Bringing a new medical device to market can be a daunting task, but 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 Early
Outside 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.
Early supplier involvement (ESI) in the development cycle is the best way to contain costs while maximizing the benefits that come from utilizing suppliers’ specialized skills. By engaging key suppliers early in the process and focusing on the desired results, an OEM can quickly address any potentially sticky issues, drive out unnecessary costs early on, encourage innovation, and improve project organization. Without ESI, a manufacturer runs the risk of unnecessarily lengthening the overall development cycle, increasing the number of design revisions later in the process, and ultimately ending up with a device that is too complex, too expensive, or too difficult to manufacture.
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 the each design review to ensure that the product can, in fact, be manufactured effectively, efficiently, and reliably as designed. It’s a good idea is recommended to have a single program manager from the plastic supplier appointed early to the project; this , creates assuring a single point of contact for all internal disciplines internally as with someone who well as understandsding the specifications, can help interpreting customer needs and, manageing customer expectations and 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’s important to be open to implementing suggestions and aimed at improving the designfinding, analyzing 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.open and functioning, and continuous feedback enabling real time course corrections to be made, product development should 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 Manufacturing
While 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.
In addition, tInstead, the team should be well-versed in Designing for Manufacture and Assembly (DFMA); they should have a clear understanding of the product’s end use so they can focus on creating the simplest, most robust component while avoiding excess parts and unnecessarilyy tight tolerances. By including from the start tooling, manufacturing, and quality engineers using integrated CAE, CAD, and CAM tools you can avoid many of the pitfalls that can trip up your product development and cause costly revisions.Computer enhanced analysis tools such as FMEA (failure modes and effects analysis), CAD/CAM (computer aided design /computer aided manufacturing), and mold filling analysis are useful examples of upfront analysis tools that can help avoid many of the pitfalls that can trip up a product development process and cause costly revisions. A team that engages the entire supply chain and makes use of ESI can effectively decide when and how to include each discipline as the project proceeds. The result is a solid product design that is informed from the very beginning by every aspect of product development including considerations for manufacturing, quality control, and regulatory disciplines. Once again, this is where early supplier involvement can yield benefits. A good supplier can recommend material substitutions where appropriate to reduce cost and/or improve performance as well as suggest common processes for greater manufacturing efficiency and faster time to market.
To plan a successful launch, it’s it is essential to execute a controlled design process—one that incorporates early cross functional team involvement. collect manufacturing input via DFMA and to involve the team early. Look for balance in designing for scalability, quality, moldability and assembly. The design process not only must include needs to include 2D/3D prints and models but should also focus on . Sspecification development, must encompass individual components requirements, cost and volume targets, sub-assembly requirements, final device requirements, regulatory plan, packaging and sterilization requirements, and a robust quality plan. in-process and/or release testing.
Utilize the Supplier Early
Today’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 shortened development cycles, minimized tooling costs, improved design flexibility, and promote innovation.
Both rapid prototyping and prototype toolingRapid prototyping and prototype tooling are very important in the development of a high volume precision plastic component. Rapid prototyping has enabled design engineers to quickly and efficiently work through a wide range of design concepts without costly and time-consuming retooling. There is a wide variety of modeling techniques that fall under the umbrella of rapid prototyping and selecting the best method for a particular design methodapproach can pay dividends further along in the process. Some common techniques include including stereolithography, selective laser sintering, droplet based manufacturing, multijet modeling, laminated object manufacturing, and fused deposition modeling. By involving the supplier early on, OEMs can ensure that the appropriate modeling technique is used for a particular project which can ultimately simplify the design verification process and avoid costly delays in both time and money.
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 compounds 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.As a result, rapid prototyping enables design engineers to envision, test, and improve product designs with previously unheard-of flexibility and speed.
Once design intent is proven and accepted by the development teamrapid 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.
Once 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” from the single cavity trials.” . 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 Production
New 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.
To help ensure success, a formal, documented production mold design review should be performed by the supplier. This should include all team members as well as any additional internal personnel with the expertise to look at the project from a fresh perspective. Critical features should be measured, critical data collected, and manufacturing readied for tool sampling. Debugging begins with the first sampling and can often require significant adjustments.; the supply chain should be kept in the loopESI will help in case there are issues to be resolved because the supplier has been engaged throughout the entire product development cycle, so no time is lost bringing someone up to speed when a problem needs to be resolved.
With the entire manufacturing process reviewed and approved, the new high-cavity manufacturing mold debugged and functioning properly, it’s time for the team to perform that crucial initial feedback on part quality.
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-precisions 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.