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