At home and abroad, medtech suppliers prepare to rise with the new year's tide
In this Outsourcing Outlook newsletter, Contributing Editor Steve Halasey examines the latest industry news concerning outsourcing/contract manufacturing.
India Moves Toward Quality Systems
India's regulatory authority for medical devices, the Central Drugs Standard Control Organization (CDSCO), is proposing to bring the country's requirements into line with a quality systems approach to device manufacturing.
In December, CDSCO circulated for comment the draft of "Good Manufacturing Practices and Requirements of Premises, Plant, and Equipment for Medical Devices, and In Vitro Diagnostic Kits and Reagents" that would bring Indian regulations into line with current international quality systems standards for medical devices, specifically, Bureau of Indian Standard (BIS) 15579 and International Organization for Standardization (ISO) 13485. Under the new scheme, each medical device or IVD manufacturer would be required to "evolve a quality system in line with BIS 15579/ISO 13485." The draft document includes separate sections specifying requirements for factory premises used for manufacturing notified medical devices and in vitro diagnostics kits and reagents. Use of the ISO 13485 standard is expected to ease compliance among many device companies that already use the standard to meet regulatory requirements in other markets.
According to KPMG, such changes in Indian regulation may be only the tip of the iceberg, as the country now seems poised for significant growth. The government is promoting initiatives to boost business sentiment and revive the economy, including fostering a conducive environment for doing business in India, cutting red tape, simplifying procedures and removing bottlenecks, facilitating single-window clearances, and allowing the foreign direct investment needed for jobs and asset creation. Highlighting India's high-growth potential will be the subject of a webcast hosted by KPMG, "Investing in India: The Next-Generation Economic Powerhouse," on Wednesday, January 21, 2015, from 11:00 a.m. to 12:00 p.m. EST.
A Comeback for Device Reprocessing?
In spite of the potential to achieve substantial cost savings, most device companies would prefer not to have anything to do with the risks and liabilities involved in reprocessing single-use devices. But Northeast Scientific Inc. (NES), Waterbury, CT, a privately held, FDA-registered device reprocessor, is out to change industry thinking about the safety of reprocessing.
Founded in 2005, NES launched its catheter reprocessing service with the support of its corporate partner, Vascular Solutions Inc. , Minneapolis, MN, in 2012. After nearly three years of operation, Vascular Solutions reports, NES has successfully reprocessed more than 75,000 ClosureFast catheters.
The ClosureFast radiofrequency ablation catheter, which is manufactured and marketed by Covidien plc, Dublin, Ireland, is the most popular product used in the United States for performing endovenous therapy for the treatment of varicose veins. Reprocessing of ClosureFast catheters is a service offered exclusively by Vascular Solutions in collaboration with NES, which received FDA clearance to reprocess the devices in 2011. To date, more than 600 US vein practices have contracted with Vascular Solutions to have their ClosureFast catheters reprocessed by NES.
NES's validated reprocessing system for ClosureFast involves multiple stages, including decontamination, cleaning, drying, packaging, labeling, sterilization, and biological quarantine testing. Its facility was designed specifically to reprocess single-use devices. The process employs a high-capacity reverse osmosis deionized water system for cleaning, and only environmentally safe detergents are used. NES performs all sterilization in-house using 100% ethylene oxide systems that limit waste and ensure sterility. Each catheter is subjected to multiple inspections to ensure that quality standards are met. As part of the process, functional testing of each reprocessed device and heat-seal packaging is carried out in NES's Class 10,000 cleanroom.
The safety and reliability of such reprocessing may get a closer look from FDA later this year, when the agency takes up the topic in conjunction with its final guidance on reprocessing medical devices in healthcare settings. Issued as a draft in May 2011, the agency's guidance on "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" made it to the A-list of documents planned for publication in 2015. And even though the scope of the guidance is not meant to cover the processes used by reprocessors of single-use devices, recent experience in the field seems likely to get a second look as the new guidance is finalized.
Calumet Eyes 2015 Growth
Calumet Electronics Corp. , Calumet, MI, a privately held manufacturer of printed circuit boards (PCBs) has announced an initiative for 2015 to recruit technical business development firms across the United States, Mexico, and Canada, to further diversify and grow the industries they serve. At the beginning of January, the company announced that it had recruited 9 firms with a total of 48 sales representatives serving companies in the medical device, aerospace, defense, commercial, communications, and industrial controls industries.
According to the company, the salesforce expansion signals its commitment to North American manufacturing, to providing sustainable jobs, and to serving a more diverse customer base. "A diverse customer base is key to sustaining and growing in any economy," says Mike Kadlec, Calumet's vice president of corporate development. "That is why we're recruiting field partners with a wide range of relationships." New firms representing Calumet Electronics include:
· Interstate Marketing, CA
· MINK Associates Inc., KS
· ProComp Sales, TX
· Tricord Technologies, MN
· CRP Technical Solutions Inc., IN
· Technology Solutions Electronics Inc., FL
· BattleShip Technologies, NC
· MacAllister and Associates, ME
· Advanced Connection Systems Inc., MD
Maine-based MacAllister and Associates has 25 years of experience selling to high-tech OEMs specializing in medical device, life science, and defense technologies. Company founder Scott MacAllister says, "Calumet Electronics is ready to support sales teams with great turnaround and an expert engineering team. This allows us to more significantly and quickly develop new opportunities on the East Coast."
The Reshoring Initiative (Chicago) has issued a call for updated information from companies that have been involved in returning operations to North American shores. Early in 2015, the organization intends to publish large portions of its data about the return of manufacturing to North America, providing more accurate insights about the breadth and progress of the reshoring trend. The call is directed to companies that have brought to North America any work, products, components, tools, and so on.
Company-supplied information will be used to refine the organization's database, which encompasses OEMs and suppliers reported as having reshored, kept from offshoring, or foreign direct invested (foreign companies investing in the United States) The organization provides instructions for registering and updating company information in a blog post .