Henri Asselin, VP of Engineering and Technology, Beacon MedTech Solutions

The pressures of launching new and next-generation medical, life sciences, and bio-processing products and equipment to market faster and more efficiently are steadily increasing and are felt across an organization. The short turns tend to put engineering in the position of operating under condensed design times. This has resulted in tighter tolerances and an increase in dimensions on plastic component drawings with the intent to lower the time-to-market and development costs.

Over the last 15 years, contract development and manufacturing organizations (CDMOs) have seen the number of dimensions on a component drawing increase from a couple dozen dimensions to a couple hundred with the expectation of flawless manufacturability and assembly. With so much focus on achieving the individual component dimensions, the development of the assembly techniques and overall feasibility of the design will be drastically delayed. At this stage of the development process, there should be much more focus on the overall design, even if the components aren’t yet meeting specifications.

Design for manufacturing (DFM) and assembly is achievable when expectations are greater, and timelines are shorter with a strong medical CDMO partnership. How do you ensure your CDMO relationship will produce the quality products you need to meet the demands of your customers without the headaches? It is with true collaboration. As stated by the Lean Enterprise Institute, “Developing products is a team sport.”

Clear communication, knowledge sharing, trust, and openness to feedback between the engineering and development team and the CDMO help everyone win, while simultaneously:

Evaluate your collaboration efforts and see if they operate at the level of communication, trust, and openness needed to achieve successful projects with your CDMO. Once everyone is working from the same playbook, you can more specifically avoid assumptions, close knowledge gaps, and look closer at the development process to boost synergies to accomplish more together.

Avoid Assumptions

Having a clear understanding of the project purpose and the manufacturing process internally and externally fuels strong collaboration. On the engineering side, you are the expert in the use and application of the end product, device, or equipment. Providing more technical information at the application level helps your CDMO partner deliver a sound evaluation from part design to tooling and molding through assembly that ensures your product is designed for optimum manufacturability, assembly, and usability.

The following are key assumptions you should avoid:

The more information that is shared, discussed, and understood upfront, the more time is saved in the long run. Uncovering unknowns and operating off assumptions are costly on many levels and decrease operation efficiency.

Close Knowledge Gaps

Just as you are the expert in your product application, your CDMO leverages collective experience and expertise in manufacturability and production. They are a trusted source that can assess designs, identify manufacturing constraints, and provide feedback to increase manufacturing—and ultimately product—success. With an openness to collaboration and feedback on both sides of the table, teams can work through improvement opportunities together to improve specifications.

Case in Point: Materials

For example, in efforts to shorten the product development process, engineers are specifying materials earlier than ever before. However, this positions you to lock into a material that may not be a good performer on the manufacturing side. This requires time and resources to develop special processes to use the specified material. There are often materials in the same families, with equivalent certifications (Class VI, gamma stable, etc.) that may be much easier to process. Lean on your CDMO’s technical expertise in plastic materials to offer design considerations and secure sound material specifications that achieve quality and performance levels.

In the instance of liquid silicone rubber (LSR), it behaves differently than other resin materials. From tolerances and measuring techniques to process performance, LSR expertise is valuable knowledge to leverage in the development process. For example, a flexible silicone material will seldomly be flat or have features that are round or straight. Specifying tight tolerances on a silicone part and measuring them in an “unconstrained” condition will often cause delays owing to increased processing time needed to try to optimize the part dimensions. Most often a silicone part will be constrained/stretched/held by other components in the assembly, meaning the dimensions in the “unconstrained” condition won’t add much value.

Case in Point: Critical-to-Quality Dimensions

The identification of critical-to-quality (CTQ) dimensions on a component is an area that works best through collaboration between the OEM and CDMO that leverages each other’s knowledge base and leads to efficiencies. An OEM utilizes their knowledge of the function of the part and engineered tolerance stack-ups to identify these dimensions on the product drawing. Often, critical dimensions on the product do not align with the critical (or process-indicating) dimensions for the manufacturing process or tool design. When this happens, the quantity of critical dimensions is the underlying driver in added time and cost to validate the manufacturing process. Working together to identify both functional and manufacturing critical to quality dimensions at the start of the project can drastically reduce project timelines and avoid unnecessary costs.

Case in Point: Prototyping Strategy

Working together to develop a solid and diverse prototyping strategy will improve the success of a project. There are many great methods to prototype components today, and they all have their own pros and cons. Knowing your goals for the prototyping exercise will help you select the right blend that offers the proper technical and aesthetic information needed to keep the designs and the project moving forward.

For example, 3D printing with like materials can give a decent feel of the product but would not be useful for getting specific materials tested for mechanical testing or aging studies. Outsourcing molded prototypes through companies that build aluminum tools will allow the team to use the parts for mechanical testing, but will not have the aesthetic properties and perfectly formed features of a production mold. These prototype methods can also help the team to develop a real-life tolerance stack-up using empirical data from these prototype parts. Evaluating needs to identify the right prototyping approach is vital to the outcome of the project and more than just “checking it off a list.”

Consider Following the Lean Product Development Process

With open communication and alignment on the purpose and intricacies of the product up front, the continued trust in each other’s expertise will show in timely, quality products. This includes trusting the process to get there. Utilizing a process like Lean Product Development principles can help you understand the specifications to keep open while driving the design forward prior to costly mistakes.

One concept of Lean Product Development, as taught at the University of Michigan, that is very powerful in product and process development is called Set-Based Design (SBD). This concept involves executing a product design program in a non-intuitive manner. You keep as many designs and features of a component open for as long as possible. A product team will down select from five-to-six design concepts to one design prior to prototyping.

The team advances multiple designs for as long as possible through SBD. As a result, they may have more than one design or a combination of designs to choose from. If there is a late-stage failure, the “doom-loop” is much shorter and the confidence in the new design will be higher. The SBD concept can also be done with features on a plastic component. By designing multiple features in the same area of the part, the injection mold can be designed with interchangeable inserts so the mold can produce multiple options of the same part. The multiple options can all be tested to see which perform better.

One would think that more options mean more time and more cost. In reality, if you eliminate options and only test and move forward with one design, then you face more time spent fixing it, more money in re-tooling your molds and designs, and potentially failure in the field.

Strengthening Collaboration for Product Development and Design Success

Properly engaging with CDMOs to launch new and next-generation medical, life sciences, and bio-processing products and equipment can accelerate your success. Through true collaboration you will produce the quality products you need in the timeframe you need it. All too often a lot of time and money is spent on generating a design package through a design house only to have the contract manufacturer request changes to the design at the DFM phase of the project. Concurrently engaging product designers, tooling designers, and process experts at the right time is very helpful to avoid that situation. Clear communication, knowledge sharing, trust, and openness to feedback among teams propel the program and partnership forward.

For more insights, visit Beacon MedTech Solutions at MD&M West 2023 Booth #1989.