Whether you are designing an autonomous surgical robot, a patient-specific knee implant, or a paperweight for all the new regulations, volumes of data are useless without the proper specification framework to filter and process it.
Which materials make the most sustainable sense and for what applications? How can we create products that balance function with recycling opportunities? With new materials available and on the horizon, the balance point is shifting toward a place that’s more sustainable.
While an apple a day may not always keep the doctor away, a wireless patient monitor just might.
Apart from Speedo swimsuits, what other biomimicry learnings from Shark skin can we use for medical devices?
Involving all aspects of ergonomics—physical, cognitive and emotional—is the only way to create tomorrow’s engaging, enjoyable and appropriate device experiences, while fulfilling functional requirements as well as intangible needs.
True sustainability isn’t about compromise; it is about creating innovative solutions that are not only good for the world, but good for business.
New and Revived: Your questions on adhesives usage answered by Christine Salerni Marotta at Henkel-Loctite.
For the past decade “translational science” and “translational medicine” have been cherished buzzwords, raising the prospect of faster, better, more seamless transfer of discoveries from bench to bedside. Too often, though, it doesn’t work. Differences in the cultures of academia and medical manufacturing, and a poor grasp of regulatory and reimbursement issues, or of what makes a bright idea into a clinically useful, commercially viable product have scuttled more than one promising innovation.
On July 19 and 20, 2010, the Food and Drug Administration held a public meeting on regulatory oversight of laboratory-developed tests (LDTs). This is considered a major step in an ongoing debate on how best to handle two different, but often overlapping, sets of diagnostic tools in a manner that best serves patient safety and public health, while recognizing the realities of clinical practice and medical product development.
Stakeholder interest was intense. The original meeting space reached capacity and registration closed within two days, prompting FDA to shift the conference to a larger venue. Nearly 650 people attended, while 650 more watched via webcast. FDA’s sense of urgency on the matter was further suggested by the June 10 issuance of “it has come to our attention” letters to six genetic testing companies, followed by another 14 on the opening day of the conference itself.
What are the issues? Why the concern? What does it all mean, and where might the Agency go?
The evaluation and management of risk throughout the product life cycle is the single most important concept in the regulation of medical devices. Yet it is difficult to define precisely what “risk” means or how to assess it in an industry where some 115,000 devices are produced by thousands of manufacturers, employing a dizzying array of technologies destined for use in varying health settings for every imaginable indication. So who determines the risk, and where do problems typically arise?