What We Learned About the Digital Transformation from Veeva Medical Device & Diagnostics Summit
We have reached an inflection point within the MedTech industry where digital transformation translates to competitive advantage. Recognizing that well-embraced, quickly deployed, and easily maintained cloud-based quality applications can vastly improve both efficacy and efficiency, further quantifiable value can be had when these applications are unified within a single suite with the same underlying platform/technology. And the resulting efficiency gains translate to time that can be allocated back to the focus at hand – product quality, patient safety, and rapid innovation.
The presenters at Veeva’s Medical Device & Diagnostic Summit and their respective stories all share the same reverberation – one can see and hear the speakers’ passion for product quality and patient safety, and their recognition that their quality applications must be able to scale with them – in growth and in innovation.
Regulations and compliance serve as the guiding principles to the quality discipline. We were honored to have seasoned veteran Mike Baca, of industry stalwarts such as Johnson & Johnson, Medtronic, and Stryker, to speak to us about salient MedTech regulations that we operate within, day-in and day-out. In addition to the regulations, Mike shared his experience leading organizations through successful FDA inspections in his presentation: FDA Inspection Preparedness and Best Practices. The session contained the most memorable quote of the summit (in my opinion) – a humorously simple, yet impactful message of “if you didn’t document it, it didn’t happen”.
Building on that foundation, leading medtech companies discussed quality modernization efforts, operations best practices, transformational initiatives involving GMP expansion, and QA/RA connectedness. We also heard how a blisteringly fast implementation of Vault QMS supported an effort to save lives.
Through her presentation – Digitizing Quality to Drive Production Velocity During Public Health Crisis – Mary Ryan, Director of Innovation, Technology, and Regulatory Affairs at Penlon Ltd. shared how Penlon, along with a multi-national consortium of manufacturers, technology and services providers, came together to help build and deliver over 12,000 ventilators in record time for NHS as part of the VentilatorChallengeUK initiative. To achieve the velocity and quality required, Penlon and the consortium implemented and validated Vault QMS as an eDHR solution, in ten days’ time from start to finish, to help scale operations and meet their goals.
Establishing a quality center of excellence was the focus of a session presented by Tristin Wolff Cope, Regulatory Compliance Officer of Biodesix. She shared how Biodesix modernized its content management, by way of an acquisition, to a modern, cloud-based solution. Biodesix was able to quickly implement and adopt QualityDocs for all of its content management needs. Tristin provided insights into the implementation, shared her lessons learned with the audience, and her best practices on establishing a quality center of excellence.
Lee Young, Principal Consultant of Lee Young Consulting, provided his observations on the diagnostics industry in his presentation, Modernizing Quality Systems to Support cGMP Requirements. From changing regulations (e.g., IVDR) to increased reimbursement rates with top line revenue impact, there is an influx of diagnostics organizations – along w/ CLIA certified labs seeking to support GMP requirements – looking to modernize and get more value out of their quality systems.
Along the same vein, Mark Ramser, Sr. Director of Global Quality at Epredia, shared how Epredia leveraged a spin-off from Thermo Fisher as an opportunity to transform both quality and regulatory solution landscapes. Mark provided an inside look to Epredia’s drivers for change, its selection process, and future plans to connect its quality and regulatory functions through the Vault Platform to help maximize efficiency and increase value.
And last but not least, Adam Burgess, Director of Quality Assurance at Oval Medical Technologies, sat down for a virtual fireside chat to discuss their expansion into manufacturing and the importance of a modern, easy-to-implement, easy-to-use content management system to make that expansion a success.
While we all agree that compliance is the keystone at the crown of the “quality arch”, having a compliant solution simply isn’t enough in 2020.