Massachusetts Medical Device Company
Client was in the midst of FDA approval for their innovative, less invasive medical device when (issues arose in 2 separate departments; Software and Quality)
Our client, a leading medical device company in Massachusetts was in the midst of FDA approval for their innovative, less invasive medical device when (issues arose in 2 separate departments; Software and Quality). These delays with embedded software and Quality documentation/regulation were quickly hindering the ability to move forward in the FDA approval process. Timelines could not be met which would result in additional delays and of course an additional financial burden. The client did not have the in-house software engineering expertise and also lacked the necessary quality testing to correct these issues. Unable to make these corrections on their own and therefore predict future performance problems, our client had ten months remaining to be prepared for the FDA due diligence and were well behind their intended timelines. It was at that point they recognized the need to reach outside of their existing staff to identify the necessary software and quality engineers that possessed the experience needed in the FDA approval process.
We began by visiting our client and team leads to understand the specific issues and requirements in order to create a full scoping plan. We met with the quality assurance, software development, software quality and regulatory teams to ensure that all group’s challenges were heard and addressed. Through our deep understanding of engineering and the medical device industry, we were able to determine that approximately five people would be needed to complete the project within the prescribed timeline. The entire project team was behind the eight ball, in that we had to achieve a 10 month completion date. The teams all signed off the plan and agreed that this was the company’s top priority.
We began by personally vetting candidates and determining the most effective engineering professionals available. We were able to position individuals properly and begin a full court press on the project immediately. For six months, the team worked together identifying potential problems in advance as well as solving the issues associated with the software. Working hand-in-hand with the client, we were able to successfully correct the embedded software as well as proactively find problem areas therefore dramatically advancing the path to the FDA approval process and a successful outcome.
This program is an ongoing success for the client and the Whitridge consultants. We have supported the rapid delivery of highly skilled and sought after talent despite the challenges of limited supply in a highly competitive environment. The success of our delivery mechanism has allowed us to expand our scope to other programs. Our federal and national laboratory community expertise allowed us to effectively support the client’s requirements, providing quality talent with highly specialized skills within stringent rate guidelines.
About Whitridge Associates
Whitridge Associates provides expert talent to a diverse group of financial services companies, technology companies, defense contractors, and healthcare providers throughout the country. With a history of over 24 years of unparalleled service to both our clients and consultants, Endorsed by their many recent awards Whitridge is one of the most highly regarded talent acquisition firms in New England.
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