Contributing Editor Ilene Wolff
Additive manufacturing is now producing all manner of medical devices, and new ideas for the process—ranging from printed surgical tools and bone replacements to human tissue—are coming from designers and engineers daily.Even the best idea, though, has little value in the United States unless the Food and Drug Administration gives its go-ahead for putting the device on the market. Full Article
Matt Bailey, Contributing Writer, Haas Automation Inc.
In India, cataracts are the most common cause of preventable blindness; one company in particular makes the equipment the country’s ophthalmologists rely on to treat the afflicted. Full Article
Senior Editor Michael C. Anderson
Connecticut Spring & Stamping (CSS; Farmington, CT), a family owned and managed company with over 380 employees, is set on achieving certification under the ISO 13485 comprehensive management system for the design and manufacture of medical device components. Full Article
Edited Senior Editor Michael C. Anderson from information supplied by Vero Software Group.
The VISI suite of CAD/CAM applications from Vero Software has been instrumental in helping a precision engineering company develop the world’s most advanced commercially available myoelectric prosthetic hand (i.e., one controlled by signals from voluntarily contracted muscles within a person’s residual limb) currently on the market. Full Article
Bryan Hughes and Matthew C. Smith, P&M Corporate Finance LLC
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. Full Article