From 3D printing to superbugs, medtech suppliers have plenty on their plates
In this Outsourcing Outlook newsletter, Contributing Editor Steve Halasey examines the latest industry news concerning outsourcing/contract manufacturing.
Vendors Build for Outsourced Medtech Growth
On the heels of a January announcement about the consolidation and expansion of its facilities in Massachusetts, in February, medical device contract manufacturer SMC Ltd. , Somerset, WI, announced that it would be expanding its facility in Costa Rica to meet the needs of current and future industry projects. Its Costa Rica facility will move to a new location within the Coyol business park in Alajuela, Costa Rica, which will double the facility's manufacturing space, and add more than 32,000 sq ft of additional space for future growth.
Also anticipating coming growth, Teleflex Medical OEM , Gurnee, IL, a leader in medical suture and fiber technology, announced a significant expansion of its manufacturing infrastructure and production capabilities for bioresorbable sutures, fibers, and resins. The multi-million dollar investment at the company's Mansfield, MA, facility includes expanded production and cleanroom areas, a new customer support center, and additional areas for research and development activities.
Supporting geographic expansion with an expanded multicultural web presence is the strategy of Smalley Steel Ring Co. , Lake Zurich, IL, a supplier of retaining rings, constant section rings, and wave springs for applications in a wide range of industries‑including medical devices. At the beginning of March, Smalley announced the launch of a Mandarin Chinese website ( www.smalley.com/cn ) to supply design solutions and product information to Chinese engineers. Supporting its growing presence in China, Smalley's launch affords Chinese engineers the capability of interfacing with the site's interactive design functions in their own language.
Medical 3D Printing Companies Eye Big-Market Outcomes
Proto Labs Inc. , Maple Plain, MN, has announced enhancements to the company's Fineline additive manufacturing service to enable the prototyping and low-volume production company to ship 3D-printed parts in as little as one day. Designers and engineers using either stereolithography or selective laser sintering can upload 3D CAD models to the company's website to determine whether their designs qualify for the quick-turn service.
Issued by Meticulous Research, Wembley, UK, a report "Global Medical 3D Printing Market Outlook: 2014‑2020" analyzes the major drivers, restraints, opportunities, and challenges that will have a long- and short-term impact on the growth of medical 3D printing around the world.
The report segments the medical 3D printing market by application and by products. By application, the major categories for 3D printing lie in dental, medical prosthetic, orthopedic, and surgical instruments. Main product categories include printers, scanners, materials, and software. North America accounts for the largest share of the global medical 3D printing market, followed by Europe and the Asia-Pacific region.
Congress, ECRI Tackle Disinfection for Duodenoscopes
Reports of patient deaths resulting from carbapenem-resistant Enterobacteriaceae (CRE) infections has highlighted the need for better methods to clean and disinfect duodenoscopes, which are believed to have been involved in the transmission of the deadly pathogens. FDA acted on February 19, issuing a safety communication, "Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication," that incorporated detailed recommendations for cleaning and reprocessing of duodenoscopes. In an updated version of the safety communication issued on March 4, FDA recommended the following steps:
· Thoroughly clean and disinfect duodenoscopes, pursuant to the manufacturers' instructions;
· Have a comprehensive quality program in place for reprocessing duodenoscopes;
· If you suspect that a duodenoscope may be associated with a patient infection, take it out of service and meticulously clean and disinfect it until it is verified to be free of pathogens;
· Inform patients of the benefits and risks associated with ERCP procedures, including the risk of possible infection;
· Discuss with your patients what they should expect following the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up;
· Submit a report to the manufacturer and to the FDA via MedWatch if you suspect problems have led to patient infections.
The ECRI Institute, Plymouth Meeting, PA, also stepped forward, issuing a high priority hazard report with recommendations to help reduce the risk of ERCP endoscope-related patient infections. "As this hazard has gained national attention, an ECRI Institute team of physicians, clinical specialists, infection control practitioners, biomedical engineers, and others have intensively researched and reviewed the best approaches to address this problem," says the report.
Not to be outdone, on March 5, congressmen Ted W. Lieu (D‑CA) and Peter J. Roskam (R‑IL) led a group of nine additional members of the House in a letter asking FDA Commissioner Margaret Hamburg, MD, to explain the agency's "current and future sanitization protocols" to prevent outbreaks of antibiotic-resistant bacteria. Noting that the agency's safety alert "does not appear to have changed the status quo," the representatives expressed concern that CRE outbreaks caused by tainted duodenoscopes are continuing to occur. "It appears that if a superior cleaning procedure cannot be developed, the best solution will be to develop a new device," wrote the congressmen.
No doubt, bright sparks in the medical device community will take the congressmen at their word, and are already working on alternatives to the current generation of duodenoscopes.
