Recent Articles

March 18, 2015 11:21 am
Tom Nadal, Director of Business Development, CleanCut Technologies
Whether you’re a seasoned medical device professional or a recent grad stepping into your first full-time position in marketing, engineering, operations, quality, or regulatory at a medtech OEM, chances are you’ll be a contributing member...
March 16, 2015 11:10 am
Tim Kissling, Owner & President, Precision Coating Technology & Manufacturing Inc.
Many medical device designers have worked with coatings suppliers to identify the right material for an application, but have later encountered unforeseen issues that result in higher costs, production delays, and sometimes, even product...
March 13, 2015 11:26 am
Albert Tsang, Technical Manager, Precision Micro
Across industry, there is a concerted and accelerating trend towards miniaturization, and nowhere more so than in the medical device sector, where demand for minimally invasive diagnostic and treatment devices is growing exponentially...
March 12, 2015 11:44 am
Alaine Portnoy, Director of Marketing, Omnify Software
LoneStar Heart, Inc., based in Laguna Hills, Calif., is developing cardiac restorative therapies for patients with heart failure that harness the heart’s ability to repair itself. Based on its integrated cardiomechanical and biomolecular...
March 11, 2015 11:25 am
Aidan Moore, Applications Engineer, ON Semiconductor
These are exciting times for hearing aid technology. If you haven’t looked at what’s available in hearing aids recently, you may be surprised to find a level of sophistication that was missing in previous generations. In fact, an increasing...
March 10, 2015 11:23 am
Mika Javanainen, Senior Director, Product Management, M-Files Corporation
Medical device manufacturers must comply with increasingly strict compliance requirements in order to sell products in the United States. The Current Good Manufacturing Practices (cGMP) and Quality System regulations (21 CFR Parts 211 and 820)...
March 9, 2015 11:15 am
Quynh Hoang, Lynette Zentgraft, Senior Regulatory Experts; Elaine Tseng, Partner, King & Spalding
A Premarket Notification or “510(k)” submission is the most common pathway by which medical devices receive authorization to enter the U.S. market, with over 3,500 510(k)s submitted to the U.S. Food and Drug Administration (FDA) yearly. FDA...
March 6, 2015 10:38 am
Nikunj Patel, Design Engineer, Hi-Tech CADD Services
One of the prominent challenges that product designers face, is not having the ability to make clients or in-house management staff to realize how the product will look and feel actually. Despite the possible advancements in 3D CAD technologies...
March 5, 2015 8:30 am
Clive Nicholls, Product Design & Development Manager, Owen Mumford
The applications of 3D printing in the medical industry will continue to grow throughout 2015 and beyond. Recent research by SmarTrech shows that by 2020 the number of 3D printers being shipped annually for medical use will have almost...
March 4, 2015 8:30 am
Carolyn Rose, Director of Strategy and Research, Insight Product Development
As anticipation grows for the seemingly limitless opportunities that big data represents for healthcare, a clear path to leveraging the massive information repository that exists today continues to elude the masses. Enamored with the possibilities...
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