Scaling to high-volume manufacturing requires companies to think ahead and prepare for the future early in the product lifecycle. Here are four points to reflect upon before your company scales up.
Gavin Wadas, B. Braun Medical, OEM DivisionHigh-volume manufacturing typically involves the introduction of automation into the medical device fabrication and assembly process. A number of benefits usually follow: Repeatability, higher quality and lower (and more predictable) long-term costs of operation.
However, many medical devices begin their life cycle below the high-volume threshold, sometimes with manual procedures. Successfully scaling to high-volume manufacturing requires foresight and planning to streamline the production process and minimize changes that could make your move to high-volume manufacturing more lengthy and expensive. (Network with B. Braun Medical experts at DeviceTalks West, Dec. 11–12 in Orange County, Calif.)
Weigh these important considerations early in the product lifecycle:
1. Design for manufacturing
Device design needs to encompass more than end-user specifications. It’s essential that devices are designed to be manufactured efficiently over the entire product lifecycle. That means taking into consideration the equipment and processes that will be required should a device be designated for high-volume manufacturing. After all, the automated, high-volume processes could be slightly or significantly different than the benchtop or prototype equipment used for producing lower volumes. Early discussion with the manufacturing team is critical to understand how high-speed automation may affect the design so provisions can be made to avoid problems when scaling up.
2. Material selection
A crucial part of designing for manufacturing is ensuring that the materials selected are acceptable for high-volume processes. Devices with injection-molded components are a perfect example. Lower cavitation might be more forgiving with a given material (such as a polycarbonate) than a high-speed system producing components in a 96-cavity mold. Some materials that are suitable for manual assembly might be incompatible with automated processes like sonic welding or mechanized high-speed clamping. The solution is to select materials that you’ve already qualified for manufacturing with different processes at various volumes. Otherwise you’ll need to burn time and money adjusting and potentially updating regulatory applications.
3. Supply chain and procurement confidence
Given the importance of material selection – and the obvious need for higher quantities of materials when producing higher volumes – it’s important to work closely with strategic procurement to ensure that the suppliers selected at the outset of a device’s product lifecycle will be able to continue supplying with the same quality and reliability when volumes increase. Will the suppliers be able step up when you ask them? Do they have a long-term commitment to producing the material or component? Will they have the financial resources and management stability to continue supplying you once you invest in automated processes? The time, expense and uncertainty of qualifying a new supplier can cut into the cost efficiencies of a high-volume, automated process.
4. Team approach to optimize efficiency
The move to high-volume manufacturing isn’t a once-and-done event. There are many opportunities to continue learning and improving after the process has been established. That demands involving the entire team, from engineers to machine operators; each brings a unique perspective. And with high-volume manufacturing, even a small improvement in cost or efficiency can be significant when extended over millions of pieces. The team approach should also incorporate suppliers critical to the capacity to upgrade to high-volume manufacturing, such as custom machine builders and mold manufacturers. The more they know about the long-term project expectations and objectives, the better they can supply equipment that will meet the design intent and match the product’s intended life cycle.
Overall, high-volume manufacturing requires a product life-cycle approach that looks beyond immediate needs and anticipates future demand. After long-term volume parameters have been established to complement product specifications, the team can determine how to meet both short-term and long-term volumes – and have a roadmap to scale and realize the benefits of high-volume manufacturing.
Gavin Wadas is Manager, Strategic Capital Projects for B. Braun Medical, OEM Division. He has more than 15 years of experience in project and program management, operations, capital planning and product engineering within the life sciences industry and is involved in managing medical device product life cycles.