Medical Device Development has become significantly more complex in the last decade. On the technical side, devices are increasingly connected with some or all of their functions duplicated or relegated to smart device apps and cloud hosted controls and storage. Security and Privacy has gone from the “Security through Obscurity” paradigm of decades past to mandatory continuous data and device protection. And the regulations and standards governing device development have evolved from a checklist mentality to a risk based process that continues past product launch. However, these changes haven’t uniformly been more burdensome. Properly architected, some products and accessories may actually fall under a faster regulatory regime.
The Harvest Circle can help with those that are new to this area or who just want to make sure they are up to date.
We aren’t a design house, instead, our expertise is in:
Architecting your connected device and surrounding systems to insure they reliably meet your customers needs
Selecting the technologies that will meet your needs now and in the future, but are mature enough to depend on
Making sure your component devices, accessories and systems take advantage of any accelerated regulatory path they are entitled to
Helping you vet and select vendors capable of delivering on a budget and on a schedule
Helping you monitor those vendors as they advance through the stages of product design and release