In our CEO Blog, CG-HG has previously discussed some of the regulatory issues facing the new mHealth Technologies being built on the ever more ubiquitous smartphones. Along with the rapid rate of innovation happening on the mobile application development side, there also is rapid innovation happening both in the integration of mHealth devices with traditional medical devices as well as with those same medical devices.
In a recent interview, Scott Amyx of Amyx-McKinsey talked about "Advanced Data Analytics" working with wearable devices has a huge opportunity to improve healthcare outcomes. This is an area where regulatory processes are in very rapid flux: Software-as-a-Medical-Device, Medical App Stores, as well as Data Analytics like 23andMe.com. Much of this software needs the sensor data from Wearables as input.
The technology in Wearables is accelerating rapidly in directions that a few years ago were hard to predict. We have already seen exploratory projects such as ultralight-weight breathable custom casts, but the big challenge with 3D printing is the cost. It still costs dramatically more to 3D print something than to produce it from a mold or a casting. That is part of why Gartner puts 3D Printing of Medical Devices at the top of its Hype Curve just waiting to plunge into the "abyss of disappointment".
Hybrid solutions are one way to transition this "abyss" for example: The ability to 3D print antennas directly into injection molded plastics . This allows injection molding of the majority of the wearable (inflatable cast, intubation tube etc.) while enabling post molding customization via electronics integration such as adding a pulse oximeter on the inside of the cast perhaps .
The advantage of hybrid devices over general purpose devices like a smart watch or a fitness tracker, is that by being "purpose built" they can be designed for the specific task at hand and nothing more. This will be one of the big steps in bringing down the cost of such devices. After all, a pedometer isn't of much use to a bed or wheelchair bound patient, and carrying an disabled pulse oximeter in a watch does little other than increase the cost of the watch.
But there is a risk with such an approach. Again it is the regulatory framework. While under current regulations a medical practitioner can prescribe that a patient use a particular device outside of its "intended use" description, doing so requires that the practitioner use their "best medical judgement" in each case separately.
This means that the medical device manufacturer cannot market the off-label usage of device, thus limiting its market. Here, ClearRoadmap® can help you and your company identify devices that might provide Substantial Equivalence for your hybrid device, reducing the cost of FDA Clearance.
These regulations are also subject to change. Currently there is an effort to create "harmonized" device registries. But it is not clear what device registry a mass customized device would go into since it is potentially treating different kinds of pathologies. Here, ClearRoadmap's Pathway tool, which documents 33 differentiated pathways through the regulatory forest can help since it is updated as regulations and processes change.
It is the dawn a of a new world and ClearRoadmap is committed to helping our customers stay abreast of the rapid changes and innovation happening.
By Karl Schulmeisters, CTO