The Center for Devices and Radiological Health, including the Division of Neurological and Physical Medicine Devices, recently established initiatives to provide a venue for patient-centered participation in the complex process of evaluating devices that have the potential to improve the health and quality of life of persons with physical impairments and functional disabilities. The evaluation of safety and efficacy of healthcare and rehabilitation devices must include the end user, the patient, and the family or caregivers.1-3
Patient-Centered Prospective
Involved in the complex task of the development of a healthcare product, therapeutic drug, medical devices, or wound care products, the typical contributors include scientists' academicians, clinicians, device developers, investors, and regulators. Although they all possess a diversity of experiences and responsibilities along the continuum, the most important responsibility is to effectively communicate the benefits and risks of medical devices to the patients or end users of the therapeutic device or product,1-3 and that indeed is the time-honored mission of the FDA. However, the FDA is now working to change the narrative from communicating "to" patients about product safety and efficacy to a narrative of communicating "with" patients or consumers by active listening (bidirectional communication). The FDA is in a unique position to provide a listening post for consumers'2 experiences with healthcare and quality-of-life technology. Evolving initiatives and literature demonstrate how the patients' lived experiences (qualitative) are antecedent to the development of a medical or surgical procedure or device (quantitative) used to ameliorate disease or enhance quality of life and function.3
Current Efforts
Several sectors in the public and private domain, including the Medical Device Innovation Consortium,3,4 the nation's first public-private partnership, are focused on medical device regulatory science and consumer input. They are moving to incorporate the patient's perspective in developing and ensuring the safety and efficacy of healthcare products and devices; this approach parallels the concept of personalized medicine and precision medicine that match patient genetics and patient preferences to medical care. Currently, and in the future, we have the ability to operate and capture data from automated devices and products. To that end, we now have the computerization of medical devices and products that are equipped to store, communicate data, operate, and control most any therapeutic device.
Beyond Moore's Law
In 1965, Gordon Moore, cofounder of the Intel Corporation (Santa Clara, California), predicted that computer processor speeds would double every 18 months (known as Moore's law). His prediction has proved true: We are seeing processor speeds jump at that rate or beyond. Moreover, microchip technology and the adaptation of computer-driven miniature motors, sensors, actuators, and transducers are parts of medical devices including "flexible robots" and devices woven into fabrics and dressings:
* A transducer converts one form of energy into another.
* A sensor converts a physical parameter to an electrical output.
* An actuator converts an electrical signal to a physical output.
The Human-Machine Interface
The advancing array of biomedical technologies possesses new capabilities to produce miniaturized, low-power, communicative, and flexible devices. This technology is making its way into the wound care arena, as well in the form of smart dressings, which measure data, bioimpedance, moisture, and pressure. Emerging technologies include flexible sensors for chronic wound management5 and smart clothing for citizen medicine, home healthcare, and disease prevention.6
The FDA has revitalized its commitment to communicate the safety and efficacy of these devices and involve the patients as consumers in the process.
References