I recently became aware that the FDA was seeking submissions regarding its proposal for patient participation in medical product discussions. The comment period closes at 11:59 p.m. tomorrow, December 4, 2014.
If you want to comment, you may add your submission here. This page explains the details and also contains a "Comment Now!" button.
Here's what I just submitted:
I have lived with type I diabetes for almost 31 years. I’ve made extensive use of diabetes devices starting with blood glucose meters in 1984. In 1987 I started on an insulin infusion pump and have since used one model or another. I added a continuous glucose monitor (CGM) in 2009 and still wear one today.
Over all these years I have been frustrated with design deficiencies that seem embedded in “FDA cement.” At least that’s what the diabetes device manufacturers have led me to believe about the changeability of their products. They cling to their FDA-approved portfolio and don’t seem to have any incentive to even remotely improve on their iteration frequency.
As a user intimately engaged with these devices on a 24/7/365 basis, I thought, at first, that the manufacturers would like my input. I have been rebuffed time and again by their customer service representatives when I call to make suggestions. I could only conclude that management did not want to talk with me.
When I’ve observed some design deficiencies, I’ve often thought to myself, “How did this ever get by even a casual user of this tech?” For example, I love to sail and pursue outdoor sports. That means playing in sunlight. Yet, none of my diabetes tech gadgets can be read in bright sunlight. Some might question, “Can’t you just briefly shade your device to see what you need to see?”
Well, that depends. When I’m single-handing a 33-foot sailboat on San Francisco Bay heeled over in 30 knots of gusting wind, threading a course between a huge cargo ship and a commuter-laden ferry, I only have a second or two to briefly grab my important metabolic data. A screen readable in the sunlight becomes an essential necessity, not a luxury. My blood glucose at that time is just as important to my personal safety as is the sea-worthiness of my boat. At this time, the entire diabetes medical device industry disagrees with me!
Well, one could counter that my experience is so far out of the norm that it doesn’t represent the typical device user. Is that so? What about the diabetic construction worker, working many stories in the air wanting to get a glimpse of her CGM display so that she can protect her safety as well as those around her? What about the young parent with diabetes watching his toddler at the local play-lot, trying to judiciously divide his attention between his personal safety and that of his precious child? Or the young–adult diabetic person running for exercise but must stay on top of her blood sugar to avoid an unplanned trip to the local emergency room?
If a strong diabetes patient advocate had been in that discussion with the business-types that argued for the cheaper display, perhaps the outcome would have been different. The diabetes tech industry knows well about this complaint. They’ve known for many years. Yet they choose to continue to produce this deficient product while they tell the patient community that they can’t change it because they’d have to go through the FDA regulatory process once again.
I could list many such design shortcomings that any experienced person with diabetes could catch at an earlier stage of the design process, when things are more malleable. The device industry is either not catching these problems or has made the deliberate decision to trade-off important features for other reasons.
The FDA’s stated interest to “develop and implement strategies to solicit the views of patients during the medical product development process” is brilliant. If successful, it will engage the manufacturers during the development cycle when changes can be made that will benefit the manufacturer, the FDA, and the patient, a win/win/win proposition!
I sincerely thank the FDA for its interest in the diabetes community. We live with diabetes drugs and devices for 8,760 hours every year. We are an untapped gold mine of information, feedback, and resource. The FDA appears to value that expertise. I wish you well with this new agenda and would be personally happy to participate in any way that might help the diabetes community.