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Industry

Medical Technologies

How digitisation succeeds in such a demanding and fast-moving industry ...

"To keep up with such demands, healthcare professionals must be able to rely on state-of-the-art equipment to document and monitor every patients treatment."
- Dr. Harald Dreher.

State of the industry

State-of-the-art equipment and technologies to support.

Today's healthcare is a very demanding and fast-paced environment.

To keep up with these demands, healthcare professionals must be able to rely on state-of-the-art equipment to document every patient treatment while meeting any requirements set by the government or insurance companies.

Such state-of-the-art equipment is not always easy to find in a market where competition has caused prices to fall below expected demand, which then leads to a reduction in the number of providers.

Doctor works with state-of-the-art medical equipment

Common challenges within Medical Industries

Special requirements are placed on an ERP system:

Key Issues
  • Maintaining Traceability Audit Trails
  • End-to-end component traceability
  • Handling temperature-sensitive items efficiently
  • Compliance with MDR, FDA, EUDAMED
  • Real-time inventory management
  • Managing patient-specific prescriptions data
Dreher Solutions
ERP Selection & Implementation: Integrating vendor data within ERP systems to maintain better control over sourcing and procurement.
Process Optimisation & Management Analyzing and improving supply chain processes to build resilience and flexibility.
ERP Project Management: Overseeing ERP projects to support UDI creation, audit trails, and seamless data integration for EUDAMED.
Key Issues & Privacy
  • Master data for device registration
  • UDI and EUDAMED integration
  • FDA data compliance
  • GDPR compliance
  • Cybersecurity threat protection
  • Seamless data flow across systems
  • Data accuracy and consistency

Dreher Solutions
Digital Strategy Consulting: Establishes secure digital frameworks to protect against cyber threats, ensuring data protection and compliance with GDPR and FDA requirements.
IT Strategy Consulting: Develops a comprehensive data security strategy, identifying vulnerabilities and implementing robust security measures across systems.
Process Optimisation & Management: Refines data handling processes, strengthening data governance and minimizing security risks by reducing redundancies and potential entry points for breaches.
Key Issues
  • Adhering to GAMP 5 standards
  • Meeting MDR (Medical Device Regulation) requirements
  • Complying with FDA regulations (21 CFR Part 820)
  • Implementing Quality Management & CAPA systems
  • Ensuring CSDR sustainability compliance
  • Maintaining ISO 13485 certification
Dreher Solutions
ERP Selection: Ensures ERP systems are configured to meet regulatory requirements, including MDR, FDA, and ISO standards, facilitating efficient compliance management.
Sustainability Consulting: Integrates compliance with CSDR sustainability requirements, tracking Scope 3 CO2 emissions and aligning them with environmental standards.
IT Strategy Consulting: Develops a regulatory-compliant digital strategy, ensuring data handling, security, and documentation processes align with standards such as GAMP 5 and GDPR.
What we do

End-to-end support.

Meet your unique business goals

Integral first step:

Process optimisation should be considered before ERP implementation as it ensures the system operates on streamlined, efficient workflows. Without it, ERP systems risk magnifying inefficiencies instead of resolving them. Process optimisation

  • Prevents automating flawed processes
  • Identifies key inefficiencies to address early
  • Aligns system configuration with optimised workflows
  • Maximises ERP’s potential for improved performance
  • Sets the foundation for long-term operational success

Learn More

Future Focused:

Building regulatory compliance capabilities within ERP, especially for sustainability and CSDR, ensures the system is equipped to handle evolving regulations. Early integration minimises future disruptions and enhances long-term sustainability efforts. The integration of regulatory compliance

  • Embeds compliance tracking into system functions
  • Ensures CSDR capabilities are built-in early
  • Supports automated compliance reporting
  • Reduces future costly system modifications
  • Strengthens sustainability and regulatory alignment from the start

Learn More

A crucial foundation:

The selection of an ERP system is fundamental to long-term success. The right system ensures operational efficiency, compliance, and scalability, reduces future costs, and enables sustainable growth. A structured and professional selection process:

  • Aligns system functions with business objectives
  • Reduces future costs for unplanned system changes
  • Supports scalability and future business expansion
  • Ensures the system's adaptability to evolving industry requirements
  • Secures stakeholder buy-in

Learn More

Crucial Transformation:

ERP implementation is crucial for transforming business operations by integrating key processes into a unified system. It enhances efficiency, streamlines workflows, and provides real-time data insights, driving overall business success. The implementation of an ERP-system

  • Unifies business functions into a single platform
  • Enhances decision-making with accurate, real-time data
  • Streamlines processes, reducing manual tasks and errors
  • Increases efficiency by automating repetitive operations
  • Supports scalability and growth by adapting to evolving business needs

Learn More

Future Foundation:

The AI and Automation module focuses on leveraging technology to improve efficiency, reduce costs, and enhance decision-making. Built on a foundation of standardised processes and clear data, this module helps businesses harness the full potential of AI and automation for sustainable growth. The integration of AI-technologies

  • Automates repetitive tasks, increasing efficiency
  • Enhances decision-making with data-driven insights
  • Improves productivity by streamlining workflows
  • Scales easily to adapt to growing business needs
  • Personalises customer experiences

Learn More

stack layer one Processes
stack layer two Compliance
stack layer three ERP Selection
stack layer four ERP Implementation
stack layer five Automation & AI

Processes

Integral first step:

Process optimisation should be considered before ERP implementation as it ensures the system operates on streamlined, efficient workflows. Without it, ERP systems risk magnifying inefficiencies instead of resolving them. Process optimisation

  • Prevents automating flawed processes
  • Identifies key inefficiencies to address early
  • Aligns system configuration with optimised workflows
  • Maximises ERP’s potential for improved performance
  • Sets the foundation for long-term operational success

Learn More

Compliance

Future Focused:

Building regulatory compliance capabilities within ERP, especially for sustainability and CSDR, ensures the system is equipped to handle evolving regulations. Early integration minimises future disruptions and enhances long-term sustainability efforts. The integration of regulatory compliance

  • Embeds compliance tracking into system functions
  • Ensures CSDR capabilities are built-in early
  • Supports automated compliance reporting
  • Reduces future costly system modifications
  • Strengthens sustainability and regulatory alignment from the start

Learn More

ERP Selection

A crucial foundation:

The selection of an ERP system is fundamental to long-term success. The right system ensures operational efficiency, compliance, and scalability, reduces future costs, and enables sustainable growth. A structured and professional selection process:

  • Aligns system functions with business objectives
  • Reduces future costs for unplanned system changes
  • Supports scalability and future business expansion
  • Ensures the system's adaptability to evolving industry requirements
  • Secures stakeholder buy-in

Learn More

ERP Implementation

Crucial Transformation:

ERP implementation is crucial for transforming business operations by integrating key processes into a unified system. It enhances efficiency, streamlines workflows, and provides real-time data insights, driving overall business success. The implementation of an ERP-system

  • Unifies business functions into a single platform
  • Enhances decision-making with accurate, real-time data
  • Streamlines processes, reducing manual tasks and errors
  • Increases efficiency by automating repetitive operations
  • Supports scalability and growth by adapting to evolving business needs

Learn More

Automation & AI

Future Foundation:

The AI and Automation module focuses on leveraging technology to improve efficiency, reduce costs, and enhance decision-making. Built on a foundation of standardised processes and clear data, this module helps businesses harness the full potential of AI and automation for sustainable growth. The integration of AI-technologies

  • Automates repetitive tasks, increasing efficiency
  • Enhances decision-making with data-driven insights
  • Improves productivity by streamlining workflows
  • Scales easily to adapt to growing business needs
  • Personalises customer experiences

Learn More

Who we do it for

Discover how businesses have grown with Dreher Consulting

Hahn-Schickard

As a non-profit they conduct research and development in the field of microsystem technology. With currently six institute directors at four locations, they have a broad range of expertise from silicon-based microsystem technology, microfluidics, lab-on-a-chip systems, mobile diagnostics, molecularly integrated test systems, biometric receptors and more.

Goal: 

  • Standardise and make process flows transparent to be optimised while increasing data quality. 

Requirements:

  • There were multiple facilities that all required differing customer processes and legal requirements in terms of documentation and validation.
hahn-schickard
Zein Pharma

Known for producing top-tier dietary supplements they operate within a highly regulated sector where product quality and safety is critical. Ensuring traceability and sourcing from raw materials right to product distribution is essential. As well as adaptability to changing international health regulations, growing demand and global market complexity.

Key Market Challenges:

  • International health and dietary regulations
  • Ensuring product traceability
  • Quality controls
  • Global supply chains and complex logistic networks
ZEIN PHARMA
Medtec & Science GmbH

MedTec Science stands for quality and reliability in medical technology. They have been developing and producing innovative, individual and intelligent solutions for 40 years. Always in dialogue with their customers and with the aspects of usability, durability and environmental compatibility in mind.

Goal:

  • To find one software solution for them and their subsidiary, instead of working from two different ERP systems. 

Requirements:

  • MedTec Science needed a new ERP that could meet both their and their subsidiaries requirements to reduce inefficient and manual document exchange, product sales of the subsidiary, while also meeting regulatory requirements within the medical technology environment.
View Case Study
Medtec and Science
Requirements

What requirements do you have to place on ERP consultants?

Advising on the selection of an Enterprise Resource Planning (ERP) system is not easy.

It requires specialised knowledge and a deep understanding to be effective as a consultant in this market segment, where companies need to increase their competitiveness by increasing efficiency or reducing costs, depending on which they choose.

ERP consultant advises clients in the medical technology sector
Regulations

Strict safety requirements

With our expertise of medical device/UDI ERP software requirements, we are already defining the requirements of the new EU Medical Devices Regulation (EUDAMED database).

This will be introduced together with UDI in Europe, which is already used in the US. It is therefore important to include these specific requirements in an ERP specification as well.

In addition to the complete support of all business processes, compliance with regulations (e.g. DIN EN ISO 13485, MDR, 21CFR820) and the globally unique labelling of medical devices with UDI, integration into existing system landscapes is also possible.

Medical personnel work with state-of-the-art industry solutions for medical technology.

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