Originally Published EMDM January/February 2003
INDUSTRY NEWS
Medical Device Material Atlas Addresses Product Development Issues
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| The Medical Device Material Atlas from LGC serves as both a training tool and a reference. (click to enlarge) |
A recently released publication offers a comprehensive overview of the issues associated with taking medical device material technology from concept to product launch. Developed by the Biomaterials Partnership at LGC (Teddington, Middx, UK), in association with the Department for Trade and Industry's Building Up Biomaterials programme, the Medical Device Material Atlas is practical as both a training tool and a reference document.
"Although the UK knowledge base is accepted as being well advanced, especially in emerging biomedical technologies, the biomaterials industry is diverse and fragmented," says Sally Penson, project manager with the Biomaterials Partnership. "Small and medium-size enterprises [SMEs] from wide-ranging disciplines make up 95% of the industry," she explains, adding that the need for such a publication was evident.
"The Atlas is the only current publication offering guidance on technical considerations, regulatory issues, and business implications specifically associated with developing biomaterials-based devices," says Penson.
The issues discussed in the publication apply to all synthetic, natural, and human-derived materials used in or as medical devices that perform, augment, or replace a natural function within a living organism, according to Penson. Examples of such medical devices include hip replacements, stents, bone cements, and artificial heart valves.
Currently, the volume does not fully address the use of tissue-engineered material in medical devices. While some related issues are touched upon, the scope is limited due to the lack of commonly accepted regulations in this area. "We plan to cover this topic in greater detail in a second edition of the Atlas," says Penson. The new edition, scheduled for release in May 2003, will also be updated to an electronic format.
"We believe that the Atlas will become a best-practice tool kit," explains Julian Braybrook, MD, head of the Biomaterials Partnership. "Sourcing, understanding, and complying with the many technical, regulatory, and commercial challenges facing new organizations is demanding. The Atlas should help to alleviate these concerns, stimulating greater wealth-creating opportunities in the industry," he adds.
The MDM Atlas is directed at those working within the biomaterials-based device sector, such as academic and industry researchers, product designers, and technical managers. The publication, which assumes no specialist knowledge, is especially useful to people involved in establishing, or having recently established, an SME. Its information is relevant to those not part of a large organization who don't have access to experts in the field. Features such as simple flow charts that support summary text boxes make the atlas a training tool for SMEs and those new to the industry.
The peer-reviewed publication also is useful to seasoned professionals by providing extended information and specific contacts. It serves as a reference tool for those cognizant of the various information sources and relevant regulations, but who lack the time to piece together the information or are unsure of how it all fits.
"I found the Atlas to be an excellent, well-presented document—invaluable as a checklist for the newcomer to the industry and a safety net for the experienced," comments one user, Brian Jones of Joint Replacement Instrumentation Ltd.
UK-based organizations are eligible to receive one free copy. A charge applies for additional copies and for non-UK-based companies. To order, contact Tina Hunt at LGC, Queens Road, Teddington, Middx TW11 0LY, UK; phone: +44 20 89437663; Internet: www.biomaterials-partnership.org.uk; e-mail: tina.hunt@lgc.co.uk.
Copyright ©2003 European Medical Device Manufacturer
