better understood and improved through proper documentation, detail, and tracking of adverse events
  • The importance of timely and accurate reporting, trending and root cause analysis of adverse events, and the importance of updating adverse events in light of newly discovered information
  • Why eClinical platforms should be evaluated for the potential to reduce entry errors and increase the quality of clinical trial data, thereby contributing to product risk reduction for patients

Webinar Hosts

Verna Manty Rodriguez

Founder and Principal, Manty Medtech; Adjunct Lecturer, Bioengineering Department, Santa Clara University

Verna Rodriguez has over 35 years of experience in medical device design, development, quality and manufacturing. In 2018, she founded Manty Medtech which provides product development and design control consulting services to the medical device industry. In addition, she teaches Design Control for Medical Devices in the bioengineering department at Santa Clara University. Her expertise includes design control, root cause analysis, risk management and process validation, and she has a particular interest in the application of nitinol and its superelastic properties to medical devices.

She received her B.S. in Mechanical Engineering and Materials Science from University of California, Berkeley. Before embarking on consulting and teaching, Verna spent the past five years as senior R&D director at PneumRx, Inc., a Bay Area start-up where she focused on leading the engineering team to develop a nitinol (nickel-titanium) implant for treating patients with severe emphysema. PneumRx was successfully acquired by BTG plc in 2015 for $475M. Prior to that, she led engineering teams at Boston Scientific and Guidant Corp. (now Abbott Vascular) for development of various cardiovascular devices including stents, grafts, balloon and ablation catheters and delivery systems.