With Gratitude

Honestly, I was going to skip writing an end of year LinkedIn post this year, but several friends and colleagues protested, so here goes.

I don’t mind saying that 2022 was a rough year, personally. Several close family members were hospitalized, including my father and husband. A harrowing moment happened during one of my husband’s hospitalizations where he went into cardiopulmonary arrest with an ensuing code blue. A choreographed team of doctors, nurses, and technicians swarmed into his room and executed several rounds of the resuscitation protocol. Right before they were going to ask me whether or not to continue, I screamed “NOT TODAY!” into my husband’s ear, along with a few more choice words. And a split second later, or so it seemed, someone yelled “I HAVE A PULSE!” The team let out a sigh of relief before they resumed their orchestrated chaos to connect him to machines and transfer him to the ICU… He had a rough few months, and I am immensely thankful for his continuing recovery at home. Unfortunately, we weren’t that lucky with our dear sweet Goose that we lost earlier this year, after 13 ? years of companionship. I'm thankful for our families and friends, including Remy. ?

Professionally, I had to implement a major reorganization at National Evaluation System for health Technology Coordinating Center (NEST) to better enable strategic partnerships while building the platform for conducting #RWE in #medicaldevices for #regulatory decision-making. Unrelated to the reorg, I recently stepped down from my position as the head of NESTcc. I'm thankful to my Chief core and Healthcare Businesswomen’s Association colleagues for their unwavering support during this year.

Please know that I am tremendously proud of the NESTcc staff, both current and former, for what we have accomplished. During my tenure, NESTcc experienced progressive growth, met each of its MDUFA IV Commitments, and had developed a strategic plan for pre- and post- market initiatives in evidence generation, active surveillance system development, and the Collaborative Community for our multi-stakeholder environment. Despite many challenges, including the pandemic and preparations for the MDUFA V working group negotiations, NESTcc made the paradigm shift from a research and testing environment to a start-up and execution mindset for growth and self-sustainability to provide value to our diverse stakeholders. NESTcc met several key milestones and nimbly pivoted as required with the changing needs of our major funder, the FDA . Because of my initiatives, many processes and policies were implemented to better ensure fiscal responsibility, continuous quality improvement through development of standard operating procedures and training for compliance with ISO 13485, ISO 27001, as well as HIPAA, GDPR, and other privacy regulations.?

As NESTcc continues to evolve, we have managed to still maintain our values of (1) a positive, engaged, multi-stakeholder collaboration, (2) flexibility for innovation, and (3) integrity to maintain the highest standards of quality, reliability, and timeliness to deliver?Quality Evidence by Design. NESTcc is well on its way to build a central and scalable system architecture for #interoperability by focusing on:

• Maximizing strategic partnerships, alliances, and collaborations with organizations that are experts in providing solutions outlined for continued innovation of the national evaluation system;
• Releasing playbooks or standards for research methods and data quality through our frameworks;?
• Using a #FHIR meta common data model (CDM) in order to transform and harmonize other CDMs such as PCORnet, OMOP, and Sentinel;
• Implementing processes for data curation and cleaning for real-world data provenance, maintaining traceability;
• Solving device identification and unique device identifier (UDI) challenges using technology solutions and providing a playbook for #UDI adoption in #EHR;
• Maintaining privacy while still providing patient-level data through data linkage and aggregation software; and
• Providing platforms for analytics on various RWD sources such as electronic health records, health care claims, patient registries, lab results, and imaging.

I am grateful for the opportunity to lead NEST with an amazing team, both former and current, and to collaborate with the exceptional and diverse professionals from this ecosystem who are passionately committed?to transforming the way medical device technologies are tested, approved, and monitored in order to ultimately empower patients make informed medical choices enabling them to live their lives to fullest extent possible.?I am indebted to the amazing NEST Governing Committee for their thoughtful input, guidance, and partnership. The dedication of our Subcommittees, Task Force, Working Groups of volunteer subject matter experts has been incredible. I am humbled by the trust each of you placed in me, and I value each relationship that has been formed.?

I look forward to the New Year and my next great adventure. I wish all my LinkedIn network a healthy and happy holiday season. May the New Year be filled with laughter!

#NESTRocks #EnjoymentMatters #OurPeopleAreOurGreatestAsset #Gratitude