An Improved Medical Device Quality Assurance Process Secures Relaunched Product

Home / Project / An Improved Medical Device Quality Assurance Process Secures Relaunched Product

The Setback

Having a product recalled in the medical device industry causes a domino effect of urgent next steps. Oftentimes, medical device companies do not have the capacity nor the experience to fix the problem and ensure it doesn’t happen again. For such a critical business issue, a recalled medical device requires a skilled project manager to respond appropriately, create a timely course of action, strictly follow the timeline and budget, and importantly, develop a medical device quality control process that protects the company from future problems.

For a prominent medical device company, this is the exact problem they encountered. After multiple product failures, the company voluntarily recalled their implanted medical device product. They didn’t understand the cause of the failure and didn’t know how to fix it. To increase the pressure, the recalled product was their flagship medical device product, so their company relied heavily upon quickly getting the product back on the market and keeping it there.

The large medical device company needed a project manager that could not only assess the current issue in order to bring the implanted product back to the market, but be able to develop and implement a trustworthy quality assurance process.

Waddell Group’s Process

When the Waddell Group entered the project, they had five other projects caught in the phase of establishing their quality assurance process. The company is a well-established leader in their implanted medical device sector, but with so many moving parts there were gaps in their quality process that were causing setbacks. Our medical device project management goal wasn’t just to improve the quality of the recalled product but to apply a process that would upgrade and secure their other products.

To find these gaps, our project manager conducted an initial gap analysis. This uncovered all parts of the medical device development process that needed revisiting, revamping, and retraining. For the recalled product, one key element of the gap assessment was improving the quality assurance process.

The next step was to develop a detailed plan that would address and fix the identified gaps. There are specific FDA regulations and international rules that the implanted medical device product needed to meet. The plan for fixing the quality process adhered to all the safety and technical standards that would prove the company is following all the necessary quality regulations and ensure a successful product relaunch.

During and after the plan was implemented, the project manager executed comprehensive quality system regulation training. Not only was the overall process improved, but each person was trained on the new quality assurance procedures. The company and its team were equipped with a compliant and thorough medical device quality assurance process.

The Results

Their recalled implanted medical device successfully re-entered the market on time and within budget. In fact, their flagship product was able to be back on the market within only 18 months of finding the solution! With their improved quality system regulation for medical devices, they haven’t encountered any quality issues that would sanction recalls, for both their flagship product and their other medical device products.

The new medical device quality assurance process improved upon their current process instead of rebuilding it. While another project management consulting firm suggested they start from scratch, our analysis determined that a majority of their process was satisfactory. By using their current process as a foundation, we were able to develop a successful quality process and implement quality system regulation training that followed the FDA and international safety and technical standards. We did this within a fraction of the time as compared to the time and expense of starting with a new process.