Medical Device Link.

DESIGN

Time to get closer

It has always been clear that many of the innovations that have transformed health care have come from the combination of progress in seemingly unrelated areas. For example, X-ray imaging came about as a chance discovery that radioactive materials left images on chemically prepared photographic plates. The increasing level of today’s scientific research is creating even more subdivisions within the scientific disciplines and there is a danger that innovation will be stifled by the inability of scientists and engineers to communicate across the somewhat artificial boundaries created by their jargon. Efforts to counterbalance this tendency are being made with the creation of interdisciplinary institutes within many of the United Kingdom’s leading universities. For example, the Institute of Pharmaceutical Innovation¹ in Bradford and the Materials Engineering Research Institute in Sheffield (www.shu.ac.uk/research/meri). These initiatives not only place researchers from different disciplines in close physical proximity so that they can more easily interact, but they are also actively exploring the ways in which converging technologies can create innovative new products.

A matter of scale

Figure 1: (click to enlarge) Technology convergence.

Figure 1 illustrates one of the fundamental reasons why convergence is becoming more important. Modern manufacturing technology provides the capability to shape and structure a wide variety of materials at a dimensional scale, that is, in the same range as biological entities such as cells and viruses, and now even at the level of large molecules. In a few years time, the ability to shape and structure material will extend down to the scale of small molecules.

Figure 2: (click to enlarge) Two routes to the nanoscale.

This capability to manufacture at the nanometre scale has been developed over many years (Figure 2). There are two routes to nanoscale manufacturing. First, the so-called top-down methods, which start with material in bulk form and then use alternating photolithography, etch and deposition patterns to form microscopic features; this process is sometimes referred to as micromachining. The second route, which has been developed in parallel with the first, is bottom-up technology, often referred to as nanotechnology. This starts from the atomic or molecular level and uses smart chemistry to assemble larger and increasingly complex structures. Recently these two approaches have converged on the same dimensional scale, allowing them to interact to form new and exciting devices with hitherto unachievable capabilities. One example of recent innovations is a microanalyser for real-time analysis of therapeutic drugs, disease markers and blood chemistry in critically ill patients (www.spheremedical.com), which combines micromachined sensors with membranes that create sensitivity to key analytes and molecules such as drugs. Another example is a DNA chip that uses top-down processing techniques to pattern arrays of sensitive molecules (www.affymetrix.com).

Table I : (click to enlarge) Technology convergence in diagnostic imaging.

This ability to make new structures holds great potential for future medical devices. These devices will combine advances in micromachining and nanotechnology with biomaterials, tissue engineering, microelectronics and information processing and communications technology.² Technology convergence is not a 21st century phenomenon. Since the beginning of medical science, many innovations have been the result of combining scientific knowledge from more than one discipline. One example is illustrated in Table I, which shows how this process has been under way for at least 100 years in diagnostic imaging.

Each new generation of imaging technology has been able to significantly enhance the information available for clinical diagnosis. Whereas early X-ray technology took several minutes to produce a simple static image with differentiation between hard (bone) and soft tissue, the latest quantum dot imaging technology^3,4 can resolve tiny blood vessels in mouse tissue in a dynamic image that shows the vessel walls rippling with each heart beat.⁵

It is illuminating to see that each generation of imaging method listed in Table I depended on the introduction of at least one completely different technology from what existed before. In parallel, each imaging method has also benefited from incremental technological developments that have delivered steady improvements in cost performance. Thus, one can differentiate between incremental innovation that provides steady small improvements in cost performance and the truly disruptive
technology breakthroughs that provide a real step change in performance or functionality. It is the truly disruptive breakthroughs that, more often than not, are triggered by technology convergence.

In imaging, the next technology convergence is with the technologies of miniaturisation, in particular micromachining, which is enabling large pieces of equipment to be radically shrunk down in size so that they can be used inside the human body. Some examples of this are the camera pill (www.givenimaging.com) and miniature ultrasound scanners that can fit on the tip of a catheter to image the inside of a blood vessel (www.volcanocorp.com).²

Point-of-care diagnostics

Table II : (click to enlarge) Blood-glucose measurement.

Point-of-care (POC) diagnostic devices provide another example of the impact of converging technologies. Here, the technology is at an earlier state than imaging technology. The technology progression shown in Table II relates to blood-glucose measurement. The earliest testing methods were used only by qualified medical staff and required careful interpretation before being used to adjust the dosage of insulin. By the end of the 1980s, small hand-held instruments were in widespread use, which, because of their proven reliability, were used with confidence by patients to control their own insulin dosage. Subsequent technology developments have focussed on delivering information about a wider range of blood parameters in POC instruments that combine fast accurate measurements with ease of use. The growing incidence of diabetics is stimulating an intense search for a noninvasive method of measuring blood glucose without the need to pierce the skin to take a blood sample. The Roadmap in Figure 4 illustrates the diversity of new technologies being developed to meet this challenge.

How to foster convergence

Figure 4: (click to enlarge) Future blood-glucose measurement technologies.

The aforementioned examples illustrate the essential role that technology convergence plays in new medical product innovation. For the sake of the future growth and profitability of the medical device industry, technology convergence must be encouraged. The following suggestions are offered and involve action at organisational level in academia and industry as well as courage and vision at an individual level.

In academia it is clear that different technical disciplines need to be brought together to stimulate multidisciplinary solutions to many of the unsolved clinical needs. The creation of cross-disciplinary institutes should be encouraged and these will be even more effective when the various types of scientists can be colocated and encouraged to interact at a personal level in an informal way, as well as through formal project groupings.

In industry, engineers and scientists should be encouraged to move through different departments and functions rather than become increasingly specialised in one narrow discipline. Companies must also be willing to partner with others from unrelated sectors of industry to create the multidisciplinary teams needed. Individuals will need to move out of their comfort zones and be prepared to learn new technical disciplines, at least to the level where they can interact with specialists in other fields. The reward will be a new generation of innovators following in the footsteps of giants such as Leonardo da Vinci.

Dr J. Malcolm Wilkinson is Managing Director at Technology for Industry Ltd, E-Space North, 181 Widsbech Road, Littleport, Ely CB6 1RA, UK,
tel. +44 1353 865 400, e-mail: jmw@tfi-ltd.co.uk, www.tfi-ltd.co.uk.