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Partner Presentation: Connected HealthThis changing landscape is creating an exciting opportunity for the emerging area of connected health, and MMAs may offer particularly apt solutions to the challenges of monitoring patients remotely.
Smartphone technology is promising for use in remote patient monitoring for several reasons. David Pettigrew, Sagentia’s Vice President of Connected Health, sums up the advantages: “Benefits to medical-device manufacturers include cost savings through not having to develop a completely new device, leveraging existing platforms while adding more sophisticated sensing and data capabilities, and using an interface that consumers know and understand and is already part of their everyday life.” The result: Devices are far more likely to be adopted and used correctly.
The Regulatory Pathway
The U.S. Food & Drug Administration (FDA) has created three categories of MMAs:
- Unregulated: This lowest tier consists of wellness-focused apps such as exercise trackers and heart-rate monitors that many consumers use in their fitness regimens.
- Enforcement discretion: This middle category includes disease-focused apps that work as simple professional calculators (for instance, measuring and calculating mean arterial pressure, or assessing a Glasgow Coma Scale score); or that provide coaching for patients with conditions such as cardiovascular disease, hypertension, diabetes, and obesity.
- Regulated: This highest tier consists of specific patient- or disease-monitoring and treatment-responses, such as infusion pumps, which act as medical devices and could cause harm to patients if faulty.
“Of more than 43,000 health-related apps available, by 2013 only 103 were FDA-regulated,” Tighe says. “But the regulatory pathway for the use of smartphones and data aggregation has recently become much clearer.” In fact, the FDA has now defined the regulatory pathway for MMAs and released draft guidance proposing deregulation of medical data aggregation systems. This clarification, she says, significantly reduces the risks of these opportunities for medical technology companies.
“Currently, most FDA-regulated apps are either stand-alone or act as accessories to existing medical devices, and allow the smartphone to act as a ‘dumb-user interface’ or a ‘data pipe’ to the cloud,” Pettigrew adds. “However, with the clearer regulatory pathway, emerging concepts are now starting to push the boundaries, and are moving towards using the smartphone/tablet hardware and software to perform more advanced functions.”
An emerging example of this is Setpoint Medical’s implantable neurostimulation device (currently in development), configured via an iPad app. This device is aimed at treating patients with debilitating inflammatory diseases. It consists of an implantable microregulator, a wireless charger, and the iPad prescription-pad application.
Addressing Two Critical Questions
Sagentia believes there are two critical questions for medical device companies entering this space: First, how do you develop a regulated MMA and incorporate it into a medical device? And equally important, how do you make money from doing so?
In addressing the first question, Pettigrew notes that successful MMA development starts with the right mindset. “This is not just another mobile app. It’s not just a software tool,” he says. “MMAs should be treated like any other medical device. Risk analysis is key, and careful system design will ensure that safety critical functions are implemented appropriately.”
Once companies decide to incorporate an MMA, they follow the same type of development roadmap used for any other medical device. The presence of an app doesn’t fundamentally change the methodology, Pettigrew notes: “First, you need to define the intended use. This is critical for defining whether the app will be regulated by the FDA, and it identifies predicates. You then need to map your core user requirements so that you understand what information is needed, how it should be presented and when,” he continues. “Next is designing the high-level system architecture to minimize patient risk and ensure that it is usable.” The final step: development under the ISO 13485 medical-device standard.
As an example of how to manage the risks of including apps in connected systems, Tighe cites the VeriHaler, which Sagentia has developed to monitor patient adherence to treatment for asthma or chronic obstructive pulmonary disease (COPD). VeriHaler uses wireless acoustic monitoring to provide valuable feedback to users, physicians, or other health-care providers, promoting correct inhaler use and rapidly detecting any deterioration in a patient’s condition.
The key to answering the question about generating revenue lies in defining the value proposition early and optimizing the business model. “In this environment, there’s the opportunity to be very creative with business models,” Tighe says. “Examples include pay-per-use analytics, risk-sharing reimbursement, and patient self-payment.”
She recommends defining the MMA’s targeted value proposition and business model up front. Doing that will help gauge the likely level of FDA involvement, align with the company’s business strategy, and help ensure that the app is designed as effectively as possible for its intended uses.
Bottom line, according to the Sagentia executives: With the regulatory situation becoming clearer and the cost of technology reaching feasible levels, connected health and MMAs truly have the potential to disrupt the health-care market. With such great opportunities available, it’s no surprise that many medical device companies have connected health on their agendas. It’s also clear that the key to success in this emerging space is getting the business models right.
