Mobile Medical Apps Attract OEM, FDA Attention

Mobile communication devices, particularly smartphone and applications, have already changed how we handle many aspects of our lives, such as personal finance, shopping, travel and entertainment. They are also radically changing the way we think and make decisions about our healthcare.

Manufacturers of regulated Mobile Medical Applications (MMA) bear the onus of having to prove their device’s safety and efficacy to regulatory agencies. These manufacturers are held to regulatory standards, and any proclamations that they make about their MMA must meet regulatory labeling requirements. While barriers to market entry are high, the rewards of taking an MMA to market are higher if the manufacturer embraces the MMA strategy in a deliberate and systematic fashion, all the while paying close attention to critical success factors surrounding reimbursement, regulatory and clinical areas, and proving improved clinical outcomes for patients.

This article introduces the MMA topic, background and current framework of MMA and examines the life cycle of an MMA.

What are Mobile Medical Applications?

FDA’s website¹ defines mobile apps and MMAs as:

“…software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software. Mobile medical apps are medical devices that are mobile apps, meet the definition² of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.”

FDA’s MMA guidance³ document explains that FDA does not intend to regulate all types of MMAs, but only a subset of them. To help us understand the types of MMA that FDA does intend to regulate, we can categorize MMAs as one of the following.

MMAs that FDA will not regulate – Typically a mobile app that is used in healthcare or lifestyle management does not fit the definition4 of a medical device, in that it does not diagnose, cure, mitigate, treat or prevent a disease in man or animal. FDA does not intend to regulate such mobile apps. Examples include electronic medical textbooks or an electronic listing of diseases and conditions, educational tools for training healthcare providers or patients, healthcare office workflow automation tools, etc.

MMAs for which FDA intends to exercise enforcement discretion – Sometimes, a mobile app may fit the definition of a medical device, but pose a low risk to the public health. FDA intends to exercise enforcement discretion for these. Examples include devices intended to help patients with certain diagnosed psychiatric conditions to maintain behavioral coping skills, motivational mobile apps, GPS-based apps alerting patients to certain environmental conditions, apps that use gaming technology to motivate patients to do physical therapy exercises and apps that allow patients to send an alert or emergency notification to first responders.



Recent orthopaedic-related
MMAs cleared by FDA include:

Biomet ORTHOSIZE
templating software


Brianlab Dash Hip and Dash
Knee Smart Instruments


Materialise
SurgiCase Connect


Smith & Nephew Spatialframe.com V5.0
web-based software

MMAs that FDA will regulate – These meet the definition of a medical device and pose risk to public safety if they do not function as intended by the manufacturer. Examples include those that transform a mobile platform, such as an iPhone, into a regulated medical device with an existing medical device product code, apps that connect to an existing device type for purposes of controlling its operation, function or energy source, and apps that display, transfer, store, or convert patient-specific medical device data from a connected device. (Product codes, developed by the Center for Devices and Radiological Health, are unique and associated with a particular type of devices and code of federal regulations. For example, LFR, CGA, NBW and CFR are a few of the product codes associated with glucose test systems under 21 CFR § 862.1345.)

The Lifecycle of a Mobile Medical Application

MMAs

Simplistically, the lifecycle of an MMA follows that of a medical device. Life begins when the MMA is conceptualized. At this stage, the manufacturer has some type of quality system in place. Regulatory and reimbursement strategies are formulated. A clinical strategy is developed, if the MMA requires clinical data to provide regulators with assurance of safety and efficacy of the device. As part of MMA risk assessment, hazard analysis, usability/human factors and software development lifecycle considerations can be implemented in parallel with strategy development. At the verification and validation stage, each software input requirement specification is verified and validated with a ”pass” result. Product freeze is then declared. At this point, if the MMA requires a clinical study, an Institutional Review Board submission follows and MMA study is initiated upon approval.5 Upon study completion, data points are gathered and summarized into a regulatory report for submission. Upon a successful submission, clearance is obtained. The manufacturer begins marketing and distribution, as well as ideation discussions for the next generation MMA.


For an MMA to follow a successful lifecycle, the critical success factors lie in the reimbursement, regulatory and clinical strategies. Some of the most successful MMAs in the marketplace provide improved clinical outcomes to providers and patients and can generate and sustain revenues for companies. Many have utilized data points derived from randomized, controlled studies to support their clinical and reimbursement claims.

How Mobile Medical Applications Enable Better Clinical Outcomes

Current successful MMAs provide value to patients and providers by delivering improved clinical outcomes and deriving sustained revenues to manufacturers.

AirStrip Technologies develops remote patient monitoring MMAs. The core value proposition of Airstrip lies in giving physicians the ability to remotely monitor patients. Imagine a healthcare campus which includes multiple buildings and floors with operating, examination and other facilities distributed on different levels or buildings. How valuable is it for the physician in that complex to be able to remotely monitor one or all of his patients’ vital signs in real time? Improved outcomes are achieved by physicians being able to engage with hospital patients better and more rapidly react to unexpected changes in vitals.

MMAs stay ahead of the curve because they are innovative and continue to create value to patients, providers and caregivers for improved clinical outcomes. MMAs, however, are not dependent upon a particular therapeutic area or indication. An MMA can be utilized with a musculoskeletal and orthopaedic product (investigational or marketed) and demonstrated to create value to stakeholders.

Conclusion

Medical device and biopharmaceutical companies increasingly seek avenues to innovate and demonstrate improved clinical outcomes. Innovation opportunities abound, and manufacturers are beginning to embrace MMA in their clinical development, marketing and business strategies to respond to the call for improved outcomes.

This article originally appeared in ORTHOKNOW®. The full version can be found here.

References

1. FDA
2. Medical device is defined on FDA’s website
3. Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications, September 25, 2013
4. Definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
5. Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects.

Prithul Bom is Director of Medical Device and Diagnostic Development at Theorem Clinical Research. She has 17 years of healthcare industry experience and her medical device experience includes over 50 medical device projects in areas of software device review as an FDA-accredited Third Party with multiple regulatory substantive review and clearances, clinical protocol development, literature review and research, and over 200 medical device training and research assessment programs.

Ms. Bom began her career in healthcare in 1998 as an application developer. Her specific expertise in software, MMA, diagnostic and orthopaedics is directly tied to her multi-faceted healthcare experiences in clinical research, regulatory, training and software programming. She serves as a guest lecture at St. Thomas University in Minnesota and George Washington University in Washington, D.C. She can be reached This email address is being protected from spambots. You need JavaScript enabled to view it..