A Race Against Time: Developing New Systems In Face Of Obsolescence
The Research and Development VP of a company that was a leader in the diagnostic capital equipment space required a medical device project manager to lead a product and systems upgrade. It was a large, multi-year, 10+ million dollar project that had already failed.
They needed a capable medical device project manager who was well-versed in electro-mechanical systems, embedded software, and medical device hardware and was able to effectively drive a multi-faceted team.
The Challenge: Looming Obsolescence and Time Pressure
As the product included both hardware and software, the company had already performed due diligence and estimated 2 years before the current version of their product became obsolete. They were looking to have the advanced version of the product launched in the market before that happened.
In fact, certain core components and programs incorporated in the current product were already obsolete. They had difficulty finding parts for repair and upgrade, leading to a search for new vendors and parts to replace them.
There were challenges common to a company with 10+ years in the market with the current team. There were stablished habits with project and organizational communication issues.
Since the new device had a predicate, a 510(k) was the required FDA regulatory path, along with the necessary CE approvals for a Class III device. The challenges of the regulatory rules and approvals needed to get it to market were paramount to the project success.
The company had both a development and production goal, and a limited time to do so. They needed to get the upgraded product approved and launched before time ran out.
The primary need was for a project manager who could perform day-to-day team management, drive the alignment of the team to the project plan, maintain quality standards, and determine the project execution and communication methods.
The Solution: A Project Manager Familiar With Medical Device Regulations, Electro-Mechanical Systems, Embedded Software, Medical Device Hardware, And A Hands On And Assertive Style.
As this project was a follow-on, the company needed someone who could cut through the inefficiencies all companies have developed.
When approached, Waddell Group assigned a right-fit project manager to work with the project team. They decided to use the Phase Gate Project Management Technique to develop a comprehensive plan involving:
- – Goal setting
- – Defining the approach
- – Teasing out the relevant information from subject matter experts
- – Interfacing with relevant groups and management
- – Ensuring team members meet their commitments
And making sure the project happened on time and on budget.
They reviewed the requirements for the project and system with the goal of including just what was needed for the project to be successful without going over or under. The current requirements had a lot of things that weren’t essential for the project. The project manager worked with the team to narrow the list of features to something that was doable while making sure additional features could be added in the future. This was carried forward in the designing and manufacturing processes.
This included determining new vendors for the new components, streamlining the project team, and recruiting the ‘right fit’ team members for the project.
We used our 4 step framework to stay on top of the regulatory requirements and help the company prepare for the 510(k) US FDA, and CE approvals. This included, but was not limited to, helping them with documentation and support for clinical trials, etc. This was done keeping in mind the company’s unique problems and challenges.
The Result: Project Completed Ahead Of Schedule
In 2 years, the diagnostic capital equipment company was successfully able to get ahead of the production schedule. They have the hardware completed ahead of schedule and are getting ready to make the regulatory submissions for which we helped them prepare.
Our project manager guided the team to a successful and improved product, and we developed a trusted partnership with the company.
Contact Us Today
To start or improve a project with The Waddell Group, contact us at 952.221.3333. Our goal, and that of our consultants, is to fast-track your product to the market while resolving any developmental and/or regulatory issues that arise during the process. We’ll be glad to help with your medical device project management needs.
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