There is a big difference between manufacturing for the short-term inventive R&D phase and confirming product design for reliable and regulated manufacturability over the long haul. Our engineering and manufacturing teams at EmbedTek have seen and solved all different types of challenges that would have prevented medical device manufacturers from scaling up production.
Following is the first in a series of articles outlining the most common mistakes we’ve seen and how to avoid them.
Be careful using consumer grade components that don’t offer the traceability and life cycle management required for scale.
Designers tend to use products that are most easily accessible (i.e. purchase from Newegg/Amazon) or limited in quantity when they are at the beginning stages of product development. When they only need one unit to test a concept, they buy what works best at the time, not thinking about price per unit or if the manufacturer is likely to be around in a year.
Consumer grade components available with the latest technology today should be considered with caution for two reasons: longevity and traceability. Over time, there is no guarantee of consistent supply, and there is always the risk for unannounced changes to components. Traceability and process control also are factors – the U.S. Food and Drug Administration (FDA) requires manufacturers to track medical devices and their components from manufacture through distribution. Not all consumer grade components follow standards of traceability.
Original equipment manufacturers (OEMs) need control their product’s lifecycle by developing a comprehensive maintenance and replacement schedule for each component used. This includes the creation of a bill of materials (BOM) and end-of-life (EOL) report listing each component’s relevant certifications, when the component needs to be replaced, and other components that will need to be replaced along with it. OEMs can maintain the BOM by communicating with strategic suppliers on a regular basis to learn about pending updates or changes.
Don’t let scalability be the factor that undermines a product’s success. When OEMs take steps to align the agility of their R&D-proven technology with building a scalable supply chain, they can create a manufacturing approach that will support growing the business as the product demand increases.
For more insights and success stories, download our free white paper, Simplify and Scale: Get to Market Faster by Avoiding These Common Hurdles