Surprising costs to scale up production. A material that mysteriously stops performing consistently. A diagnostic test that works perfectly in prototype but swings out of tolerance off the manufacturing line. On the road to fast and efficient new product commercialization, these are an engineer’s worst nightmares. Sometimes these issues arise despite the best-laid plans. There are some steps to avoid these problems and other common pitfalls, here are three:
#1 Involve Key Stakeholders in Material Decisions — Before the Design Freeze
As the building blocks of any medical device, materials can make or break a new product launch. That’s why it’s so important to prioritize plenty of time and resources toward selecting the right materials. Involve all key stakeholders from the very beginning of product conceptualization, from internal R&D, quality, marketing and engineering team members to external materials suppliers, converters and contract manufacturing organizations (CMO). Consult with regulatory bodies and consultants along the way, as needed.Some device developers make materials decisions too hastily. For example, it can be tempting to specify a certain material out of convenience (i.e., “we have it in stock”) or price. A material may meet the initial required minimum performance criteria, unfortunately not enough attention may have been given to material quality and supply stability. Both can have significant ramifications as the product design moves out of prototyping into production. Are the material’s physical properties well suited for high-speed manufacturing processes? Can the material vendor provide small as well as large quantities when the time comes to run trials and mass produce? Is the material vendor able to provide materials that are specified to meet the required tolerances?
Device developers are always looking for new ways to redesign diagnostic tests, such as lateral flow immunoassay cassettes like these. Avoid production pitfalls by engaging with supply chain partners in the earliest product development stages. Image courtesy of Web Industries Inc.
These are all important questions to discuss among trusted supply chain partners. Even so, under pressure to meet launch calendar deadlines, many device developers will “freeze” a design after their device’s diagnostic test meets the minimum performance and regulatory criteria. As engineers know all too well, after a design is frozen the flexibility to make changes is lost. At that point, it may require a lot of paperwork, new regulatory filings and additional rounds of testing to approve alternative materials.
#2 Consider Manufacturability — Even in the Concept Phase
As it should be, the concept stage of product development is filled with creative thinking. It’s a time of exploration, and no one wants to snuff out the inventive spark by raising a lot of caveats as to why something won’t work. Still, it can be a mistake to put off practical considerations, such as precisely how a product will eventually be manufactured. Here again, as with the initial materials selection process, there are benefits of getting some early perspectives from supply chain partners.
Consider this scenario that arose for one diagnostic device maker. The R&D department developed an unconventional plastic cassette device design that required the addition of adhesive to the plastic frame. Manufacturing’s automated assembly machinery did not have the capability to apply adhesive or place an adhesive-backed strip to this particular design mold. The manufacturing group had to modify a piece of equipment to be able to assemble the device, which significantly increased the capital cost.
Materials can behave quite differently when processed on high-speed manufacturing lines vs. low-volume prototyping equipment. Before freezing a design, it’s important to test the limits of raw materials across their full product specification range. Image courtesy of Web Industries Inc.
This situation is complicated because by the time the device reached the manufacturing group, the design was frozen and the company decided to leave the design as is and bear the additional capital costs. To change the design at this phase of commercialization, the company would have had to scrap material, invest in a new mold and repeat performance studies. This would have significantly delayed the launch timeline and caused the business to miss the product’s clinical trial windows. It was a lesson learned at a high price.
#3 Design with Usability and Mass Production in Mind
Device developers are closer to device end users than any other supply chain partners, and they understand the importance of usability. But on the quest to innovate, it can be challenging to know where to draw the line on adding features to a design. What do customers care about the most? What bells and whistles are truly needed vs. nice to have? Quite often, it’s to the developer’s advantage to get a second opinion from a production partner. How will the new feature impact the final price point of the device? Will the customer be willing to pay a premium for it?
Here is another cautionary real-world case. A medical device developer created a prototype of a diagnostic disposable that included finger imprints on its sides, designed to allow the end user to comfortably handle the device. However, the imprints made the top and bottom of the cassette asymmetrical, and this design feature made it impossible to automatically feed bulk cassettes into automated assembly equipment; it required manual feed of the equipment, drastically decreasing productivity and impacting output volume.
A usability study showed that the user did not naturally grasp the cassette along the side edges. Instead, it was easier for the user to grab the cassette with his or her thumb and forefinger. All of this was revealed before the final cassette design was set in stone. With some changes to benefit the user experience and manufacturability, the final design was highly usable — and mass producible. It’s often advantageous for device designers to partner with a CMO who can help with both defining usability and ensuring manufacturability.
For a new medical diagnostic device, the transfer of ideas from concept to production is not without its fair share of perils. However, by using some basic guidelines up front, you can save significant time and money, while giving your product a higher chance for success.
Claudio Hanna is business development director for Web Industries Inc., a specialist in outsourced flexible material converting and end-product contract manufacturing, including medical devices that have flexible materials. Contact Web Industries at BPhillips@webindustries.com or 1 508.898.2988
