Columns

The Link Between Medtech and Connected Medical Devices

A connected medical device communicates health data externally to the patient, caregivers, loved ones, and providers.

Maria Shepherd and Mark Gambale09.06.23

There’s an emotional cord that connects us all, just like in the song, “What’s Love Got to Do With It?” As Tina Turner sang in the song, medical devices have been one of the physical cords that treat much of what afflicts us, allowing us to remain healthy and enjoy the people we love. Beyond the physical link of medtech, how are digitally connected medical devices changing the dynamic of preventive and curative care?

A majority of medical devices, even those powered by electronics, are closed loop, meaning the data and algorithms remain within the device. In contrast, a connected medical device communicates health data externally to the patient, care givers, loved ones, and providers.

Why Is This Important?

Connected medical devices represent a significant trend because they continue to advance patient outcomes and reduce costs in hospitals and at home. Research forecasts the number of connected medical devices—including those found in healthcare facilities, personal monitoring devices, and hospital beds—will grow from 39.5 million units to 94.9 million units between 2019 and 2024—a CAGR of 19%.¹

As the number of devices continues to multiply, so does the opportunity for hacking. This intensifies the critical requirement of creating robust medical device security and advanced authentication capabilities. As such, a software development partner skilled with privacy, security, and compliance across connected devices is essential to your strategy.

Without a clear development strategy, companies without connected devices could be excluded from future opportunities and possibly lose valuable distribution channels. The market advantage a competitor gains from creating a connected device is significant, especially if the device is reimbursed.

For example, ResMed is using the connected device strategy to their competitive advantage with the myAir app, an exclusive feature available to ResMed AirSense and AirCurve CPAP users. At The Medtech Conference in 2022, CEO Mick Farrell told the audience his team shifted from considering patient data with the outdated “How do we monetize patient data?” lens to a strategy that sends personal data to patients. Now, ResMed patients are incentivized to use their CPAP and learn their daily sleep scores with the myAir app. By gamifying patient sleep scores, ResMed keeps patient data for analytical purposes that could produce important patient outcomes and reduce costs, while also improving ResMed’s competitive advantage in the extremely aggressive and competitive CPAP sales space.²

Connected devices can help with preventive care and treatment, which drive a continuum of quality of life for people, becoming essential for both ends of the spectrum. If connected devices become the standard of care, then disconnected devices have the potential to become less relevant. And, while the future has always been uncertain, we can be sure the trend is going to be more digital and dynamic.

How can a medtech executive keep up with the rapid changes in technology? The power of digital technology in medical devices in the form of embedded software, connected devices, and apps have created a revolution in the quality of life for patients. How might your product communicate the status of a patient condition?

What Could an App Do?

As an example, the gait of a patient that has undergone knee surgery can be tracked via Zimmer Biomet’s mymobility app and communicated to the surgeon. In what other ways can connected devices change how care and recovery are delivered? As mentioned previously, devices that contain electronics and embedded software have a higher capability for providing prevention and treatment through the benefit of closed-loop algorithms. Each healthcare product has the potential to be connected to a device, patient, caregiver, loved one, and provider.

As a medtech supplier, what should you know about how apps can connect your devices? Following are several considerations as you prepare to shift your innovation curve to include connected devices via an app.

ROI for an App and Connected Device

What’s the potential impact to revenue and profits? In general software, margins are around 75%, according to Deloitte.³ By EOY 2022, greater than 90% of global businesses were relying on a configuration of hybrid cloud deployment.³ Gartner, the technology consulting giant, assessed the market size of cloud application services in 2021 as $146 billion and predicted it will grow almost 17% to reach $195 billion by 2023.⁴

Connected healthcare technologies are the next wave of change that will carry innovative companies ahead. One of the main drivers of this explosive growth has been the increased ease and flexibility of deploying, maintaining, and scaling software solutions delivered via the cloud. The marginal cost of adding a new customer is insignificant compared to the marginal profit represented by creating a new revenue stream from providers, payers, patients, or any other combination. The following are potential benefits of having a connected device and app:

Deliver new or improved patient outcomes
Increase the efficiency of care
Create defensible competitive advantage
Grow market share and margins
Retain customers in a hypercompetitive space

Example of a Medical App

An application called Dexcom Follow is linked to one of today’s costly comorbidity diseases—diabetes. Type 1 and Type 2 diabetes are well known as growing conditions that are complex to manage. There are a number of glucose monitoring devices on the market. Some of them are connected devices (connect to an app) and others are closed-loop.

Dexcom Follow provides information on insulin levels for patients with diabetes. Through this app, up to 10 people can have access to a patient’s glucose levels. The Dexcom Follow App is part of the Dexcom SHARE system, which allows patients to share their glucose levels with their care providers.⁵ This example is unique since the app is able to communicate with glucose monitors from more than one medical device manufacturer.

Although this is not the norm for apps, you can see the utility of thinking of an app in multiple ways. The value of an app can go far beyond the person using it and their loved ones.

What’s the value proposition of your medtech? What could it be by connecting it to an app, analytics engine, AI and ML model, or EMR? Imagine the improvements in efficiency when medical devices can update and deliver data to the EMR. With up to 25% of the cost of healthcare being administrative work such as documentation of patient care and retyping a patient’s name and health condition,⁶ the need for connected devices and solutions becomes even more critical. There are many options to consider; however, it all comes down to the value to the patient (or end user) and the cost to the provider and payer.

Cost to Get Started

The cost to get started on an app depends substantially on how much work has been completed. There are five required phases for building apps that enable connected medtech devices and therapies. These include:

Assessing market fit
App design
Development, verification, and validation
Compliance and clearance
App launch

At a minimum, multiple security and privacy certifications are required for apps that connect to devices, patients, providers, and EMRs. HIPAA, SOC2, and FDA clearance are among the core compliance and clearance requirements. However, additional requirements apply, especially as the complexity of communications between the solution, patient, provider, and payer interact in new ways.

How Much to Invest?

As a reference point, a new medical app that connects to a product or therapy modality typically requires an investment of more than $250,000. Variability in device complexity and completeness of the aforementioned five steps will significantly impact the cost of developing a connected medical device. Furthermore, considering the potential for advanced analytics, AI, and ML for driving improvements in patient health and efficiencies is important. Regardless, the possibilities and potential benefits of connected devices are only limited by our imagination.

Regulatory Pathway

The main classification of an app is called MMA (mobile medical app). The FDA continues to clarify policies for software as a standalone as well as across platforms. If the app’s function meets the definition of a medical device and includes functionality that creates potential risk to a patient’s safety if the device were to not function as designed then a submission is required.⁷

The Medi-Vantage Perspective

Like another of Tina Turner’s songs, “The Best,” being better than all the rest takes commitment to constant innovation. Will this wave pass you by or will your organization ride it toward a whole new path of potential profits and possibilities? Staying ahead of your competition with connected devices and apps is one key method to ensure you are the best.

References

Maria Shepherd has more than 20 years of leadership experience in marketing in small startups and top-tier companies. After her industry career, she founded Medi-Vantage, which provides marketing and business strategy and innovation research for the medical device industry. Shepherd can be reached at mshepherd@medi-vantage.com. Visit her website at www.medi-vantage.com.

Mark Gambale is the director of business development at Headway. He has turned companies and teams from underperforming to being leaders in their market. Gambale listens to learn the needs of the market, and, with those insights, develops strategies to disrupt the status quo. He’s led teams of developers and product managers to launch powerful products ahead of schedule. Gambale can be reached at mark.gambale@headway.io. Visit his company’s website at www.headway.io.