Developing a medical device has always been a complex process.
Choosing the right component part at the right time is one of the most important aspects of medical device product design. Unfortunately, many medical device or high tech companies don’t utilize a standardized method for selecting electronic parts. And relying on archaic management tools, such as Microsoft Excel, to manually manage product data can cause medical device companies to make dangerously incorrect selections.
Manually searching for and selecting components is time consuming and error prone. It can result in incorrect or incomplete part numbers, missing information on various attributes and a host of other inconveniences and errors.
Part obsolescence is an ever-present risk to medical device companies. Even parts must die someday—bless their hearts. Managing part data in-house makes it difficult to plan for obsolescence issues, as forecasts are often based on data that is inaccurate or incomplete. Being caught unaware on a part going end of life (EOL) can be catastrophic, causing costs to skyrocket and delayed shipments. Additionally, faulty manual risk management processes caused by a bad part can lead to several medical device nightmare scenarios.
Imagine you have a device that you’re expecting to last for ten years—it’s working well in the market, its components are readily available, and suddenly one part goes obsolete. Because of one component, your entire product is now at risk. In an absolute worst case, your company might need to spend millions of dollars to redesign because of one component. By subscribing to an electronic component database and proactively assessing components with complete data knowledge, the service ‘cleanses’ components and provides visibility into their potential risk of becoming unavailable or non-compliant.
Another issue medical device companies face is a growing plague of counterfeit parts, which if packaged in the design, can sabotage a device. No company wants to hear that its medical device failed while performing surgery or that its medical scanner was not able to detect cancer—after making high-spend advertising claims that it does.
To battle counterfeit risks, some database providers have developed algorithms—similar to the formulas devised to forecast EOL components—that examine how long a suspect part has been on the market. The system can also detect whether any counterfeit reports have been made on the component in the past, and verify how many distributors still carry inventory on this product.
Usually counterfeiters will go after parts that are on the gray market—parts no longer being carried by authorized distributors. Counterfeiters know companies are in a panic to get a hold of these parts. Yes, there are tests and measurements and methods in the market today, but you are not going to be able to test every single component, so there is always a risk.
When the electronic component database is integrated into a product lifecycle management (PLM) system to manage the BOM and associated engineering change orders, medical device engineers can validate and assess all parts up front with cross references, lifecycle, parametric, obsolescence forecasts, regulation compliance and inventory data to swiftly assess their legitimacy for inclusion into the NPD build.
Modern product development platforms help medical device companies eliminate errors caused by manual data entry and streamline the transfer of your product record to downstream systems for accurate design, change control and manufacturing with precision.
A component database, when integrated with a product development platform, is the only realistic way medical device companies can comply with ever-changing compliance mandates and frequent adds to both the REACH and RoHS hit lists.