Medical Device Development Compliance & Regulatory Testing
Simbex works with medical device manufacturers over a wide range of commercialization readiness – from grant-funded to startups to Fortune 500 companies. When it comes to developing innovative technologies in the medical device space, however, manufacturers of all sizes and experience ask us the same question:
What testing evidence is required to comply with US regulations and get to market?
Determining the testing evidence for regulatory clearance begins with evaluating the technology, its intended use, and the desired indications for use.
Let’s look at a hypothetical example: a medical device wearable that is intended to be worn continuously on elderly dementia patients for the monitoring of activity and physiological signals while living in a nursing home. The data from the wearable are transmitted to a hub in the facility which are then stored in “the cloud” and accessible by the nursing facility staff for managing patients and by the physician via physician-specific web portal.
From this data, the physician is expected to make therapy or treatment recommendations. From the product description, we can derive the range of testing evidence that could be required for this type of device. Clarity on the required testing is based on how the device will be designed.
|Product Feature||Regulatory Testing||Rationale|
|Worn continuously||Biocompatibility||Devices that intended to contact patient skin must address biocompatibility risks per ISO 10993 series. Risk severity is associated with design (e.g. Adhesive vs wrap)|
|Electrical Safety/EMC||Powered medical devices must address electrical safety and compatibility risks per IEC 60601 series. Continuous device use brings up the issue of power. Electrical design and safety requirements differ between devices which are disposable and those which are rechargeable.|
|Use/worn by elderly patients||Biocompatibility||Elderly patients tend to have drier, more fragile and sensitive skin, which puts them at higher risk for irritation and even pressure ulcers.|
|Usability||The device must be shown to be safe for use by elderly patients by conducting regular formative usability tests per IEC 62366 Usability Engineering process.|
|Use/worn by dementia patients||Usability||The device must be shown to be safe for use by dementia patients by conducting regular formative usability tests per IEC 62366 Usability Engineering process.|
|Use by nurses to manage patients||Usability||Usability testing should be conducted to determine if the nurse is able to adequately monitor patient status based on the data display|
|Use by physicians to prescribe therapy||Usability||Usability testing should be conducted to determine if the physician is able to adequately make treatment recommendations based on the data display|
|Collect patient protected health data||Cybersecurity||Requires compliance to Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules|
|Collect patient physiological health data for recommendation of therapy||Design Controls||Testing or a level of assurance that the data generated by the device are provided with needed accuracy for the physician to make treatment recommendations.|
|Transmit patient health data from wearable to hub||Electrical Safety/EMC||Data transmission from the device to a hub cannot interfere with other devices in the facility, nor can it be affected by interference from other devices. Electrical compatibility risks must be addressed per IEC 60601-1-2.|
|Cybersecurity||Wireless communication and data transfer design must show evidence of risk mitigation from relevant software vulnerabilities|
|FCC||If the device does not include an off-the-shelf wireless communication module that already has been FCC certified, then the device is required to have its own FCC ID.|
|Other marketing claims||Clinical/Usability||All claims must have substantial clinical and/or usability evidence. Agreement on marketing claims can help frame testing.|
|*This is not an exhaustive list of potential product features for this type of device. Refer to relevant FDA Guidance documents and recognized consensus standards for product type for guidance in required testing.|
Contact us to determine what regulatory strategies should be integrated into your medical device development process.
The most efficient, cost-effective and compliant way to get medical devices to market is to know the regulatory requirements early and in every aspect of a medical device’s lifecycle. The assessment of potentially applicable regulations should be taken on at the start of development or even before development begins, as it helps define the shortest path to success. This is one reason why so many companies have trusted their product development efforts to Simbex.