December 1, 2011
Features
Custom skull implants on demand? Exactly
Laser-sintered prosthesis made of PEEK in conjunction with additive manufacturing make complex, custom cranial implants a reality....
Disinfecting medical devices
What is the effect of sterilization on polymers?...
5 tips for selecting cleanroom filters
Choice of filters can be critical to product quality, production yields and regulatory compliances when it comes to cleanrooms, both new and existing....
Q&A: Designing the future
What’s ahead for medical device design? Read on as members of the design, research, and regulatory teams at Providence, RI-based Ximedica (www.ximedica.com),analyze medical device design of the future, from 2012 and beyond. Discussing their thoughts with Research and Product Strategist Hope Hopkins (as moderator) are Chief Innovation Officer and Co-Founder Aidan Petrie; Research and Product Strategy Principal Jessica Willing-Pics; and Clinical & Regulatory Affairs Senior Vice President Tom Varricchione. ...
Talking supercomputers could play pivotal role in medtech
IBM Watson supercomputer could prove to be important physician’s tool....
Departments
Editorial: Polls reflect industry concerns
FDA and to a slightly less extent, AdvaMed, are not effectively representing industry concerns over the 510(k) product review process. The FDA’s CDRH (Center for Devices and Radiological Health) federally funded budget of $272 million should be decreased. And the time and money spent to gain US approvals hurts America in terms of having the latest medical technology available vs. the rest of the world. These are some of the findings of this past year’s MedicalDesign.com Reader Polls....
Industry Viewpoint: A new vehicle for challenging competitors' patents
The intellectual property strategies of medical device companies include not only obtaining and protecting their own rights, but monitoring and challenging the rights of others. ...
R&D Notebook: The growing importance of software verification and validation in medical device design
The third edition of IEC 60601-1 takes on a new role, bringing risk management into the very first stages of the product development process....
Advanced Materials: Metal is material of choice for MIS tubing applications
Key steps involved in designing and manufacturing metal precision tubing for minimally invasive surgical applications...
Medical Manufacturing Technology: Looking at an alternative to pneumatic sealing for medical design
An electronically actuated tooling system provides a clean, reliable alternative to traditional pneumatic sealing devices for critical medical design applications....
Medical Manufacturing Technology: Building an effective design and validation process for medical devices
An effective design process should ensure that risk management, verification and validation are built in to all steps of the development lifecycle instead of implementing these steps at the end of the process. Identifying potential risks and issues in the product early and throughout the steps of the design process adds control measures that mitigate potential hazards....
Tech Spotlight on pressure sensors: taking care when specifying critical care medical device sensors
Understanding how the specific application needs relate to sensor specifications is imperative in the selection process, especially in critical-care applications. When it comes to medical applications, designers may want to consider specifying an ultra-low pressure sensor. ...
News
Collegiate competition showcases medical inventions
Invent Now, a nonprofit organization that recognizes and encourages invention, announced the first prize winners of its annual
Grant awarded to develop biodegradable implants
The National Science Foundation awarded a $175,000 grant for research aimed at developing biodegradable medical implant materials that would promote tissue regeneration and disappear after serving their functions in the body....
Breakthrough device to help reduce premature births
A new device is set to change a horrible statistic: 12.9 million babies are born too soon every year, and 1 million of those babies die. The United States has the second highest rate of prematurity (1 of 8 babies) in the world. The CerviLenz device will help reduce those staggering numbers. ...
HELP hearing receives AdvaMed approval
AdvaMed commends the HELP Committee for holding this important hearing. The medical technology industry is committed to ensuring patients have access to safe and effective medical devices and diagnostics while advancing America’s leadership in medical innovation...
ISO watch
Accudynamics (www.accudynamics.com), Lakeville, MA, manufacturer of components for medical and diagnostic equipment, received ISO 9001:2008 recertification for maintaining a quality management system. ...
Join the discussion on medical grade adhesives and stick-to-skin apps
Fabrico (www.fabrico.com) Kennesaw, GA, wants to know whether you feel medical grade adhesives should be used in every stick-to-skin application. ...
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