FDA experts discussed regulatory considerations for orthopaedic sensing, measuring and advanced reporting technology (Smart) at the organisation’s latest public workshop.
FDA Approved
As reported in Orthopedics Today, FDA experts discussed with medical device companies about the scientific and regulatory challenges associated with Orthopaedic Smart devices.
Conversations ranged from what types of devices will require clinical evidence, what devices will need complementary software and why data matters to both researchers and patients.
Joshua Chetta, FDA biomechanical engineer and lead medical device reviewer mentioned that devices such as those with novel technology or those with a change in its intended use will require clinical evidence to support the regulatory decision.
Colin O’Neill, MS, of the FDA gave a presentation on sensor technology and pre-clinical activities for orthopaedic devices.
For sensor technology, complementary software may need to be evaluated based on its level of concern. There are major, moderate and minor levels of concern. I think these sensor capabilities and evolving indications and such —they are going to potentially alter the benefit/risk profile.” O’Neill said.
Other members at the workshop spoke about how Smart devices and applications can engage patients in their treatment and how clinicians can benefit from them.
Mark I. Froimson, MD, immediate past president of American Association of Hip and Knee Surgeons, said: “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-centred.”
Smart technology was said to be able to help bolster patient engagement, assist clinical studies and change what clinicians measure, Froimson said.
Aenor Sawyer, MD, of University California, San Francisco, spoke about how Smart devices can help clinicians monitor how devices are functioning.
“We really need certain components— the signal detection, the processing, the transfer, the power requirement, biocompatibility, the longevity, reliability and precision. 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.”
“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.” Sawyer added.
Other topics such as potential cyber-security issues and the experiences of Smart devices by patients were discussed, as well as the development and acceptance of innovative technologies.
In addition, presenters discussed engineering of orthopaedic sensor technologies. They discussed the current research being conducted regarding sensors being used in orthopaedic devices, as well as future applications for Smart technology.
Lisa Ferrara of OrthoKinetic Technologies, said: “We need to take innovative leaps in medical technologies and this is going to be crucial in the future. Current market developments will lead to patient-specific treatments and we already are starting to see that with specialised drug plans, etc.”
“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?