My first 30 days as the inaugural Executive Director of the National Evaluation System for health Technology Coordinating Center (NESTcc) have been a whirlwind of activity and an exciting first glimpse into NESTcc’s planned contributions to the medical device world. I joined NESTcc because I believe there is a unique opportunity in the medical device ecosystem to catalyze activities around evidence generation in support of the shared goal to improve patients’ health and quality of life.

A health economist by training, I come to the NESTcc from the Patient Centered Outcomes Research Institute (PCORI) where I spent 5 years overseeing the launch of large clinical research network, PCORnet. There too we started from an ambitious vision that needed to be operationalized over a short period of time. From PCORnet, I bring the experience of working in multi-stakeholder environments, experience with data infrastructure and research methods, and a focus on sustainability. A key lesson from my experience in PCORnet is that when leaders step up to find common ground, it’s possible to make progress towards transformational change.

The time is right for NESTcc to catalyze change in the medical device space. The Coordinating Center has been conceive by leaders at the FDA and the medical device industry, with input from patients, clinicians and other experts,  as the body who will lead and support this change. Under the umbrella of the Medical Device Innovation Consortium (MDIC), it is being launched with support from the FDA to build its initial organization and activities.

As I join the NESTcc, I have set milestones in 3 key areas for our first year of operation:

First, the inaugural multi-stakeholder NESTcc Governing Committee will be announced in early summer. It will have representation from patients, clinicians, the medical device industry, the FDA, MDIC, health plans and more. The Governing Committee will help steer NEST’s strategic direction and will announce deliverables early summer.

Second, the NESTcc will be identifying key demonstration projects whose purpose is to provide proof of concept for scalable approaches to evidence generation across device types and across the total product life cycle.

Third, by the end of 2017, a sustainability model for NEST will have been developed in order to keep the initiative going beyond the initial seed funding from the FDA and the MDUFA IV commitment.

It’s truly a privilege to serve in this new role and I look forward to meeting with many of you in the future as NESTcc activities get underway and getting your input and recommendations.

Please check back periodically as I report back on progress and developments for the NESTcc. You also listen to my first interview with MedTech Insight:

 

Rachael Fleurence
Executive Director
NESTcc