All articles by Cms Admin
Cms Admin
Better by design: keeping the user in mind
User-centred design is a legal requirement for medical device development that goes well beyond ensuring basic safety. Jennifer Martin of the University of Nottingham expains why exhaustive research and testing play such an integral role when it comes to satisfying user requirements.
Injection moulders pump up the volume
Medical device manufacturers are under pressure to produce innovative, high-tech products in ever greater volumes. Harald Schmidt of Mold Hotrunner Solutions tells Medical Device Developments how injection moulded plastic parts in general, and hot runner systems in particular, can offer flexibility and cost-efficiency to the booming healthcare industry.
Patently obvious: the importance of a strict IP regime
For all its difficulties, the international patent system is still a hugely important way of safeguarding new ideas. Mark Pullen of Watermark discusses the need for strong contractor relations, the effects of the global downturn on research and development, and the coming of age of China’s intellectual property regime.
Choosing the right EMS partner
Demand for contractors that can provide end-to-end electronic manufacturing services is set to soar. Mike Tendick of Plexus Corp explains to Nic Paton what cash-strapped medical device manufacturers need to look for when selecting an outsourcing specialist.
Acoustic micro-devices make sound progress
Early detection of circulating tumour cells in peripheral blood may help determine the effectiveness of cancer therapies. Itziar González of the Spanish National Research Council explains the benefits of a new, non-invasive approach that uses ultrasonic technology to identify suspect cells.
Down to the wire: health IT infrastructure gets smart
The wireless networks that connect electronic medical record systems to medical devices are rapidly evolving. Elly Earls talks to Philips’ Paul Coss and Delroy Smith and Welch Allyn’s Garrison Gomez about two of the primary types of infrastructure available to transmit life-critical patient data.
The need for speed: the US race to improve device regulation
US regulators’ plans to share data, quickening the medical product approval process, have met with a lukewarm reception. Thomas Novelli of the Medical Device Manufacturers Association explains to Rhian Owen why the FDA and CMS’ proposed ‘parallel review’ process is attempting to solve more issues than it can handle.
PEEK performance: a next-generation biomaterial
Polyetheretherketone, or PEEK, was originally developed in the late 1970s by the US aerospace industry, which was taken by its properties of stability at high temperatures and thus its potential for high-load, high-temperature applications. In the late 1990s, a highly pure and implantable grade of PEEK known as PEEK-OPTIMA was commercialised by Invibio Biomaterial Solutions and subsequently embraced by the medical device industry. Since then, the use of medical grade PEEK has grown exponentially, as Dr Steve Kurtz, corporate vice-president and director of the biomedical engineering practice at Exponent, explains.
Device + biologic = a winning combination
Combination device manufacturers face challenges regarding sterility, shelflife, packaging and mixing active ingredients. Colin Toombs of PA Consulting talks to Nic Paton about the rewards and potential pitfalls of bringing such cutting-edge products to market.
Value judgements: Q1 medical device deals
Rising valuations caused M&As and asset transactions to fall in value by 75% in Q1 2011, reports GlobalData.