MCRA Presentation Highlights Importance of Digital Health Moving Forward
On June 23rd, the Musculoskeletal Clinical Regulatory Advisors, LLC, better known as the MCRA, hosted a webinar presentation, “The Future of Medical Devices: How Covid-19 and the reside of digital health has changed the Regulatory, Clinical, and Reimbursement Dynamics in the Medical Device Industry.”¹ MCRA is a highly respected medical device and biologics CRO and consulting firm with a 16-year history of success and expertise. Attendees learned about the impact COVID-19 has made on the medical device industry, as well as the rising importance of digital health methods.
Following introductions, the presentation sets the scene. The global pandemic has incurred a massive hit on the medical device industry and hospitals by halting elective surgeries. It’s estimated that a total of 28 million elective surgeries will have been canceled by the end of the pandemic, with an estimated cancellation rate of 72.3%. While these cancellations are necessary for the safety of patients and the availability of hospital space for those fighting the coronavirus, this impact still requires an adaptation from hospitals and the medical device industry as the world moves forward through this challenging time. In the presentation, MCRA calls for “an accelerated timeline for all stakeholders of digital health.”¹ Those stakeholders include regulatory and compliance agencies, customers, and developers and manufacturers. These stakeholders must leverage digital health in order to recover from this industry setback, as well as improve the quality of care in a time when in-person treatment is not particularly safe.
The presentation also highlights the differences between telehealth and telemedicine. While both enable remote care, telehealth is non-clinical while telemedicine enables remote clinical services. MCRA predicts telehealth and telemedicine to change medicine in several ways, starting with biometric monitoring collecting data. That data will transform the management of chronic diseases. Beyond that, digital health strategies will push healthcare to decentralize and become more patient-driven, increasing the number of patient-doctor interactions. Finally, digital health technology and healthcare IT will integrate, driving a new need for cybersecurity to become a pillar of digital health design and innovation.
One section of the presentation called attention to innovative digital health technologies in four categories: Diagnostic Apps, Disease Management, Remote Medical Exams, and Orthopedic Monitoring. The technology chosen for the Orthopedic Monitoring category was TracPatch. MCRA highlighted TracPatch’s ability to measure range of motion and ambulation, key patient data metrics for surgeons and physical therapists as they provide care for total knee replacement patients.
Consensus and the TracPatch Division are excited to be contributing to the digital health movement. TracPatch provides healthcare providers with real-time objective patient data, resulting in optimized outcomes and evidence-based care. With remote patient monitoring, providers can gain insights into a patient’s condition without ever having to meet in person. In a time when in-person care is not safe, TracPatch allows for continuous care management.
- Stiegman, Glenn, Tonya Dowd, Iman Ahmad, Michael John, and Nicole Batista. “The Future of Medical Devices: How COVID-19 and the Reside of Digital Health Has Changed Regulatory, Clinical, and Reimbursement Dynamics in the Medical Device Industry.” MCRA. Lecture, 2020. http://cwinfo.centerwatch.com/cw-web20609-medical-devices-and-digital-health-after-covid-19.