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Elos Medtech’s OPEX approach What is in it for me as an OEM?

Elos Medtech’s OPEX approach: What is in it for me as an OEM?

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Do you know our motto? It is striving for excellence in everything we do. However, focusing on operational excellence, built-in quality, and continuous improvement all comes down to one thing: What is in it for you as an OEM? In this post, I break it down to answer the question.

What is OPEX in medical device manufacturing?

OPEX is an abbreviation of Operational Excellence. It is often described as the journey to optimize an organization’s processes so it can create more value for its customers while using smaller amounts of resources.

OPEX is not a fixed goal. It is rather something that is regularly achieved. Therefore, it requires continuous improvements.

To us as a CDMO, OPEX is about ensuring that we operate excellently throughout our organization and always look for ways to improve our performance. It is our way of systematically and continuously improving our processes to become more Lean, reduce waste, and create value for our customers.

To concretize: We want to deliver high-quality products at the lowest cost and in the most efficient way possible while reducing waste.

A leading global CDMO for medical devices.

Our long-term strategy is to strengthen our offering and develop our competencies in our expertise areas to remain a leading global CDMO for medical devices in our markets.

Our OPEX strategy is to develop our production processes continuously and systematically through continuous improvements, waste reduction, visualization, and standardization. Through efficient, automated, and digitized solutions, we can create cutting-edge production.

We do the right things – and we do them right.

Our OPEX work means ”doing the right things and doing them right”. It includes competent leadership, systematically developing our skills, and constantly improving our processes. This way, we achieve built-in quality in every process and world-class operation.

What is in it for me as an OEM of medical devices?

You can ensure your customers that your medical devices are of the highest quality. Your capacity demand and expectations will be met, and you can harness innovation and sustainability from a trusted CDMO.

We work as a global team across borders.

As a company, we recognize that the energy our employees put into their daily work is our most important asset for building world-class manufacturing. The phrase ”stealing good ideas with pride” is a valuable insight when applied within our own organization. By collaborating across borders as one team and sharing expertise between our sites globally, we can build a more robust offering.

What is in it for me as an OEM of medical devices?

No matter where you are or which production site you use for development and manufacturing, you will benefit from our global knowledge and expertise.

We focus on development, learning, and training.

The cornerstone of a learning culture is that everyone has a ”growth mindset”. Our culture is not only to learn and apply what we have learned but also to feel engaged to share our knowledge with others through teamwork. It is crucial for creating long-term results where continuous improvement is more than a technology – it is a way of life.

What is in it for me as an OEM of medical devices?

You will benefit from the results of our growth mindset: The better we get at development, design, and production, the better your products get.

We put the customer first.

Lean is a systematic method for minimizing waste. It focuses on identifying parts of a production process that do not provide customer value. We foster a culture where everyone is committed and empowered to apply Lean to maximize customer value.

What is in it for me as an OEM of medical devices?

You will have your products delivered according to the agreed delivery time, in the correct quantity, and with the highest quality. You can rely on sustainable, no-waste, effective production.

We have a problem-solving mindset.

We have a problem-solving mindset throughout our organization. There are always ways to improve processes, eliminate waste, and create error-proofing methods with problem detection early on. Our culture is based on encouraging ideas and being agile for improvement suggestions.

What is in it for me as an OEM of medical devices?

You can feel confident that we not only detect and solve problems at an early stage but also prevent them from happening in the first place.

We focus on operational efficiency.

Our operations strategy serves as a platform for all our sites to improve performance and add value. Our operations management is our fundamental approach and methodology in our organization, with teamwork as a base and customer satisfaction as a result.

What is in it for me as an OEM of medical devices?

You will benefit from shorter lead times, a flexible supply chain, higher efficiency, and lower cost – ultimately feeling satisfied with our products, services, and capabilities.

We continuously improve our processes.

Continuous improvement is a method for identifying opportunities for streamlining work and reducing waste. The cycle of continuous improvement – identify, plan, execute, review – is a mindset we have adopted across our operations. We constantly improve and systematically develop people and processes to create value and prosperity while reducing waste.

What is in it for me as an OEM of medical devices?

You will benefit from more cost-effective solutions as we do not focus on cost in the first place. By working with continuous improvement and doing the right things throughout the entire process, the total cost will eventually drop.

We empower our people.

We strongly believe that our employees are our greatest strength. Providing each employee with a supportive environment that encourages them to come up with innovative and bright ideas, and do their best, is our way of empowering people.

What is in it for me as an OEM of medical devices?

You can rely on engaged professionals who will go the extra mile, learn more and faster, and be more creative, to work for your advantage.

We focus on what is best for the customer.

In a customer-oriented company, all employees, regardless of role, base their decisions and actions on the belief that what is best for the customer is also best for the business. The basis of our customer focus is to develop collaboration with our customers to get ideas for improvements and cost savings.

What is in it for me as an OEM of medical devices?

You will benefit from the security of a mutually fruitful and valuable customer relationship based on communication, dialogue, and understanding.

We sustain the gains by standardization.

“Sustaining the Gains” is part of our continuous improvement culture. It is the concept that once any improvement has been achieved, the next step is to standardize and maintain it. A high retention rate creates greater opportunities to maintain what we have achieved.

What is in it for me as an OEM of medical devices?

You can rely on your products that are produced with high-quality equipment, efficient production, and stable processes based on proven effective methods.

The result? Medtech Quality Excellence.

Developing and manufacturing medical devices that impact human health comes with great responsibility. Patients put their trust in the tools used to treat their bodies. And the creators of those tools –  you, the OEM – put your trust in us, the CDMO.

And so, the result of all our efforts is Quality Excellence.

Do you need a trusted CDMO for medical devices? Visit our website to learn more.

5 Injection Moulding Trends in the Medtech Industry

5 Injection-Moulding Trends in the Medtech Industry

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The art of injection-moulding has been around for decades. But over the years, the technique has become more refined and the materials more sophisticated. Today, it is possible to produce plastic details with maximum precision and accuracy in dimension and surface. However, new market demands are constantly challenging the production process. In this blog post, I will share 5 injection-moulding trends in the medtech industry and what we do at Microplast to keep up with the new demands.

1. Injection-moulded products produced in Europe are becoming more attractive

The last fifteen to twenty years, China has had a dominant position in mass production of injection-moulded plastic products, and many companies have outsourced their production to the country due to its low labour cost. But we are now starting to see companies returning their production to Europe because of quality reasons. Chinese medtech companies purchase moulding tools as well as injection-moulded plastic products from Europe because of the poor quality in their domestic market. At Microplast, process control and quality follow-up have always been an extremely important part of our production process to meet the most stringent requirements on quality. We follow appropriate ISO standards and ensure a high level of process management and control. Quality awareness permeates our entire operation.

2. Automation is leading the way for injection-moulding in the medtech industry

In recent years, a wave of automation has swept over the medtech industry worldwide. There is an ongoing trend to increase production efficiency with the benefits of reduced human labor costs, saved energy and materials – but more importantly – improved quality, accuracy, and precision. To meet the demands of tomorrow’s market, Microplast recently extended our production site in Sweden and made ambitious investments in the latest high-tech robots, injection-moulding machines and equipment for clean room manufacturing. This allows us to further increase and streamline our production of injection-moulded products.

3. More partners along the supply chain are realising the advantages of traceability

Traceability is an important factor in the production of medtech products, especially the small plastic details used inside the body, as non-compliant materials can be a matter of life or death for the patient. Today, more partners along the supply chain are realising the advantages of traceability. It is in multiple partners’ interests to comply with local and international policies and regulations, and reduce the risk of non-compliant materials entering the supply chain. Traceability also provides coordination between authorities and relevant bodies, and can be used as a method of stock control and monitoring. At Microplast, the injection moulding process is fully traceable, from the point at which the thermoplastics material is delivered to us, until the products are delivered to the end user. Every batch has its own unique identification, allowing it to be traced at any time through our database.

4. Higher demands on delivery precision and packaging of medtech products

We can see a clear trend where more customers place higher demands on delivery precision and packaging. Many companies want to maximise the efficiency of their logistics and have their products delivered to the door – sterilised, packaged and ready to use in a clinical situation. At Microplast, we now have the possibility to carry out the actual injection-moulding of the plastic products in clean rooms, where we also perform testing, product assembly, packaging and labelling. Thanks to our VMI system, we can also guarantee that our customers always have the right number of products at the right time.

5. Customers request a single source from design to manufacturing and distribution

Another strong trend in the medtech industry is that companies want to outsource not only the manufacturing, but the entire production process – to one single contract manufacturer. The reason is higher demands on work processes, documentation, quality, accuracy and precision. To meet this challenge, Microplast is offering a complete performance, meaning that we take care of everything from design and manufacturing to packaging, distribution and logistics. To us, an important part of this is working closely with our customers, especially in the design and development phase, bringing knowledge to the table and helping our customers make the right choices of materials and injection-moulding processes right from the start of their product’s life cycle.

We produce more than just a piece of plastic – we produce life-changing medical devices

At Microplast, we have been producing injection-moulded plastic products since 1971. A lot has changed over the years, but one thing has remained the same – our products still make a difference. Our products are used in medical areas such as diagnostics, cardiac rhythm management and in vitro fertilisation, meaning, we actually help save people’s lives.

It is with great pleasure I can say that we look forward to new market demands in the medtech industry, so that we can continue to improve life saving products! Does that make sense to you? Please let me know by sharing your thoughts it in social media.

Also, read:

The Microplast Story – from a basement operation to over 900 injection-moulded parts

We now double our capacity thanks to our new factory at Microplast

The expert of thermoplastic components with fine tolerances

4 techniques for measuring injection-moulded plastic parts

Mathias Andersson Managing Director at Microplast

“We now double our capacity thanks to our new factory at Microplast”

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Because of a growing medtech industry and high customer demands, Elos Medtech decided to expand their factory in Skara, Sweden. I interviewed Mathias Andersson, Managing Director at Microplast, about his role at the company, the reasons for the expansion and in what way the expansion will benefit Elos Medtech’s customers.


Mathias, tell me about your career at Microplast. What does your role as Managing Director involve?  
Well, I started working as Managing Director at Microplast in March 2012, a little over four years ago now. When recruiting for my position, they were looking for a market-oriented Managing Director who would be assigned the mission to increase turnover while maintaining profitability. The mission was also to, within five years time, expand the factory. But thanks to all of the competent employees and their hard work, the expansion of the factory didn’t need to wait that long, but saw the light of day already after four years.

In my job, I mostly work with strategic matters to continue to enable future growth. I often discuss with our customers about their future needs, and together we create what we call a road map, which enables us to plan ahead to make sure that our customers’ needs are in line with our capacity. In this way, we make sure to always stay at the forefront of our industry. Another part of my job is to make sure that we have the right organization and competence, and that we invest in the latest equipment, to maintain a high degree of automation. Beyond that, I have traditional Managing Director tasks, for example responsibility for the operations and budget.   

Prior to Microplast – what was your occupation?
The last ten to fifteen years I have worked with Marketing and Sales in leading positions. During that time, I operated within business-to-business and worked mainly in the plastics industry. Just before I started working at Microplast, I worked as Marketing and Sales Manager at a company manufacturing plastic packaging for the food industry. My responsibility was dairies in the Nordics and food-service products in Europe. There are tremendous demands in the food-industry when it comes to for example clean environments, therefore it has a lot of similarities with the medtech industry. In addition, I have also worked with technical support with a focus on quality, product training and sales support, among other things. One could say that I have a solid background and experience in different businesses, mainly within the industrial segment.

So, tell me a little bit about Microplast. What kind of business do you have there?
Microplast was founded in 1971, so we turn 45 years this year! Elos Medtech acquired Microplast in 2011, at that time we were 13 people working here. Today, we are 24 people working in the facilities, which consist of both office space and a factory. At Microplast, we manufacture technically advanced plastic parts for the medtech industry. We manufacture plastic parts for products such as hearing aids, pacemakers, diagnostics, analysis instruments, disposable articles for blood analyses, dental products and surgical instruments suitable for orthopedics. Above that, we  provide production in clean rooms, as well as produce and assemble products, which we deliver to our customers after sterilization.

We also offer a number of different refining steps where we use ultrasonic welding, machining, printing, assembling and packing. We do everything we can to give our customers as much value as possible. We work with all kinds of plastics but mainly high performance plastics like for example PEEK, POM and PVDF. These plastics replace metal and are meant to cope with specific demands such as chemical resistance or heat resistance, or be exposed to pressure or heat. We also work with polyolefins like for example PS, PE, PP in medical grades to use in disposable labware products.         

Soon, you will inaugurate your new factory expansion at Microplast. What are the main causes for the expansion?
One of the objectives when I started as Managing Director was to increase sales and consequently expand our factory. Our current factory has become too small, with no room for the production lines that we need. Due to the increased demands from both current and new customers, we needed to expand, which we of course are glad to do! Our new factory will handle projects from both new and present customers, and the purpose of the expansion is to be able to grow long-term with our customers. Our workshop is now attached to the new factory as well, so we have the possibility to broaden our post processing in form of assembling, completion of products and much more. To deliver finished details is an increasing demand from our customers, one that we will be able to undertake more of with the new expansion.         

What was your role in the project, and how has the process proceeded?
In autumn 2014, we started with the planning of building the new factory, and the board gave clearance for construction start in spring 2015. My role in the expansion process was to be a part of a steering group consisting of a couple of key persons. Together with an internal construction coordinator and an external project leader, the steering group has made sure that the functions and spaces which we have ordered are at the right place at the right time, and in line with our budget and strategy plan. Subcontractors and an architecture firm have been responsible for construction, architecture, and project management. From the moment we put the shovel in the ground, the project has taken us little less than a year. For such a major project, the process has been really efficient. The new equipment consists of several new machine lines. However, we will not fill the whole factory from start, but we will successively invest in new equipment to be able to adjust our equipment to the future needs of our customers. We now have the possibility to double our capacity compared to before, which is great!

What have you got planned for the inauguration day?
The inauguration will take place the 26th of April, which is the same day as the Annual General Meeting, which will be held later that afternoon. There will be a guided tour of our facilities, both the present and the new one. Inauguration speeches will be held and we will have specially invited guests such as shareholders, stakeholders from Elos Medtech, the municipality, press, vendors and customers.

What will the expansion of the factory mean for the customers?
Our customers will be able to assign more production to us and we will be able to offer a commitment that means more processing and more delivery of finished products. We will have a high degree of automation, with focus on quality as usual, which means that we will be strong compared to our competitors. Our expansion enables us to grow with our customers. Our goal is to grow and expand our business to meet the increased requirements in the medtech industry. We also create a platform to increase and supply the right competence internally.

What kind of challenges and trends do you see ahead, within the medtech industry?
The product development is much faster today than it was before. Today there is a larger focus on both patient safety and patient benefits. This will lead to higher demands, both on the manufacturers and the product owners, which are our customers. A challenge is to cope with these demands and make sure that we always are best when it comes to quality, delivery and production. With our new factory, we believe we are a force to be reckoned with in the future, within the medtech industry.  

Thank you for a nice chat, Mathias. Your expansion of the factory at Microplast sure sounds exciting, as well as promising for the future of the medtech industry. If you have any questions, please contact us or visit our website to read more about Elos Medtech and Microplast.    

Unique Device Identification – Improving Patient Safety

Unique Device Identification – Improving Patient Safety

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Even though a medical device is designed and validated to be safe, it doesn’t mean that it is free from risks. Therefore, FDA implemented a regulation establishing a common worldwide system for product identification on all medical devices. The system for Unique Device Identification (UDI) benefits both patients and businesses in the medtech industry – here is why!

UDI – marks and identifies medical devices within the healthcare supply chain

The Unique Device Identification is a system used to mark and identify medical devices within the healthcare supply chain. The UDI is expected to improve patient safety by helping to identify counterfeit products, and by improving the ability for staff to distinguish between devices that are similar in appearance but serve different functions. It is also expected to facilitate and improve the recall process, and create efficiencies within the medical system. In 2013, the U.S. Food and Drug Administration (FDA) released the rule that will be implemented over several years in the U.S. market. UDI will also gradually be implemented in other parts of the world.

Unique device identification for medical devices – the European Landscape

Other countries around the globe are progressing their own track and trace strategies for medical devices. In early 2013, the European Commission released a recommendation upon a proposed structure for the UDI requirements system in the EU. As the industry awaits the finalized regulations from the EU, some have looked at the FDA and predicted that the EU regulations are likely to become the same or similar to FDA’s regulations.

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Rapidly identifying a device – one of many important advantages

The implementation of UDI offers a lot of advantages. It is intended to improve patient safety, modernise device surveillance and facilitate medical device innovation. UDI helps to trace what type of product it is, where it is and who the manufacturer is. The identification must be in both human- and machine-readable form. A UDI on a device label or package consists of two parts. The first part is a device identifier which is a mandatory, fixed portion of the UDI that identifies the labeller or manufacturer, and the specific version or model of the device. The second part is a production identifier, which is a variable portion of the UDI, which define information such as the batch number or serial number of a specific device, as well as the expiration date and other information needed for full traceability.

FDA has accredited issuing agencies that provide Automatic Identification Data Capture (AIDC) technologies standards for unique device identifiers in the U.S. Those are non-profit organisations such as GS1 and Health Industry Business Communications Council (HIBCC).

GUDID – a database for storing information about each device

As part of the UDI system, FDA has also created the Global Unique Device Identification Database (GUDID). This database includes a set of data attributes, and the device labelers must submit and maintain certain information about each device. In collaboration with the National Library of Medicine, the FDA has created a portal to make device identification information available for everyone. This portal is called AccessGudid and could be useful to patients, caregivers, healthcare providers, hospitals and industries.

UDI – for a more safe and sustainable medtech industry

As one of Europe’s leading development and production partners of medical technology products, Elos Medtech continuously focus on updates and developments in the medtech industry. When it comes to UDI, we are preparing to provide solutions based on our customers demands. With patient safety as Elos Medtech’s top priority, the implementation of UDI is considered to have an important role in the development of a safe and sustainable medtech industry.

I hope you gained some valuable information when reading my article. If you have any questions, please visit our website for more information. Also, feel free to contact us, or comment on the article in our social media channels.