Closed-loop quality management brings all data points together from cases, complaints and issues so that everyone across the supply chain can support business processes.
This practice is specifically difficult — and key — in the life sciences industry, where regulatory compliance can slow down the development process of already-complex devices.
Closing the loop in medical device manufacturing promises a payoff. Modern practices in quality assurance could lead to a 10 to 15 percent increase in the earnings of medical device companies and even more in the years ahead, found McKinsey.
Put inversely in other McKinsey findings, the direct cost of poor quality in the medical device industry is double the direct cost of ensuring good quality:
"Non-routine quality events—such as major observations, recalls, warning letters, and consent decrees, along with associated warranties and lawsuits— cost the industry between $2.5 and $5 billion per year on average. This includes $1.5 to $3 billion per year on non-routine costs, plus $1 to $2 billion in lost sales of new and existing products."
Sherrie Nance, VP of Global BioDevices R&D at Zoetis, Michael Pawlyszyn, SVP of Healthcare and Life Sciences at Salesforce, and Mike Casey, VP of Global Information of Technology at Cantel joined Propel’s VP of Professional Services, September Higham, for a rapid-fire perspective on managing mergers and acquisitions, engineering change order cycle times, and much more.
Here were the highlights from these market leaders who are using technology to collaborate and resolve product issues faster, beat competitors to market, and improve product quality.
Learning from the case to complaint process
Mike Casey said one of Cantel’s key findings was that many of their quality complaints actually originated from cases in their service environment. “Cases can become complaints,” he said, which led to helpful questions for their teams to ask themselves, such as, “Is that product performing for the customer as planned?”
Sherrie Nance said that closing the loop in quality at Zoetis meant learning from what the cases to complaints process had to teach about what to change in development.
Zoetis was encountering issues in complaints in quality testing, so they had to go back and change their quality testing to reflect real-world inputs and catch issues earlier. Without the visibility a closed-loop system provides, that discovery would have been much more difficult.
Visibility through a single source of truth
In a closed-loop system, “It’s all about data interoperability,” said Michael Pawlyszyn — an interoperability informed by many, many data inputs.
With a single source of truth, for instance, the supply chain team knows that engineering is making a change, so they don’t order unnecessary parts, and engineering knows about supply chain shortages so they don’t design unavailable components into new versions.
Product lifecycle management (PLM) used to be disconnected from other legacy systems that were all hosted on premise, with huge efforts required to pull data from the PLM and move it anywhere. Instead, empowered stakeholders who have full context as they develop products using a cloud-based PLM solution increase speed and scale, versus starting from scratch with tracking down data every single time.
Salesforce enabled this modular capability of cloud-to-cloud integration, said Casey. Nance added that a cloud workflow deployed across the entire system reduces errors, whereas even when using digital systems, when multiple systems aren’t integrated correctly it can cause more issues.
Casey commented that in particular, mid-sized companies never have enough people, so it’s important to focus the people you do have on what matters most. “Cloud means there are things you don’t have to manage,” he said.
Within a closed-loop system, where product, quality and customer records are all integrated within Salesforce, it’s easier to tie a complaint to a customer record, understand the cases against a certain product, and then feed it back into product design — the closed-loop advantage.
In certain challenges and restraints placed on medical device companies, this connection to records extends its usefulness. The European Union requires electronic instructions for use (eIFU) to be presented to the general public via a website. As a regulated document, it’s crucial to present the right information on demand. Cantel Medical worked with Propel to use Salesforce Communities and its content capabilities to serve as that website.
Navigate change management through growth and acquisitions
Having fully digital PLM implemented can make mergers and acquisitions go more smoothly, taking your intellectual property into an environment more people can utilize and successfully adopt. When people understand that vision, they buy into it. Superficially, patents and trade secrets are a company’s intellectual property — but even if a company has those in hand, product teams may not be able to execute on it. The whole story is in the documentation, agreed Nance and Casey.
“In change management and acquisitions and rapid growth, your IP is tied up in documentation like BOMs,” said Nance. “The value of acquisition lies in the work they’ll need to do to reproduce a product reliably.”
In a world gone remote, having access easily available across teams during an M&A process is especially invaluable, providing a holistic view of changes made and a seamless transfer of knowledge without bulky onboarding or unsafe in-person training.
In divestitures as well, a sale goes much more smoothly on a closed-loop system, or in moving from one contract manufacturer to another. It’s all contained within the same platform, and bringing on new members or handing the reins to someone else is straightforward.
Pull better reports and analytics on change order cycle times
Engineering Change Order (ECO) cycle time is a key metric to pay attention to. Nance found that some of her engineering team at Zoetis were hesitant to put product into their quality process, because they were afraid it’d get stuck there. In a closed-loop system, both engineering and quality have visibility into time stamps and expected outcomes, which helps build confidence in the quality process.
Factoring in priority levels is also important, said Nance, mentioning that a high-priority product lagging behind in a workflow should be flagged sooner than low-priority items. Pulling simple reports on ECO cycle time makes this easy.
It’s important to reduce change order cycle times when considering the market potential of a product, said Casey.
“Each month a product’s not on the market is a lost month of revenue,” said Casey. “I can’t be moving on to my next product if there are issues to resolve.”
Historical bottlenecks in ECOs were paper-based and strictly administrative. Now, electronic bottlenecks are in workflow bumps due to multiple non-integrated systems, especially cutting into profitability, with missed quality issues having to be resolved after the fact.
Closer, more frequent reporting on ECO cycle time opens up a world of workflow optimization possibilities, where the following questions may need to be asked:
- Are the right people approving products?
- Are there too many people in the process?
- Where do people need training?
- Where can you influence that cycle to get to a better outcome?
- Where are the gaps where people don’t understand the decisions they have to make?
More often than not, closing the loop and unifying on one digital platform illuminates physical, human gaps on the shop floor and within workflows.
“People, processes, platforms have to change together, or the change isn’t effective,” advised Casey, adding, “I can make your process go really fast — but a bad process can go fast too.”
Making the shift to a closed-loop system
When implementing digital transformation projects in the medical device industry, companies are deploying a complex system capturing complex products in an already-complex regulatory environment. The last complication piece? People stuck in their ways.
“Sometimes adoption is harder than you think,” said Nance. “You can make progress highlighting vulnerabilities in legacy systems and outlining a workflow that protects all interests.”
Understanding under the stress of an audit or even just submissions can unite a team behind a closed-loop system, said Nance, highlighting the table stakes of bringing the right device to the right customer at the right time and with the right services supplementing it.
Pawlyszyn’s closing advice to medical device manufacturers seeking to implement closed-loop practices at their organization: “Don’t forget the macro goal or lose sight of it.”
“Whether departmental, business, geographic or corporate-level, you need constant affirmation, communication and alignment to the impact upstream and downstream, reinforcing the journey especially with remote workers dropping off where alignment gets lost,” he said.