Medical Devices Development
The development and deployment of medical devices and radiotracers into the NHS remains a complex, multi-step pathway requiring integration and validation before use in first-in-patient studies (a pre-requisite for adoption of new medical technologies). The regulatory pathway for approval is complex and requires specialised support. To overcome the obstacles that hinder translation, the Centre provides a team of specialist “core” staff, including a Quality Management System (QMS) team and a Health Technology Assessment (HTA) team specialising in software and device evaluation from King’s Health Economics and King’s Technology Evaluation Centre (KiTEC). These posts provide statistical and economic modelling support and advice on regulatory processes, intervention effectiveness, and ethics applications. Using the HTA expertise available has helped our research groups determine the value proposition of their technology and demonstrate its clinical efficacy and cost-effectiveness. Utilising our regulatory expertise to develop novel technologies in accordance with national and international evidence standards ensures clinical and commercial uptake.
Quality Management System
The QMS is hosted by the School of Biomedical Engineering and Imaging Sciences located at the St Thomas’ Campus of King’s College London, run by staff from the Wellcome/EPSRC Centre for Medical Engineering (CME) and the facility for the Manufacturing of Active Implants and Surgical Instruments (MAISI).
The activities performed encompass early proof of concept research right through to first-in-patient studies of medical devices. The QMS team’s goal is to apply best practices in the design, development and manufacturing of research prototypes to facilitate their clinical translation and meet the requirements of our customers, patients and end users. The processes will operate “like a funnel” with unambiguous decisions taken as projects progress to ensure that the appropriate processes are applied and where these are not yet regulated, they are maximally harmonised with recognised standards so that continuous refinement and improvements leads to the most effective translational pathway. The quality system will provide a common framework to achieve this.
Health Technology Assessment
New interventions and technologies are constantly being developed and refined but their impacts on health, and implications for health systems, are not always clear. Health technology assessment (HTA) is a systematic and multidisciplinary evaluation of the properties of health technologies and interventions covering both their direct and indirect consequences. It is a multidisciplinary process that aims to determine the value of a health technology and to inform guidance on how these technologies can be used in health systems around the world. HTA is a transparent and accountable process that can be used by decision makers and other stakeholders to support the decision-making process in health care at the policy level by providing evidence about given technologies It has been described as a bridge that connects the world of research to that of policy making.
For more information, visit: www.who.int/health-topics/health-technology-assessment#tab=tab_1
King’s Health Economics and King’s Technology Evaluation Centre (KiTEC)
We offer a full HTA service delivered by our highly experienced team of health technology assessors, health economists, literature review analysts, medical statisticians, and clinical consultants. This “one-team” approach delivers quality, consistency, and efficiency for our clients.
HTA is the bridge between evidence and policy-making, providing a range of stakeholders with evidence-based information to guide decisions around the efficient allocation of resources. An HTA report assesses the product’s clinical and economic value relative to current clinical practice, including where a product is deemed to provide sufficient incremental value at an acceptable price to justify its use by the health service.
In many key markets, gaining approval by national reimbursement, pricing, or HTA agencies is critical to the commercial success of a new product launch.