Learning from your competitors' mistakes
Immersing in the "arts" is an important aspect of medical device design. This includes focus group review with surgeons and other end users. We often think of industry bench marking as looking up brochures and other publications on existing products. I feel that valuable design input can be culled from FDA's post-market surveillance data.
When embarking on a design project, the urge is to dive immediately into the design process and think of all kinds of cool designs. We must resist this urge! All these years of designing medical devices has taught me that insight into problems of existing products helps me to come up with more robust designs and possibly more elegant solutions. Now, I would not start a design project until I know what kind of problems my competitors are having. Furthermore the information is available at your finger tips.
Viewing reports on Adverse Events
FDA has a Manufacturer and User Facility Device Experience Database (MAUDE). MAUDE has data on reports of adverse events involving medical devices. The data consists of voluntary, facility, distributor and manufacturer reports. An on-line search facility is available that enables the user to search the CDRH (Center for Device and Radiological Health) database for information on medical devices which may have malfunctioned or caused a death or serious injury.
Personally I found the forms and databases user-friendly and very easy to navigate. FDA deserves kudos for enabling users (not just healthcare professionals) to have access to reports on adverse events. Ultimately it is the consumers (patients, relatives) that decide whether or not they want to use a medical device or product and hence have a right to assess the risks/faults associated with the device/product concerned. But for us as designers, this is an invaluable source of information. Try it and you will be amazed at the kind of information you come up with.
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