Medical Device Developments : All Issues

In the past, patients requiring prosthetic limbs have had to endure extended waiting times as a result of the limitations of manufacturing processes - and, even once their limb has been produced, the risk of it not quite fitting was ever present. However, thanks to breakthroughs in technology, CNC machining and rapid prototyping have helped overcome these problems, as Elaine Figgins and Anna Reyes-Potts explain.

The drive by many healthcare providers to become more sustainable is now impacting on their procuring practices and will filter through to their suppliers. Elly Earls talks to Anja Leetz and Beth Eckl about the drive to alter manufacturers' priorities and create a more sustainable sector.

The issue of regulation and differences between the US and European models has long been a matter of interest. In the wake of the FDA's Dr Jeffrey Shuren's testimony to a US Senate Committee, we spoke with Tom Novelli of the MDMA and Eucomed's John Wilkinson to get their views on this hot topic

The ongoing drive to shrink medical devices shows no sign of letting up, but one of the biggest issues is reducing the size of the electronics used. Abi Millar talks to AWAIBA’s Martin Wany about the challenges the medtech industry faces and some of the practical steps his company has taken to address them.

As the use of injection moulding grows, for medical device manufacturers the use of cleanroom technologies is becoming essential. Ellie Broughton investigates this trend.

ConvaTec’s Todd Smith discusses the growing globalisation of the supply chain and the issues this push raises for today’s medtech organisations. Many see this model as a way of accessing new markets, but barriers such as communication and regulatory hurdles stand in the way.

We also report on new biocoating technologies, how to transfer biomarkers into a lab-on-a-chip, the rise of robotic technology, and the pros and cons of the Brazilian medical device market.

Polyetheretherketone - or PEEK - is being used more widely in medical devices and the organic polymer thermoplastic is said to be transforming large swathes of the industry. But, as Steve Krutz of Exponent, Inc tells Nic Paton, it’s the development of spinal implants that stands to benefit the most from this technology.

Although so-called combination products have gained a lot of attention in recent times and are, many believe, at the forefront of the next generation of medical devices, PA Consulting’s Colin Toombs warns that device manufacturers face significant challenges. Issues such as sterility, shelf-life, packaging and the mixing of separate active ingredients will be among those requiring the most attention, he explains.

Historically, intellectual property and patent protection have been the cornerstone of almost every industry. China’s rise to manufacturing prominence has drawn attention from manufacturers and their legal teams. As Mark Pullen of Watermark explains, in spite of recent high profile cases, the international patent system is still the best form of defence.

Also in this issue, we look at the early detection of cancerous cells and how medical devices can incorporate wireless technology to connect to EMRs, and profile the ten leading green devices on the market and in development.

According to Pharmaceutical Market Research, point-of-care diagnostics represented 15% of the in-vitro diagnostics market in 2010 and this market share is expected to exceed 30% by 2014. Yet lab-on-a-chip devices can be difficult to control. In our cover story, Shuichi Takayama, Amy Hsaio and Sasha Cai Lesher-Perez, University of Michigan, describe three strategies that use microfluidic technology to overcome their operational complexity.

In Electronics, Dr Paul Steffens, Institut Laue-Langevin, talks to Nic Paton about unlocking the secrets of higher temperature superconductivity, explaining that high-temperature superconductors could eliminate the need for cooling in MRIs.

Elsewhere, we speak to GreenBlue’s Katherine O’Dea and Baxter’s Art Gibson about sustainable packaging and Dr William Robert Jarvis, Jason and Jarvis Associates, about the latest advances in antimicrobial coatings.

Advances in technology mean that there is now a much wider choice of materials for medical devices – from conductive polymers to shape memory materials. Len Czuba, president of Czuba Enterprises, talks us through the complexities of choosing the right polymer for a medical device.

Meanwhile, the highly publicised recall of 200,000 Baxter infusion pumps across the US in April 2010 served to highlight the issue of medical device safety. In our cover story, Stuart Levine of the Institute for Safe Medication Practices explains about how wireless connectivity between smart infusion pumps and other hospital systems can protect patients. The commotion caused by the recall, it turns out, could end up having a positive impact on the industry.

This issue also includes our Top Ten of 2010, where we profile the medical technologies that have made the greatest impact in the past year. How will they change patient care in 2011 and beyond?

You could be forgiven for assuming that miniscule implantable medical devices powered by a human heartbeat still belong in the realms of science fiction, but these are fast becoming a reality. In this issue, Zhong Lin Wang explains how research in the field of nanopiezotronics will transform the way medical devices are powered.

Ian Papautsky, University of Cincinnati, is convinced that lab-on-a-chip technologies are mature enough to make the transition from academia to industry. His team has found a way to transport liquid electronically in virtual channels. Although these technologies have life-saving applications, Mark Gasson discusses the security risks associated with implanting computing technologies into the human body.

Oz Harmanli focuses on the long and arduous process of getting a medical device to market. Choosing the right contract manufacturer will make things a lot simpler, he advises.

In this issue of Medical Device Developments Tom Novelli reports on the ongoing criticism of the 510(k) clearance process and how it has raised questions about the ability of the FDA to police the industry. Like regulation, the design of device packaging is critical to the success of any product. Russell Darley, Institute of Packaging Professionals' Medical Device Technical Committee, says many packaging issues can be traced back to the design process. He argues there needs to be clear objectives when embarking on a packaging design; designers must understand the needs of the end user as well as the function of the device and the processes of their own company. To make financial investment in product design manufacturers need to feel they are protected against counterfeits of the entire device or aspects of it. Elsewhere, James Pooley, World Intellectual Property Organization, offers an insight into the world of patent protection.

The issue of regulation is one that shadows the industry. For all of the concerns that it stifles innovation and threatens to drown the industry in bureaucracy it helps to set the standards, providing clear guidance on expectations.

Part of that process is the auditing of a manufacturing facility. What many people don't realise, according to Norm Howe of the VCI, is that the auditing starts as the inspectors enter the grounds, as he explains to Nic Paton.

Also in this issue, the MDMA's Thomas C Novelli delves into what is fast becoming the murky world of healthcare reform. The proposed device tax, new legislation and concerns over what constitutes effective research are raising concerns about a sustainable product pipeline.

In our cover story Professor Kevin Shakesheff explains the growing interest in regenerative medicine. It seems almost a million miles away from traditional manufacturers but the paths of these two innovative sectors are sure to cross.

2009 was perhaps one of the most economically challenging years for some time. While some businesses failed to survive, others took advantage of the situation and strengthened their positions through acquisitions. The biggest casualties were innovation and the product pipeline. GlobalData looks at the downturn's impact on project financing and the vital role SMEs play in supporting the sector.

As well as the financial crisis, it has been suggested that innovation is stifled by regulation. As Eucomed's John Brennan reveals, this coming year will be no different. He investigates some regulatory changes that will require device manufacturers to provide clinical evidence as to their assertions.  

This issue also includes the second part of our rundown of products that have shaped the medical device field in the past ten years. It has been a decade of innovation that has ultimately benefited the patient.

Over the past few months the industry and its manufacturers have continued to perform relatively well against a backdrop of continued economic worry. The question of US healthcare reform has become much more of an issue for medical device manufacturers.

A perhaps more pressing matter is possible new regulation governing the promotion of device products. As Thomas C Novelli explains, growing concerns over the information being made available to vendors when looking to purchase devices may lead to a tightening of regulations by the US FDA.

The use of software in ma3nufacturing is growing in importance and so too is the work being done by software developers. Daniel J Staresinic, Thomas W Maurer and Rami Azulay look at the levels of investment into software and what they might mean for an increasingly money-conscious sector.

There is also a rundown of ten of the leading innovations in the medical device field, with a further ten to come in the next edition.

Although the global medical device industry has escaped the worst of the global economic downturn there is still a need to be more calculated about risk and to scale back ideas. In this issue Eucomed's Rosanna Tarricone examines this trend in the light of reduced healthcare expenditure.

Moving on from finance, the key driver in the device sector has always been innovation. Public and private companies as well as academia are working to find the 'next big thing'. Dr Terry Clyburn and Daniel Steines discuss some of the inventive work being done to tailor joint replacement products to the specific needs of patients.

The cover story focuses on the efforts of Dr Stephanie Lacour and her team at Cambridge University to find a method of enabling patients to wear devices. This project has been hampered by an array of issues such as the use of chemicals and heat affection electronic function. Despite this, there is great potential in the stretchable electronics project. View Issue

These past three months have been some of the most economically challenging for quite some time, but the medical device sector is renowned for being one of the most robust in the world. While
there have been some bad news stories, there is also plenty to be optimistic about.

One thing to come out of the crisis has been the push by governments to create green economies. However, according to Bill Roth, while the industry is doing a great job of developing new technologies, its record is not so good on environmental responsibility – or it’s keeping rather quiet on the matter. In our cover story we investigate the work that the sector is doing to be more environmentally conscious and the business case that lies behind it.

Regional and domestic sectors face their own challenges over the coming months, as Eucomed's John Wilkinson explains. Europe is facing a difficult time as the lack of available funding begins
to take its toll.

In this edition pioneering scientist Dr Robert Langer shares his thoughts on the current state of the medical device sector. More is needed to be done to secure funding for some of the most crucial and exciting research projects being carried out. He also considers what the election of Barack Obama might mean for the medical field and talks about ways of attracting younger talent to the industry.

Also in this issue, Kevin Stout of the Supply Chain Council considers how reassessing the supply chain structure can help make a business more competitive through efficiency. While this particular function is crucial to ensuring cost-effectiveness and reputation, very few companies are aware of the benefits of continual evaluation and cross-industry collaboration.

Meanwhile, Thomas C Novelli of the MDMA discusses the proposed US healthcare reform. He explores what it will mean for the industry and how innovation and new technologies will be affected.

Medical devices are getting smaller and smaller as manufacturers and the medical community as a whole push to reduce the impact of implantation and application on the end user. Nanotechnology has had a major effect on the way devices are designed and used.

Dr Diana Hodgins has recently completed a four-year research project into the reduction of electrical circuitry for medical devices. In our special report she explains her findings and what they mean for the future development of smaller and more adaptable devices.

Also within this edition of Medical Device Developments, we look at the investment opportunities within the German device market. Meanwhile, Jeremy Gilbert explains the innovation needed to increase wear and compatibility of joint replacement implants.

The innovative device sector never fails to amaze. Synthetic silk "spun like a spider" is one development that could dramatically change the way in which clinicians meet the demand for bone substitutes. Our cover story investigates the practical uses of this innovation and how it might realistically be adopted.

The use of Bluetooth technology has also changed the way we operate and its influence in the device market is clear. Devices often utilise Bluetooth's capabilities to communicate with their local environment. Our report looks at the technology and the benefits it will offer both patients and practitioners alike.

Meanwhile, regulation continues to play its part in shaping the global sector. While its impact is influential during the design and development of a device, accreditation and manufacture, authorities have a responsibility to assist manufacturers in the wider market, as Tony Sant and Dr Evangeline Loh explain.

Medical devices, like the industry itself, are going through continual change; a new technology can shape the development of a product, direction of a company and ultimately future treatments for patients.

Perhaps one of the biggest challenges is an ageing global population. In response to this device manufacturers are having to look at new technologies while physicians and clinicians focus on new techniques for allowing people to grow old and maintain their quality of life. Lorrie Kelly investigates the growing pressure arising from the increased need for hip and knee replacement surgeries and how manufacturers are responding.

The recent development of a microchip might, some time soon, allow amputees to control their prosthetic limbs by simple thought. Dr Justin C Sanchez talks about his team's work, how it could change the lives of patients and what it might mean for the future of certain medical devices.

In this issue we look at the ways medical device manufacturers are improving the fight against medical-related infections. Jason O Clevenger Ph.D looks at how the industry is working to reduce the risk of infection from medical implants through the use of antimicrobial coatings. Eucomed's director general, Maurice Wagner, asks why the European market is lagging behind its global counterparts in R&D and offers some solutions to boosting investment and hence innovation.

The growing popularity of air filters has been welcomed by manufacturers, particularly promoting the message that they can help reduce the risk of cross-contamination. Despite this and the use by hospitals of air filters in some applications, Sean Duggan tells Medical Device Developments they are not yet being used to their full potential and calls on clinicians to improve their knowledge of these potentially life-saving tools.

In this issue, Maurice Wagner, Director General of Eucomed, discusses the regulatory obstacles faced by China in its battle for basic healthcare. Meanwhile, Ruth Sharples of Frost & Sullivan assesses the European bone graft market.

We also look at the truth behind sexual discrimination in healthcare, with evidence from Christina Anné of Cook Women’s Health. Powering portable medical devices has become a huge issue for the medical device community, and Dr Robin Tichy expands on the suitability of lithium ion batteries.

In this issue, Jori Frahler of MDMA argues that by not adopting ICD-9, the USA is lagging behind the rest of the developed world; Lawrence Knuckey and Charles Sidebottom look at how the IEC's standards for electrical procedures have improved patient safety over the last 100 years; Dr Steven Goodman discusses how light microscopy can be used in developing medical devices; and Jan Gates reflects on the significant elements of device packaging.

Featuring insight from Christian Campion, Quality Assurance, GE Healthcare looks at the quest for quality using the Six Sigma standards. Plus Joachim Kohn Professor of Chemistry and Chemical Biology at Rutgers University reports on the biodegradable future, and how a new device for hernia treatment has opened new doors.

We also take a look at medical device test strategies with Max Cortner of Guidant focusing on how manufacturers must devise and implement an effective production testing strategy.