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The Vital Link Between Critical Process Quality and Patients

By Robert Berger, Vice President, Contract Manufacturing, Minimally Invasive Therapies Group, Medtronic | August 10, 2016

Remember—we are answerable to the patient.

In the world of medical device manufacturing, we make products which transform the lives of our customers. In many cases, our products save lives. It’s what motivates many of us to do the jobs we do. The human impact of the vast range of products we collectively produce cannot be underestimated. Working in this industry is both a privilege and a significant responsibility: the enormous benefits of our products are matched by the damage they could cause in the rare instances that they do not perform as we expect, or had planned.
For those who spend their working lives operating machinery on the manufacturing floor it can be all too easy to forget that our devices are ultimately used on a fellow human. The terrible scenario of a product failing while in use could have the most serious of consequences, and is what has led to medical device manufacturing being one of the most highly regulated and scrutinized of all industries.
Connecting the Operator to the Patient
For those personnel who work with a finished device, understanding the connection between the product and patient may be not be that difficult—but for the many who contribute to the production of component parts like PCBAs or cable and wire harnesses, that link can be much harder to establish. Even further removed can be the operators who perform processes like heat treating, welding, and sterilization. Known as critical processes—where the results cannot be confirmed by visual inspection—they are often completed on parts, rather than on the finished device. In some cases, an operator may not know where and how the piece they are processing will actually be used. However, if the operator does not perform the critical process correctly every time, it can have an enormous impact on the overall performance and quality of the finished device.
We cannot drive the exceptionally high standards of quality we demand in our industry without forging a strong emotional link between those who manufacture all parts of the device and the patients themselves. This link between the operator and the end user has to become part of the culture of all our organizations. If we succeed in establishing this emotional link, such that the operators feel answerable to the patient, then we can provide them with the tools and processes to make the right decisions at the right time.
The Shingo Model
Another way to look at this link to the patient is from the perspective of the Shingo Model. This link is critical in medical device manufacturing and is a special case of the foundation—the Cultural Enablers Principle—that I invite interested readers to review (The Shingo Model, Utah State University, Shingo Institute 2014). Respecting the individual, safety of the employee, empowering, and involving the people—all of these core elements of the Shingo Model grow out of establishing the link to the patient.
As we further examine the value chain associated with medical device manufacturing and step into the Continuous Improvement principle of the Shingo Model, we are very quickly led to process stability and improvement. This is a tremendous area of focus for many of us working in device manufacturing—and we have much to learn from other industries. The aerospace industry in particular stands out, for the manner in which it has coordinated itself. Its use of the Nadcap program to drive quality improvement deep into the supply chain is a significant achievement. Nadcap is an industry-managed audit program run by a not-for-profit organization (the Performance Review Institute) that focuses on 17 critical processes. The program consolidates the aerospace OEM requirements and provides robust critical process audits of the supply chain. The result is explicit oversight of these critical processes, regardless of how deep in the supply chain they reside.
Switch back now to the medical device industry, and we find many of the OEMs (Medtronic included) trying to address the very same enormous task of critical process supply chain oversight ourselves. The safety of our products is as critical as it is in the aerospace industry, and our impact on people many orders of magnitude larger: Two patients every second use a product from my company. Expand this to the device industry as a whole and the number of patients being impacted every second of every single day is almost inconceivable.

Industry unites to standardize and stabilize critical processes. A MedAccred Cable and Wire Harnesses audit in progress. (Courtesy of Global Technologies)
This is where MedAccred steps in. A sister to Nadcap, this program focuses on 6 core critical processes used in medical device manufacturing and has been established by a group of more than 35 leading OEMs, contract manufacturers and suppliers. Importantly, the program is being managed at every level by the medical device industry itself.
Industry-Wide Improvement
It is not difficult to imagine the benefits if we are able to unite as an industry and find a way to collectively standardize and stabilize our critical processes. MedAccred is developing industry-agreed audit criteria for critical processes based on industry standards and best practices and as a result it is driving standardization for suppliers. For the participating OEMs, there is an assurance that all levels of their supply chain are compliant to a clearly defined set of requirements, and, therefore, that the critical processes in question are being performed well. For the multi-tiered and highly globalized medical device industry supply chain, this means the end of multiple and potentially conflicting customer requirements for standard processes, such as heat treating and welding.
And this brings us back to the beginning of this short note. The Shingo Model and its Guiding Principles are well understood in manufacturing, although achieving them requires significant work. There is precedent in other industries for aligning our efforts to improve the quality of critical processes, and MedAccred is steadily approaching critical mass to significantly influence the entire medical device industry.
Remember—we are answerable to the patient.