Smaller is better

Mike Fisher tells us how emerging nanotechnology is set to revolutionise medical devices

The ageing population, prevalence of chronic diseases and the rise of emerging economies in areas such as the BRIC (Brazil, Russia, India and China) countries has created an increase in demand for innovative medical devices that help solve true unmet medical needs. On the flip-side, economic pressures caused by an ageing population and greater demand from an increasingly knowledgeable patient population, is putting pressure on healthcare payers and driving down the cost per patient available for healthcare. Value for money is the key in tomorrow’s healthcare market. The value for money question isn’t just about medical products being lower cost; it’s about reducing the overall financial burden to the healthcare system.

Europe has a number of leading medtech companies, as well as world renowned design houses and R&D facilities, creating a critical mass. Building on this, a new discipline has now emerged at the interface of electronics and medical engineering that is leading the manufacture of revolutionary medical devices. Termed bioelectronics, it promises to transform biological systems and biomedical technology.

So where does nanotechnology come in? Over the past decade there has been significant interest in the promise that nanotechnology holds for life sciences and more specifically, healthcare. Cientifica recently predicted that the nanodiagnostics market will reach $50 billion by 2021. With the exciting potentials this area of technology offers, it is likely that it will continue to build as a sector for investment.

Imagine a world where all you need is your smartphone with an add-on device to detect any disease without the need for costly and lengthy analysis in the lab

The bioelectronics industry has been revolutionised by the strategy that "smaller is better", and using these same techniques and applying them to the medical and pharmaceutical world has opened new exciting market opportunities. Nanotechnology is starting to revolutionise medical diagnostics through earlier detection of disease, higher sensitivity, higher accuracy, higher throughput capability, more results per assay, time saving, point of care delivery and increased cost-effectiveness.

This next level of miniaturisation, into nanoscale dimensions is a booming area of research and development, with significant funding being invested worldwide. Miniaturisation in the medical device industry is already taking hold and solving a number of modern healthcare challenges, whilst allowing the production of more robust, integrated devices that require lower power and are less invasive to the patient. These smaller devices, such as lab-on-chip technology, are also more mobile and can be applied outside their historical hospital, or even surgical setting.

Ten years ago lab-on-chip was a concept without a viable market entry point but now point-of-care diagnostic systems are starting to show clear benefits in areas such as disease detection and cancer therapy. By using these applications to analyse extremely small samples of blood, interstitial fluid, urine and saliva, medics are able to use minimally invasive techniques to obtain results that are easily collected with minimal stress and discomfort to patients.

Using miniaturisation, medical diagnosis equipment can now be used outside of labs, in doctor’s surgeries, remotely, and even on mobile phones, delivering endless applications. Imagine a world where all you need is your smartphone with an add-on device to detect any disease without the need for costly and lengthy analysis in the lab. Obviously such devices will need careful control and implementation to ensure socially responsible use, but these advances would mean diagnostics, and even intervention, can be provided at home instead of in a centralised hospital. In these cases, there are multiple benefits: a reduction in the burden of running the diagnostic test in a centralised lab; a reduction in hospital visits and stays; and greater information on a patient’s disease state, as levels can be monitored over time as opposed to a single time point.

Providing early diagnosis means the right treatment can be given early, avoiding complications caused by delays. Micro and nano diagnostic devices can also provide closed-loop systems, which continuously monitor patients and immediately respond to changes in physiological conditions. This is particularly important in the Intensive Care Unit where even simple parameters such as oxygen levels, can be critical.

Miniaturisation is also being applied to macro-scale devices, such as in orthopaedics. Numerous replacement joints, such as hips, now have micro and nano-structured surfaces and coatings to decrease joint wear and increase integration of the device with the patient’s body. Such coatings increase the life of the device and decrease the risk of revision.

With applications like point-of-care diagnostics already emerging with huge benefits to patients, there is no doubt that the next generation of healthcare technology will be enabled by the use of miniaturisation and nanotechnology. Taking a simple and effective concept from the semiconductor world has already delivered a dramatic effect on medical diagnostics and is moving into drug discovery, creating new and exciting applications across a wide variety of markets.

Nanotechnology is advancing areas of drug discovery by shortening the discovery cycle. Utilisation of microfluidics and miniaturised assays can enable systems to be developed which are highly automated, sensitive and require small amounts of compound. Such systems can produce quantitative data to determine the biological and physical properties of a novel compound in a relatively short analysis time. It has also been demonstrated that in-flow synthesis is possible, coupling this with the required biological assays employing microfluidics, with sophisticated fluid handling systems could revolutionise the drug discovery process. On a regular lab scale this can take many weeks, sending samples between different groups for testing, before the properties of a compound can be determined. Companies such as Cyclofluidic, a joint venture of Pfizer and UCB, are developing these technologies to develop a closed loop drug design and testing system.

Nanoparticles are also being developed to detect physiological changes in the body and can release drugs at certain times depending on these changes. For example, it is known that there is a pH difference between tumour and healthy tissue, so this switch could be used to open drug carrying particles. These applications run alongside emerging new technologies for developing customised solutions for drug delivery systems. Nanoparticles enable these drug delivery systems to positively affect the rate of absorption, distribution, and therefore metabolism and excretion of the drug in the body.

Clearly, many of the applications in the bioelectronics market are novel and as a result are yet to be fully developed and economically viable

It is clear that nanotechnology has a lot to offer and early adopters will reap the rewards. The technology is still in its first phase of development and industry leaders believe major growth will occur between 2015 and 2035, providing the public, academia and research facilities support it now. Several commentators have speculated that nanotechnology is the wave of the future in medical technology, biotechnology and pharmaceuticals. Predictions suggest that the market could rise steeply after 2012, potentially reaching $220bn by 2015 for nano-enabled compounds. However, at the moment there is a disparity between these predictions and the actions of the very companies that are in a position to make them come true.

What we can conclude is that nanotechnology has a lot to offer but it faces a number of hurdles, such as a clear regulatory pathway and a demonstration of value above and beyond current technologies, before it can become mainstream. However, efforts are being made by industry and governments to help it to jump the technology adoption gap quickly and ensure it can assist in developing the next generation of products for significant unmet medical needs. With numerous life science applications at the early stages of development and entering the market, it is important that patient safety and clinical need are central.

The current interest in bioelectronics is driven by the many advances that this area of nanoscience promises. Individuals, companies and funding bodies are all looking for ways of investing in this recently commercialised technology and to ensure success, nano-companies need to secure support from venture capitalists and other funding bodies. However, despite the advanced developments in bioelectronics, the industry is still relatively new and there are a number of gaps in the supply chain that prohibit products getting to market in an effective manner. It is crucial with all new technologies to ensure that all parts of the supply chain interact and keep each other informed of developments and capabilities.

As with most technologies, bioelectronics will develop over time. Clearly, many of the applications in the bioelectronics market are novel and as a result are yet to be fully developed and economically viable. In the quest to make these technologies and applications available to a wider market, the cost per device is a - but not ultimately - the deciding factor. Most innovations are more expensive than the incumbent technology they replace and it can be expected that as the use of nano-enabled devices becomes more widespread, the associated costs will reduce and the applications expand much more widely. The critical success factor will be the demonstration of value to healthcare payers. The issue here is that sometimes this value will be realised in a different area than where the cost traditionally sits. For example, placing a diagnostic in the home setting could create a saving to a hospital pathology laboratory, but place a financial burden on social service/carer provision. This issue is starting to be tackled in different ways around the world, and it will be critical that companies know the market in which they operate and how their product will affect reimbursement.

Nanotechnology is starting to impact healthcare and some nano-enabled devices are widely used already – for example, the home pregnancy test uses gold nanoparticles to create the colour change that indicates the result. It is inevitable, given the economic benefits that can be derived in areas such as home diagnosis and treatment, improved drug discovery efficiency and improved drug delivery that nanotechnology will continue to be adopted and supported by the life science industries.

Author: Mike Fisher, Theme Manager – Healthcare & Life Sciences, Nanotechnology Knowledge Transfer Network (NanoKTN)