Massachusetts Medical Device Company

QUICK FACTS

Client

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)

Challenges

• Software had fallen behind the timeline for the FDA approval process requiring specific skills and experience to get back on schedule
• Required quality testing to identify software deficiencies and successfully resolve them
• They did not possess in-house software and quality engineering expertise with the requisite FDA approval experience
• Severely shortened timelines

Whitridge Solution

• Assessment of specific issues, requirements and deliverables
• Developed recruiting strategy and campaign
• On-boarded a team of five 
• Addressed all challenges

Key Benefits

• Provided client with a deep understanding of both engineering and medical devices
• All resources were thoroughly prepared and extremely experienced with the FDA approval process
• Project was completed four months in advance
• Project was completed on scope, on time and on budget
• Successfully met the timeline for FDA approval
• Actively collaborated with the client across all groups
• Project came in under budget by 40%
• Client converted several of our consultants to full time employees
• Client got to market and is now becoming a dominant player both domestically and internationally

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.  

Issues

• Software had fallen behind the timeline for the FDA approval process requiring specific skills and experience to get back on schedule
• Required quality testing to identify software deficiencies and successfully resolve them
• They did not possess in-house software and quality engineering expertise with the requisite FDA approval experience
• Severely shortened timelines

Our Solution

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.

Key Benefits

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.

• Client received a partner with a deep understanding of both engineering and medical devices
• Through established relationships, we were able to vet candidates and begin work rapidly
• All resources were thoroughly prepared and extremely experienced with the FDA approval process
• Project was completed four months in advance
• Project was completed on scope, on time and on budget
• Successfully met the timeline to get to FDA approval
• Actively collaborated with the client across all groups
• The project  successfully came in under budget by 40%
• Due to their demonstrated value our client converted several of our  consultants to full time employees
• Enabled client to get to market and become a dominant player both domestically and internationally

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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