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Considerations for Using a Mobile Medical App as an Investigational Device
The U.S. Food and Drug Administration (FDA) issued its final guidance on mobile medical applications (MMAs) on Sept. 25, 2013. (The draft was released on July 21, 2011). This guidance was updated on Feb. 9, 2015, to be consistent with corresponding guidance documents for medical device decision systems. This was a necessary update given not only the widespread use of innovative mobile technologies, but also the need for consistency and clarity about similarities and differences among medical device data systems, medical image storage devices and medical image communication devices.
Additionally, several complementary guidance documents and international and engineering standards cover valuable topics that support stakeholder decisions about approaching and implementing design and development, reimbursement, clinical research and regulatory submission. Even though standards and guidance documents are supposed to provide direction to the approach and implementation of Mobile Medical Apps (MMAs) in a clinical research setting, in the experience of Theorem and Decision Driver Analytics (DDA), confusion is abundant in the industry.
In response, Theorem and DDA published their first paper, Mobile Medical Applications in May 2015 to introduce the context, history, design/development, reimbursement, clinical research and basic regulatory frameworks with examples. The paper concluded with an assertion that medical device and biopharmaceutical companies are increasingly looking for avenues to innovate and improve clinical outcomes, and MMAs could offer an avenue to do so.
We also presented an educational webinar, Embracing a Mobile Medical App in a Clinical Development Strategy to Improve Clinical Outcomes, Increase ROI and Lower Costs in June 2015. The webinar, attended by hundreds of stakeholders, evoked deeper questions on design/development, reimbursement, clinical research and regulatory topics. This article presents a deeper discussion of the aforementioned topics, with a total MMA product life cycle approach.
The life cycle of an MMA follows that of a medical device. As such, critical success factors from concept to market at a high level are similar to those for a regulated medical device: effective development and execution of market access strategies comprising design and development, reimbursement, clinical research and regulatory clearance or approval.
Reimbursement and Health Economic Outcomes Considerations
It’s crucial for MMA manufacturers to understand that FDA approval gives manufacturers the legal right to sell their app, but it does not give the marketplace sufficient reason to purchase or use it. For MMAs to be successful in the marketplace, manufacturers must understand the following:
The current reimbursement environment is complex and evolving. It’s never been more crucial to develop parallel clinical, health economics and reimbursement strategies from the earliest phases of MMA app development.
Design and Development Considerations
The FDA's final guidance, Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2015, provides a pathway for development and documentation of the software development lifecycle of a medical app. As with any software medical device, perhaps one of the first responsibilities of the manufacturer is to determine the app’s level of concern. As opposed to ordinal risk classifications of Class I, II and III, level of concern follows a Likert measure of major, moderate and minor to determine the type of development documentation to be submitted with a premarket submission; this is based on how the app directly or indirectly affects the patient or operator.
The reason for bringing this guidance up under design and development considerations is that the documentation recommended for submission is generally the same as that generated during the app software device development and follows widely accepted software quality engineering practices. The design and development sections of submission documentation are a by-product of a properly managed and well-documented medical device software development environment, following sound engineering and good documentation practices, and are not fabricated in afterthought.
At a high level, the manufacturer would need to document hazard analysis, requirements specification, architecture, design specification, traceability and verification and validation information throughout the software development life cycle. At this point, the manufacturer would have determined the level of concern of its app and assessed how much (or little) documentation actually needs to be submitted. For example, documentation for a mobile app that functions simply to gather and report data from a wearable technology to effect some type of behavior modification or clinical outcome will look different than that for an app that controls administration of morphine to affect sedation.
The areas that a manufacturer would need to consider documenting are discussed below:
Clinical Research Considerations
If an MMA is used in research as an investigational device, applicable 21 CFR 812 provisions must be considered. Manufacturers would need to consider FDA guidance on investigational device exemption and follow recommendations and requirements stipulated therein.
Using a mobile medical app as an investigational device in a clinical research setting - and subsequently achieving clearance or approval - requires manufacturers to pay attention to activities throughout the design/development, reimbursement, clinical research and regulatory submission phases. Following recommendations presented in the available guidance documentation and standards sets the manufacturer up for success. Consulting with professionals with experience in clinical research, securing FDA clearance or approval and developing and implementing comprehensive health economics and reimbursement strategies can further accelerate time to commercial success.
Prithul Bom, MBA, RAC, CSQE, is Senior Director of Medical Device and Diagnostics Development, Chiltern; and Elizabeth Brooks, PhD, is President of Decision Driver Analytics
 “Mobile Medical Applications,” Feb. 9, 2015, U.S. Food and Drug Administration, http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf
 There are numerous guidances related to MMA development. For a list of many of the basic regulatory guidance documents manufacturers should consider, please see “Mobile Medical Applications (MMA),” a white paper available at: http://www.theoremclinical.com/smart-library.aspx
 Some of these standards include: IEC 62304:2006 “Medical device software-Software life cycle processes, available at: http://www.iso.org/iso/catalogue_detail.htm?csnumber=38421; ISO 14155:2011 “Clinical investigation of medical devices for human subjects,” available at: http://www.iso.org/iso/catalogue_detail?csnumber=45557; ISO 13485:2003 “Medical devices – quality management systems – requirements for regulatory purposes,” available at: http://www.iso.org/iso/catalogue_detail?csnumber=36786; ISO 14971:2007 “Medical devices – Application of risk management to medical devices,” available at: http://www.iso.org/iso/catalogue_detail?csnumber=38193; IEC 60601-1-11:2015 “Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment,” available at: http://www.iso.org/iso/home/store/catalogue_ics/catalogue_detail_ics.htm?csnumber=65529
 Bom P, Brooks E, “Mobile Medical Applications,” http://www.theoremclinical.com/smart-library.aspx
 “Embracing a Mobile Medical App in a Clinical Development Strategy to Improve Clinical Outcomes, Increase ROI and Lower Costs,” webinar, http://www.appliedclinicaltrialsonline.com/act/medicalapp
 “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” U.S. Food and Drug Administration, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089593.pdf
 Classify Your Medical Device, U.S. Food and Drug Administration, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm
 U.S. Food and Drug Administration, http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm412979.htm
 Handshake, https://handshake.mitre.org/
 “Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software,” U.S. FDA, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077823.pdf
 IEC/TR 80002-1: “Guidance on the Application of ISO 14971 to Medical Device Software,” http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=54146
 “General Principles of Software Validation,” U.S. Food and Drug Administration, Jan. 11, 2002, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085371.pdf
 “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” U.S. Food and Drug Administration, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259760.pdf
 IEC 62366-1: 2015 “Medical devices-Part 1: Application of usability engineering to medical devices,” http://www.iso.org/iso/home/store/catalogue_ics/catalogue_detail_ics.htm?csnumber=63179
 IDE Guidance, U.S. Food and Drug Administration, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm162453.htm
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