Medical Device Link.

 

June 2006
Medical Device Technology
Selected Contents

Materials

A Registry for Tissue Engineering Clinical Trials
D.F. Williams

Because tissue engineering products and processes are now being transferred from laboratory research into clinical applications, questions are being raised about what is the scope of an optimal clinical trial in this sector. A registry for these clinical trials is currently being established.

Filtration Solutions

This update on filtration technology highlights the opportunities offered by monofilament fabrics.

Design

Digital Flow Sensors: Reaching New Levels
U. Kanne and C. Sauvain

Microchips that combine sensor technology with digital signal processing on a single microchip can boost the performance and reduce the cost of measuring devices. How they can be employed in disposable applications such as liquid drug delivery and respiratory-flow monitoring is described here.

The Sensing Contact Lens
A. Bertsch, M. Leonardi and P. Renaud

A novel contact lens with embedded sensors is being developed for continuous monitoring of the intraocular pressure in glaucoma patients. Its mode of operation and capabilities are described.

The Role of Filtration in Drug Delivery Systems
B. Hogan

In the race to provide the patient population with effective treatment systems, filtration technologies are playing a greater role in meeting the challenges. Good filter design is reviewed here.

Effective Use of Virtual Prototyping in Device Design
E. Miller

Virtual testing as part of the product development process will reduce time and costs, but this method needs to be implemented correctly to gain these benefits. Five rules are described for effectively using analysis to drive design.

Sequencing the Human Lifestyle
A. Teller

Ever-expanding knowledge of human behaviour, which is being gathered as a side-effect of the increasing use of wearable body monitors, is set to have a huge impact on health care.

Bringing Together Technology and Market Roadmaps
J. Hogan

Effective technology development is a difficult challenge. This article reports on one company’s system, which has helped it achieve consistent, predictable success.

Manufacturing

Incorporating Microfabrication in Diagnostic Instruments
S. Burnell

As new medical diagnostics are being developed, a new and more flexible approach to microfabrication is required to support the product development cycle. This article reviews some factors that have proved useful in the successful incorporation of microfabrication.

Novel Leak Testing Techniques

Novel techniques are described that can be used whilst still applying the basic principles of leak measurement to test a range of medical devices.

Make a Mark

Component identification and traceability are critical. This guide to component marking discusses the various technologies that can be employed.

Regulations & Standards

The Challenge to Global Acceptance of Part 3 of ISO 10993
J. Carraway and C. Ghosh

ISO 10993, Part 3: Testing for Genotoxicity, Carcinogenicity and Reproductive Effects, is not a globally recognised standard. The differences in these testing requirements in Europe, the United States and Japan are explained together with guidance on when to test and efficient strategies to adopt when marketing products in these regions.

Effectively Incorporating Risk Management into Quality Systems
M.E. Donawa

Medical device manufacturers do not always recognise that the process of identifying and controlling risks is most effective if risk-related activities are incorporated into their quality systems. This article discusses a guidance document that provides practical suggestions for accomplishing this important task.

Business

Roadmapping for Medical Devices
J.M. Wilkinson

Roadmapping can provide insight into emerging opportunities and competitive threats. The various processes to produce roadmaps are described and some examples are presented.

Market Place

Dose Counting in Metered Dose Inhalers

Designs that deliver function with few parts.