Have you noticed how the medical device world is changing? It’s an exciting time. After years of improvements to the same primary product categories, we are now seeing an explosion in the number of new and different products.
Below are some of the things that seem revolutionary.
- Explosion of custom devices such as prosthetics, invisible braces, surgical reconstruction pieces
- Product interfaces which are intuitive, more like a smart phone than a computer interface
- Availability of of diagnostic testing like the genetic testing kit from 23 and me
- Exoskeletons to enable paraplegics to walk and gain independence
- Concept products which will make some of our current test methods obsolete such as a glucose monitoring contact lens
What has enabled this transformation of the medical device world?
- Revised vision of how people and products interact: Do you remember what an MP3 player looked like before the iPod, a mobile phone before the iPhone, or even the totally new category of tablets? What do all these have in common? The user interface is intuitive and easy for anyone to use. Things called “apps” simplify common tasks that used to take many menus and sophisticated knowledge to navigate. And who would have imagined that you could use a touch screen and swipes to move between pages or applications? Welcome to the vision provided by Steve Jobs and Apple. Based on changes that have occurred in how people interact with products, many of us bring that expectation to the medical device market. According to research2guidance, there are now over 100,000 apps dedicated to health and fitness for Android and iOS systems (https://mhealtheconomics.com/mhealth-developer-economics-report/). We are also seeing more products which use the smart phone interface for true medical devices. This type of interactive interface makes it so easy to use, so that it encourages users to be more involved in their own health. However, the smart phone itself is generally not considered a medical device based on the draft guidance from the FDA,. (https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429672.pdf)
- Entrance of developers from outside the medical device arena: Medical devices have often been developed by organizations that are started by someone in the medical field, such as a physician, who sees a way to address a problem they encounter or devices are developed by organizations that have been around for a while and have figured out how to navigate the complex regulatory pathways that have evolved over time. More recently, we are seeing start-ups and innovators, that are directly focused on the consumer and improving their lifestyle develop medical devices. These companies bring a fresh perspective to the category including expectations for ease of use and true integration of the device with the user. They also bring an additional viewpoint to their discussions with the regulatory agencies which have helped in the evolution of regulatory oversight.
- 3D Printing: While 3D printing, sometimes called additive manufacturing, has been around for a while, it had primarily been used to make prototypes, as a replacement for building molds or machining custom parts. Since its introduction, the fidelity of printing has improved substantially and the numbers and types of materials have grown, as well as the printer capacity. Some of you may have seen the article about the kids with prosthetic hands, which highlights some of the amazing benefits. (https://www.nytimes.com/2015/02/17/science/hand-of-a-superhero.html?_r=0) The use of 3D printing and mass customization is exemplified by the Invisalign clear aligners. In addition, the materials have grown beyond plastics and now include metals and other materials. The potential for fully customized personal medicine is now becoming a reality.
- Flexible and tiny sensors: Sensors are becoming smaller and much more flexible. Sensors which are flexible and hug the skin almost like a tattoo are now being demonstrated. Very small sensors have been growing in use, for example, the capsule endoscopy in which you swallow a pill containing a tiny wireless camera that captures images of your digestive track. (https://en.wikipedia.org/wiki/Capsule_endoscopy) While we may be a few years off from more integrated commercial products, the potential for their use is enormous.
- FDA adaptation of oversight on certain medical device: Regulatory oversight is part of developing a medical device. It is the cost of doing business. However, over the past several years, we have seen the FDA take specific steps toward a more flexible and risk based approach to new products. Fundamentally, regulatory agencies are charged with ensuring products are safe and effective for the intended use. Those who have worked with medical devices for years have typically found the FDA to be very conservative in its approach, often requiring additional data prior to commercialization that added high costs and product introduction delays for little user benefit. The changes we are currently seeing reflect better balance of risk. Some of the biggest changes have included the de novo classification pathway, adapting pre- and post-market oversight, expedited access pathway, and a greater focus on the user risk based on how the information provided will be used (e.g. 23andMe genetic marker diagnostic test classification). A report summarizing all the changes can be found on the FDA website. (https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm456969.htm)
There are many exciting changes in the medical device world. We are moving toward more integrated devices that make a real impact in the daily lives of the users. I can’t wait to see where it goes.