The MAGIC of 2020 – Believe in the infinite potential … of NEST

As we rang in the beginning of this year, I was filled with hope and excitement for 2020. Two twos, two zeros, two twenties. The repeating 2s represent life’s purpose and the repeating 0s represent all things possible, no limitations… And then came the National Evaluation System for health Technology (NEST, www.nestcc.org) advancing the use of real-world data (#RWD) to generate real-world evidence (#RWE) in #medicaldevices, #healthtech, and #digitalhealth. The impact of NEST extends across a multi-stakeholder environment of regulators, industry, academic health centers, health systems, payors, clinicians and clinician groups, and patients and patient advocacy organizations. 

I officially started my journey as the head of NEST at the Medical Device Innovation Consortium (MDIC, www.mdic.org) knee-deep in the pandemic, social unrest, political chaos, and their reverberations into every aspect of life as we knew it. And as I reflect on what NEST managed to accomplish during this incredibly unusual time, it is a testament to the outstanding team at NESTcc as well as our Network Collaborators, Governing Committee, Subcommittees in Research Methods and Data Quality, Task Forces, and Working Groups. 

In addition to ensuring all 21 Test-Cases – or pilot studies – were executed, 8 have been completed, putting us well on our way to completing one of our four key MDUFA commitments. These Test-Cases represent a wide variety of medical products across diverse therapeutic areas in discrete stages of the medical device total product lifecycle (TPLC) covering the 510(k) and PMA regulatory pathways. With the two NESTcc Frameworks that were released this year, we were also able to ensure that appropriate Research Methods were used in study design, analysis considerations, and protocol development, and that Data Quality was appropriate based upon the need (i.e., fit for purpose). Our first NEST Forum outlining lessons learned from our ongoing and completed Test-Cases occurred on 22/Sep/2020, satisfying our second MDUFA commitment. Our third commitment – seeking ways for self-sustainability – was completed as we launched Quality Evidence by Design and have already executed a contract with our first external customer and continue toward full self-sustainability. And we have begun the independent assessment of Test-Cases as they are being completed, which is our fourth MDUFA commitment.

In addition to our commitments, we launched our cloud platform build for Active Surveillance, as we develop the infrastructure to provide near real-time medical device surveillance for signal detection and signal discernment. Active medical device surveillance will better protect the end-user, the patient, by continuously generating, accessing, and evaluating large data sets on device performance and clinical outcomes associated with device use in routine clinical practice. It also improves the FDA’s ability to link adverse events with specific devices, so they are able to act quickly with manufacturers and healthcare providers to make timelier, evidence-based decisions to mitigate device problems and keep patients safe.

And because implementation of an active surveillance system would not be possible without a unique device identification (UDI) system, it is fitting that our first project launched in October under our FDA-recognized Collaborative Community is focused on UDI adoption.

This has truly been a magical year, against amazing odds. I wanted to personally extent my sincerest thanks and deepest gratitude to all the stakeholders in the NEST community who are passionate for and dedicated to its success. Most of all, I want to acknowledge my phenomenal team, who placed their trust in me. They came along for the roller-coaster ride and are now seeing the fruits of their labor. In some sense, one could say NEST represents my life’s purpose with no limitations – I’m a bunch of twos and zeros. I’m energized for all things possible as we move into 2021. #NESTRocks #OurPeopleAreOurGreatestAsset