Performing Continuous Risk Management for the Full Product Lifecycle 

Risk assessment and management is an integral part of any successful medical device manufacturer’s strategy. Failure to do so can jeopardize your products’ effectiveness, reliability, quality, and safety. Yet unfortunately risk management is sometimes viewed through the single vantage point of fulfilling regulatory requirements rather than a broader strategic process woven through the business.

Strategic risk management results in devices that are safe and effective, that undergo a more efficient design and development timeline to get to market faster, and that encounter fewer problems on the market. Performing risk management continuously throughout your product lifecycle helps you realize these benefits while mitigating threats to patient safety, compliance, and the bottom line.

Here is a closer look at how a strategic approach to continuous risk management can be woven into each stage of the product lifecycle.

During initial product design

In the early stages of product design and development, risk assessment ensures that potential hazards and defects are recognized and designed out. When risk management is a seamless part of the flow of design and development, it can form the basis for decisions about device safety and efficacy. In addition, assessing and managing risk can lower the possibility of a device encountering unforeseen problems or delays during the validation process.

Integrating risk assessment and management into the design and development process can be easier with an expert partner. Consider quality critical inspection, for instance, which serves as independent verification of quality control and may flag issues before they become full-blown crises. In addition, the device itself is only one-half of the equation; the packaging must ensure that the device reaches the patient safely with an effective aseptic transfer into the surgical suite. Therefore, incorporating package design and validation engineeringexpertise—or opting for robust pre-validated packaging options—earlier in the design/development cycle can lower risk and unlock benefits.

During design modification

Modifications during subsequent product iterations can also pose threats. During each design modification, risk assessment and management should evolve with device design to ensure that changes pose no threat to patient safety.

Here again, quality critical inspection can prove invaluable, as can the perspective on the evolving regulatory landscape only an expert partner can offer.

During production process changes

Evolving regulatory requirements can spur changes to production systems. For example, consider the conversion of non-sterile to sterile packaging as part of the European Union MDR enforcement date coming up in May 2020. Any time a process shift is introduced, the potential for error increases, elevating risk.

This type of situation is where outsourcing to an expert partner with best-in-class processes for packaging and assembly can lower risk. Doing so can ensure continuity and compliance while alleviating potential capacity constraints and helping your team focus on your core competencies.

During recalls

Problems can occur with even the best-designed products, necessitating a mandatory or voluntary recall. Savvy OEMs will handle the situation via a rigorous risk management approach. Doing so is essential to getting back into compliance as quickly as possible to minimize damage, protect patients, safeguard firm reputation, and contain costs.

A mandatory or voluntary recall presents an all-hands-on-deck challenge—but the rest of firm business doesn’t stop. Outsourcing your returns and reverse logistics to an expert partner can ensure that you bring all affected product quickly under complete control, handle repackaging or relabeling for any still-saleable product, and get it back out to the field rapidly and safely.

When risk assessment and management are embedded into your product lifecycle, you see the benefits in better devices, patient safety, shorter time to market, and a boost to the bottom line.

At Millstone, we get it. We believe that quality drives patient success and that the expertise of a trusted outsourcing partner can help mitigate risk. That’s why we’ve perfected all the capabilities medical device manufacturers need to get to market. Today we offer post-manufacturing and aftermarket services to more than 50 customers, including some of the top 10 orthopedic companies in the world. We are constantly evolving our processes and services to help OEMs achieve sustainable success. We offer clean room packaging, medical device specific warehousing, finished goods distribution, loaner kit management, advanced inspection and reverse logistics services—all with an unparalleled focus on quality.

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