Category Archives: Unique Device Identifier

The Future of Medical Device Manufacturing

As companies work to comply with changing regulations in the Medical Device industry, there is an opportunity to improve production and revenue for the savvy manufacturer.

By Anthony Cuilwik, CEO of CIMx Software

Change is happening across the Medical Device Manufacturing industry.

With the right tools, you can meet the new manufacturing regulations and improve production.

With the right tools, you can meet the new manufacturing regulations and improve production.

Additional standards are being implemented at an accelerated pace across the industry.  There is a push for electronic medical records to increase collaboration and improve patient care.  Hospital facilities and medical treatments are under increased scrutiny.  In addition, globalization of medical device production, the rapid development of new treatments, and a focused push to lower the cost of treatment are just a few of the reasons the industry must adapt and adjust to new regulations, standards and processes.

In fact, in a recent survey, 43.3% of medical device manufacturers reported changing regulatory environment as the biggest challenge they face in the future.  Companies are looking at cost efficient ways to, “… navigate the increased regulatory burden,” according to another industry report.   New standards require more detailed and careful labeling, dating, use-by dates, sourcing, detailed manufacturing records, and accountability, resulting in tightened production constraints and record requirements.  To comply, manufacturers must adopt new processes and utilize new tools.

At the same time, changes in the medical device industry are pushing manufacturers to lower cost and standardize production for a global market, while absorbing a new tax on medical devices.  As the population ages and the cost of healthcare increases, everyone must look at ways to make healthcare cost effective and more available.  To meet these goals, manufacturers must adjust their operations to improve production, lower cost and increase quality, while accommodating new regulations.

Market Pressure Driving Solutions

Outdated paper-driven shop floor processes don't offer the solution medical device manufacturers need.  Image by

Outdated paper-driven shop floor processes don’t offer the solution medical device manufacturers need. Image by

The current paper-driven manufacturing shop floors in the medical device industry simply cannot efficiently comply with the new regulations while increasing production, improving quality, and lowering cost.  Research has shown paper-driven processes increase costs, introduce errors, and create compliance issues.  In fact, 75.9% of companies reported significant business risks due to inefficient document-driven processes, including paper-based processes.

More than increasing risk, paper-driven processes significantly increase costs for businesses.  As reported by Oracle, a study by the Association for Information and Image Management (AIIM) found businesses, “spend $20 in labor to file a document, $120 in labor to find a misfiled document, and $220 in labor to reproduce a lost document,” (

Paperless Manufacturing or MES (Manufacturing Execution System) is a software solution used to manage, control, and document manufacturing operations.  A successful MES project improves productivity and profit by managing all the information needed during the manufacturing process, collecting and documenting all production data and ensuring real-time access to the production information.  No other manufacturing solution can have the profound and beneficial impact of paperless manufacturing.

MES systems have been used (successfully) in aerospace and other regulated manufacturing industries for many years, helping manage and collect the information necessary to comply with standards and regulations, while helping make production more efficient, less costly and faster to market with higher quality product.  Paperless solutions are delivering the same results and benefits to the Medical Device Manufacturing industry.  For example, these solutions offer electronic sign off, automatic data collection, process control, parts traceability, and use electronic record management, among other tools, to alleviate the regulatory constraints challenging the medical device manufacturing industry.

Adding Value to the Medical Device Manufacturing Industry

The 21 CFR Part 11 regulations from the FDA specify how to create and manage quality production records in an electronic system, providing clearly documented accountability for quality checks and production methods that meet all specifications for a product.  Similar regulations exist in the aerospace industry where MES and paperless manufacturing systems ensure regulation compliance.  The ability to complete work more efficiently and accurately, and provide continual process improvement through monitoring and analysis of collected data adds to the value of the software solution.  In aerospace companies it has been proven that a paperless solution provides regulation compliance, process improvement and quality improvement at significantly lower cost than using a paper-driven process.

Paperless manufacturing offers a holistic solution for manufacturing, addressing many of the challenges facing the shop floor.  Image by

Paperless manufacturing offers a holistic solution for manufacturing, addressing many of the challenges facing the shop floor. Image by

The current Universal Device Identification (UDI) regulation provides standards for the barcode labeling and dating of medical devices and products in general.  Because barcoding standards are different worldwide, any system that provides labels must be flexible enough to meet requirements in each country the product is shipped.  In a paper-driven shop, meeting these requirements can be costly, resulting in a number of potentially disastrous errors since there are small differences in standards that are easy to miss through quick visual inspection.  A paperless system will help ensure compliance with these regulations by managing data in production and eliminating these errors.

Global competition and a push to lower medical and healthcare costs are also pushing change in the industry.  Medical device manufacturers are increasingly looking toward platform manufacturing to reduce cost and speed time to market.  Platform-based manufacturing uses the same base frame or core parts in a variety of products to meet different requirements or price points in different countries.  Precise control of parts used in production can be accomplished more accurately and consistently using a paperless solution that validates all parts and verifies processes throughout the production process.

Value of Paperless Manufacturing

While each manufacturing operation is different, paperless manufacturing has been delivering increasing value to aerospace production for years by ensuring all production records are accurate, complete and available for analysis in real time.  Quality issues can be identified and fixed immediately.  Specification deviations are recorded and repaired or replaced immediately.  Shop floor management uses the system to monitor and control work processes, and enforces and promotes process improvement.  On the other hand a paper-driven shop floor is restrictive, error-prone and an increasingly costly way to deliver products.  Paper records or PDFs hinder the ability of a company to analyze shop floor work flow data for continuous improvement, making it almost impossible to fully implement modern process improvement programs.

When looking at shop floor solutions to ensure compliance with regulations, take the opportunity to find solutions that do more than simply meet immediate needs.  See it as an opportunity to significantly improve your current production and position your business for future growth.  Ask yourself, can you afford to continue manufacturing in a paper-driven environment, or is it time to examine paperless solutions?

A Simple Solution to the FDA’s UDI Requirement

New FDA regulations regarding UDI (Unique Device Identification) are causing worry among medical device manufacturers.  We show how you can fulfill the new requirements in a few simple steps.

By David Oeters, Corporate Communications with CIMx Software

There are times when a potential solution may cause more trouble than the problem itself.  A good example… the day I decided to use a hammer to open a jar of peanut butter.  It was a disaster we still call the “great peanut butter explosion.”  Another example – my neighbor tried to use a chainsaw to tear out weeds on his back fence.  The only thing left standing among the carnage was the weed.

The problem is the solution isn’t scaled to the problem.  In the end, you aren’t even solving the original problem, just creating a new problem.

Manufacturers working to meet the imminent deadline for UDI regulations set by the FDA are running into the same struggle – they are offered solutions that aren’t scaled to the problem.

Understanding the FDA’s UDI Requirements

The US FDA (Food and Drug Administration) is rolling out a UDI (Unique Device Identification) for medical devices.  The system will help identify product problems more quickly, target product recalls, and improve patient and user safety.  The UDI is a unique numeric or alphanumeric code consisting of two parts – the Device Identifier (DI), which identifies the specific model of the device, and the Production Identifier (PI) that identifies specific details related to the manufacturing of a device, which could include (among other things) the lot or batch number, the serial number, the date a device was manufactured and the expiration date.

When combined with the Global Unique Device Identification Database (GUDID), the FDA will be able to identify problems with a device and track defects to more effectively issue recalls.  The FDA has created an aggressive schedule for compliance – the first phase of compliance begins on September 24, 2014.  An extension of the compliance date must be submitted by June 23, 2014.

These regulations require medical device companies accurately collect manufacturing data.  Fulfilling the UDI requirements means real-time data collection, accurate archiving of manufacturing data, and shop floor control – all benefits of MES and Paperless Manufacturing.

A Solution Scaled to Your Shop Floor Needs – Phased Implementation

Why struggle with a solution that doesn't work for you?  Phased Implementation puts you in control of the project.  Illustration by

Why struggle with a solution that doesn’t work for you? Phased Implementation puts you in control of the project. Illustration by

Unfortunately, some manufacturers are struggling to meet the new requirements.  Faced with the imminent deadline, they look for MES solutions, and end up with a custom or highly-configured system that takes months (or even years) to build.   Add in the time necessary to install the system and train the shop floor in its usage and the exorbitant cost, and the solution begins to resemble the hammer to a glass jar of peanut butter.

Other times, a manufacturer will select a “module” for bar codes and labeling to meet the FDA requirements.  The vendor will offer them a data collection module or two (or three), and then a reporting module, a work instruction module, and then an integration module to put it all together.  Soon the single-module solution has become a massive MES project much more complex than anyone thought.  It’s a chain saw waiting to pull up a weed.

With paperless manufacturing and a phased implementation, you control the scope of the project and ensure the solution is scaled to your manufacturing needs.

With a phased implementation, the entire system is quickly installed straight out-of-the-box (or you use it as a cloud application).   You begin benefitting from the software in less than 30 days with UDI labeling built in from the start.  There’s no need to separately install each module or application.  There is no reason for multiple integrations or additional complexity.  Once installed, you decide what functions to turn on and pay for.  Your team is trained only on what you need.  Select the parts of the system you need to meet the UDI requirements, and focus on the functions that deliver the greatest result and ROI, resulting in a controlled transition to a more effective shop floor that easily incorporates the new FDA requirements for UDI.

Even better – you aren’t trapped by your solution.  When you and your team are ready, roll out new functionality and enhanced capabilities.  Since you are supported by the full software package, you have access to the latest software updates, releases and upgrades.  The solution will never become obsolete or another piece of legacy software.

A Different, better solution to the FDA UDI Regulations

Make your project a success with paperless manufacturing. Illustration by

Make your project a success with paperless manufacturing. Illustration by

The truth is, paperless manufacturing was designed as an alternative to traditional MES.  Utilizing the latest technology and building on CIMx’s experience as a best-in-class MES provider, paperless manufacturing delivers innovative MES functionality, including all the tools and functionality you need to meet the new UDI requirements, at less than 10% of the cost traditional MES.  Paperless manufacturing applications are easy to adapt, configure, add features and evolve without increasing the cost or creating custom software.

The UDI requirement deadline is fast approaching (if it hasn’t already passed) but you can still meet the requirements with minimal cost and complexity using a solution scaled to your shop floor needs.  You can improve your shop floor, improve quality and production, and deliver an ROI in months, not years.  Want to know more?  Give us a call or leave a message – we’re happy to help.