Medtech companies reshuffle facility locations to capture market opportunities.

In this Outsourcing Outlook newsletter, Contributing Editor Steve Halasey examines the latest industry news concerning outsourcing/contract manufacturing.

Report Measures EU Readiness for Mobile Health

Suppliers readying to make the jump to mobile health applications for the European market can get a leg up with a new report, "EU Countries' mHealth App Market Ranking 2015,"  which assesses which of the 28 EU member countries are best suited for building a mobile health business. Compiled by research2guidance, a consultancy and market research company, Berlin, Germany, the report is part of an annual research program on the economics of mobile health applications development, which was conducted for the fifth time in 2015. More than 5,000 mHealth app publishers shared their views on the current status of their work and how the mHealth app market will evolve in coming years.

Results from this year's survey found Denmark, Finland, The Netherlands, Sweden, and the UK have the highest market readiness and most mature market conditions, providing the best starting points for mHealth companies to succeed. Out of the five top countries, the UK emerged as the leader, according to 55% of mHealth practitioners. According to the study, the UK's leadership is due primarily to the openness and positive attitude of many UK doctors when it comes to new technology and integrating mHealth solutions into patient treatment.

The first part of the report is opinion-based, examining how mHealth app publishers evaluate EU member states and their respective mHealth business potential. The second part of the report is fact-based, along five dimensions:

  • eHealth adoption
  • Level of digitalization
  • mHealth market potential
  • Regulation
  • Ease of starting a business

FDA Pulls the (Guidance) Plug

Most product developers may never notice their disappearance, but FDA has recently announced the withdrawal of 47 draft guidance documents that were published before December 31, 2013, and have never been finalized. According to the agency, the withdrawals are intended to "improve the efficiency and transparency of the guidance development process."

In the Federal Register notice  announcing the move, the agency asserted that its guidance workload has increased in recent years as a result of both statutorily mandated guidances and requests from the public for guidances to clarify specific issues. "Many of these draft guidances were not finalized, most often because of higher priorities and resource issues," the agency wrote. "However, over the years, because of new information, scientific developments, and emerging technologies, a number of draft guidances have become outdated and therefore, should be withdrawn."

The documents being withdrawn include guidances from the agency's drug and biologics centers, as well as from the Center for Devices and Radiological Health. Among the guidances specific to devices and diagnostics are those on electronic delivery of regulatory submissions, labeling and marketing of home-use in vitro diagnostics, PMA submissions for testicular prostheses, reviewer guidance on face masks and shields for CPR, the distribution of PMA summaries of safety and effectiveness, and Class II special controls guidances for a number of electrotherapy devices.

Companies wishing to comment on any of the agency's specific withdrawals should submit their comments by June 5, 2015. Electronic comments can be delivered to the agency via the federal e-rulemaking portal at http://www.regulations.gov .

Helix Medical Captures Gore Silicone Tubing Portfolio

Helix Medical LLC, Carpinteria, CA, recently acquired the silicone tubing product line of W. L. Gore & Associates, Inc., Flagstaff, AZ. Helix Medical will supply Gore's existing pharmaceutical and biotech customers with Gore silicone tubing and reinforced silicone hose for fluid transfer and peristaltic pump operations, under the PharmaFocus Premium brand.

Helix Medical has been a long-time Gore partner for silicone tubing production. Mark Ostwald, PhD, vice president and general manager at Helix Medical, calls the acquisition a strategic expansion of the company's existing tubing line. "With the tubing from Gore we will expand our portfolio of silicone tubing with raw material specifically formulated to meet the needs of pharmaceutical and biotechnology processes."

Helix Medical says that all products, customer relations, and well established part numbers will remain unchanged as a result of the transfer. For further information, visit Helix Medical .

Reshoring Rolls On

According to 2014 summary data  released by the Reshoring Initiative, Kildeer, IL, companies in a number of major industries are returning to the United States after having offshored operations in earlier years. More than 60,000 manufacturing jobs were brought back to the United States through a combination of reshoring and foreign direct investment in 2014, representing a 400% increase since 2003. With only 30,000 to 50,000 jobs being offshored to other countries in 2014, the US realized a net gain of 10,000 or more jobs.

Reasons for companies returning to the United States often involved government incentives, access to a skilled workforce, wanting to take advantage of the 'Made in USA' image, and gaining access to automation and technology. Reasons for leaving an offshore location included issues relating to quality, production lead times, freight costs, and rising wages.

Companies in the transportation, electrical equipment, and computer products industries have made a mark on the return flow—together accounting for the return of more than 100 companies and more than 26,000 jobs. But, medical equipment manufacturers rank ninth among the tracked industries, accounting for the return of just 17 companies and only 738 jobs.

In conjunction with the University of San Diego School of Business Administration, the Reshoring Institute, Los Gatos, CA, will host a workshop on "How to Build Your Reshoring Business Case" on May 21, in San Diego. For further information contact the Reshoring Institute .