Executive Summary
We are seeing brisk changes in the world of medical devices technology. What was science fiction 15 years ago is in FDA trial today. Mechanical engineers are dealing with new materials, electrical engineers are moving to new low-power chips, and software designers are migrating to new mobile operating platforms. So my guess is the biggest challenge in completing development of new medical devices is delivering leading edge features using the new technology. We asked 35 medical device designers what they thought, and only 3% voted for hardware design and less than 10% said software design. The biggest group of respondents (over 35%) said their biggest challenge was a familiar old issue – regulatory compliance.
Now, a regulatory compliance smack of the dreaded red tape but it also has a higher purpose as the counterpart to reliability. In our survey [1] we asked designers what was the most important design goal in for the medical devices they work on, the largest number of respondents (over 50%) voted for reliability. When the lives of my family are on the line, I want everyone playing by the rules and I want your device to work.
