DESIGN

Reasons to adopt nanoproducts

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Nanotechnology is being applied to medicine at an ever-increasing rate and virtually all fields of medical practice are likely to eventually be affected. Diagnosis, imaging, drug delivery, in vivo monitoring, the design of biomedical materials and regenerative medicine are all areas in which huge research is taking place and where products incorporating nanotechnology are likely to appear in the market place. But will they be used? It may seem strange to ask this question given the potential benefits and improved efficacy that are frequently quoted for nanomedical products. But it is nevertheless a valid question.

Nanomedical products face a number of challenges before they can reach the market and some of these will be analysed further in future editions of Medical Device Technology. These challenges include being able to effectively analyse and manage risks, including new risks that may be associated with the nanotechnology component of the products; regulatory compliance; health care technology assessment; and funding and reimbursement issue. But one of the biggest, yet often neglected, challenges will be in relation to education and training.

Convincing the clinicians

To facilitate the introduction of new nanomedical products there will need to be an understanding amongst all involved stakeholders of how they work and their inherent benefits and risks. There will need to be a convincing argument why they should replace existing products with which medical professionals are already fully familiar. The nanoscale properties of materials may result in products that are more specific (such as in diagnosis), more accurate (such as in imaging), that can result in better and more localised use of smaller quantities of drugs (such as in targeted drug delivery), that offer better biocompatibility or other desired properties (such as in advanced biomedical materials and regenerative medicine), or that are cheaper to manufacture. Whatever the benefits, they need to be clearly communicated with information on any residual risks in the product that cannot be further reduced. Without these elements in place, it is unlikely that there will be professional uptake by those whose primary concern is effective treatment and patient safety.

The training need

Currently, nanomedicine rarely features in mainstream medical training or in continuing professional development. Some postgraduate courses are beginning to appear that incorporate elements of nanomedicine, but these are generally not geared to the needs of clinicians or to other professionals currently in post. Yet, by the time the current intake of medical students graduate as doctors and subsequently complete their two-year foundation programme, many new nanomedical products are likely to be appearing. For medical professionals, there seem to be two main training challenges with regard to nanomedicine:

• introducing some element of training about the applications of nanomedicine into medical degrees
• introducing training about nanomedicine into the continuing professional development of current medical professionals.

In addition, there will be a need to train other professionals to a reasonable level of understanding of nanomedicine. For example, researchers, regulators and those involved in the assessment of new medical technologies will need training so that they can adequately assess the value and impact of nanomedicine as part of the regulatory, health care technology assessment and funding and reimbursement processes.

An encompassing subject

Nanomedicine is highly multidisciplinary in nature and draws from a convergence of many scientific and engineering fields. It comprises the application of nanoscale science and nanotechnology to the development of new products, methodologies and therapies in a number of areas including,

• imaging such as molecular, oncological, vascular and neurological
• in vitro diagnosis
• in vivo diagnosis
• biosensors
• advanced biomedical materials, including “smart” and functionalised materials and surfaces
• regenerative medicine and tissue engineering
• drug design and targeted drug delivery
• theranostics
• gene and cell therapy
• novel medical technologies such as man-machine interfaces
• translational nanomedicine
• nanotoxicology.

A basic training module in nanomedicine would ideally comprise an overview of

• some of the terminology used
• the basic scientific principles underlying nanoscale characteristics of materials
• how nanotechnology is being applied in each of these fields
• what benefits it can bring such as faster or more accurate diagnosis and improved treatment
• what issues such as risks remain and how they are being addressed
• any important ethical considerations such as patient safety, confidentiality, security and environmental
• case studies of technologies or treatments as appropriate
• an indication of possible timescales for the development, approval and introduction of new products and treatments
• nanomedical risk management
• nanomedicine and ethics.

For those already specialising in a field of medicine, training could also include in-depth reviews of how nanotechnology is being applied to individual clinical disciplines such as

• oncology
• cardiovascular medicine
• neurology
• orthopaedics
• the targeting of drugs to specific organs and tissues
• the regeneration of tissues and organs
• clinical applications of new or “smart” materials.

A new disease paradigm

In considering the need for training in nanomedicine it may also be useful to consider whether its application will further influence our understanding of medicine. Our view of medicine has already radically changed over the past couple of centuries. What would have once been considered dangerous or painful surgical procedures are now commonplace; and the introduction of anaesthetics, antibiotics and other drugs have largely banished many diseases and treated commonplace conditions so that their absence is taken for granted.

In his book, Nanomedicine, Volume I, Basic Capabilities, Robert Freitas Jr,¹ analyses the various views of medicine and concepts of “a disease.” He proposes a shift to a “volitional normative” model of disease. In this model, Freitas defines normal functioning as

“…the optimal operation of biologically programmed processes as reflected in the patient’s own individual genetic instructions, rather than of those processes which might be reflected in a generalised population average or “Platonic ideal” of such instructions; the relative function of other members of the human population is no longer determinative. … Second, physical condition is regarded as a volitional state, in which the patient’s desires are a crucial element in the definition of health. This is a continuation of the current trend in which patients frequently see themselves as active partners in their own care.”

Freitas argues that, because nanomedicine enables doctors to intervene at a molecular or genetic level, views will change about “diseases” or conditions that we accept today or which are rarely treated. He gives examples such as addictions, allergies, food intolerances, minor physical “annoyances” such as cosmetic blemishes or physical irregularities, diseases caused by unknown agents, unwanted syndromes, and psychological traits. Furthermore, he notes that one potential weakness in the model is the ability of patients to make fully informed decisions concerning their own physical state.

However one may view this proposed model, it seems likely that nanomedicine will herald a new era of being able to treat, on a frequently individual patient basis, conditions that are today untreatable or currently accepted as “normal.” In terms of training, medical professionals for this eventuality, and in a future where patients will be much better informed and will wish to take an active role in determining their own treatment, some radical new paradigm shifts may need to be considered.