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In previous editions of the SME Medical Manufacturing Yearbook, P&M Corporate Finance has provided commentary on a variety of market forces impacting medical device manufacturers, such as regulatory considerations, reimbursement, M&A and venture capital activity. This year’s article will touch on several of those same dynamics, with a focus on the 510(k) approval process and the 2.3% medical device tax, which went into effect on January 1, 2013.

Laser technology for drilling precision holes has taken a leap forward with faster, cheaper, high-accuracy fiber lasers, which are used in the aerospace industry for turbine engine hole-drilling and other industries. Short-pulse picosecond fiber lasers are likewise making inroads, drilling small, precise holes for the medical and microelectronics industries.

n last year’s SME Medical Manufacturing Yearbook, P&M Corporate Finance provided an update on regulatory, reimbursement, M&A and venture capital activity. This year’s article will address several of the same areas, as well as provide an outlook for 2012.

While robots have been deployed in high-profile surgical applications in recent years, using a specialized apparatus like the da Vinci surgical system, the majority of industrial or commercial medical uses for robots are somewhat more commonplace.

Many industries have been making parts with micron dimensions for some time, but in the last few years, the market for miniaturization has expanded. The demand is not only for small parts, but also for small complex features on larger parts. This is due chiefly to the switch to modules in which the functions of several parts or subsystems are not handled by a single complex unit.

3D Systems announced its decision to expand efforts related to regenerative medicine and bioprinting.

Materials engineered for use with specific printers and qualified for verifiable repeatability and accuracy help ensure long-term mechanical properties ranging from heat resistance to biocompatibility.

If everyone were to stand in a single-file line, patients on the U.S. organ transplant waiting list would form a line over 70 miles long.

While 3D printing for dental applications is generally recognized as a mature technology, material innovation continues apace. An emerging trend has been for machine and material suppliers to augment their portfolios by working with or acquiring outside partners.

DanaMedInc.’s Pathfinder ACL Guide is a biocompatible surgical device enabling surgeons to better reconstruct partially or fully torn anterior cruciate ligaments (ACL) and reduce the risk of re-tearing.