From design to production: Custom molders, OEMs must follow blueprint to success

LOWELL, Mass.—Contract manufacturers play a key role in the rubber product industry.

They may mold components for a large company that needs a particular product manufactured, or help a newer company take a design and transform it into a reality.

Those playing in the contract molding business have to be ready to cover all bases, from quality and regulatory issues, to cost/risk assessments, and the scope and technical requirements of a project, according to Henri Asselin, vice president of engineering and technology at Beacon MedTech Solutions.

According to Asselin, the Lowell-based firm has a full range of capabilities, including engineering, tooling, precision molding, liquid injection and molding; can help customers launch new products and scale production of plastic and silicone parts, products and assembled components; and help customers meet accelerated demand amidst evolving regulatory requirements, increased risk and rising costs.

As a contract manufacturer, Asselin said Beacon MedTech works with companies who want little to no input from the molder, as well as those who need a great deal of guidance.

"We see a spectrum of both," he said. "On one end we see very large, skilled, experienced OEMs come in and everything is pretty much locked in. On the other end, you can have a startup come in and say 'I want this to do that. Can you guys help?'

"... And both relationships are fine and both work. It's just knowing what the expectations are from both companies that will make that project successful."

There can be potential challenges between OEM customers and contract manufacturers, so it is vital that the two are in close alignment to ensure the success of a new product, from launch to full commercial production volume, Asselin said.

To keep both sides on the same page, he outlined a range of "Pillars of New Production Introduction."

This basic blueprint starts with product design and ends with sustaining production, and has the required benchmarks along the way.

Communication between the contract molder and OEM also is critical when moving from one pillar to the next, to ensure both sides are in agreement before moving to the next step.

Contract molders don't own the designs, Asselin said, so OEM customers understand how their product works, how it has to be tested and how it will be used in the field.

He added that firms like Beacon MedTech have to keep up with the quality and regulatory requirements for their customers.

From a contract molder's perspective, it is vital to be able to weigh the costs and risks of every individual project.

"Traditionally, contract manufacturers would go out and purchase capital equipment, whether it's molding machines, testing systems for product development. The customer would pay for specific tooling," Asselin said.

"At the beginning of a project, the customer communicates the scope and scale of a project. We quote from there, (since) understanding what investments must be made by the molder and contract manufacturer is critical. You know what the risk is to that product launching, and launching to the degree that the customer hopes it will get into the marketplace."

When working with medical devices and in life sciences, all OEMs have optimistic marketing projections, looking to sell a million assemblies in the first year, which would prove fruitful for both companies.

The challenge, Asselin said, is when those forecasts don't come to fruition.

And the investments a contract firm has made in terms of space, staffing and equipment is critical. So knowing the scope and technical requirements upfront is crucial.

"Everybody wants these projects to take off in the market but that doesn't always happen," he said. "So it's very important to understand what the risks are, what the best estimates are for these forecasts so that things can be scaled up properly. What kind of tooling, what class of tooling. Are assembly techniques going to be hand done or fully automated, or a mix of both?

"Comprehensive communication and understanding the scope in all the requirements is very important. Contract manufacturers have expertise in their areas, but we often don't know how a product is used in the marketplace."

Having a true understanding of what requirements are locked in and what can be modified is vital for a project to be successful.

In a perfect world, a customer would give Beacon MedTech the specifications, the design, tooling and everything needed to meet the requirements.

"In 28 years, I don't think I've seen that once," Asselin said. "There are always requirements from the OEM that have to be modified, whether that is material modification or design tolerances. It's very important to understand which ones are truly 'musts' and which ones are 'wants.' "

Where a project is in the development or design cycle also can be a hurdle to overcome, he said. In an ideal case, a company has done its research, produced a prototype, tried multiple materials, assembled it and tested it.

"On the other side of the spectrum is we have a design, on paper, or have a sketch. There might be some models and 2-D drawings, but is it the first time they've been molded, first time that they've been assembled, first time that they've been tested," the Beacon MedTech VP said. "Obviously that is a very different scope than something that has been fully developed."

A lot of companies will divide the manufacturing into suppliers that do components, sub-assemblies and full assemblies. The understanding, he said, is that all of these components have gone together before. But the custom molder needs to know if they have been assembled in multiple fashions, if they've been tested and if they work.

"And how many different materials have been tested," Asselin said. "We have to make sure we're not just pigeonholing ourselves to one material or to one family of materials. Sometimes that's required, other times it's important to try different families, to understand the performance and the manufacturing of those materials."

Also critical is making sure there is an understanding between the custom molders and their customers on every aspect of the part design inputs.

"Often a drawing doesn't communicate every single aspect of the part," he said. "Specs have to be developed between the customer and the contract manufacturer as the project goes on and more knowledge is gained."

Knowing the functional requirements of a component once it is in use also is a must. Custom molders understand their area of expertise, but normally aren't experts in what the device is doing in the field.

"Through multiple projects with customers, we gain a lot of that knowledge, but in the end we're there to manufacture and tool and test and collaborate (with customers) to understand what are the requirements out in the field," Asselin said. "We also need to understand how a component will work with other things in an assembly. "If we're making three components and it's going into a 100-component assembly, we have to understand how it's going to interact with the entire system."

There are many reasons an OEM picks a certain material for a project.

It may bring a functional value or offer particular properties necessary for part performance. Custom molders also need to know what secondary processes, such as cryogenic deflashing, may be needed.

Pricing, as always, plays a critical role. Beacon MedTech may get a request for silicone, and then inquire if a thermoplastic elastomer is a viable alternative.

"All our customers come to us and they have a subset of materials because they have approval in all of these materials in other devices," Asselin said. "So they pick one of those in the drawing and we end up making it out of that material. And it may not be the best material."

Another challenge is whether or not the material is readily available, and getting that material in the right quantities at the right price in the development cycle.

When the product goes into production, will it be available in sufficient quantities to make it a feasible choice?

Some other items to consider when making sure the pillars of new product introductions are covered include:

• Product design: Must be designed for safe operations and so it functions under the proper conditions;
• Tool design and build: Make sure the tooling is appropriate, has the proper level of quality and is sustainable throughout a product's lifecycle;
• Process engineering: How is the part made? Are tolerances appropriate for that manufacturing method being employed?;
• Moving from new product introduction into production: Ensure that all requirements are met when launched into a full-scale manufacturing environment. Asselin said many companies have teams to handle this critical step; and
• Sustaining over the lifecycle of a project: Will the tooling wear properly 10 years into a production cycle? Who's taking care of maintaining tooling, changes and line extensions?

"It is important that all pillars are covered," Asselin said. "It doesn't really matter by who. Just so there is someone within the system who has the expertise of each one of those pillars. Not only are the pillars important, but the interaction between the pillars, such as the interaction between product design and tooling design and engineering."

The expertise of each party—the OEM and the custom molder—will help a project reach a successful conclusion, according to the Beacon MedTech official.

The OEM knows how the product works, what its intended uses are and the potential risks involved.

Conversely, the custom manufacturer has expertise in tooling, molding, assembly, materials and how they all will interact with an OEM's design.

"You need to work together to ensure the OEM understands what the contract manufacturer is building, and the contractor knows what the product and system does in the field," Asselin said.

As a general rule, he said custom projects take from 1 to 1½ years on the short end, but he's been involved in programs that have taken three to four years to go through the development cycle.

And when it gets to that point, it's the hope of any contract molder to be the one producing the goods once the project reaches commercial production.

"When tooling and equipment is embedded in a facility and you've done the program, generally the commitment from the customer is there to keep that production with the (custom molder)," Asselin said. "But there are times when they have another supplier, or something doesn't work.

"And sometimes OEMs bring manufacturing capability in-house. So those are the ones we don't know if we'll have them for the long term. The goal, though, is for us to have the equipment and to have the project long term."