Making Keys, Looking for Locks: Technology-Driven Versus Patient-Focused Medical Devices
Ultrasonics are a broad category of timbres that are at frequencies too high to be heard by humans. This includes medical ultrasonics, sonochemistry, material characterization (chemistry), and underwater acoustics (sonar).1,2 Basically, humans have attempted to harness the power of sound frequencies for therapeutic purposes by converting them to physical energy at the human-machine interface (ultrasound transducer heads) to produce heat and energy through reverberation of tissue. However, a concurrent, persistent search has been conducted for strong evidence to support therapeutic ultrasound.3 The use of curative ultrasound in wound care has yet to meet the standard of a fully evidence-based practice. On the other hand, using medical ultrasound for (nontherapeutic) diagnostic imaging purposes is an established practice in cardiology, obstetrics and gynecology, venology, and urology.2,4
The sequence of events for a device or modality to achieve common use in practice ordinarily starts as a “fad” irrespective of the field. Technology adoption in wound management takes a similar path: the technology moves from a fad to a trend and then finally to accepted medical practice, often without the elusive Cochrane standard of evidence for the manufacturer, research investigator, and the patient who may be helped by an FDA-cleared device. I am of the firm belief that the process of medical product development in the United States is the root cause of this lack of demonstrated evidence or utility; why else would it take decades for therapeutic ultrasound to have evidence for its use in wound care at the same time it is being utilized?
The emergence of medical devices is often technology driven rather than clinically and patient centered. What is driving this practice is a rapidly increasing technology-driven management philosophy that pushes for the development of new goods or services based on a firm’s technical abilities to produce them, instead of proven demand; to make keys first and then look for locks to open.5 Practically every breakthrough innovation is based on a technology-driven orientation rather than clinically driven innovation.5
The process for FDA approval is made based on safety concerns, proof of concept, and preclinical data. Wound care products are categorized by the FDA, depending on their specific design and intended use. Perhaps a patient-centered product design should be considered in reverse order, based on
This suggested sequence for product development is in line with the FDA’s stated goal to listen to consumers’ lived experiences with healthcare and quality-of-life technology. Evolving initiatives and literature demonstrate how these experiences are foundational and antecedent to the development of a medical or surgical procedure or device to ameliorate disease or enhance quality of life and function.