HomeEventsPhd Defence Katarzyna Markiewicz

Phd Defence Katarzyna Markiewicz

health technology assessment of medical devices during development 

This thesis was written under the assumption that the implementation and adoption of new medical devices can be supported by an early assessment of economic and clinical perspectives. The early stages of the medical device development are found crucial, as early in the lifecycle the device development process can either emerge or conclude without major financial drawbacks for the company. An assessment of medical devices starting at the early stages could result in a decrease of the failure rate at each stage of further medical device development, and thus in an increased Research and Development (R&D) efficiency. This, on the other hand, could lead to more successful reimbursement of new medical innovations and better prioritization of devices that are most likely to succeed.However, as the iterative use of medical device assessment alongside their development is relatively new and unknown, many questions remain.

To answer some of those questions, this thesis particularly addressed the:

  1. clinical need and methods to engage various stakeholders within the medical device development,
  2. the evaluation of the commercial viability of medical devices early in the lifecycle to prioritize development of the most “beneficial” technologies using potential added value to society and, hence, economic returns,
  3. the adaptation of a decision support tool for the manufacturers to be used alongside the medical device development process.

First of all the focus of the research was on investigating the current state of the art in the early assessment and the identification of an assessment methods reported in the literature that help to inform decisions during the development stages of medical devices (Chapter 2). The results obtained from a literature study were synthesized in a form of a survey for the Dutch medical device manufacturers that aimed to investigate the use of early assessment methods in practice (Chapter 3).

The results of these studies indicated that an early assessment holds the promise for more informed decisions that could improve the pace and the efficiency of the device development and guarantee their successful implementation in the future. However, there is no well-developed framework for an early assessment, which makes evaluation of its value difficult. Although many methods seem to be in use within the medical device industry, there is no clear understanding of how those methods are conducted, what evidential requirements are to be met and how this supports the decision-making process in companies.

Furthermore, the understanding of how an early assessment in the medical device industry is conducted determined the choice of the methods/approaches, identified as promising and relatively easy to use, to be tested on the examples of real medical devices under development in further research. Medical devices that were used as case studies during this research period were all being developed by a spin-off companies and research groups of the University of Twente. They were selected as a convenience sample based on their characteristics to cover the whole range of disruptive and incremental innovations of both add-on supplies as well as therapeutic and diagnostic devices.

As a part of the Clinical consideration, the focus was first on applying iteratively a stakeholders analysis as a tool to identify potential clinical need for new medical device (Chapter 4). The literature study on stakeholder engagement indicate that it can be an important first step to identify unmet clinical needs, as well as clinical, organizational and regulatory barriers relevant for strategic decision making. It should thus become an integral part of the device development process. However, the results of the stakeholder engagement research conducted within the framework of this thesis indicate that the stakeholder engagement alone has only limited ability to change the manufacturers concept and objectives in medical device development.

Stakeholder engagement research was followed by simple health economic calculations based on the Headroom method combined with the Return on Investment analysis (ROI) to determine the potential commercial viability of several medical devices (Chapter 5). Early health economic modelling is promoted as an important part of an early assessment of medical devices. While there is a focus on the use of complex methods, such as cost-effectiveness analysis or cost-benefit analysis, the Headroom method seem to be best aligned with the requirements in early development. Also, the headroom methods seem most suited to link the potential return of investment for the manufacturers with the value added to the healthcare system. It might thus be an answer to the growing need of performing value-based pricing of medical devices at the early stages of the development and define their potential commercial viability.

Finally, in Chapter 6 a general scoring model widely used to evaluate New Product Development (NPD) was adapted to fit into the medical device industry. The results of that research indicated that NewProd model could become a practical tool to support manufacturers in medical device development, offering a decision support about the potential of medical devices to compete effectively in the market and generate profit. It could thus support successful portfolio management and project prioritization, and lead to more informed resource allocation decisions within the company. However, further work is necessary regarding the actual use of the adaptedmodel as a decision support in the early stages of medical device development.