From the Desk of the CEO: Women in the Workplace

Last month, it was International Women’s Day. I’ve been processing my reaction to this day, and I’ve found myself feeling both hope and discouragement. On one hand, I love seeing that the great women in my life, at E4D and around the world, being honored. On the other hand, I am disappointed that we still need a day to try and balance the gender disparity.

This day celebrating women goes back to 1909 in the US and, more than 100 years later, studies show that we still have:

  • 47% of women in entry-level jobs, which reduced to only 21% at C-Suite
    • Women of color are still vastly underrepresented, with only 3% of C-suite jobs (1)
  • COVID-19 challenges (childcare, work from home, etc.) are impacting women in the workplace more significantly than men
    • 76% of women vs. 54% of men (1)
    • Moms of young children lost jobs at 3x the rate of fathers (2)
  • US Census Bureau shows that little was done to bridge the gender wage gap between 2018 and 2019, with women earning $0.82 for every dollar earned by men
    • If you add controls for skills, education, occupation, age, etc., it’s still only $0.88 on the dollar per Pew Research

Just to be clear – I’m a strong advocate for men in their career, as fathers and contributors to the greater society. Regretfully, I’ve also seen men face discrimination because they were involved parents, co-sharing parenting responsibilities with their partners.

For all the conversations and even laws that have been passed, the scales are still not balanced between men and women in the workplace. Research has shown that one of the primary causes for the ongoing gaps is that more women than men miss the first rung of the ladder. There are several reasons for this, and you can read more of the details in the study.

In my experience, one of the biggest challenges is that women in the workplace aren’t included in the day-to-day natural interactions that occur between men. The men gather together grabbing lunch or beers after work.  They plan golf events and just simply gather around the “water cooler” and talk. Naturally, both personal topics and work topics get discussed. Relationships and networks get built, and some degree of informal mentoring takes place.

When it’s time for that first level of promotion, it’s natural for recommendations to be made for the men who have been building this network. They just don’t know the women candidates as well. Unfortunately for women, once you miss the first rung, each rung gets harder and harder for many of the same reasons.

There are several other reasons, often related to unconscious biases. While there are many different ways we can be biased, one simple expression I’ve noticed more as I’ve worked in the south is the way men often refer to the women on their team as “girls” or “ladies”.  While many do not initially intend to create a bias, the message is that one is less mature or experienced, maybe even dependent on the men. For many, it’s an inadvertent behavior; they might even think they are being polite. But it sets the tone for others to power up over those same women, that their value is not equivalent to the men.

When I informally poll my women and men friends who are in leadership, almost universally, the women have had an experience of being accused of sexual favors in response to a promotion, none of the men have. This has been my own experience.

So, all of us, myself included, need to continue to check our behaviors and bias to ensure that the world we leave our daughters, nieces and sisters, as well as our sons, nephews and brothers, is finally balanced for all genders. There is great information available to give specifics, and I encourage us all to continue making this a critical part of our leadership. We have the power to make this right.

Photo Sourced from E4D Technologies

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

Prototyping the Perfect Product with Subtractive and Additive Manufacturing

Bringing a product to market is a massive undertaking. There’s a lot to consider from defining the initial product concepts to shipping the final product to the customer. At E4D Technologies, we know what it takes to bring the product you’ve imagined to life. As a contract manufacturing partner, we can offer expertise every step of the way. In the beginning stages of product development, the focus is always on prototyping and testing. There are many different rapid prototyping technologies, and the best choice depends on your product and your needs:

 

What Is Rapid Prototyping?

Rapid prototyping is the quick production of a physical part using 3D computer-aided design (CAD) coupled with manufacturing technologies that don’t have the delays of custom tooling or the limitations of machining. Whether you’re thinking of a product’s enclosure or an internal part, when the finished prototype closely matches the proposed design of the part for the product, it’s said to be a quick or rapid prototype instead of a tooled or machined.

 

Additive manufacturing, also known as 3D printing isn’t the only way to prototype a part for a product but can be the least expensive and quickest. Other processes include subtractive manufacturing, injection molding, and compression molding. Subtractive manufacturing is when blocks of materials are milled or carved to remove the excess and produce the desired shape. In contrast,  injection molding and compression molding are processes where a liquid or semi-solid material is forced into a shape before going through a solidifying process. These processes are typically more costly and take additional time to get the initial parts which makes them not as desirable for rapid prototyping.

 

How 3D Printing Can Be Used for Prototyping

People have become obsessed with 3D printing because of how quickly it can produce prototypes as well as manufacturing assembly fixtures. It is a more cost-effective solution for fixtures or prototyping in a low volume than some of the alternatives like injection molding, compression molding or subtractive manufacturing. One advantage of 3D printing is that you don’t need to buy an expensive mold or compromise the design so that it can be milled to make the prototype, allowing you to create things that are difficult to produce based on cost and capability factors. But the most significant advantage is how quickly 3D printing can produce a new iteration of a concept or an idea. It may take 2-3 weeks to make a machined or molded prototype, but with 3D printing, new adjustments can be produced within a day or two (depending on the complexity of the prototype).

 

When it comes to prototyping a product, 3D printing allows you to quickly create intricate designs for a relatively cost-effective price. How cost-effective it is to prototype with 3D printing depends on the complexity of the product. At E4D Technologies, we use our engineering and 3D printing capabilities in house to iterate product improvements. Our engineering and design teams can iterate through the design possibilities and work through the solutions physically with these prototypes in days when machining or casting the same pieces might have taken weeks.  

 

Rapid Prototyping from a Manufacturing Perspective

Our team is certified in lean manufacturing principles, which focus on eliminating waste while maximizing production speed and quality. With this in mind, our design and engineering teams are constantly questioning what tool or fixture might make the assembly process faster, more efficient and more easily repeatable. We utilize 3D printing internally to create new tooling fixtures to use in our manufacturing processes. For example, this is a solution for creating something unique that is perfectly designed to hold a piece in place while you work on assembly. We find this incredibly useful when it comes to optimizing a manufacturing process over time.

 

Check out our video below to see research and design in action:

 

What Is the Solution for Prototyping the Perfect Product?

The short answer is that there is no single solution for prototyping every type of product. Many factors go into prototyping, such as cost, complexity and turnaround time. When you’re looking for the ideal contract manufacturing partner, you need to consider if your needs match their capabilities. Subtractive manufacturing and additive manufacturing both have their advantages and disadvantages, and the right contract manufacturer should be able to determine which method you need to produce your perfect prototype. 

 

Whether you’re looking for a new design partner or you aren’t sure where to start, E4D Technologies is here to help. Our team works together, under one roof, with unique specialties that cover all major technological disciplines. We have the experience you need to design, develop and manufacture your perfect product to bring to markets worldwide. 

 

Contact us today to learn more about what E4D Technologies can do for your business. 

 

Photo Sourced from E4D Technologies

Here’s How We Do It: How We Use the Lean Manufacturing Pull System

At E4D Technologies, we have a long list of tools and systems that we use to maximize the efficiency and productivity of our manufacturing process. One of the tools that we use to reduce waste and increase efficiency is the lean manufacturing pull system. While this is a common practice in manufacturing, it has proven to be valuable at E4D Technologies by ensuring that we only produce enough products to meet demand. Here is everything you need to know about lean manufacturing pull systems from E4D Technologies:

 

What is a Pull System in Lean Manufacturing?

Pull systems are a lean manufacturing strategy with the overall goal of reducing waste in the production process. Generally speaking, manufacturing companies that use the lean manufacturing pull system will only replace components used in the manufacturing process once they have been consumed, so they are only making enough products to meet customer demand. By using this system, all of the company’s resources are able to immediately be sold, optimizing inventory turns and cash flow.

 

Lean Manufacturing Pull System Vs. Push System

The pull system and the push system are two forms of manufacturing products, but the two sharply contrast each other. They are essentially opposite forms of deciding the quantity of products or components you will produce in a certain period of time. While the pull system only manufactures components as they have demand, the push system manufactures products to meet a demand plan. Essentially, the pull system can be described as “just in time” while the push system is “just in case.”

 

The Benefits of Using a Pull System

Since E4D Technologies follows the guidelines set in place by lean manufacturing, we are able to greatly benefit from the advantages of using a pull system. We are able to reduce waste throughout the process since no overproduction occurs, as well as reduce the cost of storing excess inventory. There are times, though, when a hybrid approach is required.

Whether you decide to use a pull system or a push system in manufacturing will depend on the demand of your product and how quickly you can manufacture your product. If one component of your process has a much longer lead-time or process time, you may need to push that component or process while pulling the balance of the components and products. The goals are to always consider what can bring the most value to the customer, while also eliminating the most waste. Want to learn more about our manufacturing process? Check out our blog today!

Photo Sourced from E4D Technologies

Here’s How We Do It: How We Use the SMED System Lean to Change Over Quickly      

At E4D Technologies, we work hard to simplify our manufacturing process as much as possible to reduce waste and maximize efficiency. One of the tools that we to accomplish this goal is the SMED system, or single minute exchange of dies. Here is everything you need to know about how E4D uses the SMED system to maximize efficiency in production:

 

What is SMED in Lean Manufacturing?

SMED stands for single minute exchange of dies, which is a system to dramatically reduce the amount of time it takes to perform equipment or process changeovers. While originally, SMED was for changing over machinery, the principle is relevant to any change over in your production process. Changeovers of any kind can take hours away from production time if companies aren’t constantly working towards making them as simple as possible. The overall goal of SMED is to reduce changeover time to single-digits, working to complete each changeover in minutes.

 

Internal Vs. External Components of SMED

The main components of the SMED system are internal and external elements of changeover. Internal elements must be completed while the equipment or production line is stopped, while external elements can be completed while the equipment or production line is running. The goal of SMED is to reduce the number of internal elements via streamlining, removing or converting to external elements in your changeover process. Using external components will allow you to work on changeover while the production line is still moving.

 

The Benefits of Using a SMED System

Utilizing the SMED system can dramatically reduce changeover time for manufacturing companies of all sizes. No matter the type of machinery or production line, there is a simplified process for completing most of the changeover steps externally. Companies that use this system are able to lower manufacturing costs by reducing equipment downtime, while also producing smaller lot sizes and increasing their responsiveness to consumer demand.

Since we follow the guidelines set in place by lean manufacturing at E4D Technologies, we utilize the SMED to increase our productivity, while also standardizing our changeover process to improve consistency and quality. Want to learn more about the manufacturing process at E4D Technologies? Check out our blog today!

Photo Sourced from E4D Technologies

Is Outsourcing Manufacturing Right for You?

The core reason to consider outsourcing manufacturing for any company is to gain a competitive advantage in the market place. There are numerous reasons for partnering with a manufacturer and many reasons to choose one over the other. The team at E4D Technologies is here to help walk you through the reasons why contract manufacturing could be a good decision for your business. Here are a few things to consider before you sign a contract:

The Financial Benefits of Outsourcing Manufacturing 

First and foremost, outsourcing isn’t the ultimate solution to saving money. Sometimes, it doesn’t make fiscal sense to outsource at all. In other situations, outsourcing might be the best decision. One strong reason to consider outsourcing is to address gaps in your business’ capabilities. Finding the right contract manufacturer can create a hybrid approach where each organization plays to its strengths and helps save the expenses from duplicating those resources in-house that may not be needed long term. Often the ROI doesn’t make sense when the skills and resources exist with the outsourcing partner. If you have available capacities in both facilities and people, outsourcing may not be right for you at this time.

The Case for Resources or Skill Gaps 

One common gap that can be solved through outsourcing is related to capacity. You may not have any manufacturing facilities, and the costs to build and fit-out space is not a good ROI. You might not have enough space or capacity, and so instead of using capital to increase the manufacturing space, you can partner with an existing factory at an outsourcing company. 

You might also have a gap with specific skills. Perhaps you need support with a design project and your core design team is overbooked, or there is a unique technical skill required for the project that is not part of your core team. Finding a full-service contract manufacturer like E4D Technologies can help your company solve those problems. A full-service manufacturing team consists of individuals who have all the disciplines needed for global supply chain manufacturing and management. If you’re looking for a partner who will help you every step of the way, our team is here to help you with all of your manufacturing needs. 

What Is the Outsourcing Partner Security and Confidentiality around Your Products and Intellectual Property?

Protecting your Intellectual Property (IP) is important, and having trust in your manufacturing partner is critical. As you consider who should be your outsourcing partner, you need to understand how they manage and protect customer propriety and confidential information (including your IP). You should also expect to clearly see defined responsibilities and ownerships of intellectual property (IP) in your contract. Typically, the manufacturer will own their methodologies and processes around the manufacturing system, and the customer will own the product’s IP. 

Reputation, experience, and capabilities are some of the major factors you have to consider when choosing a partner. Some of the questions you should ask yourself and your team when deciding on contract manufacturing companies are:

  • What do other people say about the manufacturer? 
  • Do they have the reputation of protecting their customer’s data?
  • How long has the company been manufacturing products? 
  • Does the manufacturer have controls in place that keep the customer and the IP safe? 
  • Is their factory open for you to visit? 
  • While touring the factory, how do you feel about the protection of other client products by the manufacturer?

As an outsourcing partner who has both their own IP and has managed and protected our customer’s IP, we know that IP protection is essential for any partnership. That’s why the team at E4D Technologies has specific protocols and safety guards to make sure our client’s IP is safe 24/7. Our team consists of highly-skilled and talented manufacturers who give our company the feel of a large manufacturer but gives our clients the customer care of a small contract manufacturer. 

How Aligned Is the Contract Manufacturer with your Products, Requirements and Size?

Another factor to consider when thinking about outsourcing manufacturing is who will be the best fit for your needs. When deciding which contract manufacturer to partner with, you might want to review the median size of companies that they work with, the types of products they currently support and any regulatory experience they have that could align with your product needs. 

Since many manufacturers work within a specific industry, a lot of their capabilities and processes might be similar to the way your competitors build their products. Working with the same manufacturer that your competitors work with might give you an advantage or allow you to operate on the same playing field. The manufacturer will know how to produce your product giving you the high-quality advice you need while supplementing the experience you lack. If you do not want your outsourcing partner to manufacture in the same space as your competitor, you might be able to negotiate that in your contract. However, most contract manufactures gain their leverage by working on several similar or competing products. The crucial factor is if they protect all of their customer’s information and IP. If so, it should not be a concern if they have competitive products. Alternatively, you might be able to request that the same teams of engineers don’t work on the competitor products even if they are built in the same factory.

Lastly, the benefit has to outweigh the cost. As stated before, the price increases with the more exclusivity you want with a manufacturer. Yes, outsourcing can help with labor costs, expertise gaps, and factory space, but will it make fiscal sense for your company? In some cases, it might make sense to build specific parts of your product on your own while outsourcing other components. When it comes to our team, we have ample experience working with highly-complex products from anywhere from medical device manufacturing to product design. Our team is here to help walk you through everything you should consider while choosing a contract manufacturer, and we’re willing to help you determine the best ROI for your product. 

As a full-service contract manufacturer, we’re capable of handling the outsourcing manufacturing needs of many businesses. Our team is here to help you whether you need someone to reverse engineer, help you with your sketch to scale or manage your product life cycle. We can help companies in many industries, including optical, industrial, mechanical, medical, and software. For more information about our company, and to see if we’re the right fit for you, contact our team 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

Fireside Chat with E4D Technologies: How the Pandemic Has Impacted Global Supply Chains

Many people are worried about the COVID-19 impact on technology and the global supply chain. Will the global supply chain have to shrink in order to get stronger? Can we expect to see a change in technology logistics and the global economy coming out of Coronavirus regulations? We sat down with Tammi Carter and Brett Hetherington to provide our industry with insight, personal experience, and analysis of the logistics in technology after the dust settles with COVID-19. Here’s a fireside chat with E4D Technologies about the supply chain:

What Are the Flaws the Pandemic Exposed in The Global Supply Chain?

“Countries around the world addressed the pandemic in different ways. While some countries remained relatively open, others suspended production until they could safely address how to keep their employees safe. How were people going to work at their job without exposing themselves or others to COVID-19? In some cases, governments responded by placing tight restrictions on workers and even forced some manufacturers and suppliers to close their doors for an undetermined amount of time. Regretfully for some companies, this was too big of an impact and they have closed their doors for good. – Tammi Carter

“Coming out of the pandemic, many companies have had to face the harsh reality of relying too heavily on a sole source supplier. Those companies who had already reviewed their supply chain and eliminated much if not all of the sole source components, the impact of COVID was significantly less harmful.

Another element that protected companies was their scalability. As competition increased, and pressure for the existing and remaining suppliers increased in areas of COVID support. Without having the proper infrastructure for documentation, procedure, and training, companies who could still function within government regulations still faced the challenge of being understaffed and ill-prepared to train the number of workers needed.” – Brett Hetherington

What Have Companies Learned about Being Flexible and Agile?

“As people began to rush to stores to pick-up essentials, the global economy was in a crisis to continue to supply consumers with goods and services. Many businesses realized the importance of infrastructure and logistics in order to keep their customers happy while managing to stay operational. Properly scaling a business up became a necessity, but also effectively scaling a business down was equally crucial in specific industries. With a lack of supply and demand, how can you manage to stay operational? Companies not only had to find a way to cut costs, but they also needed new sources of income. One of the biggest challenges in many business structures and systems was the lack of training, documentation, testing, and discipline in their field. While some companies could handle the drastic change, others went out of business because they couldn’t ramp up or ramp down production due to a lack of organization.” – Brett Hetherington

“The supply chain also faced a challenge with logistics. Not only from the standpoint of having a sole supplier but also from the perspective of audits and inspections. How could you continue to perform the standard supplier audits when global travel was largely banned? Companies that had strong suppliers and a strong existing quality system found transferring to a virtual audit and review relatively simple. However, if none of that infrastructure existed, then it became a real test of trust between the client and the supplier. In some cases, to add additional suppliers or to eliminate the need for global travel, some companies have considered adding additional domestic suppliers..” – Tammi Carter

How Will the Supply Chain Look Coming Out of the Pandemic?

“There is no doubt that there will be fewer players in almost every industry. In [our] opinion, there won’t be drastic changes to how the global supply chain functioned before the pandemic. Ultimately, the world is too interconnected. It would be difficult to quickly change how it operated for decades before this point. We will see companies doing a thorough analysis of the supply chain and look for opportunities to dual-source and, as much as possible, source domestically. ” – Tammi Carter

“We do think that companies like E4D who are not able to do the majority of the work at home, will adapt lessons learned from this pandemic as it relates to keeping employees healthy at work. We would anticipate physical layouts of factories to take social distancing into consideration where possible. Wearing masks and some safety procedures will likely stay to protect workers from team members exhibiting cold or flu symptoms. More than likely, people will continue to wear masks when feeling ill, cleaning habits will stay in place, and we may even see an impact on factories’ design and layout.” – Brett Hetherington

What Will E4D Look Like After the Pandemic?

“As an essential business, E4D was open to support our healthcare professionals. We definitely experienced a slow down in some market segments while others grew exponentially. We attribute our abilities to our reliance on our strong quality systems and our flexible and creative team. We were able to function because we successfully ramped up our systems while simultaneously scaling down other areas of our business. Our documentation, training, procedures, testing, and discipline allowed us to keep our team on the manufacturing floor while supplying our customers with their orders. Some aspects of our company had to change, and with every change, we were transparent and honest with our team to make sure everyone was on the same page. E4D Technologies is more experienced, knowledgeable and agile than ever before. We couldn’t have done it without our fantastic team, and we’re so grateful to still be here today. Our process, development and company culture kept us moving forward even during the difficult moments.” – Tammi Carter

Ready to partner with E4D for manufacturing or design? Our advanced experience in technology design, manufacturing technology and logistics in technology can help your business achieve all of your goals. All aspects of our company work under one roof so that you can access all of our unique technological disciplines. If you’re ready to hear what we can offer your business, we want you to contact us today.

Photo Sourced from E4D Technologies

Understanding Medical Device Regulation Needs and How We Help You Bring A Product to Market

Navigating medical device regulations and obtaining product approvals on your own is a daunting and challenging task. Understanding and applying medical device regulations effectively can make or break a company for any new technology. At E4D Technologies, we have the industry knowledge and expertise to help you understand the requirements of global medical device regulations and how to bring your product to market as soon as possible. Here are some ways E4D can help you:

Understanding Medical Device Regulation by Country

Every country has its own set of rules when it comes to a new product introduction. Medical devices are regulated by the FDA in the United States, by Health Canada (HC) in Canada, the NMPA in China and, the European Commission (EC) in the EU. With many countries having their own set of rules, licensing requirements and labeling regulations, this can cause a whirlwind of confusion for any company trying to manufacture medical devices. Through our experience, we’ve learned that meeting all the requirements for one organization’s set of rules doesn’t always mean that you’ll be able to get clearance in other countries. China always requires in-country testing regardless of approval from other countries. In Europe, the regulatory process is quite different than that of the US.

Not all medical devices are regulated equally. Since medical devices will use different technology and materials, and will have different indications for use, the risk of each category of device is treated differently. For instance, a medical device implanted in a person’s heart will have to undergo rigorous testing. The company will have to report in great detail about any life-threatening occurrences that may happen as well as serious, minor or if no injuries have occurred. These high-risk devices have to complete long and detailed clinical trials and often take several years before they can be introduced into the market. Even some PPE products could fall into life-threatening high-risk categories. On the other hand, lower risk devices such as many dental devices and non-invasive devices are able to enter the market much faster.

Assessing Risk and Establishing Benefits through Research

Every government medical device regulation can be connected to keeping patients safe and to the device’s effectiveness while clearly defining the risks. Medical device product development requires risk assessment and extensive research and testing of the product. The main questions government regulatory entities will ask are, “does it do what you claim it will do?”, “is it safe and effective for your claimed indications for use?” and “is it substantially equivalent to your claimed predicate device?” Taken directly from the FDA, “The legally marketed device(s) to which equivalence is drawn is known as the predicate device(s).” While your product is going through the development life cycle, you and your team will need to ask yourself:

● Does the device do what it claims to do?
● What is the risk of this product failing?
● What are the failure points?
● What happens if the product fails? Will failure create serious or life-threatening risks?
● How can we prevent the device from failing in high-risk situations?
● Do the benefits of using the device outweigh any residual risks?

Developing a medical device can take a lot longer than anticipated. The leading cause for companies failing to bring a medical device to market is usually connected to establishing substantial equivalence to the chosen predicate device. The key in this stage is to have a comprehensive timeline with attainable goals and room for error. Many unforeseen obstacles can appear during the development phase, and we always advise our clients to plan for the unknown.

Testing, Manufacturing and Bringing It to Market with E4D

Bringing your new medical device to market is extremely difficult on your own. Meeting with experts in the industry who have established experience is one of the best ways to bring your medical device to market. One route you may consider going down is hiring an independent medical technology consultant. This may require a significant amount of funding, time and resources because most consultants are expensive. Without having to bust the bank or causing you to take two steps back with your new technology, we would eagerly lend you a helping hand.

At E4D Technologies, we have a dedicated team of experienced technology consulting experts, technology logistics personnel and global supply chain leaders. We have worked with companies to help bring their new product to market, and we’ve helped them navigate through a broad range of medical device regulations. Our team can help you with development, usability, testing, risk assessment, regulatory/compliance submissions and manufacturing, all under the same roof. You need someone who can ask the right questions, give you the correct answers, guide you through any process and be realistic with you every step of the way. Our experienced team knows how important your business is to you, and we want to help you succeed.

Whether you are looking for a new manufacturing partner or you need an experienced team to help you navigate medical device regulation requirements, the team at E4D Technologies wants to hear from you. With unique experience and specialties covering all major technology and manufacturing disciplines, we’re confident that you’ll find exactly what you’re looking for through E4D Technologies. Understanding and meeting regulations and requirements for new technology and existing technology doesn’t have to be overwhelming, and we’re waiting to hear from you today.

Want to learn more about what E4D Technologies has to offer your business? Contact our team to find out how we can help and meet your specific needs.

Photo Sourced from E4D Technologies

Thanksgiving Letter to Our E4D Family

As Thanksgiving approaches, we wanted to take a moment to reflect on the year, remember how far we’ve come and look forward to the future at E4D Technologies. We want to share a Thanksgiving letter from Tammi Carter to our E4D extended family, our vendors, and our customers. Please take the time to read our Thanksgiving letter and think about the things you are thankful for as we close out 2020. 

A Thanksgiving Letter from Tammi Carter

As the holidays approach, I can’t help but reflect on the traditions of my family.  At Thanksgiving, as my family gathered around the table, which was weighed down by all the fantastic food that my Mom had prepared, we first went around the table and each person expressed their thanks for someone or something from that year.  Of course, when I was a child, I just wanted to get it over with and dig into the amazing food, and maybe more truthfully, I really just wanted to get to the homemade pies Mom had made for dessert.  

As the years went by, I began to realize how meaningful it was to hear what my family and friends were incredibly thankful for each year and I began to enjoy who and what I would thank at each Thanksgiving dinner. Sometimes we celebrated the joy of a new family member or some years it was the celebration of the life of someone we lost that year or the feeling of gratefulness for overcoming a difficult situation. Many years later as I’ve continued this tradition I’ve learned that people are rarely grateful for the physical things they have, but, instead, they are thankful for the cherished people and relationships they’ve developed throughout the year.

At my childhood table, we were supposed to limit our sharing to one or two things because, after all, Mom didn’t want all the excellent cooking to get cold!  But when I consider all the significant aspects of E4D – it’s impossible to limit my gratitude to one or two things. So continuing the tradition of my family, here are some of the reasons why I am thankful this year…

To the E4D Team 

I’m so thankful and proud of the amazing team we have at E4D.  During this COVID year, this team could have settled for good enough, but they refused to settle.  They’ve taken a good company and made it great.  They never stopped innovating and finding new and better ways to serve our customers.  I’m grateful for all the teams’ sacrifices that helped us navigate challenging times. There were pay cuts, furloughs, cuts to the coffee budget and so many other things the team offered to do to help us survive the impact of COVID. They inspired me and encouraged me in those early days of COVID when things were so unsettled. I cannot express how thankful I am to have each and every member of the E4D team here today.  They truly are the secret to our success. 

To the E4D Extended Families

Surrounding all our great team members are their family and friends. We are incredibly grateful for their support of our team. We know that their influence, support, and encouragement create strong, creative, innovative, and tenacious team members.  We couldn’t be the great company we are without the strong support team!

To the E4D Owners

E4D and I are grateful to have great owners who support our innovations around the globe. Year after year, they have been a driving force behind our operations. Even during uncertain times, their support didn’t waver.  They provide a strong foundation for us which enables our success.

To the E4D Customers

All of this would not be possible if we didn’t have such great customers! Many businesses don’t have the privilege of working with customers who they genuinely like and get to help them transform the world through their amazing products.  It has been a pleasure being a part their success and assisting them in making the world a better place for all of us. 

To the E4D Vendors

Of course, we wouldn’t be able to provide unparalleled service without our vendors who jump through all our forecast changes and smile (or at least they pretend to)!  Nothing is possible without the whole supply chain coming together to make sure we can design and manufacture our customer’s current and upcoming products. Thank you for your flexibility, understanding, and unparalleled service. 

So as I close this out and prepare to gather around my table full of friends and family, on my list of things to share will be the blessing of being part of the E4D team!  

 

Happy Thanksgiving, 

Tammi Carter

 

There is so much to be thankful for after this unprecedented year. Thank you for taking the time to read this Thanksgiving letter, and we encourage you to contact our team to let us know what you’re thankful for this year.