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It is a common misconception within the medical device industry that preclinical studies only occur during the design phase of the Product Development Process (PDP). In reality, they have value at every stage of the development lifecycle – from concept efforts through product launch, and post-market support.
Join us for our upcoming webinars as we discuss the critical role preclinical studies play throughout the PDP process. Presenter Mike Bravo (Director, Preclinical Strategy) will provide insights and various perspectives into how medical device manufacturers can maximize preclinical value during each development stage.
Webinar attendees can expect to walk away with a better understanding of the following topics:
- Design: Preclinical studies are most widely used during the medical device design process. Learn how these types of studies can assist device organizations to accurately and efficiently evaluate prototypes in an effort to move to an optimal, and final, device.
- Regulatory: It is vital that device manufacturers demonstrate that their product performs as intended to satisfy regulatory authority standards such as safety, performance and efficacy. Understand how global regulatory authorities align, or differ, as it relates to preclinical requirements. Also learn tips and tricks for maximizing study design to meet international requirements, including how to prospectively collect data to leverage all anticipated global commercialization markets.
- Clinical: When performing clinical trials and post-market studies, it is important to accurately pinpoint specific data types that will be collected. Learn how the information gathered during a preclinical study can provide information to assist manufacturers in best identifying the data points that should be measured within the clinical stage.
- Reimbursement: Increasingly, reimbursement is becoming a large focus throughout the device development lifecycle. Understand how preclinical data can support reimbursement strategies, and assist in identifying the best-fit reimbursement plan.
- Marketing: Beginning early within the PDP, the marketing phase can benefit greatly from preclinical studies. Learn how preclinical data can play a significant role in supporting “buzz” for a device prior to commercialization, in addition to helping set the stage for gaining a larger market share.
Time will also be allotted for Q&A.