Over the past 25 years, health authorities, hospitals and physicians, as well as patients themselves, have increasingly focused on the complete documentation and Traceability of customer complaints and patient claims. In the same period, the U.S. Food and Drug Administration (FDA) continuously expanded its regulatory requirements, systematically raising market entry barriers in the U.S. healthcare market for manufacturers of medical devices. With 16.6% of all exports, the USA is by far the largest export market worldwide for German companies. Now that Europe has also followed suit with the introduction of the new MDR (Medical Device Regulation) and the revised DIN ISO 13485:2016, companies in the field of medical technology are facing various challenges.
In times of globalization and global competition, two areas are particularly important. In addition to the constantly increasing regulatory requirements, it is above all the international competitive pressure to which companies in the German-speaking countries have been increasingly exposed in recent years. Digitization will be an important instrument for securing the future. The medical technology industry is very heterogeneous with many medium-sized and only a few large companies. For small and medium-sized companies, which are rather worse off financially, it is important to make the right investment decisions in the course of digitization.
In recent years, companies have focused primarily on processing the high order situation and adapting to new regulatory conditions, but now the focus is shifting towards digitization. But what is the digitization status of German SMEs?
In production, Access databases, Unix applications and Excel tables are still used as electronic solutions as instruments for process control and documentation of the product creation file. In most cases, documentation is also done on paper. In the process, handwritten notes and improvements are repeatedly found on the printed operating orders - a common practice that does not comply with the regulatory requirements. The archiving of paper-based product creation files is carried out internally or externally in fireproof filing cabinets. In the case of faulty batches or complaints, a time-consuming search process begins in order to find the right documents and identify affected predecessors or successors.
Customer inquiries about delivery dates can only be answered imprecisely and with great effort, as the order management does not contain any current information on the status of production. Deviations from the time schedule are therefore not recognizable.
Even non-validated ERP systems are often used for data acquisition and transmission of quality-relevant information. In addition, data records for products are maintained in different software systems without a comparison taking place between them. A holistic, company-wide approach of CSV (Computer System Validation) is usually completely lacking.
While paper is available at all times without technical aids, the digital company is dependent on external factors: How dependent are work processes on fast and stable Internet access?
These factors should be carefully considered before any decision is taken. However, it is questionable to what extent companies can escape digitization in the long term without significantly weakening their market position. The selection of software manufacturers is particularly important here, because only those who have answers to the risks of digitization can be seen as a reliable partner.
Nowadays, every company needs a digitization strategy in order to survive in the fiercely contested competition of the future. In the long run, transparency in production, and thus production optimization, can only be achieved through digital processes, because otherwise no real-time data is available. A PDA system (production data acquisition) within the MES is therefore indispensable at this point.
If companies produce at different locations, this point is even more important for planning activities.
According to a study by the Fraunhofer IAO, companies are showing a clear trend towards the future use of digital assistance systems in manufacturing and assembly. Why? Quite simply, there is a lack of stationary workstations where up-to-date information can be provided on an ongoing basis. In addition, digital assistance systems can minimize waiting times and walking distances in these areas. All this leads to precisely fitting, functional workplaces and ultimately to greater efficiency. The systems that provide this information on the shop floor and pass on the collected data are called MES.
ERP is the leading system in the process flow between ERP and MES. Because the basis of an MES is usually the information from the ERP. These include order data such as type and quantity as well as material availability. This information is used for rough planning in the ERP system. This means that although orders are assigned to shifts, they are not assigned to a production time that is exact in time. Machine groups are assigned in the same way, but no specific individual machine. The allocation of concrete resources takes place in the second step of the so-called detailed planning.
Some ERP systems support detailed planning. Orders are split into work processes, machines and personnel are assigned and scheduled for an exact time in production.
The online monitoring by PDC recording and evaluation of the production results in relevant data, which are fed back to the ERP.
In this way, a control loop is created in which two systems for information acquisition and process optimization are optimally integrated.
With the help of KPIs (Key Performance Indicators), the progress and degree of fulfillment of production targets as well as critical success factors can be transparently evaluated.
These KPI indicators include, among others:
With the introduction of an MES, continuous transparency from incoming orders to invoicing is achieved, including the entire production process. In this way you can improve the reaction speed, adherence to delivery dates, profitability and ultimately also the competitiveness of your company.
In contrast to other industries, a meaningful MES solution in medical technology must be able to meet some regulatory requirements. These include the subject of traceability, compliance with FDA Act 21 CFR Part 11 on the use of Electronic Records / Electronic Signatures and the provision of a product creation file. Further functions of a MES are:
However, not all MES solutions are the same. There are more than 180 providers of such systems in Germany. Most of them come from mechanical or electrical engineering. As a rule, they meet the requirement profiles defined by VDMA data sheet 66412-1 or VDI data sheet 5600, but do not take into account the medical technology-specific regulations for software systems in production.
One example is energy management. It is certainly an important module in the process industry, but plays a subordinate role at assembly stations in medical technology. In contrast, safe process control is all the more important and must be adaptable for every company. Other functions can be mentioned that are specifically required only by certain industries. Paperless production documentation in medical technology can only be implemented with a 21 CFR Part 11-compliant software system ; other industries do not have to take this into account.
In recent years, a real specialization of MES solutions has taken place in areas such as automotive, medical technology, pharmaceuticals, mechanical engineering, etc., and this specialization seems to be increasing further. Regulatory reasons in particular are a catalyst here.
Due to the innovations in the regulated area and the ever-increasing competitive pressure, the need for constant adjustments arises. Changes and innovations affect the production area in particular. For this purpose, the maintenance of a quality management system as required by DIN ISO 13485:2016 is indispensable. An overview of the FDA's most frequent "observations" during its inspections in 2021/2022 shows how relevant the topic of software validation and production documentation already is in medical technology companies:
CAPAs (21 CFR Part 820.100)
Complaints (21 CFR Part 820.198)
DHR/DMR/CSV (21 CFR Part 820.181/184/70i)
Defective products (21 CFR Part 820.90)
Process validation (21 CFR Part 820.75)
Table: FDA "Observations" during inspections in 2022/2023 from the annual FDA Report
The number of "observations" in the area of Device History Records (DHR)/Device Master Records (DMR) is increasing the most compared to all other areas. This shows that many companies have gaps in the legally compliant presentation of their production processes, including traceability.
Many companies were not aware that Computer System Validation (CSV) is also affected in relation to all software systems in the company. All quality-relevant software systems must be fully validated.
In connection with the establishment of the EUDAMED (European Database for Medical Devices), even Class 1 products must in future be provided with a UDI (Unique Device Identification) and made publicly accessible in the database.
Other topics such as cloud computing, data integrity and Long term archiving are also part of digitisation and must be integrated into the overall strategy of the IT organization.
The situation is also changing for SMEs (small and medium-sized enterprises), which have so far not appeared as OEM manufacturers (original equipment manufacturers) within the meaning of the MDR regulations. Even though there are still different interpretations of the new MDR, it seems clear that the OEMs are responsible for the technical documentation and must at least make it available to the notified bodies of the PLM (Private Label Manufacturer).
Regulations are an obstacle to digitalization. Another "blocker" is the usual documentation on paper and the fear of switching to electronic processes. Today, documentation in the production of many small and medium-sized enterprises (SMEs) is still largely paper-based. Order cards, test reports or also construction drawings are available in printed form and production orders are enclosed. If at all, the content is digitised in a subsequent, additional step.
The use of mobile end devices can considerably improve this data acquisition and thus provide a basis for a comprehensive use of relevant data in the production. In particular, the comparatively low investment costs for hardware are to be emphasized for manufacturing SMEs. In addition, most employees are already used to dealing with a large number of different end devices from their private lives, so that the introduction is usually quick. Intuitive and simple operation ensures short familiarization times, acceptance by employees and rapid information gain in everyday production.
The fact that the employees support the digital transformation is an essential prerequisite for their success. Unfortunately, there are often worries and reservations here: Many employees fear being left behind by the changes.
It is therefore extremely important to openly explain the opportunities and risks of digital transformation and to take employee concerns seriously. Address existing concerns openly and demonstrate the benefits of digital transformation to employees so that they actively drive change. Experience shows that once digital data capture is in place, no employee will want to do without it because it makes their job easier.
Digitization often goes hand in hand with networking. New interfaces are often created. And thus potential attack surfaces for hackers. Cybercrime has been on the rise for years.
In order to counter the risks associated with the digitalisation of one's own company, an individual risk analysis should be carried out at the outset. What data is available? What does the IT infrastructure look like? What happens if data is deleted or damaged? How expensive can a successful cyber attack be for the company? It is advisable for every company to include protection and security measures in its digitization processes from the outset. If processes are already designed according to the individually necessary security aspects, expensive subsequent adjustments or necessary changes can also be avoided. Successful digitisation and IT security should go hand in hand, or as the IT Security Management Report of the Federal Office for Information Security (BSI) puts it: Information security is the prerequisite for successful digitisation.
Waiting is not an option: according to a study by IMD Business School and CISCO Consulting Services, 40 percent of companies will find themselves in a changed competitive environment in 2023.
From this it can be concluded that many companies will be concerned about their own existence in the future if they ignore the topic of digitisation.
This means that the question is not "whether" but "when" a regulatory correct MES solution should be introduced into production. The most important prerequisite is a corporate culture in which all employees are convinced of such a project. The long-term existence of SMEs in particular will depend on the intelligent use of the diverse IT offerings.
In the future, a production order triggered by the customer could independently steer itself through the value chain. It reserves processing steps, plants and materials and automatically controls execution. It recognizes impending delivery delays, organizes additional capacities as far as possible and reports unavoidable delays directly to the relevant customer. The production systems used exchange drawings with each other and organize their order sequence in the same way as maintenance and repair requirements with each other. If this vision becomes reality, we are talking about industry 4.0. Even though many SMEs still have a long way to go here, the first step must be taken if they are to have any chance of achieving the goal.