Originally Published MPMN May 2008
MPMN recently spoke with Donald J. Dobert (left), president of contract manufacturer ATL (Menomonee Falls, WI). Below are his thoughts pertaining to the process of choosing a vendor for medical disposables manufacturing.
Q: What's one key quality control feature an OEM should look for in a vendor?
A: An internal document control system. An OEM has to make sure that the vendor can not only retrace the steps of any defective disposable product, but that there's a paper trail.
Q: When touring a manufacturing facility, what's one important question the OEM should ask?
A: Ask to tour or audit the vendor's suppliers. It's not enough to only assess the vendor's quality system. If the vendor is ordering supplies on its customers' behalf, the OEM has to make sure that poor quality isn't being introduced into its products by third parties.
Q: What's a common pitfall that OEMs encounter when choosing a vendor?
A: Recently, I've noticed a number of OEMs having problems with overseas vendors. I would advise firms to be very careful about outsourcing to China because of the risks of inferior quality and counterfeiting.
Q: What's the single biggest factor to consider during the vendor search?
A: I would say manufacturability. Innovations aren't always designed with manufacturability foremost in mind. An OEM's engineering team needs to have a clear idea of exactly how the vendor plans to produce the disposable. Ideally, during meetings, the vendor will be capable of suggesting practical design changes that will improve manufacturability.
Firm Accommodates both Small and Large Production Runs
Providing assistance from the initial design of a disposable medical product to its final market distribution, a contract manufacturer's services include injection molding, RF welding, custom assembly, and packaging. The company is certified to the ISO 13485 standard and operates a production facility with multiple cleanrooms. Prototyping and fabrication services are performed in an on-site machine shop, and the company can accommodate short product runs as well as high-volume production.
Medical Plastic Devices, Montreal, QC, Canada
Service Provider Enables Offshore Disposables Manufacturing
With regional offices and more than 80 vendor partners in China, a company offers medical disposables manufacturing overseas. Tooling, plastics processing, metal stamping, die casting, electronic assembly, and commercial printing services are available. The overseas staff includes project engineers, quality control specialists, and logistics coordinators who provide oversight throughout the manufacturing process. Local vendor partners are screened with a testing program that requires successful production of injection-molded items, PCB assemblies, and various subassemblies.
Smart Sourcing, Long Island, NY
Contract Manufacturer Offers Defense against Counterfeiting
A contract manufacturer of disposable medical products offers laminating, custom die-cutting, printing, pouching, cold sealing, and packaging capabilities. The company recently opened a Class 10,000 manufacturing facility that includes two Kestrel two-axis measurement systems suitable for evaluating medical components down to 0.0001 in. A labeling system is used to package products with an invisible, nondegradable digital forensic marker that can confirm the validity of a supply chain and prevent counterfeiting.
ATL, Menomonee Falls, WI
Facilities with Overlapping Capabilities Reduce Customers' Risk
Specializing in manufacturing sterile, single-use medical devices, a company's services include plant transfers of existing customer product lines to various domestic and offshore locations throughout the United States, Mexico, and China. Outsourced design and development services for new disposable products are also available. Multiple facilities provide overlapping manufacturing capabilities to mitigate risk and ensure uninterrupted supply. The company undergoes regular quality system and regulatory compliance audits conducted by both FDA and customers.
Avail Medical Products, Fort Worth, TX
Company Manufactures Class I, II, and III Medical Devices
The capabilities of a contract manufacturer specializing in disposable medical products include design, development, packaging, and in-house sterilization. Devices used in cardiovascular surgery, spinal applications, and neurostimulation are among those manufactured by the company. In addition to operating a Class 100,000 cleanroom, the service provider also offers insert and injection molding on machines ranging from 10 to 200 tn. Class I, II, and III medical devices can be fabricated.
Remington Medical Inc., Alpharetta, GA