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And with that, I ask the question for which this post is named: “Can design controls accelerate medical innovation?” While this question may seem out of place, there is logic to it. This logic is based on a 20-year observation brought to into focus with 2020 vision. Innovation begins at the fuzzy front end of design, so that is where this journey begins. From this vantage point we can see significant hurdles. They are in front of us, and we clearly see them. We know that one day, down the road, we’ll need to produce our solutions under good manufacturing practices. We will have to do verification and validation testing to get there. We have a complex ecosystem to navigate with barriers to entry including market considerations, intellectual property, regulatory pathway to approval, and medical economics.

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