Here’s How We Do It: Gage R&R Manufacturing to Validate Testing and Continuously Improve

At E4D Technologies, we have a wide variety of tools, systems and processes that help us ensure we are doing everything as efficiently and accurately as possible. Gage R&R is one of the tools we use to validate the accuracy of our measurements. We believe that by creating reliable products, we can create safer medical devices for consumers and doctors alike. Here’s everything you need to know about gage R&R manufacturing with E4D Technologies:


What is Gage R&R Manufacturing?

Gage repeatability and reproducibility (gage R&R) is the process of finding the variation in the measurement data gathered from gauging equipment to determine its accuracy. Essentially, this is a process used to determine the accuracy of a measuring system. By gauging the quality of your measurement system, you are able to determine if there is variation in the manufacturing process. Our goal is to limit the amount of variation in the process to provide accurate products.


What’s the Process of Gage R&R?

First, you must determine if your product will require gage R&R. We do this by examining the risks involved with creating products that don’t require a high level of accuracy. Some products, such as plastic forks, may not require gage R&R due to the low risk associated with inaccuracy. Other products, however, such as pacemakers, quite literally create life and death situations if the product isn’t as accurately manufactured. Due to the resource required to perform a gage R&R, we only perform these tests based on the risk assessment and customer requirements.

Our goal with gage R&R is determining if our manufacturing process is repeatable and reliable. In a typical gage R&R process, appraisers start by taking measurements of samples from different trials and collecting the data. Different appraisers collect data from samples using the specified measuring equipment and compile the data. The compiled data would then be calculated to determine the variation amongst the different samples for an accurate gage R&R.


What Factors Determine if the Variation is Acceptable?

We determine if the gage R&R collection data is acceptable compared to the industry standard of acceptable variation. We determine three different factors, each with its own set of industry standards. The three factors to determine in a gage R&R study are the percentage contribution, total gage R&R and the number of distinct categories. The acceptable results are as followed:


Percentage Contribution:

1% or less – Acceptable

Between 1% and 9% – Conditionally Acceptable

More than 9% – Not Acceptable

Total Gage R&R:

10% or less – Acceptable

Between 10% and 30% – Conditionally Acceptable

More than 30% – Not Acceptable

The Number of Distinct Categories:

5 or more distinct categories – Acceptable

3-4 distinct categories – Conditionally Acceptable

2 or less distinct categories – Not Acceptable


What is the Importance of Gage R&R to E4D?

There are risks involved with not understanding the measurement system you are using to create a product. Let’s use a tire for example: if you need to refill your tires with air and the measuring system is faulty, you could overfill your tires and it could explode. Measurement is an integral part of any manufacturing process. That’s how we determine if the product is good or bad before we ship it out. It’s basically predicting the quality of our manufacturing process.

The value of working with a technology manufacturer and designer like E4D is that we are able to coach you on what manufacturing your product will require. We are here to help you save time and money by only using tools that are necessary for your product. To us, it’s all about risk management, safety and efficiency. Want to learn more about our processes? Check out our blog today!

Photo Sourced from E4D Technologies

How E4D’s Company Culture Contributes to Our Success in Design and Product Manufacturing

At E4D Technologies, we know that a company with a healthy organizational culture will outperform a company with an unhealthy culture. Many companies are smart, but many struggle with delivering timely results with minimal interpersonal drama and disorganization. Patrick Lencioni defines a healthy organization as one that “has minimal politics and confusion, a high degree of morale and productivity and a very low turnover among good employees” (The Advantage, Pg 5). Our smart and healthy organization has successfully competed with much larger organizations and withstood the test. While many of those larger organizations have a brilliant and skilled workforce, we have the advantage of having the strength of a healthy organization to complement our smaller but equally skilled team. As a company that has focused on organizational health and creating a culture where people want to come and work, more than two-thirds of our team has been with us for more than five years; and half of that has been around for more than ten years.

Our culture enables us to innovate technology every day while genuinely enjoying the work that we do and the people who work with us. It helps us succeed in creative development, problem-solving and a variety of essential components of our business. We know every company has a culture, but not all companies intentionally develop a culture that promotes their purpose and values while looking to bring their customers the best value.

Here’s how our company culture contributes to our success in contract design and product manufacturing:

We Like to Say E4D Means Employees 4 a Difference

We understand that progress in the technology industry encompasses more than producing a great product. Not only does E4D make a difference for our customers around the globe with innovative products, but we also bring value to our local communities. We want our company values and ideas to go beyond the walls at E4D Technologies and positively affect people outside of our organization. For example, we make a difference in our community of Richardson, Texas, by uniting our employees in our company-wide volunteer program. We are blessed to be part of a great community that is a vital part of our employees’ lives.

We exist to enable individuals, teams, and companies to have the freedom to move forward. Our team places a heavy emphasis on creating opportunities for our employees to help our neighbors achieve their freedom to move forward. Serving our communities also has the added benefit of building stronger, long-lasting relationships with our employees, which are strengthened as we work to serve the community together.

Leaving Our Egos at the Door

As the cliche goes, “cash is king.” But the reason to be in business is to use that cash to create value. Our team strives to create an environment for the benefit of our customers, employees, end-users, investors, and communities based on mutual improvement, growth, and overall service. Contrary to most beliefs about business, profit is not our only purpose but a direct result of our aim.

One of our core values is that we “leave our egos at the door.” This means that we acknowledge that it takes the whole team, regardless of title or role, to bring the best value to our customers and our employees. We value the diversity of experience, education and culture of our team. We recognize that we all have something important to contribute to each other, to our customers and to our community. Together, our team of experts has nearly 600 years of combined experience in all major engineering disciplines, and our team represents more than ten different countries. Under one roof, we work together to make complex technologies simple and bring our customers’ products to life. Through leveraging our diverse skills, cultures and experience, we provide everyone with the freedom to move forward.

This mindset and value breaks down silos and politics that can impact an organization’s health and deter the company from moving efficiently and effectively to what brings the most value. Our company culture brings our entire staff together with one motivating goal of moving forward. We want to make a difference in the future of design and manufacturing, and we’re working towards this goal every day.

Aversion to the Status Quo

We know that when you don’t innovate, you die. Sometimes it happens quickly, but often it happens slowly. We are motived to have an on-going, vibrant company and believe strongly in continuous improvement. Another of our core values says that we are “averse to the status quo.” Every day we look to improve our products and processes while helping our customers do the same. Throughout our 17 years as a company, we have refused to back down from the variety of challenges that have been presented. We have competed with industry giants, but with tenacious, creative, and innovative employees, we continue to transform every aspect of our organization.

No matter what you’re looking for out of a design or manufacturing partner, E4D Technologies is here to help you move forward. Our innovative approach to medical device manufacturing and regulatory experience has allowed our technology to be sold globally. We would like to offer that same opportunity for your product. Want to learn more about all of the ways E4D can help your company thrive? Check out our offerings today!

And if you want to work at a company with an organizational culture that makes coming to work every day less of a chore and more of a motivating factor, reach out to us today to see what opportunities might be available.

Photo Sourced from E4D Technologies

What Do I Need to Know If I’m Looking for a Contract Manufacturing Partner?

Key Questions to Ask a Design and Contract Manufacturing Partner

It’s time to find a design or contract manufacturing partner. It might be the first time you’ve engaged a 3rd party contractor or you may have tried it once before and it didn’t go well. Many companies can find it challenging to understand what they need out of a design or manufacturing partnership. There are companies of all sizes and specialties, so how do you choose the right one for your needs? Here are some of the key questions to ask a potential partner from the experts at E4D Technologies:

Successful Partnerships Are Based on a Good Financial and Capacity Match

The first step to finding a contract manufacturing partner should always be finding one that aligns with your financial size and volume requirements. Many times we see companies that are early in the product life cycle with lower volumes and revenues trying to align with very large companies that excel at high volume and high revenue accounts without great success– especially in medical device manufacturing. Your company and your future partner are looking at cash management and both parties will benefit when expected revenues and volumes are more aligned.

When you are researching the right partner, ask your potential partner about their sweet spot for the size of a customer. They should provide you with a range that aligns with your anticipated needs. If they don’t have an answer or their answer is significantly different than your companies revenues and capacity needs; they may not be your best fit for a design or contract manufacturing partner.

Matching Capabilities is Key for Design and Manufacturing

A second key part of finding the perfect contract manufacturing or design partner is matching their capabilities to your production or design needs. Some high-level things to consider:

  • Do they have the required certifications you require?
  • Do they have experience in products similar to yours?
  • Do they have experience in global procurement?
  • Do they have the necessary quality systems in place?
  • Do you need support with Design? If so, they should have in-house engineering?
  • Where do they manufacture and does it align with your needs logistically?

For example, if you have a high regulatory product like a medical device, it is much easier and effective to partner with someone who has already built medical devices and understands the regulations in the various countries you want to sell your device.

If you need design support, what types of engineering skills do they have in-house? What will they have to outsource?

Just like most relationships, the more you have in common the easier the partnership will be over the long term. The goal in this step is to try and understand how your future partner best aligns with all the elements you require to help you bring your product to market, scale it, and improve it.

Assess if This Manufacturing Partnership Will Provide Value

The first two steps help you narrow down the list to those partners who can best support you and your product. While there are many different factors to consider when determining a manufacturing or design partner, finding the one who will provide the most value to your business is essential. The most crucial factor is that you need someone who is able to ask the right questions and give the right answers. You need someone with the experience to be your coach in the process. The partner will help you, based on their experience, on how to reduce costs, improve efficiencies, refine designs, determine the right logistics for your products and, most importantly, tell you upfront if they don’t have the capabilities to help you.

If you are looking to engage design service from this partner, they should bring value not only to the design but around the management of the Intellectual Property (IP). Conversations over intellectual property are made during the contract negotiations and it should be clear if they own the IP or if you own the IP when the design work is completed. They should also be able to demonstrate that they have a track record of protecting IP. At E4D Technologies, it is always our goal to let our partners own their IP. We work with our partners to make sure that they understand the controls and contract agreements that protect their intellectual property. Because at the end of the day, a healthy partnership is built on trust and transparency.

Lastly, consider proximity. Depending on your needs, it might be important to have a partner who is located within easy travel distance so that you can go and see the process and products. This can be important in the early days of a product or relationship. Perhaps proximity is more important when you consider logistics and your end market. Depending on the product size and weight, it might be more important to find a manufacturing partner that is in relatively close proximity to your end market to mitigate logistic costs. Your choice between two manufacturing partners might come down to their time zones and how important it is to you to communicate quickly with them during your working hours. These are all important considerations in determining the value of potential design and manufacturing companies.

Ask for a Tour of Their Manufacturing Facility if Possible

One of the key factors in choosing a manufacturing contract partner is transparency. You want a partner who will open the doors of their facility to you, so you can see for yourself the site, the processes, products, and the quality they have currently in place. Keep in mind that this will likely require you to sign a nondisclosure agreement for your protection and for their other customers.

If you’re in the market for a new manufacturing or design partner, E4D Technologies would love to see how we can help your business grow. Our team works together under one roof, each with a unique specialty covering all major technological disciplines. We have a deep understanding of what it takes for a powerful product introduction into markets across the entire globe, especially in highly regulated industries.

Want to learn more about what E4D Technologies has to offer your business? Contact us today!

The Significance of the Six Sigma Black Belt with E4D Technologies

At E4D Technologies, we work hard to deliver exceptional quality in everything we do.  One of our core values is that we are “Averse to the Status Quo”. This drives us on a continuous improvement journey throughout the whole organization. Two of the tools in our continuous improvement toolbox are:  Six Sigma and Lean manufacturing. Here are the reasons why Six Sigma and Lean manufacturing are so significant to our processes at E4D:

What Is a Six Sigma Black Belt Certification?  

The Six Sigma Black Belt Certification is one of the most comprehensive certifications in our industry. Any person who can rise to the challenge to complete this certification is certified in the Six Sigma philosophies and principles, and they’re a master of using the DMAIC process to reduce variability while leading and supporting the Six Sigma team. We have one Certified Black Belt on our team, but the principles of Six Sigma are taught to our entire engineering team. These principles keep us focused on continuously improving the reliability and quality of our products and processes.

What is the Significance of Lean Manufacturing?

Lean Manufacturing is similar to the principles of Six Sigma in some ways, but completely dissimilar in others. The concept of lean manufacturing is based on eliminating waste while maximizing customer value. In following the guidelines of Lean Manufacturing, we look at the 8 wastes and continually look for ways to add value and eliminate waste.

eight wastes manufacturing

dmaic manufacturing

The Differences Between Six Sigma and Lean Manufacturing

As a leader in advanced technology used for manufacturing, we believe that every great system serves an important role in the workplace. Lean Manufacturing and Six Sigma may sound similar at first, but the differences are important to understand. Lean manufacturing is a process for reducing waste in the workplace, while Six Sigma works to reduce variations. Both present tools that help make the design and manufacturing process more effective.

We are huge proponents of both Lean Manufacturing and Six Sigma. We work hard to deliver a manufacturing experience that puts our clients, and their products, first. To find out more about how we can help manufacture your products with future technology innovations and processes, contact our team today.

Header Photo Sourced from E4D Technologies