March/April 2009
Medical Device Technology
Selected Contents
MATERIALS
Material Matters Column: The Delicate Balancing Act of Metallic Biomaterials
David Williams
Ever since metals have been used within the human body, there has been controversy over whether they do harm as well as good. There is now another dimension to this issue provided by experiences with recent metal-on-metal hip replacements.
Implications of Material Selection on the Design of Packaging Machinery
J.P. Merritt
Material selection has significant implications on the design and cost of horizontal-form-fill-seal packaging machinery. To avoid excessive costs, machine redesigns and project delays, material selection must be reconciled early in the project and revisited throughout the construction of the machine.
Novel Alloy for Speciality Needle Applications
E. Keehan, C. Cavanagh and V. Gergely
A novel cobalt-chromium (CoCr) based alloy, optimised for speciality needle applications, has been benchmarked against Type 304 stainless steel in a series of mechanical test and experimental needle trials. The results reported indicate that the CoCr alloy has the potential to overcome current limitations in endoscopic and minimally invasive surgery.
Use of Polymeric Materials in Orally Inhaled and Nasal Drug Products
D.M. Dohmeier, D.L. Norwood, G. Reckzuegel, C.L.M. Stults and L.M. Nagao
To maintain a high standard of quality in the materials and components used in the container systems of orally inhaled and nasal drug products, manufacturers need to collaborate closely with all those in the supply chain. Best practices in information sharing, particularly in relation to change control, are outlined here.
MANUFACTURING
Micro Moulding: The Route to a Successful Product
B. Whiteside and P. Manser
This account of a company’s struggle to take its product from concept to market reality details how micro moulding techniques can help meet difficult design requirements and create successful products with increased output.
REGULATION & STANDARDS
Avoiding Surprises When Implementing a Single Quality System
Maria Donawa
European medical device manufacturers are sometimes surprised to learn that operating ISO 13485 alone is not sufficient to meet United States (US) quality system requirements. This article discusses important considerations for meeting US and European requirements when operating under a single quality system.
ONLINE EXCLUSIVE: MARKET PLACE PRODUCTS
THE INTERVIEW
The MDT Five-Minute Interview
Medical Device Technology’s (MDT) series of interviews offers personal perspectives on the diverse and dynamic medical device technology industry. Here, we talk to Marcel can Kasteel.
THIS ISSUE
Developments Across the Industry
- Robo-surgery is safe and capable
- Facial reanimation technology
- Healthy projections for 2009
- A sound and growing ultrasound market
- Aid to more effective product marking