Medical device development is a significant multi-faceted undertaking that requires a holistic approach combining theoretical scientific and biological knowledge, along with an understanding of the regulatory and commercialisation process. Devices based on ElectroMagnetic (EM) therapeutic technologies, specifically, hold great potential for the treatment of diseases. These technologies provide treatment through modification of tissue temperature. Specifically, HyperThermia (HT) therapy is a medical treatment which alters tissue temperature in the body to just above a normal physiological level. As one of the oldest known treatment modalities in oncology, it is used to sensitize tumour cells, making the cancerous tissue more susceptible to chemotherapy and radiotherapy.
Today, EM HT is a promising technology used to treat cancerous tumours that are resistant to standard treatments. Targeted EM HT has been demonstrated to be particularly effective in the treatment of cervical cancer, breast cancer, cancers of the head and neck, sarcoma in adults, and germ cell tumours in young children. Other thermal-based EM technologies include RadioFrequency Ablation (RFA) and MicroWave Ablation (MWA), and offer promising treatments for liver, kidney and lung cancer. Both methods cause the direct coagulation of diseased tissue (i.e., death of the diseased tissues), and allow for high spatial selectivity in terms of targeting the cancerous tissue while protecting the surrounding healthy tissue. MWA is more of an emerging technology, where the focus is on further increasing the targeted heating volume relative to RFA, while protecting more of the surrounding healthy tissue. Nowadays, it is generally recognised that such treatments should be paired with proper treatment planning procedures such that patients are offered personalized treatment. The design and development of treatment planning requires knowledge of dielectric and thermal tissue properties in order to determine the distribution of absorbed energy and the temperature. These parameters characterise the interactions of EM fields with the body.
The Challenge underpinning EM therapeutics is the need for reliable, accurate knowledge of the dielectric and thermal properties of human tissues and how these parameters change with time, temperature, hydration, and blood perfusion. Limited usage of these modalities is found in clinics, however the potential to apply them to wide range of clinical conditions has not yet been exploited.
Additionally, there remain fundamental questions underlying treatment planning, which call for a cooperative and coordinated effort (yet noncompetitive, as it requires establishing a generalized consensus) that is well suited for a COST Action. Therefore, MyWAVE COST Action, with the acronym emphasizing the use of electromagnetic waves for personalised, patient-specific treatment.
Additionally, dielectric and thermal properties can be incorporated into computational models to assess the technical risk of a proposed medical device, and to optimise its design, efficacy, and safety. Without adequate dielectric and thermal knowledge, engineers are forced to develop prototype systems and complete costly patient pilot studies in order to gather the same preliminary data, which heavily burdens budgets of small and medium-sized enterprises (SMEs). The lack of structured literature on tissue properties also makes the regulatory path for the devices more expensive and complex. On the other hand, larger companies have not been carrying out this research in a structured and open fashion, instead they have been focused on specific, limited product-based studies. This challenge is not limited to EM hyperthermic therapies but also to other uses of microwaves, such as diagnostics and theranostics.
Furthermore, very often researchers working on the development of medical technologies are not fully aware of, and not trained to address, the clinical and commercialisation challenges facing novel medical devices. For this reason, researchers may choose to investigate clinical needs that are not in line with those identified by medical professionals, or that are not commercially viable (due to lack of market size, strong competing technologies, or insurmountable technical risks).
These challenges, will be synergistically addressed by this collaborative network, which will bring together engineers, scientists, academics, medical professionals, and experts from the market-commercialisation community. This multidisciplinary network will provide technologists with the opportunity to fully recognise and understand the clinical and commercialisation challenges of medical devices. The medical community will identify niches which require attention by the scientific community and will support and provide feedback on medical devices and technologies as end-users. The market-commercialisation community will act as a bridge, facilitating the translation of technologies from the laboratory to the clinical environment. Bringing these varied communities into one collaborative network will result in a much-needed holistic approach to the design, development, and commercialization of EM therapeutic technologies. This Action will increase the interaction, cooperation, and reciprocal understanding between participants from different scientific and technical domains by offering international, interdisciplinary, and intersectoral workshops, Training Schools (TSs), and Short Term Scientific Missions (STSMs), to expand expertise across technical and non-technical areas of medical device innovation and commercialisation.
