Comparison, trends and significance of the results

Comparing the results to the theoretical background, it can be seen that while the docu-mented processes were found mostly compliant with the regulatory requirements and standards in the process review of the case study, the implementation in practice, for example creating records of what has been done in the product development, is what needs to be paid more attention to. This is in line with the conclusions of the theory chapter, in which it was also recognized that one of the biggest challenges for medical device manufacturers is often to evaluate which requirements they are subject to and especially how those requirements should be fulfilled in just their company and situation.

The interview results show that the continuously evolving, various requirements of differ-ent markets, let alone the customers, discussed in the theory part directly cause a need for continuous development in all functions of the company: many interviewees stated that they did not feel educated enough on the regulation applicable to their work, and all of them pointed out smaller and bigger aspects where different requirements should be turned into reality.

Between the different interviewees’ answers, there were plenty of similarities: many de-velopers highlighted similar points of improvement with each other, as did the manage-ment team members. Some proposals were also stated by almost all the interviewees, despite their job description. Similar, larger themes could also be observed in all inter-views. The differences between the interviewees’ outlooks, in turn, were quite minor. No

completely contrary opinions were stated at all – however, it is worth noting that the interviewees did not get to see each other’s answers and state their opinions on them.

Depending on the interviewee’s job description and the function where they work, differ-ent emphases could be observed in the discussions. Naturally, the interviewees had more improvement ideas for the parts of the processes and tasks which they work with daily and less for the ones they engage in less frequently. In conclusion, a few larger trends could be observed in all the interviews, while the differences in the answers of different interviewees were quite slight.

A total of three larger themes that were present in all interviews could be identified. First, more structure and consistency are needed both in individual projects and, more gener-ally, in processes and systems. Similar practices and tools should be used in all projects and the projects should be followed through with consistency and regularity. Processes and for example the use of different systems for data storage should be harmonized.

Second, more training or education on the regulatory and other requirements and the different processes should be organized, or the communication made more effective. For example the knowledge on customer-related processes and regulatory requirements re-lated to the product development processes were considered insufficient by many. Thus, awareness of the internal processes and related regulation should be increased among the whole staff. Finally, many processes should be optimized and updated for the current situation, size of staff and number of projects of the company. From small procedures, such as the management approval procedure, to bigger ones, such as whole parts of the quality and product management processes, should be re-evaluated and improved to suit the current situation better.

For the case company, the most remarkable significance of this study is the proposals of improvement for their processes. They can be utilized to implement improvements designed by employees to the processes and aspects determined by the company in the beginning of this study. Some of the proposals are almost readily applicable, as the in-terviewees provided plans on how they could be implemented, while others require a little more planning before they can be implemented. The proposals could be considered in the order that they are prioritized to in the previous chapter, however, the order should first be reviewed and adjusted by a competent person, as the prioritization in this work does not consider all possible factors affecting the urgency of the proposals. In addition, as this study only covers four processes, a similar approach could later be applied to other processes in need of improvement.

Further, implications relevant to the company can also be derived from the three larger themes that were identified from the interview answers. They should be paid attention to

as such – by making changes and improvements in accordance with them to the pro-cesses at focus – but can also be applied to a larger context. All the three themes are not only applicable to just this exact situation and phase of the company, but could be seen as points of continuous, incremental improvement: creating consistency and struc-ture to processes and projects, training and dissemination of information on regulatory and other kinds of requirements as well as optimization and updating of processes are all rather continuous processes than single short-term tasks. In addition to the specific proposals for improvement, these themes could be considered guidelines over a longer period of time.

As this study was conducted as a case study focusing on only one company, the results and their consequences cannot be directly generalized to other similar companies. After all, the objective was to gain an understanding of the situation and improvement possi-bilities of just this company. However, at least the three larger themes identified from the results may have indirect consequences to and are worth reflecting for companies in similar phases of business and situations as the case company of this study. Of course the product that the company manufactures, number and competence of staff and other factors affect the applicability, but in general, consistency and structure of processes and projects, knowledge of regulatory and other requirements and continuous process opti-mization may be likely to affect a company positively, especially if these themes are previously disregarded in the company. Also the conclusions of the theory part support these considerations: according to literature, companies manufacturing medical devices benefit from regulatory competence and are required to constantly review and adjust their processes to comply with the changing requirements from different sources. The degree of influence depends naturally on the company and its current situation. On the other hand, this study and its method managed to provide at least some insight into the improvement needs of the company. Thus, a company in a similar situation planning a process development project can consider this approach in their plans on the implemen-tation of the project.

Similar conclusions can be drawn considering a larger audience, the different operators of the medical device market and the whole sector. Again, the proposals from the case study are too specific to be generalized to a larger context, but the three themes identified from them may give guidelines of what kind of actions can be taken to promote entrepre-neurship and support businesses in the medical device sector. As the field is strongly regulated and knowledge on regulatory and other requirements was found to positively contribute to the company’s success on both the theory part and case study of this work, perhaps entrepreneurs and employees in the sector could be supported by providing

training and education on regulation and regulatory competence for example through seminars, conferences or courses. The providers could be for example governmental offices, interest organizations or unions with interest in supporting and advancing do-mestic enterprises. On the other hand, also universities could provide courses and edu-cation on regulatory affairs to those studying to work in the sector. Aside from knowledge on regulation and requirements, the same applies to the other themes: if they are con-sidered applicable to more companies than just the one in this study, information on them and how to implement them in individual companies could be disseminated by the same operators as in regard to regulatory competence.

While promoting these themes may support and help companies manufacturing medical devices, they should also be considered by other operators. For example, as incremental improvement and optimization of processes can be beneficial to at least start-up compa-nies in the sector based on the theory part and the case study, also operators such as competent authorities, notified bodies and even customers such as hospitals could en-courage a company culture in which incremental and continuous improvement is carried out – after all, it is also their interest that manufacturers work as efficiently as possible to provide safe and effective products. Same applies to consistency and structure in pro-cesses and projects. Especially in joint development projects where, for example, a soft-ware or other product version is developed in collaboration with a university, hospital or a customer, all parties should be committed to a working culture supporting consistency and structure and thus reasonable schedules, workloads and ultimately employee well-being.