By Thomas Taylor
Bringing a new medical device to market can be a daunting task. It can be especially so when it involves complex, precision plastic components that need to be manufactured cost-effectively in high volumes. That’s why it’s critical to understand every step of the process and implement proper planning and project oversight from the very beginning.
Start the Conversation EarlyOutside suppliers play a crucial role in virtually every medical OEM’s manufacturing process. Smart ones treat their suppliers more like partners and less like vendors; by working closely with key suppliers early in the process, they can create more value, improve quality, and reduce overall time to market for even the most difficult or critical components.
| High speed multiple capability assembly |
When assembling a project team, be sure all disciplines needed to bring the product to completion are represented on the team and are included in each design review to ensure that the product can, in fact, be manufactured effectively, efficiently, and reliably as designed. It is a good idea to have a single program manager from the plastic supplier appointed early to the project; this creates a single point of contact for all internal disciplines with someone who understands the specifications, can help interpret customer needs, and manage customer expectations, while providing consistent communication to all. Team dynamics can make or break a project, so make sure team members can work well together – all the experience and expertise in the world is useless if the group can’t work together as a team.
The glue that holds the team together is communication. With good communication comes improved cooperation, better use of resources (both internal and external), better understanding and execution of deliverables, and the ability to make improvements throughout the entire design, development, and manufacturing process. This includes encouraging feedback and creating an environment in which the company listens to comments, proposals, and ideas from the suppliers. It is important to be open to suggestions aimed at improving the design and closing any gaps in the process.
With the proper team in place, robust channels of communication can be established to ensure the design process will proceed quickly and smoothly. Equally important, good communications between the team and company management can help ensure development buy-in and continued support.
Design the Component for ManufacturingWhile it may sound fairly obvious, it is surprising how often designers – lured by the siren song of “What if?” – veer off course into the murky waters of “design creep.” “Design creep” is the place where the original concept gets lost under layers of “added functionality” or “enhanced performance.” The end result is often a component that is either too expensive or too complicated to produce. Again, early supplier involvement will enable a better outcome for the project, helping the development team stay focused by providing input, expertise, and guidance, unencumbered by internal departmental dynamics.
| Precision molding |
To plan a successful launch, it is essential to execute a controlled design process – one that incorporates early cross functional team involvement. Look for balance in designing for scalability, quality, moldability, and assembly. The design process not only must include 2D/3D prints and models but should also focus on specification development, cost and volume targets, sub-assembly requirements, final device requirements, regulatory plan, packaging and sterilization requirements, and a robust quality plan.
Utilize the Supplier EarlyToday’s global plastic suppliers provide a wide variety of upfront services from product research and design support to rapid prototyping and prototype tooling. Utilizing a supplier for these activities – especially early in the process – can shorten development cycles, minimize tooling costs, improve design flexibility, and promote innovation.
| Precision hand assembly |
Just as the techniques for rapid prototyping have been refined over time, so have the materials used in the various techniques; again, ESI can help sort out the best ones for specific modeling requirements. Resins that were previously brittle and useful mostly for appearance models have been improved to the point where they are well-suited for creating living hinges and models for physical testing.
Once rapid prototyping has proven the design to this point, pilot tooling can be very beneficial to the overall program. It’s important that everything match or mimic the production environment as much as possible, including the tooling and construction materials used. Typically, a single cavity tool is produced for pilot programs keeping final manufacturing cavitation in mind.
After product testing has been completed with pilot tooling and the data collected, it’s important for the team to review the data and perform “lessons learned.” If it appears that modifications are necessary, now’s the time to make them. It’s easier and more economical to take the time and do it now rather than to be faced with delays and changes later. This cost effective approach mitigates risk by enabling questions such as: “Will it work?” and “What degree of variability is acceptable?” to be answered.
High Volume ProductionNew tooling technologies enable higher cavitation molds to be used for manufacturing even complex plastic components, helping to control cost. By using high cavitation molds where possible, capital expense such as equipment, labor, and energy can be reduced. As production tooling gets underway, this is the perfect opportunity to revisit the higher cavity mold with the lessons learned from the pilot program and refine, if necessary, as part of the advanced quality planning process.
| Quality control visual inspection |
As the product development cycle moves into high volume manufacturing, the team’s multi-disciplinary approach can help ensure success by confirming the entire production process. The science of injection molding has been significantly improved over the years, enabling non-uniform melt conditions to be virtually eliminated with properly designed and managed high-cavitation molds. But there’s still art as well as science involved in producing high-volume, high-precision molded plastic medical components, accurately, reliably, and repeatedly. It’s vital that the team see that best manufacturing practices are employed from the start and that the entire process is robust, dynamic and includes ongoing parts evaluation and data review under a documented quality plan.
ConclusionESI is critical for bringing new medical device products to market in today’s highly competitive, low margin environment. ESI, from conceptual design to high volume production, will help limit the overall product development time, reduce risk, and lower cost. Through the creation of a team environment with open communications and early supplier involvement, the smoothest possible product development process and the best possible product launch will be ensured.
ONLINEFor additional information on the technologies and products discussed in this article, visit Nypro Inc. at www.nypro.com .
Thomas Taylor is vice president of global marketing and business development for the healthcare business segment at Nypro Inc., a global manufacturer of custom plastics offering integrated contract manufacturing. He has extensive international experience in developing and marketing disposable medical and diagnostic products in the OEM healthcare market. Taylor can be reached at 978- 368-4726 or firstname.lastname@example.org .