From critical design errors to poor communication, outsourcing solution providers have experienced the gamut of problems from working with medical device clients who don't always know the best route to take to ensure a product's success. In order to help prevent instances of avoidable difficulties before it is too late in the process, this article shares tips and expertise from a group of industry professionals serving medical device manufacturers.

By Joyce Laird

Manufacturing systems at Donatelle

Joyce Laird has written a number of articles for a variety of industries, including the medical device manufacturing market.

The medical device market is consistently changing. Many OEMs of all sizes are moving away from manufacturing and are focusing their resources on their core competency—designing products. This feature digs into what creates a great working relationship between an OEM and contract manufacturer.
While many things cause challenges to a smooth working partnership, four areas repeatedly came up when discussing this area with the contributors.
Bad Prototypes
The biggest challenge that all contract manufactures agree on across the board are products that simply can't be easily manufactured.

Historically, this problem comes up when an OEM goes to a small shop just for the prototyping. It is relatively easy to build a few excellent prototypes, by manually customizing each facet of the design just for certification.

"If they have already submitted to the FDA," Dana Schramm, VP of engineering, Donatelle says. "This makes it very difficult for them to incorporate design changes that will make the product easier to manufacture. It puts the OEM in the predicament of weighing whether to push out the product launch date in order to modify the design to make the product easier to manufacture, or to take the consequences and launch the product with a 30% or higher loss per run."

Dan Adlon, VP of strategic business development, IBS says, "There is an adage that says, 'You build in 80% of the cost and effectiveness of automation at the very front end of the design.' So, to be designed for manufacturability, it's imperative to have early involvement with a partner who knows automated assembly."

Finishing off an implantable device

Bad Designs
The second most common challenge is incomplete design documentation. Frank Molgano, engineering manager, new products and process development, Eastern Plastics, IDEX, notes that not having detailed design data and engineering documentation can cause delays.

Rich LaFond, product development manager, Memry says, "Often we are dealing with the purchasing agent and not directly with the designer; you can lose a lot of detail in the translation. It is important to really have direct engineering contact at the beginning of a project. It takes a lot of time and effort to dig back through the chain of command to get to the design engineer."

Scott Rymer, process engineer, manages the Swiss machining group at Norman-Noble. He says that there are occasions where in Swiss turning, the customer wants a hole dimension that simply is impossible to do because of too much reliance on 3D modeling software without detailed specifications to back up the model. "Many features can look great in SolidWorks but the product is virtually impossible to manufacture on a machine."

Continual Changes
The biggest cost and time drain is the never ending design. Rich Molnar, manufacturing engineering manager, Norman-Noble notes that many design engineers have multiple ideas that keep changing, instead of grabbing one and sticking with it. "Because they are constantly revising, the product becomes a moving target," he says. "It's understandable to see a few minor design changes here and there, but we've been seeing radical, overall changes that basically create a totally new product."

"When we've already started the design process and tooling has already started, and then we get asked to make changes, it adds to cost and time delays," Rich Gallagher, global director of engineering for the Teleflex Medical OEM Group agrees.

Bad Material Parameters
Finally, lack of knowledge regarding material capabilities on the part of the customer is a challenge. Sean McPherson, VP of marketing, Helix Medical says. "I'll focus on silicone, but, this would apply across most thermoplastics and other elastomers too. The number one issue is that a customer will come to Helix with a part that has tolerances that are based on other, more rigid materials, that in the case of silicone aren't achievable. Other times, they have designed around such a generic silicone, it is basically not a real product."
The Keys to Success
Following are eight pointers that are sure to help any outsourcing partnership move towards becoming a more profitable one.
1. Get the Contract Manufacturer Involved Early in the Process
Take advantage of the expertise of the contract manufacturer early in the design stage. This ensures that the product prototype design is manufacturable before anything is sent to the FDA. Combining a well designed product and process from both the design and manufacturing side will address any potential risk areas up front and adjust them with little impact to cost or schedule.Gallagher says "The earlier we are involved, the better we can help. It allows us to leverage our resources to get the best suited individuals for that technology or product type to be on the team. We can help define the specifications."
2. Stay Flexible
McPherson says that if you can't involve the selected contract manufacturer at the initial design stage, then at least leave plenty of time for adjustments and be open to design changes for manufacturability. If this is a mature product, and just moving to a new manufacturer, let the supplier know what did and didn't work in past processing to avoid previous pitfalls.
3. Provide Complete Design Data
In an ideal world, the 2D schematic and the 3D model match and come to the table ready to go.McPherson says that providing complete documentation of the part to be developed and manufactured ensures that precise tolerances are figured into the manufacturing. An experienced contract manufacturer is able to look at schematics and 3D models and point out potential issues very quickly. It may not even have to go to a prototype stage in order to identify key design issues and flag them before they become roadblocks.
4. Be Design Ready
It's always a temptation to do continual improvement, but having a design freeze can be one of the most beneficial things an OEM can do. Get a stable product that can be validated and manufactured."If you want to do everything, the design iterations may never stop," Craig Berky, VP, research and development, Interplex Medical says. "You can always keep improving, but then the product may never get to market. Make a decision and let us get generation one to the market fast. Then we can look at gen. two and gen. three with more features, but, first grab that market share."
5. Don't Spec Materials Until You Know Them
Learn about the raw materials before designing them into a product. If you don't have a contract manufacturer selected to talk with, call on some raw material experts first. To design proper tolerance and actual part function with a specific material in mind, do this well before locking in the design.Nitinol is a good example. "You can make a collapsible device that once catheterized and deployed, pops right back into shape," Dennis Norwich, process engineering manager, Memry says. "That's the strength of the material, but many customers don't understand the limitations and think it can do a lot more than it really can."

It's more than just making the device; things like sterilization can affect material choice. "Plastics for medical devices are often tricky because typically, you're looking at sterilization," Steven Snell, engineering manager, UFE Inc. says. "That throws an extra little factor in to consider. In some cases, if you're going to gamma radiate, there are certain materials that you can't use, others that you don't want to use, and others that are great. So, that makes a big difference."

6. Have a Realistic Expectation
Because of the regulatory processes required to develop and launch a new product, it is imperative to have a realistic time blueprint."Even when all the blocks are in place, a process takes time to do it right," Schramm says. "Often a company comes to us and gives us a product launch date, but when we sit down and lay out the validation plan, it simply can't be accomplished within their desired time period."
7. Share Product Function and Market Information
"In an ideal world, all OEMs would tell me about the pathology they are trying to treat," Debra Van Sickle, VP, Peridot Corp. says. "What is it you're trying to do? Is this a spinal device or is it a delivery system for diabetes? The better understanding of where this instrument or component is going, the better I can develop a process for it.""When coming to the table, I want to know what their quality requirements are," she adds. "I want to know their AQL levels and criteria. I need to know that up front because that's a very labor intensive process. If we have to 100% inspect every dimension on the device, that's going to take a lot of time to do. These can't be mentioned as afterthoughts."

Have a good handle on market pricing and pass that knowledge on to the contract team. Understanding where the customer needs to be in product pricing to be successful, can drive decisions for alternate design and manufacturing trade offs to best fit the goal.

Volume to market is another issue. If the run is targeted at a few hundred a month, a thousand a month, or millions a month, each needs an optimized process to suit it in the most cost effective manner.

8. Shop Around
Tour potential suppliers' facilities to understand what their machinery and/or materials can and can't do. Make sure they can provide all that is needed for the application. If they have to outsource a key process, that's an added cost.If working at the design stage, look for a supplier with a reputation for producing good prototypes that can be manufactured anywhere.

"Always look for suppliers that specialize in the process that is needed. If you have a plastic machined part, work with a plastic machinist, not a metal machinist," Molgano says. "Also, look for a supplier with a strong quality system in place and the required certifications."

In any working partnership, both sides need to know each other's expectations, identify price targets, set key milestones, and identify critical deadlines. Outsourcing to the right match can effectively create a partnership that is so close, it is like adding a division to the OEM's company.
For additional information on the technologies and products discussed in this article, see MDT online at and the following websites:


Meet the Contributors
Because processes and materials differ from device to device, it was important to get input from a diverse group of contract manufacturers.

Donatelle provides primary services geared to injection molding, machining, contract assembly and packaging. The two markets the company is most heavily involved with are electrophysiology and orthopedics, with approximately half of the products they manufacture in the implantable area.

Eastern Plastics, IDEX is the largest and oldest plastic machining company in the world. They focus on medical devices and diagnostics. "We get involved with surgical instruments, implantable devices, blood analysis, components for instrumentation, and clinical chemistry analyzers," Larry Dawson, VP, business development, says.

Helix Medical LLC has a corporate umbrella that covers a range of medical device contract manufacturing services. The company specializes in medical grade silicones and thermoplastics.

Integrated BioSciences Inc. (IBS) specializes in high volume, high speed automation. Their contracts average from 35 to100 million pieces per year.

Interplex Medical LLC grew out of their own need as a small medical manufacturer. "There were a lot of contract engineering firms, but they were set up to deal with the big companies only. We were just too small for them," Craig Berky, VP, research and development, says. So, they set up a full service contract company that would meet the needs of the medical device manufacturers of all sizes.

Memry Corp.'s core competency is Nitinol. The company processes materials for guidewires, deployable stents, wire form and laser cut stents, and many components that go into guidewire and catheter assemblies.

Norman Noble Inc. handles everything from Nitinol shape setting to laser machining and Swiss tooling. The company is known for producing prototypes for certification that are designed for manufacturing.

Peridot Corp. started as a high tech prototype operation. Debra Van Sickle, VP, says that today Peridot offers a myriad of processes in-house including certified clean room assembly.

Proven Process Medical Devices Inc. services the entire life product cycle for low to mid-volume customers. "We focus on Class II and Class III therapeutic devices and patient diagnostic devices, including active implantables," Kenneth Fine, president, says.

Rich Gallagher, global director of engineering for the Teleflex Medical OEM Group says, "We specialize in everything from machining orthopedic screws to orthopedic torque wrenches; metal, titanium, specialty aluminums, coatings—the gamut; anything for orthopedics including molded silicon handles. We are a full service shop."

UFE Inc. started primarily in injection molding and now has four business units, injection molding, mold manufacturing, a design group, and a contract assembly group. All groups are complimentary to the contract manufacturing group. "The majority of what we do is in disposable devices," Steven Snell, engineering manager says.