Asia’s Medtech Power Markets

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 $3 billion in 2013

First, the Taiwanese government released a report in late May projecting a more than seven percent growth rate for the country’s medical device sector, to $2.71 billion, in 2013. Demand for contact lenses and blood glucose monitors, in particular, will fuel this growth, according to the Taiwan Industry of Economic Affairs’ Industry and Technology Intelligence Services. Accordingly, manufacturers specializing in vision care and diabetes management devices stand to gain from commercializing in Taiwan. Read more…

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Eucomed Publishes Guidance on RoHS 2 for Medical Device Manufacturers

The Eucomed Electronic Devices Working Group has published a guidance document to clarify conformity assessment requirements for manufacturers of medical devices that fall within the scope of the recast Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment 2011/65/EU (RoHS 2). Like the medical device directives, RoHS 2 is a CE marking directive, and there is some overlap in the conformity assessment procedures, which the guidance explains. It also addresses the role of the Notified Body in relation to conformity assessment of devices that must comply with RoHS 2. Read more…

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Medtech Research Hub Formed in Hamburg

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 the medical technology arena, notably regarding orthopaedics and nanoelectronic implants. Read more…

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Big Data Optimises Personalised Cancer Therapy in Italy

When choosing optimal treatments for cancer patients, doctors must consider a number of factors: age, general health, weight, the medical history of family members, the current state of the disease and much more. Big data, in the form of a collaboration between IBM and the National Cancer Institute of Milan, may be able to connect those dots.

Begun in 2012, the project uses data analysis technology to correlate a patient’s personal data and disease profile with available information of past cases and clinical guidelines. To determine whether a patient should undergo chemotherapy, for example, the physician can match his or her individual case with a series of comparable past cases. The outcome will guide the physician and patient in choosing an appropriate therapy. Read more…

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

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 of the estimated 15 people each day who die waiting for an organ transplant in the United States alone. “Researchers all over the world are on the constant quest for finding ways to avoid transplanting organs and are creating them, instead. Several such research teams have recently demonstrated that human organs can be created through 3-D printing,” he writes. Vasan cites one Australia-based research team that is reportedly three years away from printing patient-specific body parts including cartilage, muscle, and nerve cells. The researchers predict that we will see human organs being printed in just 10 years. Read more…

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

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 modifying an existing device. FDA and industry will discuss issues, ideas and comments on suggested processes on 13 June 2013 in Silver Springs, Maryland. The meeting also will be webcast, and an archived version will be made available within 24 to 48 hours after the conclusion of the meeting. Read more…

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France Implements Remaining Sunshine Regulations for Healthcare Professionals

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 be followed by a government circular that will clarify the concepts embodied in the decree. And some clarity is needed. Read more…

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Swiss Partnership Develops Instrument that Measures Elasticity of Living Tissue

The strong Swiss franc has been the bane of Switzerland’s industry, which is reliant on exporting products and selling its expertise globally. Indirectly, however, this trying economic situation is also driving innovation. A partnership between the Swiss Centre for Electronics and Manufacturing (CSEM) and CSM Instruments, both based in Neuchâtel, is one example.

The collaboration between CSEM and CSM has resulted in the development of an instrument that measures the elasticity and rigidity of biological tissue. Described as the first device of its kind to perform these measurements in a physiological environment, the Bioindenter initially will be confined largely to disease research. However, the developers see broad future applications in diagnostics and tissue engineering. The project moved forward under the umbrella of the Commission for Technology and Innovation, a programme that was established to counter the adverse effects of the strong Swiss currency. Read more…

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Medical Packaging Engineers: Where Does It Hurt?

Medical Packaging Innovation, the online community of medical packaging experts, has launched a poll to identify the issues that medtech packaging engineers wrestle with on a daily basis. All survey participants will be entered in a drawing to win a Kindle Fire. Read more…

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More Noncompliant Implants Marketed by Ceraver

Le Parisien newspaper reported this week that Ceraver, which made news earlier this month when it was revealed that it sold improperly certified hip implants to hospitals, has also marketed noncompliant knee implants. According to the daily, which also broke the hip implant story, some 50 patients are walking around with knee implants that did not go through the required regulatory process. Chastened by the negative publicity generated by the hip implant scandal, Ceraver management came forward and informed authorities that its Ceragyr knee implants also were commercialised without CE marking.

The national health authority, ANSM (which replaced Afssaps in 2012), recalled the noncompliant hip and knee implants on 28 May. In doing so, the agency stressed that the products did not pose a health risk. Read more…

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The Value of Validation in Medtech Packaging

Packaging abuse is all in a day’s work for Frans Kateman, Production and Validation Engineer at Sealed Air Nelipak (Venray, Netherlands). He drops packaging from various heights, exposes it to heat in an accelerated ageing chamber, subjects it to high pressure conditions, and shakes it every which way. Following a visual inspection of the sterile barrier and a peel-strength test, he injects blue dye into the packaging and watches to see if it penetrates the seal. Finally, if no bubbles escape the packaging when it is held under water, it can be said to have passed the test.

Kateman was one of several experts at the Packaging and Process Validation Seminar held on 23 May at the Sealed Air Nelipak facility. He joined other speakers in stressing the importance of packaging design validation testing for medical device manufacturers. Read more…

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Wearable Technology Is the Next Megatrend, Credit Suisse Analysts Say

Wearable technology such as smart watches, fitness monitors, shoes and headsets is the next big trend, say Credit Suisse analysts in a report published last week. Companies need to pay attention to this field because it will have a “significant and pervasive impact on the economy”, the authors say. The market will grow rapidly in the next three to five years, from about US$3 billion to US$5 billion today to US$30 billion to US$50 billion. Read more…

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