Every year, products that are commercially available in any country may be submitted, in one of the following categories:
Critical-care and emergency medicine products;
Dental instruments, equipment, and supplies;
General hospital devices and therapeutic products;
Implant and tissue-replacement products;
In vitro diagnostics;
Over-the-counter and self-care products;
Radiological and electromechanical devices;
Rehabilitation and assistive-technology products;
Surgical equipment, instruments, and supplies.
Criteria guiding the MDEA judging process
A panel of jurors with expertise in biomedical engineering, industrial design, business and R&D management, medicine, human factors, and basic sciences reviews the products according to the following criteria:
Innovative use of materials, components, or processes in the fabrication of the product;
The ability of the product development team to overcome design and engineering challenges so that the product meets its clinical objectives;
User-related design and engineering features that improve healthcare delivery, with special attention to functional innovations that broaden the scope of users, change traditional medical attitudes or practices, or offer significant use-related improvements;
Design and engineering features that provide enhanced benefits to the patient (e.g., comfort, fit, service access, safety, appropriate aesthetics, overall improvement of healthcare);
Aspects of product design and engineering that improve the manufacturer’s profitability;
Product features that improve the overall delivery of healthcare.
Although it is generally expected that there will be only one gold winner in each category, the jury may assign any number of gold and silver awards. The public announcement of the winners is made in April (in partnership with the Medical Device & Diagnostic Industry magazine).
Would the MDEA winners be also considered winners by those who are struggling to improve health care systems?
A technology that is equally or more effective and costs less than its current alternative
A technology that can be used safely and effectively by less skilled and less costly personnel
A technology that can be used safely and effectively in any kind of setting and in all geographical areas
A technology that solves a health problem permanently or that produces diagnostic certainty
A technology that does not trigger side effects or reduce a patient’s mobility or autonomy
A technology that does not pose ethical dilemmas or give rise to equivocal social transformations
Box 1. What constitutes a better innovation from a health care system perspective? (Lehoux 2006)
When looking at Box 1, one may say that two out of the six MDEA criteria are compatible with health care system challenges, but lack an explicit reference to cost-effectiveness and to the settings where the technology can be used safely:
“User-related design and engineering features that improve healthcare delivery”
“Product features that improve the overall delivery of healthcare”
Usability is an issue that matters from a health care system perspective and two MDEA criteria are also compatible: “User-related design and engineering features […], with special attention to functional innovations that broaden the scope of users […], or offer significant use-related improvements” and “Design and engineering features that provide enhanced benefits to the patient.” However, usability should be understood broadly as encompassing not only the practical functionality of a device, but also the multiple ways that humans interact with it in the context of their daily lives.
Finally, the sustainability of innovation matters. It refers, on the one hand, to the various ways in which manufacturers’ commercial viability (not necessarily “growth”) can be established and, on the other hand, to the capacity of the health care systems to absorb innovations. Perhaps to the MDEA criterion of “Aspects of product design and engineering that improve the manufacturer’s profitability”, one should add the innovation’s impact on health care system economic sustainability.
To summarize, in order to promote the design of more valuable innovations from a health care system perspective, the current MDEA criteria could be complemented with insights about the comparative value of innovations given current health care needs and cost implications.
Lehoux, P. (2006). The problem of health technology. Policy implications for modern health care systems. New York : Routledge.