It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where he’s now vice president of digital innovation. His focus has switched as well.

At J&J, he looked inward, responsible for delivering the strategy and plans for simplifying and standardizing quality systems across the company of 126,000 employees. At Sparta, he looks forward to the future, driving growth strategy, supporting R&D in product development, and influencing how the company’s products and solutions can “participate in the larger IT ecosystem.” McCarthy’s outlook on quality is both deep and broad, and with both types of black belts to his name, he understands the value of practical disciplines. So when he speaks with an evangelist’s enthusiasm about quality management’s role in life sciences, he also promotes a sense of what’s actually possible. The result is a fascinating glimpse around the bend to what lies ahead.

Taran March: Continuous manufacturing is an accepted model in life sciences, particularly for pharmaceutical production. With it the need for automated, real-time quality control is obvious. How about for the medical device sector? Are continuous manufacturing, and related quality applications, applicable?

Stephen McCarthy: We have to ask ourselves, what is a medical device? The medical device industry as a whole is so complex and diverse. For instance, we often forget to bracket diagnostics into the medical device industry, and we should. There are so many different types of medical devices—an MRI machine, a hip implant, spinal surgical equipment, sutures, even just contact lenses. The list is endless. So in many ways continuous manufacturing tends not to apply in some of those examples.

But when you understand the manufacturing process in more detail, many times med-device companies are making formulations—for example, things like coatings for hip or knee implants—and continuous manufacturing does tend to apply there. Whether they be medicines or therapies or coatings for med devices, in general continuous manufacturing will become standard practice, but the benefit of it is less impactful to the med-device segment. It’s not as though continuous manufacturing is essential; it’s happening as a result of the innovations going on in the Fourth Industrial Revolution.

TM: You say the point of manufacturing is changing in life sciences, as is the point of care. What are these concepts, how do they affect one another, and where does quality come into it?

SM: I like using the example of two of our biggest customers. One is a medical device manufacturer, and one is a pharmaceutical manufacturer, both very well-known. They supply to one of the biggest hospital networks in the country. I was at a conference last summer where the chief procurement officer of the hospital network held a panel discussion with the chief supply-chain officers of both the pharma and med-dev companies. The chief procurement officer of the hospital network turned to the supply chain officers and said, “You guys are now raw-material suppliers to me.”

What he meant was that instead of shipping just finished goods—you know, drugs and devices—they’re also shipping materials, and the hospital network is now making drugs, devices, and therapies right there in the hospital. In fact, one network has 30 manufacturing facilities making the type of products that we’re talking about. In the medical device sector, it’s the rise of 3D printing, which again is a direct outcome of Industry 4.0. So instead of you or me having exactly the same implantable hip, tomorrow they’ll do an MRI and print the hip specifically for our anatomy. It’s all outcome-based medicine now.

The other example is personalized medicine and gene therapy. Last year there were more personalized medicine applications going through the FDA system than any other drug type. Manufacturers can make a drug basically in a batch of one. They’ll make a treatment or therapy for your genome, but they won’t make it back in the factory of the pharmaceutical company. They’ll “make it” right there in the hospital clinic. So the point of manufacture becomes closer and closer to the patient.

As the nature of the product changes and becomes unique to the anatomy or physiology of a particular patient, the point of care also changes. Again, it’s all about outcome, all about cost. If you don’t need a hospital bed, and you don’t need all the things that go with that, this has an enormous impact on the overall healthcare system, and it’s a direct result of Industry 4.0 and cloud technology.

TM: Who owns quality in that process?

SM: We don’t have the answers to that yet. Let’s use the hip implant example and say a med-device manufacturer sends the raw material, and maybe some kind of digital template, to the hospital. But the hospital bought the 3D printer from whoever makes 3D printers, and the surgeon’s technician physically prints the hip. So the question of who is the legal manufacturer is a really complex and difficult one.

But maybe more important, invariably something will go wrong with one of these hips, and there will have to be a complaint, a root cause investigation, a corrective action, perhaps even a recall. Who’s going to do those? That’s a comprehensive list of different quality system capabilities. So even more significant than the impact on manufacturing will be the impact on the postmarket, surveillance end of things—how you do complaint handling, and how you do root-cause investigation. How do you manage a recall?

I think our side of the industry, Sparta Systems and our competitors, owes the industry the answers to those sorts of questions. We should not leave it to the FDA and the manufacturers to figure it out and then come and tell us what it is they need. We have a very strong role to play in determining what quality systems can enable these amazing innovations.

TM: In an Industry 4.0 future, the core capabilities of quality will broaden. What will these capabilities include, and why will they be important?

SM: Our abilities to process vast amounts of data and the changing environment that we serve mean we have a whole different customer to think about. Maybe it’s CVS and Walgreens, all the clinics, but it’s certainly the hospitals.

The whole supply chain is becoming virtualized. More than 60 percent of it is now outsourced to contract manufacturers, and the supplier diversity is becoming more complex. We’ve got people making complex biologics and partnering on design; patient input is having a bigger impact on what, where, and how you design products.

From a quality perspective, you need the same capabilities that you needed yesterday. There’s a very traditional view of quality systems—you know, corrective actions, complaint handling, audits, and so on. But if we are going to enable things like continuous manufacturing in pharma and biologics, we start to expand our perspective of what a quality system—with a small ‘s’—really is. Could it include things like formula-recipe management and visualization?

Complaint handling is a good example. How do I make sure that we have quality systems that enable manufacturers and healthcare providers to print hips and deal with the inevitability of there being a problem? I used to be able to say, “I know lot 100 is good, but lot 101 is bad because I can look at the destructive testing done in the lab and verify the results.” In a continuous manufacturing context, I am no longer able to do that.

So while I think we will always need the same quality system capabilities that we are familiar with, we will need to apply them in a very different context to a very different user. And we will have to integrate them more broadly. We also really have to innovate in terms of the capability that we deliver.

TM: How does human talent fit into a future of automated quality?

SM: We still need people in the factory of the future. Maybe we need fewer of them than we needed last year, but we’ll still need people.

As we develop the internet of things, how we connect things to each other, I’m interested in the internet of people: How do we connect people to the factory of the future? How can we use things like augmented and virtual reality to reduce human error?

We will be able to really focus on human-error reduction, but it’s also going to take education, right? The reality is the workforce is going to be impacted because there’s a whole different language that’s being created. There’s a whole different set of skills.

We will need talent that is able to deal with big data, IoT, and augmented reality. The talent is out there, and it’s growing. Schools are more focused on it. What we’re seeing actually is a lot of cross-pollination from different industry verticals.

Other industries are already using these technologies. It’s just that it’s more challenging in the life sciences space. We’re not going to lose anything. Nothing’s going to break as a result of all of this, but we’re not going to get the true value out of these amazing innovations as quickly as we should.