The reasons behind the founding of the joint project are alterations in the framework conditions of the medical technology sector.
The current introduction of new regulatory principles is causing problems for the industry. Specifically, the new regulations are the “In Vitro Diagnostics Regulation” (IVDR) and the “Medical Device Regulation” (MDR).
As a result of the changes to the classification laws brought about by the IVDR alone, 80% of all existing medical devices are now affected, instead of 20% in the past, and some of them have to undergo new certifications. These and other circumstances, which will be highlighted in a separate blog post, lead to significantly extended as well as increased certification processes of medical devices.
At the same time, the extended certification processes are also accompanied by recertifications. Products that are already ready for the market must once again undergo lengthy tests in order to achieve the status of market readiness. Scandals in the past, such as the use of incorrect silicone material for breast implants, are to be avoided in the future through the introduction of the new regulations. For the companies concerned, the changes in the regulations will result in additional work and associated costs. These costs can be so high that large parts of the product portfolio are no longer profitable.
What is a barrier for some companies is nearly impossible for others to overcome.
For large companies, the new regulations of the MDR and IVDR represent an obstacle, which is associated with a large expenditure of personnel and capital. However, due to their financial strength and personnel capacities, large companies are usually able to compensate for this additional expense without having to make far-reaching and drastic changes to their product portfolio.
However, not all companies have this high level of capacity. The new challenges are particularly problematic for small and medium-sized enterprises (SMEs). They cannot spare the staff to carry out internal restructuring, let alone to bridge long certification periods financially.
However, the new challenges arising from the changes in regulations are only part of the problem that SMEs have been facing for years. Another challenging aspect is the growing digitalization of today.
While this is certainly an advantage on the consumer side, digitalization is increasing the complexity of product development on the production side. The increasing complexity in turn increases the difficulty of keeping track of the “big picture”.
Code integrations, software functions, bus systems and switching sequences must be viewed logically as a whole and linked in a meaningful way in order to avoid product errors. Furthermore, the networking aspect and the ecosystem of the products must be considered and these must be placed in a “system of system” context. These additional dependencies drive up both development and production times significantly.
Seen in this light, the introduction of the new regulations for SMEs is just the last straw that could break the camel’s back and make product development no longer worthwhile.
The AMeLie joint project is therefore intended to offer SMEs a procedure to strengthen their innovative power and secure their competitiveness.
AMeLie’s approach consists, among other things, of making conventional systems engineering approaches tangible for SMEs and additionally developing new approaches.
Up to now, SMEs have hardly derived any benefit from systems engineering methods, since many of the approaches are tailored to larger companies and are therefore not suitable for direct application in SMEs. Therefore, the existing methods and functions must be adapted accordingly to ensure their tangibility and usability for SMEs.
In order to find out which methods and functions of conventional SE are suitable for SMEs, these are collected and passed through an “SME filter” in a first step. What remains are those approaches that can also be applied to SMEs. The methods that are not suitable for use by SMEs will be further developed and streamlined by the AMeLie partners so that they can also be used by SMEs.
To ensure that the purely theoretical approaches are reflected in practice, there is a regular exchange between the project’s internal partners. Four of them are SMEs themselves and can thus share from their own experience which problems they are facing and which of them urgently need to be addressed. In addition, direct contact with the partners provides information about their goals and thus what can be worked towards directly. Based on constant communication with the SMEs, a specifically tailored procedural logic can be created. The framework that holds the logic together consists of four supporting pillars.
The classification of corresponding ASE-Capabilities takes place under the four pillars of the procedure logic
Each of the supporting pillars has its own heading:
- „Skill Management“
- „Context & Customer Understanding“
- „System Mastery“ und
- „Process Efficiency“
Under each heading there are four ASE capabilities. Figure 1 shows an abstract representation of the structure of the procedure logic.
These four capabilities per pillar are not only derived from interviews and surveys with SMEs, but also from various sources such as accompanying research and reference models. They are therefore characterized by the observation from different perspectives. Through this, new impressions can be gathered in the process logic and old impressions can be challenged.
With the help of the process model, it should be possible to shorten development processes and reduce costs in the long term. In this way, the currently declining product portfolio of SMEs can be boosted and their existence secured. In addition, the procedure logic serves the integration of the certification thought into the development process at an early time. This means that structured planning and forward-looking thinking can be used to counteract the lengthening of the certification process.
Besides filtering methods and functions of SE, AMeLie pursues the goal of appropriating the positive aspects of digitalization and making them specifically useful for SMEs
In addition to providing helpful documents, one AMeLie partner in particular will be involved in creating a supporting IT tool. On the one hand, this IT tool should help to establish the developed ASE approaches faster in the corporate structure of the SMEs. On the other hand, it should realize a cost-effective implementation of the ASE approaches. For this purpose, the IT tool needs to be easy to use and intuitive for the user.
This means that additional personnel can be dispensed with when it comes to integrating the ASE approaches into the corporate structure.
AMeLie is not only dedicated to the development of new tools and strategies: Part of the collaborative project is also the testing and agile incorporation of newly gained insights from the pilot series.
The evaluation of newly developed strategies and tools is carried out by means of various pilot waves
By testing the strategies and the tool in exemplary companies, qualitative statements can later be made about the improvements that occur through ASE. First, the tests will be carried out on the participating partners from the medical technology sector. In a further pilot step, SMEs from other sectors are to make use of the strategies and the IT tool, because in the end the tools that are developed within the framework of AMeLie should be available to all SMEs across all sectors.
If one considers SE, simplified, as a large construction kit full of methods, functions, documents, tools and structuring mechanisms, ASE is an extension of it. Without this extension, it could be almost impossible in the future to take into account all the interrelationships and interfaces, coordinations and logistics of complex, technical systems. Especially in the field of medical technology, a well-thought-out approach to product development is essential in order to avoid mistakes.
AMeLie still has about two years to complete all the projects listed. The work and the exchange have already been in full swing for a year.
The blogposts, which will be created and published over the coming months, offer insights into the working methods of the participating partners. They also highlight concrete methods and strategies for structuring and present exciting products from the medical technology sector.
In addition, regular updates will be published on milestones reached in the research project.