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Medical Device Manufacturing

Build More Quality Medical Devices Profitably With Microsoft Dynamics 365 Cloud Solutions

Meet Compliance

Full Traceability

Manage Services

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Medical device manufacturers are highly regulated and face fierce challenges daily. They need to trace products from the source to the recipient to meet strict quality standards and stringent compliance with the FDA and other government regulatory agencies. 

Your business depends on closely following controlled processes to produce products that meet stringent quality standards and creating documentation to validate all procedures. That's why medical device manufacturers turn to Turnkey Technologies for functionality that grows their competitive advantage.

Industry Trends

Medical devices include articles, instruments, apparatuses, or machines used in the prevention, diagnosis, or treatment of illness or disease or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health purpose. 

The U.S. medical device manufacturers' market size was valued at USD 186.5 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 5.0% over the forecast period. The rising prevalence of chronic diseases and the increasing geriatric population in the country are the key market drivers.

 

Cited: www.grandviewresearch.com/industry-analysis

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Your legacy business management system may be holding you back

It is critical to know the actual cost of manufacturing medical devices so you can make better purchasing and pricing decisions. If QuickBooks (or your legacy business system) may not fit your business today and can't deliver an integrated solution to meet complex supply chain requirements and help you meet quality standards, your operations suffer and you will miss out on market opportunities. Running your business with disconnected finance and operation puts you at risk. 

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Strict Compliance rules require you to track medical devices no matter where they end up.

Medical device manufacturers are responsible for tracking devices from the source to the hospital, doctor, and patient recipients even when sold through distributors as part of the strict compliance requirements you must meet. If there are recalls, you need complete visibility to notify recipients quickly - whether you are producing spinal cord replacement parts, a pacemaker, or other medical devices.

 

The Turnkey team are masters of Microsoft Dynamics and can upgrade and enhance your business management software so you can meet regulations with ease. Microsoft built its solutions from the ground up with business, compliance, and security in mind. 

There's no substitute for experience when acquiring a technology partner.

Turnkey professionals have extensive project and business process experience to ensure successful outcomes. We know the complexities of medical device manufacturing and apply our technical knowledge to solve the stringent regulations and logistics that are a must-have to succeed in the industry.

Our disciplined approach and attention to detail make all the difference for a smooth transition to Microsoft Dynamics 365 ERP. We deliver implementations with a proven, repeatable methodology. Our "been there, done that" consultants know best practices gleaned from years of solving issues for other companies. Rely on a team that knows your industry, understands modern technology, and can help you achieve a competitive edge. 

Our customers gain a competitive advantage working with Microsoft Dynamics 365 ERP. A LargeMedDeviceMFG recognized the value of keeping Microsoft Dynamics 365 software in place to continue manufacturing operations that already worked flawlessly. When LargeMedDeviceMFG bought SmallerCompetetor, they chose to keep them on Microsoft Dynamics 365 manufacturing even though they used SAP at the corporate office. They invested close to a million dollars creating two-way integration with SAP instead of moving off Microsoft.  SmallerCompetetior kept its manufacturing line producing with no disruptions.

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Top Industry Challenges

1.

Managing your business by spreadsheets is cumbersome - Transform how you work by incorporating manual spreadsheets into one-touch, real-time, refreshable reports. Save time spent reconciling disparate spreadsheets to match reality and "crossing your fingers" on the accuracy of your data. Instead, rely on automated, intelligent reporting for information that is always accessible and accurate. 

2.

You can't meet quality goals if your workflow processes are disconnected from your ERP system - Medical device manufacturers are challenged to implement business processes to ensure quality products and earn FDA Validation. They look for consistent results by documenting and collecting data with a granular inspection process. 

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3.

Essential Issues:

  • Traceability

  • Generating complex barcoding and labeling

  • Tracking a product after the customer receives it

  • Process control

  • Tracking donor information

  • Raw material inspections and quality inspections to ensure only the best products are used

  • Specific support for the mobile field medical device sales team

  • Line of business integration for surgical set management, replenishment of Implants

4.

Producing a quality medical device is just the start - Manufacturers must also coordinate life-saving services to support medical device use. It is critical to gain a 360-degree view of your resource capabilities, whether partnering with surgeons in the operating room for device implementation or delivering other essential educational services.

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Benefits to expect with Turnkey Technologies by your side:

Meet compliance requirements

  • Keep track of and document every activity such as equipment use and FDA requirements for line clearances. 

  • Protect the workspace from mix-ups and minimize the burden of manually maintaining logbooks. 

  • Automate and ensure data integrity with electronic signatures, audit logs, and automatic data collection.

Collect and Visualize Real-Time Production Data

  • Turnkey can boost efficiencies by connecting your external applications and devices. Integrate devices, sensors, cameras, and machines throughout your operations. 

  • Synchronize data between your best-of-breed applications and Microsoft ERP to reduce manual data entries and the resulting errors and duplications. 

Enable Review by Exception

  • Achieve faster predictable release of products from manufacturing to customers by improving efficiencies. 

  • Streamline documentation to ship and release products on time. 

  • Eliminate errors and the time wasted fixing them. 

Guide and support workers

  • Provide detailed, easy-to-understand work instructions with media-rich content. 

  • Protect your processes with workflows, ensure equipment is cleaned and calibrated correctly, and streamline data collection. 

  • Help workers get up-to-speed faster when introducing or updating products.