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Practical Use of FEA for Medical Rubber Components
A good understanding of rubber is essential to getting the most out of finite element analysis for this material.
(September, 2010)
The U.S. Innovation Struggle: 
One Model to Follow
The U.S. leadership position in terms of healthcare innovation has been largely taken for granted. A convergence of recent events, however, has changed the landscape. The balance of trade is decreasing, and foreign governments are growing their own industries. Lengthy FDA timelines are make it d...
(September, 2010)
September 2010 Contributors
Michael Imhoff, MD, PhD, is the managing director of Boston MedTech Advisors Europe GmbH (Dortmund, Germany). He is board certified in surgery and intensive care medicine and has 16 years of strategic consulting experience for leading companies in the g...
(September, 2010)
Highlights of Proposed Changes to 510(k)
Some of the important changes proposed by FDA’s report include the following:   Introduction of Class IIb Devices. These devices, which may include implantable or life-sustaining devices, would usually require the submission of clinical data and manufacturing data in the 510(k) notice, ...
(September, 2010)
So Many Polymers, So Little Time
With so many options, manufacturers should arm themselves with enough information to make a smart choice.  
(September, 2010)
A Stricter 510(k) Process Offers Challenges, Promises
FDA has released its long-awaited plans to shore up the 510(k) clearance system used to get many medical devices to market. In August, the agency published a 120-page report to define which devices are appropriate for the approval pathway and when those applications would require additional evidence...
(September, 2010)
Juggling Act: How to Design with Multiple Materials
Collaborating with manufacturing partners fosters efficient innovation when working with two or more materials.
(September, 2010)
FDA Continues Campaign to Upgrade Quality
After going after makers of infusion pumps, the agency has focused on makers of enteral feeding tubes.
(September, 2010)
User Fee Rates Announced
Table I. Medical device user fees for FY 2011. FDA has announced the user fee rates for FY 2011. Federal law stipulates that the fee rate for each submission type is set at a specified percentage of the standard fee f...
(September, 2010)
Frost & Sullivan Honors Siemens for CT Technology
Frost & Sullivan has awarded Siemens Healthcare its 2010 North American Frost & Sullivan Award for Technology Leadership of the Year in the computed tomography (CT) imaging market. The award was based on industry analysis and cited Siemens’s long history in dose-reduction products, the...
(September, 2010)
Streamlining the Complaint-Handling Process
A risk-based approach to complaint handling could help capture commonly missed data and reduce the burden on medical device OEMs.
(September, 2010)
Deciphering De Novo Reviews
The overall review duration for de novo submissions has climbed in recent years. Is FDA living up to its end of the deal?
(September, 2010)
The Basics of Medical Device Risk Management
What is risk management and why do you have to pay attention to it now, more than ever before?
(August, 2010)
The MX Q&A: Euan Thomson, Accuray
Radiosurgery start-up is finding a receptive audience for its noninvasive cancer-treatment system.
(August, 2010)
Designer Molecules Could Lead to Fast Medical Images
Georgia Tech professor Seth Marder, center, is part of the team that developed a new photonic material that could facilitate all-optical signal processing Optimizing molecules for photonic use could provide a foundati...
(August, 2010)
Device Puts Preterm Labor in Check
This image is a rendering of the cervical ring and sensors. The prototype measures 50 mm in diameter. A new device developed by biomedical engineering students at Johns Hopkins University (Baltimore) could help doctor...
(August, 2010)
U.S. Focuses Enforcement on Manufacturers
Device companies should scrutinize reimbursement advice they offer to customers submitting claims for government payments.
(August, 2010)
A Patently Good Idea
Recent court rulings highlight the importance of legal counsel in order to avoid patent infringement claims.
(August, 2010)
Managing Outsourcing for Success
The secret to success begins and ends with communication.
(August, 2010)
August 2010 Guide to Outsourcing Contributors
Tim Bosch is vice president of architecture and consulting at Foliage Software Systems (Burlington, MA). He directs consulting and development efforts for a variety of projects, which have included medication management system architecture assessment and p...
(August, 2010)
August 2010 Contributors
William A. Hyman is a professor of biomedical engineering at Texas A&M University. His primary areas of professional activity are in medical device design, system safety, and human factors. He is pr...
(August, 2010)
New Interval Offers Confidence—Without Limits
Reasonable confidence limits for binomial proportions could be easier to defend to regulatory bodies, including FDA. Reasonable limits are not statistically different from the sample proportion.
(August, 2010)
Effect on Preventative Care
In addition to treating chronic conditions, telemedicine aims to improve the quality of preventative in-home care. The Continua/IEEE standards for medical devices such as blood glucose meters also apply to preventative products such as pedometers and modules for aerobic exercise. Notably, Nike has d...
(August, 2010)
Medical Devices Come Home
Open standards and new technologies have the potential to make treating chronic conditions more cost effective.
(August, 2010)
Top Tips for Scaled Manufacturing
Outsourcing and scaled manufacturing 
go hand in hand.
(August, 2010)