Drive Medical Device Growth with ERP Excellence

Enterprise Resource Planning (ERP) systems can help Medical Device manufacturers succeed in today’s competitive market

The Medical Device industry has been on a steady growth trajectory for the past dozen years or so, and most analysts believe it will hit nearly US$800 billion by the end of the decade. Much of the current growth is being driven by a healthy demand for more complex, innovative, and data-driven products, such as smart devices and wearables, medical robots, and devices that rely on artificial intelligence, machine learning, and virtual and augmented reality.

At the same time, however, accounting firm KPMG asserts that “a shadow hangs over the sector in the form of a relentless downward pressure on pricing” as “healthcare budget restrictions and new reimbursement regimes continue to snip away at margins.”

Demand for innovation and reduced healthcare costs—plus a steady supply of disruptive new players in the marketplace—are creating a complex web of opportunities and challenges for Medical Device manufacturers. To capitalize on the opportunities and minimize the risks, it’s important for these companies to:

• Enhance operations through automation
• Tighten up supply chain and quality management capabilities
• Improve compliance with Good Manufacturing Practices (GMP)

A comprehensive Enterprise Resource Planning (ERP) system—one that’s purpose-built for Life Sciences organizations—can help Medical Device manufacturers do all this and more.

Improve Operational Efficiency and Productivity

An ERP system can help Medical Device manufacturers streamline operations by providing real-time visibility into all aspects of the business and automating many manual tasks. Better tracking of parts and materials can reduce inventory costs, for example, and more accurate order and delivery tracking can greatly enhance the customer experience.

Increase Agility and Responsiveness

When managers can make better decisions and identify issues early—before they become bigger problems—business leaders can focus more time on strategy and less time putting out fires. An ERP system creates a single source of truth for all your business and manufacturing data, which is housed in a centralized repository and can be mined for real-time insights about your business. With the right ERP system in place, you can respond more quickly to changing market conditions and quickly answer any queries that come in from the regulatory bodies that oversee your activities.

Make GMP Compliance Much Easier

The right ERP solution can help your manufacturing team comply with GMP guidelines from raw materials and component parts to finished products. Here are just a few examples of how Medical Device manufacturers can more easily follow and enforce GMP guidelines with a purpose-built ERP solution:

• Real-Time Data
  An ERP system can help you track and manage all the data related to materials, equipment, procedures, and processes in near real time. For instance, Enterprise Asset Management (EAM) solutions, especially if integrated with dedicated rental applications, can provide visibility over the location and status of devices and proactively support periodic maintenance.
• Audit Trails
  An ERP system can rapidly generate detailed audit trails that document system access, data changes, and inventory transactions, making it easier to answer questions from regulatory bodies.
• Process Control
  An ERP system can help streamline operations and eliminate human errors. Integrating your ERP solution with a PDM/PLM solution and/or a CAD/CAM system, for example, can streamline the design process and ensure robust version control.
• Quality Control and Assurance
  By providing powerful analytics tools and automatic alerts, an ERP system can help you identify issues early and take corrective action before they impact quality.

Without an ERP system, Medical Device manufacturers may find it difficult to ensure the integrity of their data, identify and recall defective products, or manage operations efficiently. Failure to comply with GMP can lead to fines and penalties, in addition to product delays and increased costs.

Rely on AX for Pharma for a Purpose-Built ERP System for Medical Device Manufacturers

By implementing the right ERP system, Medical Device companies can reduce the risk of non-compliance with GMP, improve the quality and safety of their products, and maintain or grow market share as the industry evolves with a wider array of personal, technology-driven devices.

To learn how AX for Pharma 365™—a comprehensive ERP solution that’s designed exclusively for Medical Device manufacturers and other Life Sciences organizations—can help your business drive growth, innovation, and efficiency, contact us today. Our configurable solution, built on Microsoft Dynamics 365, is easy to implement and validate and has been proven effective with leading Pharmaceutical companies, Biotech firms, and Medical Device manufacturers in the U.S., Europe, and Australia.