Corporate Strategy Consulting
Consulting for Medical Device Manufacturers
Balancing Innovation and Regulation in the Medical Device Industry - Cost-Effectively
Few sectors are as strongly influenced by regulatory requirements as healthcare - particularly the medical device industry. Companies in this field must comply with numerous international standards and evolving guidelines, which continuously change or emerge. These regulations limit the strategic flexibility of medical device manufacturers, yet they still face the same pressures for action as other industries. With our consulting services for the medical device industry, we help you strike the right balance between cost-effectiveness, innovation, and compliance - positioning your company for long-term success.
What Are the Core Challenges for the Medical Device Industry?
Cost-Effective, Compliant Development and Production
The cost pressure in the medical device industry is constantly growing due to the volatile world economy and ongoing multiple crises. At the same time, the need for flexibility is increasing, as changes to medical products, manufacturing structures, and supplier networks become more frequent. In this context, developing and producing medical devices efficiently while ensuring compliance is essential. Strategies such as lean management and advanced product quality planning (APQP) can help achieve this balance.
More Efficiency in the Product Development Process
There are many advantages of advanced product quality planning (APQP) in medical technology: efficient product development, reduced development and approval times, increased efficiency, and early error prevention instead of correction loops. By identifying potential problems at an early stage, unnecessary correction loops are minimized, resulting in cost-efficient, lean, and targeted product development while maintaining high product quality.
Our white paper gives an impression of how advanced product quality planning (APQP) can optimize your product development process.
DownloadDigital Transformation
The underlying conditions for digitalization in medical technology are more complex than in many other industries. Strict standards apply in areas such as risk management, IT security, data protection, and connectivity. For example, before medical device software or applications can be approved for use, they must undergo software validation or computer system validation (CSV). Additionally, each digitalization effort involving production processes or systems requires renewed compliance verification, leading to increased costs. A well-planned, long-term digitalization strategy is therefore essential in this industry.
Resilient Supply Chain Management
Due to high quality requirements, qualified, efficient, sustainable and robust supply chains are essential in the medical device industry. Their implementation requires reliable supplier management, thorough risk assessments and qualifications, as well as comprehensive incoming goods inspections. In addition, based on the risk assessment, quality assurance agreements (QAAs) must be established with nearly all suppliers. A key prerequisite for effective supply chain management is the continuous optimization of the supply chain—to identify and mitigate risks and to build resilience throughout the network.
Quality Management
Regulatory requirements for quality management (QM) in the medical device industry are extensive and continuously evolving. Directives and laws – such as EU MDR and EU GMP, 21 CFR 820 – require the implementation of a QA system (for example according to ISO 13485) for medical device manufacturers. Additionally, many other requirements must be met, such as the implementation of a risk management system (for example according to ISO 14971). A 360° analysis from Ingenics Consulting can support you in identifying relevant areas for action and implementing the necessary adjustments.
Internationalization
The complex regulatory requirements for medical technology—both in Germany and globally—make transnational production and distribution a significant challenge. Medical device manufacturers must guarantee efficient, compliant production at the production site and also demonstrate that they meet the current requirements on the sales marketThis often involves equipment qualifications and validated, compliant IT systems. In particular, a relocation of production to outside of the EU can prove to be very complex.
Investment Backlog
Due to high profit margins, for many years there was little need for process optimization in medical technology. But now, because the underlying legal conditions have changed (for example, due to the EU MDR), the status quo has been undermined. For many medical technology companies, substantial efforts and investments are necessary to meet current and future regulatory requirements. In addition to strategic realignment and comprehensive process development, this may require extensive investments in digital, compliant production and in resilient supply chains, including the possible relocation of production sites.
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To survive in the medical device industry, it is not only important to manufacture efficiently and cost-effectively and to establish the necessary expertise, but also to comply with all regulatory requirements. Our consulting team can support you with a holistic approach.
Corporate Consulting for Medical Technology: How Can Ingenics Consulting Support You?
Ingenics Consulting not only combines technical and industry knowledge in a holistic approach but also keeps an eye on regulatory requirements for all projects.
Introducing change processes in the medical device industry and capitalizing on opportunities offered by new technologies and trends is a highly complex endeavor. Compliance with all relevant regulatory requirements must be ensured, and every step must be carefully documented.
Ingenics Consulting stands by your side as a reliable partner throughout the process. Our consultants support you with expertise across all key areas—ranging from strategy consulting and project management to innovative production solutions, logistics concepts, and factory planning —always with regulatory requirements in mind. Additionally, we support medical technology companies on their path to becoming zero-emissions companies.
In this way, our consulting team works with you to cover the entire course of the project. We not only develop powerful concepts but also ensure sustainable and compliant implementation, backed by years of regulatory experience. At Ingenics Consulting, both consulting and implementation come from a single source.
As a management consultancy, we offer proven approaches that can be implemented quickly, while also bringing in valuable cross-industry perspectives. We are well connected within the medical device industry and maintain an active exchange of experiences with partners and subject matter experts in the market. As a result, our customers can be confident that their strategies remain fully compliant with current regulations.
Medical Technology Consulting: Our Range of Services for Medical Device Manufacturers
Ensuring Compliant Production
Establishing manufacturing structures that are both efficient and compliant with regulations presents significant challenges for medical device manufacturers and suppliers. That's why we offer a comprehensive service portfolio to ensure compliant production and quality assurance: from production structure analysis to technical and economic feasibility studies to equipment and cleanroom qualification, as well as process validations in accordance with all relevant regulatory requirements (e.g. ISO 13485, 21 CFR 820, EU MDR).
Establishing and Optimizing a Change Management System
Making changes to products, systems, and manufacturing processes safely and effectively is critical for medical device manufacturers. Our consulting team supports you in designing and implementing an effective change management system for both development and production. We create a customized strategy, define clear processes, take over project management, and conduct training sessions to ensure smooth implementation. In parallel, we establish a KPI-based monitoring framework that tracks the effectiveness of the measures taken and ensures long-term success.
Non-Conformity (NC) und Corrective and Preventive Action (CAPA)
Bei Produktionsfehlern in der Medizintechnik ist eine schnelle und effektive Reaktion essenziell. Wir unterstützen Sie bei der Entwicklung und Implementierung eines schlanken, konformen NC- und CAPA-Prozesses. Unser Ansatz umfasst die Erstellung maßgeschneiderter Prozesse zur effizienten Identifizierung, Analyse und Behebung von Abweichungen. Durch gezielte Systemintegrationen stellen wir sicher, dass diese Prozesse nahtlos in Ihr bestehendes QM-System eingebettet und Ihre Mitarbeitenden geschult und trainiert werden. Zudem helfen wir beim Aufbau eines Monitoring-Systems, um Ihr Prozess-Framework zu überwachen und kontinuierlich zu optimieren.
360° Analysis of Quality and Risk Management
The effectiveness and efficiency of a quality/risk management system cannot be linked to individual aspects. Instead, a holistic approach is needed. The 360° analysis from Ingenics Consulting is ideal for this. Our expert team analyzes your process landscape, identifies gaps in regulatory compliance, and uncovers opportunities to design processes and systems more efficiently. With our 360° analysis, you establish a solid foundation for further improvement measures—such as developing or optimizing a change management system or implementing an efficient Advanced Product Quality Planning (APQP) process.
Establishing Compliant Product Development Processes
Regulatory compliance must extend across the entire product lifecycle, starting with product development. That’s why we support medical device manufacturers in establishing compliant, efficient, and modern product development processes (PDP), using methods such as Advanced Product Quality Planning (APQP) and Business Process Management (BPM). This also includes supplier and equipment qualifications, validations, and adherence to all design control requirements, ensuring the highest product quality and full compliance.
Safeguarding Approval Activities
We support you in obtaining approval for your medical technology products in various markets. This begins with an analysis of the regulatory requirements your product does not yet meet for market approval. We also ensure the preparation of accurate and compliant technical documentation. Furthermore, we safeguard the approval activities in all necessary processes by integrating regulatory affairs. If necessary, we will also support you in follow-up activities, such as establishing a compliant quality and risk management system.
Establishing an Efficient and Compliant Supply Chain
Our services in supplier management guarantee a robust, compliant and reliable supply chain, which meets the highest quality and efficiency requirements. We oversee the development and qualification of suppliers, conduct second-party supplier audits, and establish an efficient supply chain management system. Additionally, we support you in assessing supplier risks, coordinating quality assurance agreements (QAAs) when necessary, and implementing a risk-based incoming goods inspection process to detect and eliminate potential weaknesses.
Optimization of Outsourced Processes
Outsourcing in strictly regulated industries like medical technology is always a risk, because outsourced processes must meet the same requirements as internal processes. We offer a range of services with which you can strengthen and optimize your process landscape. These include risk analyses and assessments, support and guidance during validation activities, as well as the preparation and planning of internal and external audits (1st and 2nd party). In this way, we ensure that your business processes, including outsourced ones, consistently comply with defined quality standards and regulatory requirements.
Knowledge Transfer and Training Courses
Efficient knowledge transfer and targeted training programs are essential for the establishment and continuous improvement of development and production systems. We support you in the process with customized training courses and workshops, which prepare your employees for all challenges posed by the medical technology industry. Depending on your needs, focus areas range from quality and risk management to NC and CAPA processes, as well as compliant product development, including supplier and equipment qualifications.
