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Designing Your Device with The End in Mind, Keeping the Required Clinical Trial in Your Sights as Early as You Can

Vicki Gashwiler (Executive Director, Strategic Development-Medical Device &Diagnostics , Premier Research)

Nach Dave (Vice President, Development Strategy , Premier Research)

Location: 210B

Date: Wednesday, February 12

Time: 1:15pm - 2:00pm

Track: MD&M Conference: Product Development: Effective Strategies for Moving from Engineering to Production

Vault Recording: TBD

Your company has been working on a medical device that could be classified as a Class II DeNovo or a Class III. Having met with the regulatory agency it seems that a clinical trial may be necessary. The circumstances are typical: limited budget, uncomfortable timeline, a scarcity of skilled clinical trial professionals, and limited knowledge of short-term clinical strategy. And you recognize that the success of the device — and possibly the company — depends on the outcome of this trial

That’s a lot to consider, but you’re not alone. There are many highly skilled people and organizations to help plan and execute such studies. Some contract research organizations specialize in exactly this type of situation and can help you meet your objectives, ideally getting involved immediately after — if not before — you meet critical funding milestones. You want to adopt a one-team approach and an agreed-on definition of attainable objectives, combined with proper planning and execution of a high-quality, timely trial at a reasonable cost. This will improve the likelihood of meeting study objectives and establish continuity that aids in development of more advanced trials.

This talk will highlight the many aspects a company must consider in planning and executing a trial, and keeping the end in mind as you determine the proper steps of your device’s development lifecycle. Topics to consider include:

  • Developing a strategy
  • Design considerations
  • Defining the objectives of the initial trial
  • Operational considerations

Presentation File

MDM2020_final.pdf