St. Jude Begins U.S. Study of Smallest Pediatric Mechanical Heart Valve
The HALO trial represents a new opportunity for surgeons seeking a valve replacement for pediatric patients with no alternative approved treatment options.
Biomaterial Coating Promises More Successful Medical Implants
Researchers are studying a new biomaterial that helps healthy cells adhere to the implant, fend off bacterial cells and thus, reduce the likelihood of the implant being rejected by the body.
Regulatory Innovation Should Adapt to New Health Economy
Forty-three percent of pharma and life sciences executives now support FDA evaluating drugs and devices based on both clinical and economic effectiveness.
How Good is Good Enough? The Importance of Medical Device Performance Specifications
Telling the parent their child has a temperature of 38.674 °C may be an impressive engineering feat, but the last two digits have no real value and any time spent in development getting there was misspent.
Why is Biocompatibility Testing of Medical Devices Critical?
Even if a material that makes up the medical device has been tested for biocompatibility, processes such as manufacturing, packaging, aging, and sterilization may have adverse effects on the material’s composition and how it reacts in different environments. Because of these potential changes, biocompatibility is an important test protocol that must be completed for every medical device end product prior to receiving global regulatory approvals. An upcoming series of seminars, organized by UL, will discu…
Trends to Watch For in Medical Device Industry
Access to recently developed materials, new technological deliveries and access to new markets are only a few of the trends that have affected changes in the medical device market and industry.
Apps: Fun or Medical Devices?
Popularity of smartphone applications, or apps, has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in. In this article, we discuss when an app is simply fun and when it needs to be regulated as a medical device.
Choosing the Right Solution for Issue Management and CAPA
CAPA provides visibility into critical product quality characteristics, failures/ non-conformances, and resolutions to these issues for smarter decisions across the global, extended enterprise. With the right solution, design, manufacturing and quality improvement teams can share the same views of the information they need to directly impact Six Sigma and Lean initiatives.
3D Printing and the (New) Product Development Road Map
Whether you’re an engineer, designer, or technical tinkerer, here’s a basic road map to a few of the most important aspects of modern 3D printing.
Overcoming Barriers to Improvement in Product Development
Despite a clear need to get better development lifecycle management solutions in place, companies are restricted by tight budgets, validation overhead, and bureaucracy. In this Q&A, Matt Harp and Angie Pepiot at Seapine Software share their insights.
