(Author: Christina Bober)
Link: Article as PDF
The road from a good, health-promoting idea to a medical device is long and undoubtedly challenging. Anyone who has ever successfully brought a product to market knows about the many challenges that product development brings with it anyway. A seemingly insurmountable mountain of regulatory requirements in the field of medical device development is added to these challenges.
Medical device development is sensibly regulated. In a sensitive area such as working on products that can have a direct impact on patient safety, it is necessary to establish rules. For example, there is a need for consistent risk analysis that focuses on the welfare and safety of patients. A product should not be allowed to be approved as long as the risks for the patient outweigh the medical benefits.
However, the level of regulation should not lead to nipping sensible, health-promoting product ideas that increase the healing and comfort of patients in the bud, or to making the path to the finished medical device as rocky as possible for them. Unfortunately, however, small and medium-sized companies in particular are currently getting the impression that this is exactly what is happening.
Many products contain software, require software and/or become "more intelligent" through the use of software and thus more helpful for the patient.
If a product is to be developed that contains software, the question arises as to whether in-house competencies and resources are available in this development area. If this is not the case, these can be built up or parts of the development can be outsourced. If it is medical software, this question must also take into account that this entails additional regulatory requirements, such as those of IEC 62304, for which further expertise and regulated processes are required.
For small and medium-sized companies in particular, one approach to a solution can be to cooperate with other development partners who have precisely this expertise. In this way, each partner can shine in its own area.
If the decision is made to outsource certain activities, soventec comes into consideration as a partner in the area of software development, since it is precisely in this definable area that our expertise lies.
We have been developing software in the regulated medical device sector for many years and can support and advise your internal software development team.
In addition, we can take over the standard-compliant development of software for you.
In such a software development project, we are ideally already at your side in the specification phase.
For the outsourced part of the project we lead the risk management and the usability engineering process and hand over to you your software as well as all required QM documents at the end of our joint project.
You can then use the documents directly in the certification process.
There is no such thing as a typical project for soventec. Every cooperation has its own challenges and the companies involved are at different points.
Oriented to a completed development project for a customer, the following scenario describes a possible form of cooperation:
As a manufacturer of a medical device, you have a product on the market for several years and are planning to release the next generation of this product. Your expertise lies in the design and production of excellent hardware, which you also sell successfully. In recent years, technologies have evolved and you want to set new standards in hardware as well as in integrated software components and application software. Limited human resources are available for new product development.There are no plans to build up new software expertise.
In a comparable project, soventec was involved in the development at an early stage and took over the following building blocks:
Joining forces in development projects with partners who have expertise in different areas and keep an eye on the project goal together can not only bring speed to the development process, but also increase cost efficiency.
Where does your project stand? Are there processes you want to outsource? Let's work together on the challenges!