Analysis of Quality and Product Management Systems in a Medical Software Start-Up Company
Sauranen, Sara (2021)
2021
Biotekniikan DI-ohjelma - Master's Programme in Bioengineering
Lääketieteen ja terveysteknologian tiedekunta - Faculty of Medicine and Health Technology
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Hyväksymispäivämäärä
2021-06-18
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tuni-202105265482
https://urn.fi/URN:NBN:fi:tuni-202105265482
Tiivistelmä
While the rapid development of technology brings various new solutions to the challenges of health and healthcare, their regulation to ensure safe and effective care is developed constantly. Especially software as a medical device are subject to quickly evolving regulation, as they are becoming more and more common. With the continuously developing requirements that also depend on jurisdiction, medical device manufacturers must ensure effectively that their processes and products comply with all relevant requirements. In this study, the main objectives are to discover what factors must be considered in the design of quality and product management systems of medical software companies. The linkages between regulation and business strategy are defined as well. Four of the quality and product management processes of the case company, Disior, are examined and proposals for their improvement are collected.
The objectives were reached by studying the topic through a literature review, interviews with professionals and a case study. In the literature review, the most important concepts of medical device and especially software regulation and quality and product management systems were clarified. Also the strategic linkages were studied in the literature review, but in addition, interviews were done with professionals with expertise in investments and medical device business to discover how regulation affects the competitiveness and financing of medical device manufacturers in their opinion. In the case study, a process review was conducted on four processes of the case company and related records. After that, six employees were interviewed about the current compliance with the process descriptions as well as how the processes could be improved and the improvements implemented in the interviewees’ opinion.
It was found that in European Union, the central legislation of medical devices comprises Medical Devices Regulation and In-Vitro Diagnostic Medical Devices Regulation and in United states of America, the Code of Federal Regulations Title 21. Although regulation varies in different jurisdictions, in many markets the most important standards that should be followed designing quality and product management systems for medical software products include ISO 16142-1, IEC 62304, IEC 62366-1, IEC 82304-1, ISO 14971, IEC/TR 80002-1 and ISO 13485. How compliance with regulation is implemented depends on the size, product variety and target markets of the company. It was concluded that regulation affects the competitiveness and financing of companies and is thus linked to their strategy. Regarding competitiveness, market access, sales and distribution strategies and the efficiency of research and development processes are impacted by regulation and regulatory competence. Financing is linked to regulation as the regulatory status of a company and its products are closely evaluated by potential investors.
The case study resulted in 22 proposals for improvement for the software development, maintenance and risk management and the product realization processes and general-level aspects. Some proposals include a plan on their implementation as well. The proposals were prioritized into three urgency level groups based on their frequencies in the interviews. In addition, three larger themes were identified from the proposals: the need of more structure and consistency, the need of training and education on regulatory and other requirements and processes, and the need of continuous optimization and improvement of processes. Both the individual proposals and themes were also considered from a strategic perspective. It can be recommended that the proposals are implemented in the case company. The themes should be considered by not only the case company but also other similar companies. Other operators, such as regulators and universities, may reflect how they can support the medical device sector and its growth and individual businesses in the light of the findings and themes identified in this study.
The objectives were reached by studying the topic through a literature review, interviews with professionals and a case study. In the literature review, the most important concepts of medical device and especially software regulation and quality and product management systems were clarified. Also the strategic linkages were studied in the literature review, but in addition, interviews were done with professionals with expertise in investments and medical device business to discover how regulation affects the competitiveness and financing of medical device manufacturers in their opinion. In the case study, a process review was conducted on four processes of the case company and related records. After that, six employees were interviewed about the current compliance with the process descriptions as well as how the processes could be improved and the improvements implemented in the interviewees’ opinion.
It was found that in European Union, the central legislation of medical devices comprises Medical Devices Regulation and In-Vitro Diagnostic Medical Devices Regulation and in United states of America, the Code of Federal Regulations Title 21. Although regulation varies in different jurisdictions, in many markets the most important standards that should be followed designing quality and product management systems for medical software products include ISO 16142-1, IEC 62304, IEC 62366-1, IEC 82304-1, ISO 14971, IEC/TR 80002-1 and ISO 13485. How compliance with regulation is implemented depends on the size, product variety and target markets of the company. It was concluded that regulation affects the competitiveness and financing of companies and is thus linked to their strategy. Regarding competitiveness, market access, sales and distribution strategies and the efficiency of research and development processes are impacted by regulation and regulatory competence. Financing is linked to regulation as the regulatory status of a company and its products are closely evaluated by potential investors.
The case study resulted in 22 proposals for improvement for the software development, maintenance and risk management and the product realization processes and general-level aspects. Some proposals include a plan on their implementation as well. The proposals were prioritized into three urgency level groups based on their frequencies in the interviews. In addition, three larger themes were identified from the proposals: the need of more structure and consistency, the need of training and education on regulatory and other requirements and processes, and the need of continuous optimization and improvement of processes. Both the individual proposals and themes were also considered from a strategic perspective. It can be recommended that the proposals are implemented in the case company. The themes should be considered by not only the case company but also other similar companies. Other operators, such as regulators and universities, may reflect how they can support the medical device sector and its growth and individual businesses in the light of the findings and themes identified in this study.