Blue Vistas
A recent report says the denotation of Bluetooth means that in just three years time there will be more devices utilising the technology than there are people in the world. But what lies ahead for medical devices? Nick Hunn, vice chairman at the Mobile Data Association and author of the report explains.
Injection Moulding, Plastic
It has long been understood that injection moulding offers manufacturers a more cost-effective, less labour-intensive way to manufacture parts for their medical devices. But rapid injection moulding is perhaps the newer kid on the block, so what benefits could it offer?
MATERIALS AND BIOMATERIALS
A Novel Idea?
The use of stem cells and tissue and bone regeneration within medicine has split opinions for some time. Will the concept find a place in today's already diverse medical device sector? Professor Kevin Shakesheff discusses the possibilities, his own work and that of the medical community.
Working Inside Out
Drug delivery systems evolve almost as quickly as they are designed, but drug-eluting stents continue to play a major role in patient care, as they did many years ago. What is the relationship between pharma and device manufacturers in bringing new systems to market and where do future opportunities lie as the issue of convergence takes centre stage.
Stemming from the Need
Stem cell research seems never to be far from the headlines these days with what are almost daily breakthroughs. Peter Gingras looks at how far the work has progressed and how those undertaking research are dealing with a tight regulatory framework.
Too Small to Fail?
SMEs or small to medium-sized enterprises are typically the first to suffer at times of difficulty. In Europe this has been acknowledged where the sector accounts for as much as 80% of the medical device industry. Eucomed and Dr Markus Schillo, principal at the European Investment Fund, offer an insight into the market for SMEs.
United Kingdom
Analysts are divided as to how long and deep the current economic downturn will be for individual countries. In the UK some suggest it will take 'years' to recover while others predict positive growth by the beginning of 2010. In such uncertain times, where are the opportunities for investment and where can the more ambitious businesses capitalise?
Roll Up, Roll Up
The recent publication of draft US FDA guidelines aimed at better informing the medical profession and patients on risks associated with specific devices has hit the headlines. The agency said its work looks at the promotion of the device to ensure it 'conveys an accurate and non-misleading impression of the benefits and risks of the product'. Tom Novelli of the MDMA looks at how the industry's players will have to adapt to ensure they meet requirements.
CONTRACT SERVICES AND OUTSOURCING
Taking Out a Contract
When it comes to outsourcing aspects of your device operation many would consider manufacturing to be the main function. However, the design of a device is often overlooked. Patrick Roth examines why this might be the case and looks at the pros and cons of outsourcing design services.
Clean and Clear
The industry is preparing itself for the publication of ISO 11135:2 and ISO 10993:7 and there is much speculation about how these standards will impact on manufacturers. Arjan W van Drongelen, National Institute for Public Health and the Environment (RIVM) looks to dispel the myths, discuss the impact and offers advice to ensure compliance.
FILTERS AND FLUID CONTROL
From the Heart
A team at London's King's College Hospital has been the first to successfully use keyhole surgery to replace a failing prosthetic heart valve. Olaf Wendler, the surgeon who carried out the operation, explains the procedure and looks at what can be done by manufacturers to further embrace this practice.
A Process of Automation
The development and manufacturing of a medical device is an increasingly difficult endeavour as competition grows stronger and regulatory constraints broaden. One potential method for increased efficiency is the use of software solutions to automate the various processes contributing to the development, manufacturing and marketing of a device, as this report investigates.
Shift and Move
According to a recent report distribution in the area of medical technology is about to be transformed. The continued success of companies in the area of medical technology requires new, pioneering approaches. But what does this ultimately mean for medical device manufacturers and how should they respond? The report's authors explain.
