FDA workshop provided regulatory guidance for SMART technology in medical devices
The FDA Center for Devices and Radiological Health held the Orthopaedic Sensing, Measuring, and Advanced Reporting Technology Devices public workshop on April 30, 2018, to highlight the regulatory, clinical, cybersecurity and engineering aspects of current and future ‘smart’ devices.
At the public workshop, experts in orthopedic sensing, measuring and advanced reporting technology (SMART) discussed concepts for orthopedic sensor-equipped implants and instruments that collect and report performance and health information data.
FDA experts at the day-long workshop gave presentations that provided medical device companies with regulatory guidance to be aware of should they seek FDA approval for one of their devices.
“Depending on the risk, not all devices are going to require clinical evidence to support regulatory decision,” Joshua Chetta, PhD, FDA biomechanical engineer and lead medical device reviewer, said.
Devices that will require clinical evidence include devices with novel technology or those with a change in its intended use, he said.
Colin O’Neill, MS, of the FDA, discussed preclinical activities that should be considered for any type of orthopedic device for accurate appropriation, which includes medical testing, biocapability testing, software requirements, electromagnetic compatibility, usability, labeling and analytics.
“For sensor technology, the complementary software may need to be evaluated based on its level of concern,” O’Neill, said. “There are major, moderate and minor levels of concern.”
During the regulatory considerations session panel discussion at the workshop, O’Neill said, “I think these sensor capabilities and evolving indications and such —they are going to potentially alter the benefit/risk profile.”
Engage patients in their treatment
A group of experts that mainly consisted of orthopedic surgeons discussed the importance using SMART devices and applications to engage patients in their treatment and the benefits of these devices for clinicians.
“We need to use this technology to do what we do as physicians, which is to engage patients and to empower patients and families, and to ensure information is bi-directional. That we get patient data, we provide clinical instructions, care protocols and reinforce data that is patient-centered,”
Mark I. Froimson, MD, immediate past president of American Association of Hip and Knee Surgeons, said.
SMART technology will help ensure there is patient engagement, ease the burden of clinical studies and will change what clinicians measure, he said, noting clinicians will be able to perform virtual visits and continuous monitoring at different time points.
“We really need certain components— the signal detection, the processing, the transfer, the power requirement, biocompatibility, the longevity, reliability and precision,” orthopedist Aenor Sawyer, MD, of University California, San Francisco, said. “I think for most of the things that we think about for implants that are going to be giving data we should be able to send data, as well and as often as possible create an active system or a closed loop system. And, I think it is very important to know that the smart devices will also be serving an audit trail for us in terms of understanding how are those devices functioning, not just how is the patient functioning.”
Sawyer, added, “It is the data that matters and the people that we ask to participate in the studies really understand that and it drives them to continue to engage in the questions and the process if we can show them why its meaningful, and meaningful to them not just to us and research.”
During the workshop, patients commented on their experiences with medical devices using SMART technology; one patient who received a knee replacement and another who received osseointegrated amputee care.
A panel of experts also addressed potential cybersecurity issues related to SMART technology and FDA guidance for medical device companies to consider.
Engineering in SMART technology
In addition, presenters discussed engineering of orthopedic sensor technologies. They discussed the current research being conducted regarding sensors being used in orthopedic devices, as well as future applications for SMART technology.
“We need to take innovative leaps in medical technologies and this is going to be crucial in the future,” Lisa Ferrara, PhD, of OrthoKinetic Technologies LLC, said. “Current market developments will lead to patient-specific treatments and we already are starting to see that with specialized drug plans, etc.”
She added, “It is logical for the long-term economics, but we do need the acceptance and adoption of new technologies. It must really be a disruptive and superior technology—really for maximum value. Does it offer a solution to the patient quality of life?”– by Monica Jaramillo