How New Medical Device Regulations will Impact US Manufacturers

Posted by Mike Sterling

Jun 25, 2014 6:16:00 AM

2015 may prove to be the year of new regulations.

Medical_Device_RegulationsFirst the European Union may adopt new medical device regulations, which were first proposed by the European Commission in 2012, and secondly, there will be updates to ISO 9001 guidelines.

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Topics: Medical manufacturing


In Today’s Medical World, Your Clinician Now Doubles As Your Sonographer

Posted by Mike Sterling

Mar 7, 2013 4:30:00 AM

As is increasingly the case in the field of OEM medical manufacturing, clinical practice must necessarily follow in the wake of new technologies; not the other way around.

Medical_Device_RegulationsMore and more, the traditional, distinct specializations that have underscored the organization of hospitals and clinics throughout most of the past century are getting cross-pollinated; the designation between doctor and specialist is growing ever more “blurry.” 

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Topics: Medical manufacturing


Fabricating OEM Medical Components to Help Wounded American Veterans

Posted by Mike Sterling

Dec 19, 2012 8:53:00 AM

Ardel has a long history of providing for America’s defense.

Medical_Device_RegulationsIn the early 1980s, when then-President Ronald Reagan called for a “600 ship navy” to counteract the menace of a steadily growing Soviet fleet of submarines and maritime bombers – we put our shoulders to the wheel to meet that challenge. The American Navy saw its largest incarnation since the end of the Second World War, and was indisputably the most powerful fleet that ever sailed an ocean. As the Cold War ended and the so-called Pax Americana began, we thought the time had come to begin shifting our efforts into other advanced fields of technology, areas like computers, advanced medicine, and space-borne telecommunications systems.

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Topics: Medical manufacturing, Medical Devices


Our Work Using PEEK Polymer Materials

Posted by Mike Sterling

Aug 6, 2012 5:30:00 AM

As part of an ongoing discussion about the various materials (both metallic and thermoplastic) that we work with at Ardel Engineering, we would like to discuss our experience working with PEEK polymer thermoplastics. 

Since PEEK – the acronym stands for Polyether ether ketone – is such a structurally robust thermoplastic, unusually resistant to high thermal concentrations, high pressure, and high levels of corrosion, it is sought after by performance-intensive industries of all stripes. 

peekpolymer

Its uses in pistons for automotive engines, biochemical and analytical chemical separation processes, and even subatomic particle accelerators are all well-documented. Its expensiveness and its relative scarcity place it beyond the price-range of a lot of clientele. Usually the province of 1st tier suppliers, major international companies, and well-established research universities (as well as national and state governments), PEEK is something we excel at in several of our own fields of expertise.

 
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Topics: Medical manufacturing, Aerospace, PEEK Polymer


The “Facebooking” of Medicine and its Implications for OEM Medical Devices

Posted by Mike Sterling

Jun 14, 2012 7:02:00 AM

In what many considered a surprising move, Facebook CEO Mark Zuckerberg recently appeared on NBC’s Today Show to announce a new Facebook feature that would soon be available for all the social media platform’s users to share: their organ donor status.

fb-organ-donor

Apparently Mr. Zuckerberg’s medical student girlfriend, Priscilla Chan, inspired him to instigate the new social media status, since it would be an extremely easy way for those in need of a medical transplant to seek out a potentially life-saving donor. Previously, those searching for organ transplants would have to slog through a months-long, nebulous process that oftentimes involved them sorting through long miles of bureaucratic and insurance company red tape, or would even lead to less scrupulous customers shopping for organ transplants on the international black market.

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Topics: Medical manufacturing, Medical Devices


The Advantages of Titanium Components in OEM Medical Devices

Posted by Mike Sterling

May 2, 2012 6:00:00 AM

Titanium is, without question, one of the most fundamentally important metals of 21st century construction.

Not only does titanium have cutting-edge applications in defense (the titanium hulls of US and Russian naval submarines, for instance) and space exploration (much of the metal that goes into government and commercial satellite technology is either titanium or a titanium-derived alloy), but it’s also become a critical component of today’s medical industry. The 81st element in the Periodic Table has attributes that make it indispensable for use in reconstructive surgery, dental implants, cardiovascular devices, and external prostheses.

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Topics: Medical manufacturing