Originally Published MPMN January/February 2008
Treasa Springett, president, Donatelle, New Brighton, MN.
When selecting a molding partner, you must have a clear understanding of what you're seeking from the vendor. Are you looking for it to be a transactional vendor or a supply-chain partner? An ideal transactional vendor is capable of molding a completed design to specification at the lowest possible price, and also should also be able to react quickly to production purchase orders.
An ideal supply-chain partner, on the other hand, would typically be a molder with a wide spectrum of capabilities, which might include early design and development support, assembly, metals manufacturing, and packaging. If you're attempting to bring to market an innovative technology, a supply-chain vendor should be engaged early in the process to provide input into design and manufacturing decisions. Open communication and program management are vital. Schedule updates and provide communication venues to ensure that all team members and key contacts are given timely status reports, not only on specific projects, but also on the health of the overall relationship. Allow the vendor to bring its expertise and input to the project; being open to suggestions often results in shorter time to market and better product design.
Once you determine the level of partnership or vendor engagement, it becomes critical to investigate further in order to make sure you are choosing the right company for your needs. Whether serving in a transactional or supply-chain capacity, it is crucial that the molder understands FDA requirements and can meet the regulatory specifications. You may also wish to inquire about specific molding capabilities that are increasingly in demand. Does the vendor offer smaller-shot processes? Micromolding capabilities and low-tonnage machines with precise control can be reliable solutions for demanding molding applications. In addition, liquid silicone rubber molding capabilities can be an excellent complement to rigid molding processes for OEMs seeking completely assembled products
Injection Molding Service Enables Tight Tolerances
Injection molding of single-use medical device components achieves tight tolerances, according to the service provider. Electric machinery enables accurate documentation and traceability of all components. Available services include insert and overmolding, as well as two-material and liquid-injection molding. Class 10,000 cleanrooms house 60 injection molding machines and 20 blow molding machines.
Medisize, Hillegom, Netherlands
Service Provider Offers Around-the-Clock Molding
A company's services include molding of engineering-grade thermoplastic and elastomeric materials and micromolding, as well as liquid silicone injection, insert, and overmolding. Assembly in Class 100,000 and Class 10,000 cleanrooms is available. The company's manufacturing plant operates 24 hours a day, 7 days a week, and houses more than 44 molding machines, ranging from 5 to 300 tn. Featuring a facility certified to ISO 9001:2000 and ISO 13485:2003 standards, the company also provides design and prototyping services.
Donatelle, New Brighton, MN
Specialized Overmolding Process Suitable for Repeated Sterilization
Silicone formulations can be overmolded to substrates such as stainless steel, aluminum, PEEK, and Radel in order to manufacture single-use medical devices and devices requiring hundreds of sterilizations. The company's molding process creates a hermetic seal between the silicone and the instrument; the bond can withstand repeated autoclaving and inhibits the migration of body fluids between sealed surfaces. Specific durometers, conductive or insulative silicone materials, and custom colorization are available. In addition, many of the firm's formulations are certified to USP Class VI and ISO 10993 standards for implantable-grade materials.
Minnesota Rubber & Plastics, Minneapolis
Company Molds Custom Formulations for Medical Devices
Application-specific rubber and silicone formulations are used to mold custom components for medical devices such as CAT scanning systems, dry laser imagers, and MRI systems. The company offers injection and transfer molding services and can bond components to valves, brackets, assemblies, and gears. Surface finishes can be rendered smooth or coarse by the in-house grinding department, and lubricious or tacky surfaces are also available.
Hiawatha Rubber Co., Minneapolis
Firm's Molding Machines Range from 10 to 200 tn
Insert and injection molding services are carried out on a variety of molding machines ranging from 10 to 200 tn. The company provides specialty thermoplastics, commodity resins, and liquid silicone rubber to meet custom orders. Secondary operations such as ultrasonic welding, pad printing, laser etching, thermoforming, and hot-stamping are available. The firm also offers product design and development, rapid prototyping, needle manufacturing, in-house tooling, and assembly. Developmental projects can be completed from concept through fully automated production. The company has a Class 100,000 cleanroom and is certified to ISO 13485:2003.
Remington Medical Inc., Alpharetta, GA