In life sciences manufacturing, innovation cycles are getting shorter, with more new products added to the market constantly. The pressure’s on for medical technology manufacturers to accelerate their quality processes and beat competitors to market with more advanced products — all under the watchful eye of more stringent regulatory requirements than ever before.
This pressure, along with increasingly complex pathways to regulatory compliance and approvals, creates multiplying complexity that can be dangerous for both company and consumer when it leads to rushing a high-risk product to market.
The direct cost of poor quality in the medical device industry is double the direct cost of ensuring good quality.
Releasing a product too early into the wild can harm patients, lose trust, hurt customer satisfaction, and damage brand perception. (Regulatory hurdles don’t make it any easier to repair that damage quickly, either, and rightly so.) Then, when issues do occur, poor traceability makes root cause analysis impossible to control and manage the risk down.
Controlling quality in the field is infinitely more difficult than investing in good quality systems upfront — and ends up costing much more. A closed-loop quality management system catches issues early and often, reducing and preventing this expense, while also catching inevitable poor quality in the wild and ensuring control as quickly as possible, too.
What is closed-loop quality management?
Closed-loop quality management is the manufacturing business process of proactively making all of the data and processes necessary for ensuring product quality is accessible in one central location, bringing product results from the field back for scope assessment, future issue prevention, and continuous improvement.
Effective closed-loop quality processes bring together:
- Communication channels reducing conversation silos and lost quality data
- Service issues such as cases, complaints and product quality issues
- Product and customer information from product lifecycle management (PLM), customer relationship management (CRM) and field service management platforms
- Quality & Regulatory requirements and processes such as non-conformances, corrective and preventative actions (CAPAs), SCARs and electronic instructions for use (eIFUs)
Why is closed-loop quality management important?
Product failures create costs, no matter where they happen, but proactive prevention throughout quality assurance can reduce those costs. Especially in a competitive, regulated market, closed-loop quality management can provide the necessary advantage a manufacturer needs to market new products quickly — while ensuring no quality has been compromised.
Through supplier communication and quick triage in a closed-loop quality system, life sciences manufacturers can react quickly to quality issues before products hit regulators and the market, reducing costly field breakdowns, keeping consumers safer and freeing teams up to focus on the next disruptive product.
Existing communication and data sharing methods in common quality practices don’t allow for this type of competitive speed. Most manufacturers’ communication systems operate like one-way chains, and are often easily slowed down by even the smallest compliance issues. Legacy quality systems hamper manufacturers from initial concept to delivery to the customer, with challenges of regulatory compliance and key data lost in silos along the way preventing their success.
Research from McKinsey shows that improving business processes can bring the cost of quality down significantly for medical device makers, and inversely showcased the high costs poor quality can incur:
“Indirect costs, such as revenue loss and market-cap impact related to nonroutine quality failures, can reach $1 billion to $3 billion for a medium to large medical device company. These quality failures may lead to a major compliance action, such as a consent decree requiring a plant shutdown, which can have a disproportionate cost impact. Based on high-impact medical device case examples, we estimate that, for individual companies, top-line impact can reach as much as $1 billion and market-cap impact as much as $2 billion.”
When the right teams aren’t involved early enough throughout the value chain, it’s difficult to build the best medical products.
When the right teams aren’t involved early enough throughout the value chain, it’s difficult to build the best medical products, and costs and schedules pile up as you add on that debt, possibly into the billions. This isn’t sustainable for any medical technology manufacturer of any size.
The solution is straightforward: Cross-functional groups and departments need to be involved far, far earlier in the product lifecycle, in order to not only share visibility as problems happen in real time, but learn from those problems and react to resolve them quickly.
This is only possible with a digital strategy that enables fast response to disruption, supports improved product quality and preventive actions, and meets global regulatory requirements.
Benefits of closed-loop quality management
Reduced cost of quality
Poor quality is expensive. Quick fixes and “just good enough” manufacturing processes that don’t include key departments in the supply chain (and the important data they may have about a supplier or customer) continually damage companies’ effectiveness and reputation.
In fact, the direct cost of poor quality in the medical device industry is double the direct cost of ensuring good quality, McKinsey findings revealed.
Preventative quality measures are essential, and when problems do arise, quick and complete remediation is also a must. In closed-loop quality management, field feedback and investigation, along with corrective and preventative actions, happen quickly, securely, and with no friction. This reduces costly errors and rework.
A closed-loop quality management platform also lowers the cost of ownership, where new users can be onboarded quickly and immediately have access to all the data they need to work efficiently. This also reduces maintenance expenses.
Building and servicing safe, high-quality, innovative devices that improve patient lives is the ultimate goal of any competitive medical device company.
Improved patient outcomes
Building and servicing safe, high-quality, innovative devices that improve patient lives is the ultimate goal of any competitive medical device company. Loyal customers are created and retained through high-quality product experiences. Incorporating this customer feedback in product development and across the entire product lifecycle allows teams to innovate product design and resolve customer complaints faster.
Improved compliance management
Achieving and maintaining compliance is easier when the information isn’t difficult to track down. Closed-loop quality management methodologies helps teams manage cases, complaints and CAPAs more effectively, and ensures proper employee training and management of training records.
Examples of closed-loop quality management
Integrating quality management software (also known as a quality management system or QMS) into a larger consolidated enterprise platform or ERP improves the customer experience by speeding up the process and ensuring their interactions are consistent across the product lifecycle.
A lot of different groups interact directly with customers, such as marketing, sales, customer service. Each one uses their own technology platform to do their jobs, such as a CMS or eQMS. However, when you have all these different groups using different platforms, the result is complexity, data latency and data loss, and a more distant customer.
Different groups using different platforms results in complexity, data latency and data loss.
For instance, something recorded by customer service on a field service platform has to be communicated by email or Slack to the quality team or the product team. And if these groups don’t communicate between themselves, the customer experience will be disjointed and decision making will be slowed down.
Closing the loop in a manufacturing organization's quality capabilities means that all these groups are on the same platform, where data can be shared with a few clicks. A customer issue from field service automatically triggers a complaint, which automatically initiates a product investigation, which can automatically trigger an action in the customer record. This can be accomplished in real time in a closed-loop quality management system.
For example, dual vial access device manufacturer Yukon Medical previously used legacy product quality systems that weren't scalable, and made training very difficult. Using closed-loop quality management, they were able to streamline quality management processes, stay compliant, and stay up-to-date on all customer issues and product changes within one enterprise system, rather than writing data down and typing it into siloed systems. Their closed-loop system also gave them the ability to export data and metrics needed on a per-channel basis to stay efficient and maintain company security, reducing risk.
Hear more med device customer stories at our upcoming webinar in partnership with Axendia, Getting on the Right Side of the Digital Divide.
How to ensure closed-loop quality management
Get started with an easy-to-use system that links quality and product records together in the same platform. Propel for Medical Devices is the industry’s only closed-loop quality and bill of materials (BOM) management solution for managing customer, product quality, supplier quality, product, and compliance records in a single integrated platform.
Design, build, deliver, and service high-quality products for global markets faster and with more functionality, while lowering overall business risk, streamlining quality processes and manufacturing operations management, consolidating document control and data, and ensuring regulatory compliance. Learn more.