Archive for the ‘medtechinsider’ Category

Microcontroller Enables All-in-One Device for Diabetics

Wednesday, June 19th, 2013

Integration is good, especially for diabetics. Insulin-treated diabetics typically need to to have at hand a lancet, test strips, blood glucose meter, injection device and some form of diary to manage their treatment. That's a lot of stuff to carry around. The Brighter One device developed by Brighter AB (Stockholm) ...

UK Royal Academy of Engineering Report Outlines Lessons Medtech Industry Can Learn from Engineering Sector

Wednesday, June 19th, 2013

The medical device industry has much to learn from the engineering sector when it comes to demonstrating the safety of new devices, according to a report from the UK Royal Academy of Engineering.

Galway Companies Join EU Project to Develop New Medtech Manufacturing Technologies

Tuesday, June 18th, 2013

Two companies based in Galway, Ireland's medtech hub, are contributing their expertise to a pan-European project designed to develop new technologies for medical manufacturing, reports www.siliconrepublic.com. Crospon, founded in 2006 to develop minimally invasive surgical devices, and Adama Innovations, which was spun out from Irish nanoscience institute CRANN earlier this year, ...

Metal Alloy Could Increase Visibility of Medical Implants under X-ray

Monday, June 17th, 2013

A new metal alloy could help medical implants become more visible under X-rays. The material was developed by researchers from the Materials and Surface Science Institute (MSSI) at the University of Limerick.

Puracon Expands Medical Packaging Footprint in Germany and United States

Monday, June 17th, 2013

Puracon GmbH is expanding production capacity at its home base in Germany and plans to build a facility in the United States. The new facility at the company’s Rosenheim, Germany, location will have a 6000-sq-m production area, tripling its current footprint. As part of the construction project, Puracon has commissioned a ...

Irish Engineering Student Helps Zimmer Reduce Production Bottlenecks

Wednesday, June 12th, 2013

[caption id="attachment_31439" align="alignleft" width="210"] Student Patrick Byrnes takes first prize in Irish engineering awards programme.[/caption] Zimmer Orthopaedics is eliminating production bottlenecks at its facility in Shannon, Ireland, and it has an engineering student to thank. Patrick Byrnes, who is enrolled at Cork Institute of Technology, analysed where bottlenecks occurred in Zimmer's ...

The Tangled Destinies of Europe’s UDI, Eudamed Database and Medical Device Regulation

Monday, June 10th, 2013

From the Consultant’s Corner Newsletter, June 2013 The European Commission published its recommendation for a common framework for a unique device identification (UDI) system for medical devices in April 2013. The announced primary objective of recommendation 2013/172/EU is to improve patient safety by facilitating vigilance, market surveillance and transparency through heightened ...

Asia’s Medtech Power Markets

Monday, June 10th, 2013

From the Consultant’s Corner Newsletter, June 2013 Medical device industry observers and stakeholders have touted Asia in recent months for its strong growth potential and relatively healthy economic conditions. Three Asian markets, however, have recently shown specific signs of strength generally ascribed to the region as a whole. Taiwan’s market to approach ...

Medtech Research Hub Formed in Hamburg

Thursday, June 6th, 2013

The Hamburg Eppendorf University Medical Centre and the University of Technology Hamburg Harburg have announced the launch of a collaborative research hub, Forschungszentrum Medizintechnik (FMTHH). Starting in June 2013, the new facility will combine medical and engineering expertise under one roof. Both institutions have a long history of cooperation in ...

Redefining Medtech, from 3-D Printed Organs to Wii Health

Tuesday, June 4th, 2013

As we have noted before on medtechinsider, some fascinating conversations are going on over at the Medical Packaging Innovation site. Here are three that caught our attention recently. Under the headline, "Need an Organ Transplant? Just Print It," Jayaraman Kiruthi Vasan wonders if 3-D printing has the potential to save some ...

FDA Meeting on 510(k)s and Design Changes: Is a New Policy Coming?

Monday, June 3rd, 2013

From the Consultants Corner Newsletter, June 2013 Are you prepared to submit a new 510(k) for all modifications or design changes you make to a device that previously received 510(k) clearance? If not, you should take note of a forthcoming meeting that will address FDA policies related to manufacturer requirements when ...

France Implements Remaining Sunshine Regulations for Healthcare Professionals

Friday, May 31st, 2013

If you are active in the healthcare sector in France and provide "benefits" to healthcare professionals or other industry stakeholders equal to or greater than €10, you will be obligated to make that information public. French decree 2013-414, which was published in the Official Journal on 22 May 2013, will ...