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Road to Market for Wearable Medical Devices

What does the FDA consider to be a wearable medical device?

The difference between the two classifications of wearable devices and general wellness devices can severely impact a company. Wearable devices are regulated and require FDA clearance prior to releasing the device to market, while general wellness products do not need to be FDA cleared. Misclassifying the device can cost a company upwards of hundreds of thousands of dollars due to the lack of testing or unnecessary testing being performed. FDA considers wearables to be “Remote or wearable patient monitoring devices include (1) non-invasive remote monitoring devices that measure or detect common physiological parameters and, (2) non-invasive monitoring devices that wirelessly transmit patient information to their health care provider or other monitoring entity.” This definition can be confused with general wellness products. The FDA considers general wellness devices to be low-risk devices used “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition”. Examples of these products are weight management, physical fitness, including products, relaxation or stress management, mental acuity, self-esteem, sleep management, sexual function, or energy regulation. However, there have been scenarios in which general wellness devices had shocking similarities with regulated wearable devices in terms of use cases. An example of this is when general wellness devices are being used by patients with chronic diseases to promote a healthier lifestyle to manage symptoms related to their diseases. The line that divides these two classifications lies in the claims made about the device specifically within its intended use. If the device clearly states that this device is used for disease prevention, treatment, and/or mitigation then the device would be classified as a regulated wearable device. On the other hand, if the device simply claims general improvements in health, then that will fall into the general wellness classification. Fortunately, Rook has worked with numerous companies that have had these issues. Our team can assist companies with this classification.

What is the Road map for a Wearable to Market?

The path for a wearable device to market relies heavily on its risk classification. To start this process, an initial regulatory assessment is performed on the device. Like how classification is based on its intended use, the classification of these wearables is based on its intended use. Class one devices are the lowest risk medical devices. Class two devices are medium risk, and Class three devices are the highest in risk life-sustaining like artificial valves. From the classification of the wearable, a QMS system is set up in place, training to the QMS is performed, design documentation is compiled, design and clinical testing is performed, and depending on the classification a PMA, 510(k), or De Novo.

QMS for your Wearable

A Quality Management System that is compliant with the 21 CFR 820 regulations. These regulations require the process to be implemented and carried out, including document control, management review, design control, and other pre and post-market activities. The design control for your wearable should include recommendations made by the FDA guidance concerning at-home medical devices.

FDA Recommendations for Design

Based on the guidance document the FDA released they have stated recommendations for designing a wearable for safety and effectiveness. The following topics are some of the important recommendations and considerations the FDA would like to see documented in the design and DHF creation of your wearable. The range of environmental conditions should be addressed and summarize efforts you made to account for the intended use of the environment. If the device is sterile, the manufacturer needs to state how this device will be operated in a nonsterile environment. Specifically how the user will minimize contamination in regards to fluids, solids, and airborne particles that could affect the operation. The temperature, dampness, and atmospheric pressure all need to have designated ranges. Travel instructions need to be documented with respect to international use. This would be providing information in the labeling on the adaptability of the device to the electrical supplies and voltage rates of other countries, which may need electrical converters, and labeling should include information on security screening systems. Documentation should address fluid exposure for spills or submersions, storage, user considerations, physical ranges, sensory ranges, cognitive ranges, and emotional ranges. Other design considerations that will improve the safety and effectiveness of the wearable in the eyes of the FDA. Device authentication mechanisms can help control access to certain device functions including changing settings entered by healthcare professionals. This mechanism can reduce or prevent patient harm. Maintenance needs to be addressed, primarily minimizing the requirements for maintenance to the extent possible. When considering calibration, the design should preferably eliminate the need for calibration or have minimal calibration by the user. The mechanical considerations include having a minimal number of parts that could be detached or fall off and present an inhalation, swallowing, or tripping hazard.

Electrical Considerations for Wearables

Some electrical responsibilities include unreliable sources of electricity and poor electrical grounding, specific voltage ranges, internal power source batteries explained in IFU, electromagnetic compatibility should have summary information in your premarket submissions to FDA describing the testing, address wireless technology and concerns with the “radio frequency wireless technology in medical devices” and make sure to test interference with wireless technology of devices proximal to the device. Lastly, visit the alarm systems guidance- IEC 60601-1-8 edition 2.1 2012-11, Medical electrical equipment; Part 1-8; General requirements for basic safety and essential performance; collateral standard: general requirements, test, and guidance for alarm systems in medical electrical equipment and medical electrical systems.

Cybersecurity with Wearable Devices

Cybersecurity holds a paramount position in the realm of medical devices, underscored by its fundamental significance to patient safety and data security. The FDA, in alignment with its commitment to ensuring the reliability and safety of healthcare technologies, has issued comprehensive guidance documents and standards, such as the “Postmarket Management of Cybersecurity in Medical Devices” and the “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” These documents emphasize the necessity of robust cybersecurity measures for medical devices. This importance is derived from the fact that vulnerabilities in these devices could not only endanger patient lives through unauthorized access or tampering but also compromise sensitive healthcare data. As the healthcare industry increasingly relies on interconnected digital technologies, adherence to these standards is vital to mitigate potential threats, maintain trust in medical devices, and uphold the rigorous standards of patient care and data privacy that are central to modern healthcare. This is a summary of the importance of cybersecurity to consider when developing a wearable device. More information on this topic is available in the webinar section on our website.

Wearables with Software

Software aspects to consider are to document software upgrades and how the upgrades will perform in the home environment. Some other recommended guidance documents are (IEC 62304 First edition 2006-05, Medical device software – Software life cycle processes and the identical standard ANSI/AAMI/IEC 62304:2006, See 21 CFR 820.30(g); see also 61 FR 52602 at 52616, FDA’s guidance General Principles of Software Validation (January 11, 2002), FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).

Other Miscellaneous Considerations

Human Factors testing should be considered to fully understand how targeted end users interact with the technology via a human factors validation study. Have user training and certification so that people might receive minimal training and may not understand how to calibrate, clean, and maintain the device. Validate the effectiveness of your training program- outline the responsibility of the care partner caregiver, and recipient. Biocompatibility is another necessary test that should be considered when the device is in contact with the patient that many companies have overlooked.

Risk Management For Wearable Devices

The risk management plan should pay special attention to use-related errors and hazards that the device is exposed to at home and greater potential for harm caused by the user, more risk controls based on human factors engineering, and additional resources is ANSI/AAMI/ISO14971:2007/(R) 2010, Medical devices – Application of risk management. This will help guide the quality engineer in drafting the risk management assessment. Although we are not a design firm, Rook specializes in everything’s quality and regulatory. Risk is an area that Rook has had lots of experience in, and we can help draft and oversee this assessment. More information on this topic can be found on the Rook Quality Systems Website in the blog “Risk Management in the Medical Device Industry Part 2”.

FDA guidance documents for wearable medical devices:

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