Bioscience Award Honors Ximedica's Director of Quality

The Tech Collective, Rhode Island’s Bioscience and IT industry association, hosted its first annual RI Bioscience Awards event last week – and among the five award recipients honored that night was our Director of Quality, Michelle Wu.

Read on to learn more about the critical role Michelle plays at Ximedica and why she was selected to receive this honor.

What specific role do you play? How is it critical to the achievement of your company/organization’s goals? In what way are you going above and beyond as a contributor to that success? Please give specific examples.

As the Director of Quality Services at Ximedica, I lead our group of Design Assurance engineers, Quality engineers and Quality Control inspectors. At the broadest description, my engineers serve as project team members to ensure the quality of the design and ensure control of the quality of devices built. They are responsible for leading risk management activities, for the verification testing to prove that the products we design are safe and function as intended, and building quality in so that everything we manufacturing is of the appropriate quality. To the mature medical device development company, it is understood that the Quality function is necessary. However, how the Quality folks are perceived usually varies from the hardline roadblock that prevents any progress, at the worst; or at the best, a necessary evil. I strive for a different vision of my Quality team. Not to be pure roadblocks or only on teams because we have to be there, but as team members that add value to the design and manufacturing process to ensure that everything we work on is safe and effective.

I use my role to shape and enforce this vision two main ways- 1) by creating/improving our Quality Management System (QMS) so that overall, it is flexible, risk-based and practical; and 2) Ensuring team members are added at the appropriate time in the development process, e.g. early and often. Based on our breadth and variety, our QMS has to be flexible. Our company deals with a variety of clients, from the top 30 medical device developers to venture-capital funded start-ups looking to bring a new technology/devices to market. The devices we work on vary in risk and complexity, from home-use consumer devices (like pill boxes and thermometers) to surgical, endoscopic equipment. Some of our devices are sterile disposables, while others are capital equipment. The technology ranges from pure mechanical devices to electro-mechanical devices incorporating the latest imaging technologies. Thus, the range of risks to the users vary from low to very high.

In this context, our standard operating procedures (SOPs) emphasize making risk-based decisions and documenting those decisions. In my role, I created the first comprehensive design verification SOP.

Design verification is the activity done in the medical device industry to ensure that the device designed meets the input specifications, i.e. the design outputs (the device) meets the design inputs. The procedure I created emphasizes planning, and tailoring the activities based on the risk of the device. From a practical sense, more effort and testing should be applied to functions of higher risk- features whose failure have the risk to severely injure a user are treated more critically than a feature whose failure would lead to no harm. Thus for higher risk activities, more samples would be tested, the test methods validated to ensure reproducibility and repeatability, and the acceptance criteria more stringent. The plan is the tool to document that the team decision to the planned activities, strategies for testing, and that those activities are appropriate given the risks of the device.

The second way I use my role to add upfront value to our products and to the success of Ximedica is to drive a culture of real time, early involvement. I ensure my team members are involved early and often in the development process. I believe in risk management activities (hazards analyses, failure mode and effects analyses) that can be truly useful to the development process, not activities that are done after the fact and not done just to ‘check the box.’ Thus, I assign team members as early as the concept phase of our development projects.

My team members lead risk management activities starting at the end of concept phase/beginning of the development phase. This way, the team is on board with which risks they must be aware, and which ones will be mitigated by design. It is much easier to design an interlock to prevent early misfiring of a surgical stitching device instead of shoe-horning a sub-standard solution in at the end that adds time and cost to the project as the main stitching release mechanism must be moved to make room for the interlock. Or worse yet, rationalizing how slapping a label that may be missed by the user to prevent early misfiring is adequate to mitigate the hazard.

Congratulations to Michelle and the other bright recipients of the RI Bioscience Awards! To learn more about the awards, and the Tech Collective.