How do medical device manufacturers involve users in the development process?
Involving users in the design and development of health technology pleases our logic and our reason. Isn’t it the best way to ensure that the medical devices that reach the market are safe, usable and adapted to their users’ needs? Yet, the literature shows that manufacturers are not keen on the use of systematic methods for collecting data on users’ views and needs. From the manufacturers’ point of view, the benefits of user involvement are not worth its cost in terms of resources and time (Shah and Robinson, 2007).
Documenting the beliefs and attitudes of 11 medical device manufacturers, a study by Money and colleagues (2011) provides new insights on the pros and cons of user involvement.
Whose views matter?
Their study suggests that, from manufacturers’ perspective, attending to the needs of those who are in a position to promote or purchase the technology is more salient than attending the needs of those who will actually use it. Thus, to inform their design and development processes, medical device manufacturers tend to turn to senior health professionals, surgeons or sale representatives of health authorities rather than less senior clinicians, nurses or patients.
How do manufacturers gather these views?
According to the study, manufacturers feel they have no time to engage in formal user data collection methods. Not only are these methods perceived as costly in terms of time and resources, but they are also believed to generate as many points of view as there are users being consulted, making it difficult to reach consensus and identify a clear direction to inform the development process. This is why manufacturers tend to prefer informal discussions with a limited number of experts and to rely on their own gut feeling, instinct and understanding of the market place in which they operate.
What about patients?
From the manufacturers’ perspective, patients have little if no influence on the level of uptake of medical devices. For this reason, those interviewed by Money and colleagues rarely sought their perspective. They argued that involving patients earlier in the development process often implied obtaining ethics approval, a heavy bureaucratic process believed to generate additional delays.
However, patients are involved at a later point when the efficacy and safety of devices are assessed. Clinical studies are indeed necessary to fulfil regulatory requirements. But this happens once the device is already developed.
Facilitating user involvement?
Drawing on this portrait of user involvement, Money and colleagues provide a number of recommendations that aim at encouraging or facilitating the implementation of formal methods of user involvement in the medical device industry.
However, it might be worth challenging the idea that more formal methods of user involvement are necessarily for the better. There is little evidence that manufacturers’ current way of developing health technologies is significantly suboptimal. If such evidence was available, perhaps manufacturers would show more enthusiasm in systematically and formally involving users in their development processes? For now, they seem to have found ways that they feel are reasonably safe and efficient to bring new and relevant health technologies to the market. Further research could seek to challenge these views.
|Author :||Myriam Hivon, Ph.D.
Money A.G., Barnett J., Kuljis J., Craven M.P., Martin J.L., Young T. (2011). The role of the user within the medical device design and development process: medical device manufacturers’ perspectives. BMC Medical Informatics and Decision Making, 11: 15.
Shah S.G.S., Robinson I. (2007). Benefits of, and barriers to involving users in medical device technology development and evaluation. International Journal of Technology Assessment in Health Care. 23: 131-137.