How Materials Testing Meets International Regulations for the Medical Device Market

The medical device market has a duty to patients to ensure that their products are safe and free from harm. However, this is not always an easy task, as manufacturers have not yet mastered all of the nuances involved in body implants. For instance, CNN reported last year that a company in France was found to have developed industrial-grade breast implants, which have more contaminants than the approved medical-grade gel.

The implants were then banned and authorities advised thousands of women to remove the possibly defective devices. All of this sparked debate among Europe and lawmakers began creating new ways to regulate medical devices.

Reuters reported this week that some businesses that make implantable devices, like heart stents or new hips, claim that a complete overhaul of the regulation system will put a damper on creativity and the release of new devices.

The European Commission has already brought forth a proposal for regulation improvements while the European Parliament is looking to have an entire new system of pre-market approval.

“We absolutely need that,” Dagmar Roth-Behrendt, a lawmaker from Germany sitting on the board, told Reuters. “We don’t need it for every medical device, but for certain medical devices, without any doubt, we need a more stringent prior authorization system.”

With the governments across Europe seeking more stringent regulations and higher quality medical devices, it becomes more important than ever for manufacturers in the biomedical sector to meet the needs of their consumers.

Materials testing is a necessity that manufacturers need to take part in before bringing their products to market. ADMET offers a multitude of biomaterials and tissues testing machines for the biomedical industry. Medical device manufacturers, healthcare research laboratories and top universities seek the help of ADMET to meet specific ASTM and ISO regulations, such as ASTM F543, ASTM F382, or ISO 594.

Our company offers single and dual actuator systems to determine the mechanical properties of bone screws and external fixation devices along with the strength of bandages, stents, syringes and luer connectors. The type of tests that ADMET systems can perform include compression, tension, static and fatigue, torsion, axial-torsion, and planar biaxial.

ADMET also offers the BioTense Bioreactor, which is, in essence, a miniature uniaxial test system built into a perfusion bioreactor which sits a top an inverted microscope. This allows cellular biologists and tissue engineers to conduct high resolution experiments and determine mechanobiological properties.

Closeup of BioTense Bioreactor assembly

Closeup of BioTense Bioreactor assembly

Mechanotransduction is a complicated process referring to the way the body alters mechanical loading into cellular response or motion. To better study and analyze mechanotransduction, ADMET collaborated with Professor Jeff Ruberti of Northeastern University to create the BioTense Bioreactor which provides researchers with the procedures for mechanobiology study.

What makes this product so useful is its capability to apply uniaxial mechanical stimulation and analyze cell/matrix stimulation at high magnification for approximately two weeks at a time. The BioTense Bioreactor is capable of applying force up to 7N and elongations of 25 mm.

So far, this instrument has helped laboratory researchers determine the fibroblast population and stratification process, complex and organized tissue motion, and coordination of the extracellular matrix production.

ADMET also offers manufacturers with products to determine the stiffness of pipette tips, the fatigue life of dental implants, the adhesive properties of biomedical tissue, puncture capabilities of medical needles, and the mechanical properties of metallic bone screws.

In order to meet international standards such as ASTM or ISO as well as the regulations set forth by the European Commission, medical device manufacturers should consider acquiring the materials testing machines available at ADMET.

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By |February 26th, 2013|Testing Issues|0 Comments