Medical product development is an increasingly complex process requiring thoughtful, strategic planning to move from concept to the patient. While most companies do well in planning developing and prototyping their device, planning the regulatory strategy, and evidence development strategies falls behind.

Join RCRI and Research Collective at Medical Alley Association for a morning of networking and discussions surrounding medical device innovation. Three industry professionals will provide insights into the opportunities that exist in medical product development when you integrate regulatory strategy, human factors research and testing and evidence development. A light breakfast will be provided.

Agenda:

8am: Registration & Networking

8:30am: Using Regulatory Strategy for Strategic Success

9:15am: Demystifying the FDA’s Human Factors Guidance

10am: Break

10:15am: Creating Value Through Clinical Strategy and Evidence Development

11am: Identifying User Requirements through Customer Research

11:45: Closing remarks (15 mins)

Speakers:

• Rachel Kennedy, Regulatory Snr. Principal Advisor, RCRI
• Dr. Russ Branaghan, founder and President of Research Collective
• Mary Kay Sobcinski, RN, BSN, MHA Clinical Snr. Principal Advisor, RCRI

FAQs

How can I contact the organizer with any questions?

Contact Samantha Thrun at sthrun@rcri-inc.com or Duke Fonner at duke@research-collective.com for any questions.

Is it ok if the name on my ticket or registration doesn't match the person who attends?

Absolutely. And- bring your collegues as well to engage on a lively discussion on effectively bringing value to the development cycle.