PLM – The secret sauce to preventing medical device product failures

Departments - 1 Last Look

December 9, 2021

Mistakes happen in every aspect of our lives – including product manufacturing. Whether it’s a flawed design, a material that doesn’t act as predicted, or a faulty inspection process, the result is often the same: a product recall. In 2015, 4,217 product recalls were issued by federal agencies in the United States; not that rare.

In many industries, product failures hurt reputations, consumer trust, and revenue; in the medical field, lives are on the line nearly every time. Patients depend on these products to save their lives, and one product malfunction could be tragic.

As medical products become more complex, the risk of something going wrong during the designing, manufacturing, and testing process becomes more prevalent. First, medical device manufacturers must recognize why products fail and then understand how technology, such as product lifecycle management (PLM) software, can help prevent failures before they happen.

Recognizing why products fail

Thousands of decisions are made during the life cycle of a medical device, many of which greatly impact time-to-market, productivity, cost, and in-field operation. Several stakeholders make these decisions so it’s important they have the proper data as no manufacturer intends for a catastrophic failure. However, things generally don’t fail by accident – regardless of intent to the contrary, it’s a choice to fail.

Often, failures are the consequences of mistakes at the decision-making level when a decision is rushed, or decision makers lack data. Once the first bad decision is made, it has a domino effect on the rest of the product’s life cycle. The longer this domino effect lasts, the more manufacturers try to rationalize their missteps to gain something from their wasted efforts. These evaluations can be self-harming, leaving no motivation to divert time or money to understand why the original decision happened.

How technology can help

PLM, a technology that forms the digital backbone of a company’s global product development and manufacturing process, allows each stage to inform the next.

Medical device manufacturers should leverage a PLM platform that’s both a highly configurable end-to-end enterprise solution, including applications for engineering, manufacturing, quality, and maintenance for the world’s most complex system intensive companies, while also being a resilient low-code platform that allows designated people in the business to access the information they need to do their jobs effectively. By choosing the right PLM platform, manufacturers will be more efficient across their product lifecycle and can digitally transform on the platform, sunsetting legacy technologies and incorporating more people and applications, reducing their technical debt, and increasing their ability to collaborate and transform.

PLM also plays an important role in helping manufacturers meet regulatory compliance and quality assurance of device life cycle. This automates regulatory documentation such as Device History Records (DHR) and Device Master Records (DMR), providing the transparency and traceability required to pass regulatory audits.

If manufacturers change the way they think about the product development process, businesses can get ahead of failures before they happen. Modern PLM platforms track all life cycles of the system, from conception and design to operation and maintenance. These evolving platforms meet a world of systems – where manufacturers must manage everything about a system as a system of systems first, without knowing the product design details.

PLM software is the key to helping medical device manufacturers prevent product failures and avoid catastrophe. With the right data at their fingertips, manufacturers can make informed decisions and adjust their approach to product design and maintenance.

Failures shouldn’t be an assumed risk or a cost of doing business. Some product failures aren’t preventable, but if medical device manufacturers shift their thinking and leverage technology such as a PLM platform, failures can be manageable.


About the author: Mark Reisig is vice president product marketing at Aras. He can be reached at