We have excellent expertise and excellent references in the pharmaceutical industry and in the field of medical devices. The special challenges in a regulated environment are no justification for a lack of efficiency in all areas of the company. The increasing cost pressure from generics and international competition is a challenge that only the best can successfully master.
General legal conditions
The pharmaceutical industry and medical technology industry have a unique position on account of their responsibility for the health of customers and the associated strict statutory and regulatory conditions. The processes are governed by particularly high demands of safety, quality and hygiene. This has led to high standards but also to a high extent of work in the internal organization, particularly in the areas of quality control and documentation (keywords are SOPs, FDA, GMP). However, external regulations such as the Medical Devices Act (MPG), the Law governing the Manufacture and Prescription of Medicines (AMG) or the ISO13485 standard for medical technology must also be considered.
On top of this, there are specific features resulting from extremely long development cycles for new medicines or medical devices which entail a high business risk. It has been possible to reduce the excessive bureaucracy and constantly increasing indirect areas (sales, development, planning, documentation) to a much lesser extent through goal-driven concepts.
Low cost awareness and low dynamism in change processes
A low cost awareness and a high resistance to change as opposed to improvement processes because of high profitability can often be identified. Very few companies know about the actual cost drivers in detail or have a developed process cost calculation at the important points. Detailed performance measures for essential cost and efficiency parameters (KPIs) or analyses are not even available in many cases. Total cost evaluations with regard to cost cutting are only used sparingly.
High inventories and low API production as a result of distributed international value chains
The security of supply to the market is still mainly secured nowadays through high inventories. The flexible use of the existing in-house and external production capacities is hardly ever used to strategically decrease inventories. The fact that flexible planning concepts which guarantee secure replenishment without stock building are only rarely available also contributes to this. Although the active pharmaceutical ingredient (API) is often very expensive, it is rarely managed operationally in the value chain. Losses caused by technology and process engineering are very quickly accepted as the definitive reason.
High proportion of destroyed articles as a result of overproduction, rigid batch operations, bad planning, non-synchronized supply chains
Furthermore, finished products and primary and secondary packaging materials are frequently destroyed as a result of inefficient planning and a lack of interlinking of the logistic resources.
We can assist you professionally with strategic issues:
- Restructuring of organizations as a result of changed general conditions or long-standing structures
- Assessment and restructuring of departments (e.g. QC, laboratories, production, technology)
Strategy consulting and effective management
- Concerted development of end-to-end strategies to provide for the future of companies
- Effective value driver-oriented management processes, also as part of an integrated management system
Increasing efficiency as a program
- Implementation of simple and efficient processes in the following areas: production, administration, logistics, maintenance, purchasing, quality management
We can assist you professionally with operational issues:
- Analysis of the complete supply chains to improve the use of API, reduction in raw material losses
- Optimization of planning and control batch-driven production in plants in interaction with central storage depots
- Efficiency increase in manufacture and packing:
- Shortening of the changeover times in the packaging
- Improvement of the standards in the preparation and packaging
- Improving efficiency in the laboratories, the analysis
- Improving efficiency in quality control and approval processes
- Industrialization in the assembly areas of medical technology manufacturers