Executive Director's Blog

October 23, 2017

A Busy Fall for NESTcc

It has been a busy start to the fall for NESTcc and our team has been hard at work advancing our strategic and operational goals. Having been at NESTcc for about six-months now, I wanted to share with you a few highlights of the work that is underway:

Identifying Solutions for Real-World Evidence

In October, we announced the designation of three exciting projects as NESTcc Demonstration Projects. These projects test two approaches to leveraging Real-World Data (RWD) and generating Real-World Evidence (RWE):

  • The first approach focuses on developing an electronic health record (EHR)-based network in a large health system to support evidence generation for medical devices across the Total Product Life Cycle (TPLC).
  • The second approach tests the feasibility of using a mobile health (mHealth) application that aggregates multiple sources of health data—with patient consent—to augment post-market surveillance.

While these projects make use of data generated post-approval, they have the potential to produce insights that can inform pre-market requirements and decisions across multiple medical device classes and medical technologies. We’re currently in the review process for the second round of projects and the call for Demonstration Projects for the third round is open until November 1st. We’re looking forward to working collaboratively with these Projects. The investigators bring a wealth of experience, enthusiasm, and important insights to the NESTcc community.

Forging New Data Partnerships to Advance RWE

NESTcc is engaging data partners, including health systems, to identify areas for potential collaboration on RWE. To date, we’ve had two webinars with these data partners and received valuable insight into their perspectives on the potential value of RWE for their communities and their needs from NESTcc. Over the next few weeks we’ll work with our partners to understand existing capabilities for RWE, and we’ll then begin to identify gaps and co-create solutions to provide pathways to generate high-quality evidence for regulatory and coverage decisions across a range of devices and technologies.

Engaging with our Stakeholders

One of our key priorities is working to increase awareness of NESTcc and drive forward the value of RWE. We’ve been on the road at conferences and events, sharing and discussing NESTcc with stakeholders like you. In September, we were pleased to be a part of the 2017 RAPS Regulatory Convergence here in DC’s National Harbor, the AdvaMed MedTech Conference in California, and the IMDRF Stakeholder Forum in Ottawa. I also had the opportunity to share NESTcc’s progress and strategy in an NIH Collaboratory Grand Rounds Webinar (click here to access a recording and summary of the session).

Earlier this month, NESTcc Governing Committee members Dr. Adrian Hernandez, Dr. Michelle McMurry-Heath, and Dr. Jeff Shuren joined me on stage at the MDIC Annual Public Forum, where we discussed current NESTcc developments, strategic priorities, and future opportunities for NESTcc from the perspective of the clinical research world, industry, and the FDA. You can watch the session here.

NESTcc panel at the MDIC Annual Public Forum (Left to right: Dr. Rachael Fleurence, Dr. Adrian Hernandez, Dr. Michelle McMurry-Heath, Dr. Jeff Shuren)

 

In the coming weeks, I’ll be discussing NESTcc at ICHOM (October 25th in Washington, DC) and the 29th Annual Scientific Symposium of Transcatheter Cardiovascular Therapeutics, TCT 2017 (October 30th in Denver, Colorado).

Building the NESTcc Team

After my first few months here, the NESTcc team is beginning to grow. Rachel Rath joined NESTcc as the Deputy Director in August and Hither Jembere joined NESTcc in September as a Project Manager.

In the coming months, NESTcc will be defining its long-term business and sustainability plan as well as launching efforts pertaining to data quality and actively engaging with data partners to develop a long-term strategy. I’ll continue to post periodic updates, but in the meantime, connect with us on Twitter to stay up to date on NESTcc news (@NESTccMedTech).

 

 

 

Rachael Fleurence
Executive Director
NESTcc

August 29, 2017

Establishing a Process for Designating NESTcc Demonstration Projects

One of NEST Coordinating Center’s (NESTcc) strategic priorities in 2017 is to select Demonstration Projects that further the use of real-world evidence (RWE) within the medical device ecosystem. These projects will range in size and scope, but they are intended to:

  • Develop, verify and operationalize methods of evidence generation and data use in the pre- and post-market space
  • Demonstrate scalability across healthcare systems, device types, and manufacturers
  • Demonstrate impact on patients by stimulating innovation in medical device innovation and decreasing the timeline for development and market launch
  • Inform NEST’s strategy as it builds out critical functions and processes for a future sustainable organization.

Since the call was first issued in July 2017, we received a robust set of applications from a diverse group of stakeholders and have begun to review the first set of projects. In the coming weeks, NESTcc will approve an initial set of projects as NESTcc Demonstration Projects. NESTcc will continue to accept additional applications through Fall 2017 and applications that were not selected in the first-round may be considered in future review cycles. If you or a colleague are interested in submitting an application, please read more here. The next round of Demonstration Project applications are due on September 13, 2017.

To maintain NESTcc’s commitment to transparency, we’re providing information regarding our evaluation and selection process below. As part of these formal processes, reviewers and the Selection Team members disclosed potential conflicts of interest (that is, any interests that they, or their employer, relative or other party have which could cause a reviewer or Selection Team member to act other than in the best interests of MDIC, including NESTcc, and the public), and recused themselves in instances of such conflicts of interest.

NESTcc Demonstration Project Evaluation and Selection Process

 

If you have any questions about NESTcc Demonstration Projects please review answers to our frequently asked questions or email NESTcc@mdic.org.

 

 

 

Rachael Fleurence
Executive Director
NESTcc


 

July 13, 2017

Today I am pleased to publicly announce the inaugural members of NESTcc’s Governing Committee (see press release here). We received a host of outstanding applications to serve on the inaugural Governing Committee, and the narrowing down to a final list of members proved to be a difficult task given the quality of the applications.

In line with NESTcc’s commitment to stakeholder transparency, I would like to use this post to describe the selection process. I also want to take the opportunity to thank both the applicants and the reviewers for their interest in NEST, and their willingness to serve in these first activities. There will be many other opportunities to get involved with NESTcc this year, and we hope you will remain interested in participating in other capacities as these opportunities arise.

The inaugural Governing Committee was envisioned as bringing together representatives from a diverse set of stakeholder groups including patient representatives, clinicians, health systems, medical device experts, federal representation, and payers. Members were selected through an open call for nominations published in January 2017, followed by a rigorous review process in which a diverse set of reviewers from the medical device industry, academia, and regulatory agencies reviewed a total of 55 applicants. Formal processes ensured that these reviewers disclosed any conflicts of interest and recused themselves in instances of personal or financial associations with candidates.

Below is a comprehensive outline of the NESTcc Governing Committee selection process:

 

 Solicitation

  • Application available online on MDIC website:
    • Candidates could apply or be nominated by another individual
    • Nominations were accepted by email or through the MDIC website
    • All nominees had to submit an application for consideration
    • No preference was given to nominees versus applicants
  • To comply with the Medical Device User Fee Amendments (MDUFA) IV negotiations, MDIC leadership reached out to the presidents of the Advanced Medical Technology Association (AdvaMed), Medical Device Manufacturers Association (MDMA), Medical Imaging & Technology Alliance (MITA), and the American Clinical Laboratory Association (ACLA) to request a nominee on behalf of their respective trade association
    • Nominees were required to complete an application
  • Individuals nominated by February 6, 2017 were given two additional weeks to complete an application to be considered

 

Targeted Outreach

  • After review of the applicant pool, a targeted outreach for additional candidates was initiated by MDIC leadership to ensure that all categories of stakeholders and relevant expertise were represented

 

Review

  • Reviewers evaluated between four and ten applicants
  • Reviewer conflicts were managed through a required Conflict of Interest Statement
  • Reviewers were offered the option to speak to applicants or their references

 

Consensus

  • MDIC leadership aggregated reviewer scores and reviewed total applicant pool
  • MDIC leadership conducted ad hoc interviews to gather additional information
  • MDIC leadership put together a slate of individuals that as a whole represented the experience, expertise and leadership required for the Governing Committee, for the MDIC Board of Directors to approve

 

Approval

  • The MDIC Board of Directors approved the candidates on June 14, 2017

 

 

Rachael Fleurence
Executive Director
NESTcc

May 20, 2017

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