As medical device complexity grows, the product development process often needs to improve in order to maintain device quality and safety, foster innovation, and reduce costs. Yet teams looking to make improvements often encounter resistance from management. This Ask the Expert focuses on how you can overcome barriers to improving the medical device development process.
From increasing focus on reimbursement and economic value, to impact of UDI and the medical device user fees, three industry experts discuss current market and regulatory trends and challenges shaping the medical device industry, and offer some effective strategies for companies to follow to remain competitive.
Multi-material molding, a process whereby at least one melt processible material is bonded with at least one other material to produce a single, molded component, allows designers to optimize material properties and costs, eliminate assembly processes, and even invent ground-breaking products that could not be manufactured otherwise.
The HALO trial represents a new opportunity for surgeons seeking a valve replacement for pediatric patients with no alternative approved treatment options.
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.
Forty-three percent of pharma and life sciences executives now support FDA evaluating drugs and devices based on both clinical and economic effectiveness.
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.
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…
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.
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.