The rate of innovation is accelerating. The complexity of medical devices, and the components of those devices, is increasing. It is fascinating that so often the manufacturing of those devices is still operating with paper-based processes, siloed from the innovators creating the designs. The reality is that the focus of innovation has been discovering what’s possible to create in medical devices that can advance human health and quality of life. The manufacturing of those products – to ensure that innovative concepts and designs are actually delivered to market in a consumable way, at high quality – has taken back seat on the innovation bus.
Perpetuating the problem is the burdensome culture of compliance in this highly regulated industry. Achieving compliance with regulation tends to be the goal, rather than using regulatory intent to improve product quality. In fact, the activity around meeting regulatory requirements can take the place of really understanding the meaning of the associated data, and what it might be telling both the manufacturing engineers and the design engineers.
Amid these cultural issues are a sea of point solutions, often legacy or home-grown systems initially built to solve problems that were relevant more than a decade ago. Now they define functional areas, because the manufacturing organization has become accustomed to “doing it this way.”
It is time for manufacturing operations to be an integral part of the “value streams” from product concept to end of life, and adopt systems that support end-to-end innovation, built with quality as an intrinsic component. Design and manufacturing need to be completely aligned, with feedback loops built in. We call it “closed-loop manufacturing,” a concept that unifies the innovation initiative, accelerating the production of innovative devices delivered with quality.
Register and find out more about the challenges of growing complexity of innovation, compliance vs. quality, and the value streams that leading manufacturers are adopting to accelerate the delivery of quality products in our upcoming webinar.