Strategy Consulting
Manufacturers of medical devices are under heavy pressure to transform. Global competition has become stronger in recent years due to the growing proportion of emerging markets in the global medicine marketplace and the entry of companies from outside the industry. For this reason, advancements in technology, digital transformation, and automation are playing an increasingly important role when it comes to cost efficiency and developing innovative, comprehensive healthcare solutions. Simultaneously, new regulatory requirements such as the EU’s Medical Device Regulation are placing heavy demands on the administrative and operational processes of OEMs and suppliers.
Medical Device Manufacturers Must Change
Short innovation cycles, a wide range of variants, and extremely high quality have been characteristics of the medical technology industry for years. German manufacturers, particularly small- and medium-sized enterprises (SMEs), have been able to develop competitive advantages for themselves in this global growth market thanks to their strong innovation. However, their position is more at risk than ever due to the increasing pressure from competition, costs, new regulatory requirements, and the challenges of digital transformation.
The future belongs to organizations whose primary and supporting processes are lean and high-performing and have integrated both inward and outward data. A range of levers must be pulled in order to achieve this state. Some of the items called for include:
- Critical analyses that focus on measuring how future-proof existing strategies, business models, and product portfolios are. For plans to be prudent in the future, they must also address the status quo throughout the supply chain.
- Initiatives that ensure more cost efficiency within a company and drive the flexibility of production and healthcare solutions; such initiatives cannot be realized without the smart, targeted use of digital technologies.
- Structures that are suited to meeting all regulatory requirements and standards, from the European Union Medical Device Regulation (MDR 745/2017) to MDSAP and quality management system standard DIN EN ISO 13485:2018.
Although there are currently many challenges facing the manufacturers of medical devices, their situation also offers opportunities: By getting rid of inefficiencies, optimizing outdated structures to meet regulatory requirements, and harnessing digital transformation in a targeted manner, they can maintain their strong position in the market and even significantly improve it. Now is the right time for this, especially as new regulations and standards are increasing the pressure on companies to act.
APQP: Consolidating Knowledge, Avoiding Errors, Lowering Development Costs
Advanced product-quality planning (APQP) is a systematic methodology for planning quality ahead of time. The methodology creates a product-quality plan that you can use to develop your products faster, more cost-effectively, and more reliably. The knowledge and experience (“lessons learned”) from all relevant departments are consolidated into one pool to close off sources of errors and lower development costs. It usually does not require any elaborate implementation process. Instead, all it needs are isolated adjustments that, in our experience, pay off very quickly.
Advanced product-quality planning (APQP) is a systematic methodology for planning quality ahead of time. The methodology creates a product-quality plan that you can use to develop your products faster, more cost-effectively, and more reliably. The knowledge and experience (“lessons learned”) from all relevant departments are consolidated into one pool to close off sources of errors and lower development costs. It usually does not require any elaborate implementation process. Instead, all it needs are isolated adjustments that, in our experience, pay off very quickly.
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