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Regulatory

OEMs, FDA Take Closer Look at Mobile Medical Applications

By: Prithul Bom, MBA, RAC, Theorem Clinical Research


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.

Mobile health tracking applications (mHealth apps) and activity monitors have crept into our lives. Jawbone recently proclaimed that users spend more time with their Jawbones than on Facebook. With this trend, we can expect such devices becoming lifestyle norms, demanding constant attention and engagement. Wired magazine defines lifestyle devices as “sensors worn perpetually to track personal and biological data that, over time, coalesce to create a portrait of health, habits, and behavior.”

Regulated Mobile Medical Applications or MMA are a little different than mHealth applications and healthcare lifestyle devices. MMA manufacturers 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.


Recent orthopaedic-related MMAs
cleared by FDA include:

Biomet ORTHOSIZE templating
software (K120115)

Companion iPad app; enables review and modification of images that were saved
from the desktop application

Brianlab Dash Hip and Dash Knee Smart Instruments (K110021 and K102251)
Portable, software-guided cutting block alignment tool that runs on an iPod touch and displays detailed digital measurements during surgery, helping to increase surgical accuracy

Materialise SurgiCase Connect
(K132290, most recent clearance)

Available for iPad and PC, supports creation of
a surgical plan/guides and a 3D model of
the pathology for delivery to the surgeon;
enables reduced OR time and costs, the ability to visualize the outcome of complex procedures

Smith & Nephew Spatialframe.com V5.0 web-based software (K142520)
Dedicated web app to plan external fixation cases; offers iAdjust companion mobile app f
or remote patient monitoring, allows patients
to track strut adjustment schedule

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.

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.)

Evolution of Mobile Medical Applications
The concept of an MMA is not new to FDA, which first cleared an MMA
in 1997. The inaugural MMA, RhythmStat XL System manufactured by Data Critical, was a Class II medical device created for a Palm and cleared under the 510(k) program.5 The MMA telephonically received and recorded electrocardiograph (ECG) data from a cardiac event recorder and
transmitted it to a PSION Series 3 palm top computer, one of the first
among the earliest versions of a PDA.6

Nor is the concept new to healthcare community, either. Since 1997, we have observed MMAs slowly changing the way patients and providers think about healthcare and disease management. The FDA database shows that FDA-cleared MMAs reached approximately 50 between 1997 and 2011, a number that has more than doubled since the publication of the MMA Draft Guidance document in 2011. This suggests that manufacturers have gained more clarity about the regulatory pathway for MMAs and are motivated to develop innovative technologies in the space.

MMAs are mostly Class II, follow the premarket notification pathway and are most widely used in chronic disease management, ECG and remote patient monitoring. They have begun to emerge in image diagnostics and medication management/adherence spaces.

The Lifecycle of a Mobile Medical Application 





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.7 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.
 



Regulatory Framework for MMAs

The table below is not comprehensive, but rather suggested basic regulatory guidance for the manufacturer to examine during MMA development. These documentation support regulatory requirements for FDA and provide context to understand the current global MMA framework. These titles are available at FDA.gov. (Please note that requirements for MMA regulatory approval are different for regulatory authorities outside of the U.S.)

Sometimes, in order to function as intended, an MMA may utilize a sensor or activity monitor from which it draws data for further processing. In these cases, the MMA and accessory comprise a device system. Depending upon the intended diagnosis or therapy provided, additional guidance documentation and/or standards may require examination as part of the reimbursement, regulatory and clinical strategy development.
 

Guidance Title Issue Date
 
    Off-the-Shelf Software Use in Medical Devices
   
   September 9, 1999
   
    Submission of Premarket Notifications for Medical 
    Image Management Devices 

 
   July 27, 2000

    Cybersecurity for Networked Medical Devices Containing 
    Off-the-Shelf-Software 

 
   January 14, 2005
 
    Content of Premarket Submissions for Management 
    of Cybersecurity in Medical Devices

 
   May 11, 2005
 
    Radio Frequency Wireless Technology in Medical Devices
 
   August 13, 2013
   
    Content of Premarket Submissions for Management
    of Cybersecurity in Medical Devices

 
   October 2, 2014
 
    Draft Guidance Medical Device Accessories
 
   January 20, 2015
   
    Mobile Medical Applications
 
   February 9, 2015
   
    MDDS, Medical Image Storage Devices, and 
    Medical Image Communication Devices

 
   February 9, 2015
   
    Software as a Medical Device (SaMD):
    Application of Quality Management System

 
   March 26, 2015

 

More FDA news:
Building a U.S. Nationwide Postmarket Surveillance System
Recent 510(k) Clearances


REFERENCES

1. FDA Mobile Medical Applications
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. Palm PDA devices were produced by Palm Inc. (then a subsidiary of U.S. Robotics) and launched on March 10, 1997.
6. The Psion Series 3 range of personal digital assistants were manufactured by Psion PLC; the first series of these devices was launched in 1991.
7. 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 at Prithul.Bom@TheoremClinical.com.