Monthly Archives: June 2014

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Outdated paper-driven shop floor processes don't offer the solution medical device manufacturers need.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Outdated paper-driven shop floor processes don’t offer the solution medical device manufacturers need.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

What Can You Learn About Your MES and Paperless Manufacturing Vendor?

With 5 simple tips, you can learn a lot about a manufacturing software solution before you ever sign a contract.

By Kristin McLane, President of CIMx Software

With the wrong MES or paperless manufacturing vendor, your project could resemble a giant pile of dirt hindering production efficiency.

With the wrong MES or paperless manufacturing vendor, your project could resemble a giant pile of dirt hindering production efficiency.

I have called a dozen landscapers to move a large pile of dirt in my backyard.  I still can’t get a return call or sales appointment.  I don’t have the tools or the expertise to move the dirt.  I’m at the mercy of the vendors.  How is it that I can’t find a single company to call me back?  I’m realistic – I know there are times you can’t take on new work, but a simple phone call is all I want.

What message are these companies sending to potential customers?  I don’t want to sign a contract without knowing they will deliver on their promise.  What confidence do I have in their work if they can’t even be bothered to give me a call?

I’m constantly amazed at this same lack of follow-through in the software industry.  Too many prospects tell us we were one of the few (or the only) vendors to call them back.  How is that possible?  We’re never too busy to help, and we’d love to grow our business while helping you grow yours.  It’s not that we don’t have a full calendar – we are blessed with a full pipeline of work and high standards for our product.  We want to build the system features that continue to make our products more robust, user-friendly and dynamic, and that takes time and effort.

But, we also know how frustrating a problem you can’t solve alone can be.  When you’re talking manufacturing software like MES or paperless manufacturing, build-it-yourself solutions often become disasters that spiral out-of-control, consume resources and build frustration.  So if you know that you can’t, won’t or shouldn’t DIY, then you rely on the vendors (just like me).   This can lead to frustration.  You have a problem, but the potential solution-providers ignore you.  What can you do?  Here are a few pointers I’ve learned in software and manufacturing solution industry (and I’m considering for the mud dump in my backyard):

  • It’s safe to assume if sales won’t return your calls, delivery won’t be any more reliable. 
Look for a vendor that's responsive to your needs and works with you as a partner. Illustration from

Look for a vendor that’s responsive to your needs and works with you as a partner. Illustration from

True, there are times when a single company resource (who should call you back) is giving the whole organization a bad name, but company culture is either built for exceptional service or not.  Sloppy calling habits will mean sloppy delivery habits.  Don’t expect a company that can’t call you back to deliver exceptional service.

  •  Ask the vendor about their guarantees (if they even HAVE any). 

Just like everyone else, we make mistakes.  I know no one is perfect, but when mistakes happen, we admit our error and make it right.  You have my personal guarantee for any work we do, and we put it in writing.  Problems will happen during any software project, so it pays to ask about a guarantee.

  • Question the vendor on promise-based language on the website.

Do you see paragraphs of “we are the world’s leading…,”  “fastest to…” or “guaranteed to…” on the vendor website?  What makes someone a global leader?  Who is handing out “global leadership badges” and how is that going to help your shop floor?  What benefit are you going to get from the accolades they heap on themselves?  Is that global leader also a company that outsources their help desk so you never get service when you need it?  I even came across a company that calls themselves a, “cool vendor.”  Really?  How will that help you?

  • Focus on what you need.

As a subject matter expert in manufacturing systems and workflows, CIMx consults with its customers throughout the sales process.  We often see customer teams get hungry, and create a laundry list of requirements so long the project loses steam and profitability before you ever get to production.  Determine the “top” challenges and focus on the solution to those problems to ensure project success.

I’ll be honest, the dirt is STILL sitting in my backyard as I write this blog, and I’m getting ready to call a few more companies today.  I know I need to find someone to move the dirt (or build a mud pit or hilltop fort in my backyard), but I also know that choosing the wrong solution will lead to more frustration.

Take a few moments before you call a software vendor.  Ask the right questions, and have a focused plan of action, will help ensure you’ve found the right solution, and not created an even bigger pile of problems leaving a muddy mess on your shop floor.

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.

Secrets of Saving Money with Your MES Purchase

Follow these tips to avoid out-of-control MES and Paperless Manufacturing software costs, and save money while solving shop floor problems.

By David Oeters, Corporate Communications with CIMx Software

Purchasing an MES or paperless manufacturing system shouldn’t be stressful.  A vendor should offer an honest price upfront, and be able to deliver value and functionality at a reasonable price.  But, that’s not how the process usually works.  These 6 simple tips help ensure you have the shop floor software system you need at a price you can afford.

Tip 1: Understand Your Shop Floor Needs

With a few simple tips, you can save money and solve shop floor problems with paperless manufacturing.  Image by

With a few simple tips, you can save money and solve shop floor problems with paperless manufacturing. Image by

Once work has begun on configuring and setting up your system, changes (even necessary ones) will add to the final cost of the software.  An incomplete picture of how the system will operate and support your business may lead to additional work and expenses.  For example, additional software integrations after work has begun will require changes, adding to the cost.  Make sure any vendor you talk to asks for a complete and accurate picture of how your operation works rather than trying to sell you on how their software works and solves all your needs.  Avoid problems by assembling internal resources and subject matter experts for your project team early in the process and be prepared to brief suppliers who ask for the details.

Tip 2: Beware of Custom MES

A custom MES, a one-of-a-kind system designed and built specifically for your shop floor, is a great option if you have the money and time to spend on development.  But, it is an expensive purchase.  The TCO (total cost of ownership) will be significantly higher.  You need to pay for all those developers and software engineers working on your solution. Changes or updates in the future will be solely funded by you and your business, which can easily double (or more) the initial cost of a custom solution.

Future changes to your shop floor or work flow processes will require more change, more testing, and more expenses, or your system will slowly become less efficient and less optimized.  Look for a system that doesn’t require extensive configuration or customization.  Install the system that meets your major needs with minimal work out of the box to control your initial cost and lower your TCO.

Tip 3: Avoid Modules

Many companies sell “modules” you select to “build” your own system.  It seems like a great option, but it will significantly add to the initial cost and the TCO of your purchase.  In addition to the standard integrations, each module will require integration with its neighbors.  Many times these “modules” are purchased separately, leading to costly service charges.  The project becomes more complex and costs skyrocket. The initial integration isn’t the last payment you’ll make for the “modules.”  Any software updates or patches will need to address all those modules and expenses grow.

Look for a complete solution with features you can turn on and off as needed, without requiring complex internal integration of modules.

Tip 4: Buy Directly from the Vendor

Make a smart investment with your shop floor software purchase.  Illustration by

Make a smart investment with your shop floor software purchase. Illustration by

Consultants are an appealing option for many MES customers.  But, companies who use a consultant are often left with a solution that is much more expensive than it should be.  Consultants often integrate the software, configure it to your work processes, then train your employees and maintain your system.  However, the consultant isn’t the best or most cost-effective resource.  Most software companies offer these services.  In addition, they own the computer code that is the core of your system – after all, they built it.  This means they are in the best position to quickly solve problems, deliver patches and software updates, and answer the questions you have.  A consultant will take more time, and deliver a less-than optimized solution for a higher cost.

Tip 5: Look at the Team

Many vendors will offer an entire “team” of experts as you plan your installation.  Some vendors present the team as a benefit, but how many people are really necessary to install your system?  You are paying for each team member.  The costs quickly escalate as you add service charges and consultation work for the team.  Many times, a large team means more customization and complexity.  If you see an installation growing, or you are offered a whole team, ask why.  Additional resources may be necessary, but you shouldn’t have to pay for them until they are needed.  One knowledgeable and talented individual who can manage the installation is much more valuable than a team.

Tip 6: Focus on Behavior-based Systems

MES and paperless manufacturing systems fall into two categories – template-based systems and behavior-based systems.  A template-based system uses forms and templates, and the highly-formatted data input and output drives consistency, requiring users conform to the system processes.  A behavior-based system adapts to your shop floor processes.  Users edit and reconfigure screens, opening and attaching documents as needed, and the system adapts and supports your workflow.  Template-based systems require more configuration and customization.  Users must be trained in an entirely new system, often requiring new processes and work plans.  Behavior-based systems reuse your existing work plans, and can quickly, easily, and inexpensively be reconfigured to new processes.


It’s unfortunate, but many MES vendors are quick to make promises before a contract is signed.  As the project progresses, service charges are added, additional expenses are found, and the project timeline grows until the original budget is lost in an avalanche of change orders and fees.

Protect yourself from unnecessary service charges and budget-busting expenses with these tips.  Remember the WIIFM (What’s In It For Me) factor as you work with vendors.  While paperless manufacturing and a digital shop floor will improve production and quality, eliminate errors and deliver shop floor efficiency, the price you pay depends on the decisions you make before the contract is signed.

Want to learn more, or hear how CIMx Software can improve your shop floor for less, then give us a call or send us a message today.  We’re happy to help.