Multi-dimensional readiness assessment of medical devices

Figures & data

Table 1. Factors affecting MD use.

Factors	Patient	HCW	SS
1. Device use	Recipient	Provider	Maintenance
2. Motivation to use the device	Wellness	Disease/health management	Device functioning
3. Device use training	Low – Medium	High	Low
4. Physical handling of the device	Passive handler	During medical procedure	Before or after a medical procedure

Figure 1. Dimensions and perspectives in the MDRL.

Figure 2. Mapping of MD development progress using TRL and HRL.

Table 2. Comparison of TRL, HRL and MDRL.

Level	TRL	HRL	MDRL
1	Basic principles observed and reported	Relevant human capabilities, limitations, and basic human performance issues and risks identified	Needs Assessment. Identification of scientific and design principles to address an existing medical challenge in terms of safety, clinical effectiveness, systems integration, human performance, and satisfaction.
2	Technology concept and/or application formulated	Human-focused concept of operations defined and human performance design principles established	Prototype Development. Development of a working prototype illustrating scientific and design principles to address safety and effectiveness. Potential user performance and system integration issues are identified to improve the design.
3	Analytical and experimental critical function and/ or characteristic proof of concept	Requirements for supporting human performance established	Bench Testing. Bench testing to identify mechanical, electrical, and biological engineering performance issues of the device, including ex vivo, in vitro, and in situ animal or human tissue; and animal carcass or human cadaveric testing.
4	Component and/or breadboard validation in a laboratory environment	Modelling, part-task testing, and trade studies of human systems design concepts completed	Animal Testing. Initial evidence of MD safety is established, including its performance when used in a living system. Device operator performance issues identified to enhance the design.
5	Component and/or breadboard validation in a relevant environment	User evaluation of prototypes in mission-relevant simulations completed to inform the design	Pilot Testing. Device safety established on a small sample of healthy individuals. Patient and system integration issues were identified to enhance the design.
6	System/subsystem model or prototype demonstration in a relevant environment	Human systems design fully matured as influenced by human performance analyses, metrics, prototyping, and high-fidelity simulations	Feasibility Testing. Clinical effectiveness was established on a small sample of patients with the health condition. Performance issues of patients, HCW, and support staff in using the device and system integration issues identified to enhance the design.
7	System prototype demonstration in an operational environment	Human systems design fully tested and verified in operational environment with system hardware and software and representative users	Pivotal testing. Device tested on a large sample of patients with the health condition to identify rare and adverse effects. The statistical significance of the results is established. User performance and system integration issues resolved.
8	Actual system completed and qualified through test and demonstration	Total human-system performance thoroughly tested, validated, and approved in mission operations, using completed system hardware and software and representative users	Market acceptance. Total human system performance fully tested and validated, device approved by the regulatory body, discomfort in using the device mitigated. At the minimum, tolerance of the device is attained, and at the very least, the discomfort is not distressing.
9	Actual system proven through successful mission operations	The system successfully used in operations across the operational envelope with systematic monitoring of human-system performance	Post-market surveillance. Device fully accepted by the market with high satisfaction rating and good reviews

Figure 3. MDRL key tasks and exit criteria.