As the presence of connected devices in our daily lives increases, one area that continues to experience tremendous growth is the medical device industry. The Internet of Things (IoT) in the consumer space might make life more convenient, but it doesn’t truly impact our overall health and well-being. Connected medical devices, however, do just that — and are beginning to do so with much more frequency. While many companies see wearable health technologies as the way of the future, that’s really only the tip of the iceberg. The bulk of connected medical device potential lies in weaving technology into existing analog devices to make them more efficient and effective for the patient.
Can we modernize and address the frustrations with something as critical (yet clunky and somewhat obtrusive) as diabetic glucose monitoring using technology? Can we use technology to predict precisely when an asthma attack will occur? Spoiler alert: yes, we can — but we’ll get to that a little later.
All of this potential is meaningful for multiple reasons, namely the millions of people globally that it will help. It’s also extremely beneficial for the companies responsible for helping those people. In the U.S. alone, the medical device industry earned just over $39 billion last year. This year, that number is expected to grow by about 2.6%. That means there’s a lot of opportunities to do good in this sphere in the remaining months of 2019 and beyond.
All that good can quickly turn the other direction if the software behind the device fails or encounters major glitches. The stakes for medical device software are much, much higher than say that of a connected home device. As such, the margin for error is razor-thin — or non-existent — and the process for going to market is a little more complicated.
At MentorMate, one of the niche markets that we’re proud to have expertise in is developing the software systems that power these life-changing devices. We’ve worked with a number of different medtech companies and helped them bring their devices to life. It’s offered us a unique glimpse into that world and the various approaches companies can take to enter the market. In our work, we’ve commonly encountered three of these different approaches — the startup, the biopharma supergiant, and the medtech intermediary. We’ve helped client’s in each category navigate the tricky process of incorporating custom software into their intricate medical devices.
POPS! Diabetes Care was founded on the principle that personal diabetes care shouldn’t cause undue frustration, something CEO and Founder Lonny Stormo knew all too well. As a type 1 diabetic, Lonny (along with millions of others living with the disease) experienced firsthand just how awkward and cumbersome the available tools to test and track blood glucose were. As a result, many people often forgot or simply ignored proper health management methods, and risked health complications down the road.
Thus, POPS! Diabetes Care was born. They came to us with an idea that would revolutionize glucose monitoring and simplify the lives of those living with diabetes. It was a mobile app that communicated with a Bluetooth blood-testing device to measure and track blood levels. The Bluetooth connection then securely uploads the user’s data to a cloud-based, HIPAA-compliant network.
After the device and first generation of the app passed 501k certification from the FDA, we began working with POPS! on phase two of the application. It commercialized the platform and gave healthcare professionals the ability to remotely access and monitor users’ glucose levels, limiting the need for patients to visit brick-and-mortar offices. Users can also choose to share their data with family members to reinforce the management of healthy habits in a holistic way.
At the outset, Lonny took note of a frustration in his daily life. By examining that frustration through the lens of technology and entrepreneurship, he was able to ease a critical process that he and millions of people globally go through every day.
On the opposite end of the spectrum from the startup is the well-established, well-funded multinational biopharma company. Deeply rooted in the traditional pharmaceutical world, they have access to decades worth of healthcare data that can be harnessed to bring technology into the fold and healthcare into the modern era.
MentorMate has worked with many of these companies on a number of projects. One project in particular addressed the fact that asthmatics are underserved by current medical device offerings on the market. The devices that are available fail to successfully capture the complexity of the disease and can’t sufficiently synthesize and convey data to users or inform long term symptom management. So, the company identified this gap as a focal point of its technological, pharmaceutical, and business innovation.
The solution was to create an app that communicates with multiple external Class 1 and 2 medical devices like smart inhalers, FeNO measurement devices, patches for monitoring heart rate, and spirometers via Bluetooth. When all of these devices work together with the app, they create a cohesive system that monitors various vitals and can predict precisely when an asthma attack is likely to occur. This helps patients pivot from a reactive treatment plan to a proactive one, which results in less stress to the body and lowers the amount of medication required.
Throughout clinical trials, the application gathered large amounts of data relating to users’ symptoms and the environmental conditions present during instances of severe asthma. Meanwhile, medical experts from the company worked with data scientists to determine whether fewer, more, or different data points were required to understand and predict asthma attacks more accurately. From there, we incorporated the findings from the clinical trials into the updates made to the app’s functionalities to improve its performance and accuracy.
Somewhere in between the previous two examples lies the intermediary. These are third-party companies that serve as a conduit for healthcare organizations who have the idea for a medical device but lack the product development resources to actually make it a reality. For instance, a medtech startup might have that revolutionary, life-changing idea but not the ability to actually design the physical device or develop the software that powers it.
Essentially, that startup is limited to a couple of options. They can either hire a product design team of their own (which they may or may not have the funding for), or they can turn to a company like Ximedica. As a full-service development firm, Ximedica has an exclusive focus on medical products and over twenty-five years of experience developing medical devices. Their teams of designers, engineers, and analysts to work through the nitty-gritty aspects of the project and bring that idea to life.
One of Ximedica’s clients that MentorMate engaged with was working on a delivery device that provides doses of medication into the patient’s bloodstream. Along with Ximedica, we designed and developed FDA regulated Class 2 software for the device. Throughout the entire process, both Ximedica and MentorMate actively collaborated on the analysis and evaluation of the project’s requirements, architecture, and design, all the while adhering to an ISO 13485 quality management system.
As you can see, there are a number of different ways companies can get involved in the explosive growth of the medical device industry. Of the three illustrated above, the method with the most wide-spread appeal is partnering with an intermediary who can handle the product development side of things. This approach allows in-house teams to remain lean while decreasing costly overhead for companies not quite ready to invest in their own product development teams. On the other hand, if you’re a startup with the product design chops to fully see your physical device through to production or a fully-funded global biopharma leader, the software that powers your device can still be a tricky system to master. Regardless of the approach you take, as long as your core idea is sound, there are software, security, and back end systems that can be developed to bring it to life.