Human Factors and Innovation Receive $1 Million in State Grant Funding

Submitted by najones on

In partnership with Roanoke Blacksburg Innovation Alliance (RBIA), Carilion clinic received a $1 Million state grant to stand up a Human Factors usability service and ISO compliance support for medical technology companies throughout the commonwealth, the region, and the nation. The funder is the GO Virginia initiative, a investment program setup by Virginia’s senior business leaders to foster private-sector growth and job creation through state incentives for regional collaboration by business, education, and government.

Usability for medical devices: Usability is all about the making the experience of using a device easy, safe, and effective. By taking what we know about human preferences and limitations, we can make design changes to improve functionality and reduce risk of error. Usability assessment is a requirement as part of FDA approval for all medical devices.

ISO compliance consultation: Medical device companies must navigate complex regulatory processes around Quality Management. As part of this grant, Carilion Innovations will staff up to provide consultation navigating this space. It may not sound flashy, but it's a critical and complex regulatory requirement for companies trying to bring a product to market.

How Carilion will operate: Our intention is to stand up a usability service group as part of our Human Factors department. While our Applied Human Factors team is focused on opportunities internal to the system, this group will be focused outward, providing consultation to med tech startups in the region with usability analysis. The ISO compliance consultant will operate out of Carilion Innovations.

Why it matters: These services, in addition to other investments made by the Carilion, the city of Roanoke, and Virginia Tech create an attractive ecosystem of resources for businesses looking to stand up operations in the area.

We continue to think differently about how our hospital system can serve the community and the commonwealth, while at the same time leveraging these new programs to accelerate internal innovation.

Images
 Usability testing for medical devices involves evaluating how effectively and safely users can interact with the device in real-world scenarios to ensure it meets user needs, regulatory requirements, and performance standards.
All medical devices that require FDA approval must have usability and human factors assessments done.
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