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Sustainable packaging

Sustainability in Medical Device Packaging: What Elos Medtech is Doing Today

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In our previous blog, we discussed the key challenges of achieving sustainability in medical device packaging, including the need for sterility, the use of recyclable materials, and the reduction of packaging waste. Today, we’re excited to share how Elos Medtech is actively addressing these challenges through innovative practices and forward-thinking strategies. As we prepare for future regulatory changes, our commitment to sustainability is stronger than ever.

Leveraging Post-Industrial Recycled Materials

One of the initiatives we’ve undertaken is partnering with Medipack, a supplier that uses post-industrial recycled material for our blister packaging, This is virgin material, so traceable and can be used in our industry. This collaboration allows us to reduce waste by reusing materials that would otherwise be discarded, aligning with our commitment to sustainability without compromising the integrity of our packaging.

Preparing for Regulatory Changes with Mono-Material Packaging

Currently, regulations require that all materials from operating rooms be incinerated, preventing the recycling of many medical device packaging materials. However, we are proactively working on developing mono-material packaging solutions that will be fully recyclable as soon as authorities permit. This means that when the regulations shift, Elos Medtech will be ready to offer packaging that meets both safety and environmental standards.

Minimizing Packaging Size to Reduce Environmental Impact

One of the most significant ways we are reducing our environmental footprint is by minimizing the size of our packaging. Smaller packaging not only decreases the amount of material used but also reduces the volume required for transportation, sterilization, and storage. For instance, we have developed ultra-small blister solutions for screws, and we are capable of designing similarly compact blisters for other products. This approach directly cuts down on waste and energy consumption across the supply chain.

Sustainable Material Selection

Sustainability starts with the materials we choose. At Elos Medtech, we only use FSC-labeled cardboard for our boxes, ensuring that the paper products come from responsibly managed forests. Combined with our use of Medipack’s blisters made from post-industrial recycled material, we are committed to offering packaging solutions that are as sustainable as possible. Additionally, we work closely with our clients during the development phase to create packaging concepts that are both effective and environmentally friendly.

Reducing CO2 Emissions in Our Supply Chain

We’re also focusing on reducing CO2 consumption by sourcing all of our packaging materials from European suppliers, most of whom are based in Germany (although we do have several regional suppliers). By keeping our supply chain local, we significantly cut down on transportation-related emissions, further supporting our sustainability goals.

Innovating for Waste Reduction

Looking forward, we are planning to sell our PET waste for recycling, ensuring that even our production byproducts are handled in a sustainable manner. By separating waste by material type, we can ensure that it is recycled to the highest possible standard. This initiative is part of our broader strategy to minimize waste throughout our operations.

Long Shelf Life, Less Waste

Finally, our packaging solutions are designed with a high shelf life—up to seven years. This durability ensures that repacking, which often leads to additional waste and energy use, is rarely necessary. By extending the lifespan of our packaging, we help reduce both environmental impact and costs for our customers.

Conclusion

At Elos Medtech, our commitment to sustainability in medical device packaging is evident in the actions we’re taking today. By leveraging recycled materials, innovating with packaging design, and reducing our carbon footprint, we are leading the way in sustainable practices. As regulations change, we are already prepared to meet the challenges and continue delivering packaging solutions that protect both our products and the planet.

Ready to collaborate on sustainable packaging? Contact us to see how we can help you meet your sustainability and packaging goals.

Sustainable packaging Elos Medtech

Sustainability in Medical Device Packaging: The Challenges

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At Elos Medtech, sustainability is integral to our operations. We continually strive to enhance the sustainability of our factories and products, reflecting our commitment to environmental responsibility. Today, we focus on a critical aspect of sustainability in the medical device industry: sterile packaging.

Challenge 1: Sterility

When it comes to medical devices, maintaining sterility throughout their shelf life is paramount. At Elos Medtech, ensuring product sterility remains our top priority. This commitment drives every decision we make regarding packaging materials and design.

Cleanroom sterile packaging

Challenge 2: Use of Recycled Materials

One of the challenges we face is the use of recycled materials in packaging. While using recycled materials aligns with sustainability goals, stringent regulatory requirements necessitate knowing the origin of all materials, including packaging components, particularly for sterile barrier systems. Currently, the lack of traceability hinders widespread adoption of recycled materials in medical device packaging.

Challenge 3: Making Packaging Recyclable

Designing recyclable packaging is a clear objective for Elos Medtech. However, practical challenges exist, particularly in healthcare settings where materials used in operating theatres are often considered contaminated post-use. Consequently, most materials are treated as non-recyclable waste. Despite these challenges, we are proactive in preparing our materials for future regulatory changes. By ensuring our packaging materials are recyclable when feasible, we anticipate and facilitate compliance with evolving recycling protocols.

Sterile packaging at puracon Elos

Challenge 4: Reduction in Packaging Waste

Addressing the amount of packaging used is an area where Elos Medtech can make an immediate impact. Through innovative design strategies, such as optimizing blister pack sizes and reducing outer packaging dimensions, we significantly reduce material waste. This not only minimizes environmental impact but also enhances efficiency in transportation and storage, contributing to a lower carbon footprint associated with our products.

In our next blog, we will delve deeper into how Elos Medtech is actively addressing these challenges today. Stay tuned to learn more about our sustainable initiatives and our ongoing commitment to delivering environmentally responsible solutions!

~ by Sofie Höchstetter, Vice President Sterile Solutions at Elos Life Science

Conny Jacobsson Elos MedTech

“Our focus on quality work and continuous improvements has taken the Tianjin production site to where it is today”

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Having worked many years in China, Conny Jakobsson has gained lots of local knowledge to use in his new role as Managing Director at Elos Medtech’s production site in Tianjin. He is passionate about continuous improvements, innovation and creating employee engagement. With these driving forces in mind, he wants to contribute to the development of the factory and meet the medical device market’s growing demands in China and globally.

Hi, Conny! You are the new Managing Director at Elos Medtech Tianjin, but you are not new in China, right?

True, I have been living and working in China for the last 18 years. I first moved here thanks to a position I had at Ericsson, after which I took on new challenges at electronics manufacturer Flextronics. At Flextronics, my role was to manage and develop one of their factories. Later on, I  was also a part of a joint venture between Flextronics, Ericsson and a state-owned enterprise in China. In September 2017, I was contacted about the role of Managing Director at Elos Medtech’s production site in Tianjin.

A lot of valuable experiences gained then, I assume?

For sure! My journey has given me experiences from both the customer’s and supplier’s side of businesses which I think is valuable regardless of the industry, country or position you are operating in. As for my new position at Elos Medtech, I find my previous experiences with medical equipment and their distribution to be an advantage. But also, the local knowledge and contacts I have gained from working with management, manufacturing and distribution of products in China are very helpful!

I bet! So, what were your expectations for the job as Managing Director?

What I was looking forward to the most, was to be a part of Elos Medtech’s continued work towards world-class manufacturing. I am passionate about business development, creating employee engagement, building relationships with customers and making progress every single day at work. This includes improving the business that we already have, as well as expanding our operations.

Elos Medtech’s production site in Tianjin, China opened in 2010. The production has mainly been focused on mechanical components for Novo Nordisk’s nearby located plant. The healthcare company is a world leader in diabetes care, with manufacturing dominated by various types of reusable insulin pens. In order to meet and exceed Novo Nordisk’s requirement of components of the highest possible quality, we have continually advanced our expertise and production processes during these years as well as expanded our customer base. This focus on quality work and continuous improvements has taken the Tianjin factory to where it is today and I am committed to intensifying this even more.

An equally important part of our operations in Tianjin has been to expand Elos Medtech’s presence in Asia. We want to serve more customers and include additional medical device products to our manufacturing in Tianjin.

Exciting! Can you give any examples of how you are working with these areas?

As in all Elos Medtech’s factories, high-quality work is a cornerstone of the Tianjin production site. We produce components using exactly the same material and procedures as in the production sites in Sweden and Denmark. In other words, continuous improvement is nothing new to us, but we are now taking initiatives to work with it in an even more strategic way. One example of this has been to incorporate the Lean concept “Go to GEMBA”. The whole production site is now involved in identifying areas for development, from operator to manager, and improvements are made immediately at the production floor. Failure modes, as well as possibilities, are identified and handled during the actual production process. This way of working saves considerable amounts of time and costs.

Is innovation also a part of this?

Absolutely. My view is that a culture of continuous improvements and business development fosters innovation. We welcome every new idea or solution from our employees, in all parts of the organization. In addition, we have invested in recruiting quality, technical, process and CI engineers to our team to come up with new solutions to improve process quality and minimize waste.

How is this culture affecting the operations at the Tianjin production site?

It keeps us on our toes, and we are well-equipped to provide customers with an optimized production process and high-quality products. Our engineering team can manage our customers’ entire projects all the way from prototyping and sample deliveries to approvals, serial production and final delivery. Also, since we have all the resources available on site, lead times are short and customer support is quick.

What does the future have in store for the medical device market in China?

The market is growing tremendously! There is an increasing need for Chinese customers to work with a local supplier that has a global presence. There is also a growing demand from global customers to have a supplier with local presence and manufacturing in China. At Elos Medtech in Tianjin, we have both!

There is a great commitment and engagement among our employees to continue to develop and expand our business. With this engagement, we are ready to meet more customer’s demands on capacity and innovation in the medtech industry, both locally in China and globally.

If we put work aside, what do you do when you are not on the factory floor?

Since I am working in Tianjin but live and have my family in Beijing, I commute between the two on a weekly basis. After work hours I try to take time to play squash, tennis or golf. The weekends are spent with family and friends, often enjoying dinner out in the city pulse of Beijing before I go back to the production site. It is a nice balance really!

Thank you for a really nice chat, Conny! We are happy to have you onboard and are looking forward to our continued and shared venture!

If you are interested in getting to know more of our employees at Elos Medtech, visit our Knowledge Blog. Also, stay updated on our social media channels!

Automated Production Line_Elos MedTech Pinol

Modular and automated packaging line for medical device products

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Automation has led the entire medical device market on an exciting journey. Elos Medtech in Denmark works hard to become an automated factory and continuously initiates and completes projects in automation. One of our efforts has been to build a modular and automated packaging line to secure highest product quality and increase production efficiency. After two years of intense development, the line is now up and running.

Initiatives to meet the demands of tomorrow’s medical device market

Customers on the global medical device market are demanding higher production efficiency, better precision, highest product quality and traceability down to the smallest part. One way to achieve this is by adding automation to the processes of medical device manufacturing. Through Elos Medtech’s concept The Automated Factory, we have intensely focused on optimization, automation and robotics since 2012. One of our ongoing projects during this time has been to create an automated and modular production line. Our proof of concept resulted in a packaging line for prosthetic products for implants that are packed in blister packages.

Creating a better working environment with automation and robotics

Up until recently, we packed our prosthetic products for implants one by one with tweezers, in clean rooms, wearing masks and gloves. This process required unnecessarily long production time and monotonous work tasks. To increase production efficiency and create a better working environment for our employees we started looking at alternative solutions.

Having 300 different kinds of packages, it was not possible to buy one machine that could pack all variants. So, instead of having to invest in several different machines, we started developing our own modular system. By making the system modular we can use it for packing many types of products, but also for entirely different purposes such as assembly or validation of products. The operator should be able to easily change settings and tools of the system and thereby switch to another area of application.

A modular system to pack, assemble and validate medical devices

Our technical team started working with the concept five years ago, back in 2016, and the machine has now been up and running for a few weeks. As for now, the machine is calibrated to pack prosthetic products for two types of implants.

The process starts with the operator preparing the packaging line with papers, blister packs and products to be packaged before scanning the work order. The system will automatically make sure that the corresponding production program is set up correctly. It also controls that the right components and substances are available in the standardized fixtures and that the production cell holds the right temperature. After that, the machine will pack the products while collecting information about the process, which is then available to the operator whenever needed. This information includes, for example, production time, how many products that have been packed and if any product is damaged or disapproved for some reason.

A system built from scratch by Elos Medtech’s technical team

Because the whole system is built to be dynamically interchangeable, we are continually working to expand its capabilities beyond packing. Elos Medtech’s technical team has developed and programmed the entire system from its first line of code. This is highly valuable since we can do all changes and improvements by ourselves and it makes the process of adding functionality much smoother.

Moving towards a fully automated production process

By using automation to assemble, pack and validate our products we can offer our customers a more reliable and efficient production process. Also, our monitoring and control of the system improve the traceability and quality of our products. When we remove the process of packing products by hand, our production quality becomes more consistent and we improve the working conditions for our employees.

The development of this particular machine is just one part of everything that is being made through our concept The Automated Factory. We are moving towards a production line where few parts are touched by humans. Machines will do the repeatable and heavy labor tasks while our employees use their competencies for supporting innovation and progress. The technical team cooperates with machine operators and factory workers to recognize areas for improvement and implement these. This way, we will continue to develop our services and meet the ever higher demands of tomorrow’s global medical device market.

I hope you enjoyed reading this blog article! Would you like to know more about our projects in automation at Elos Medtech? Feel free to contact us. Also, don’t forget to visit our Knowledge blog for other interesting articles.

Swemac and the Hansson Pinloc System

Customer Case: Swemac and the Hansson Pinloc System

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Last year, we wrote a blog article about The Introduction of the Hansson Pin and the Olmed Screw, describing a pin and a screw that would improve the lives of patients suffering from femoral neck fractures. As you probably know, the development moves fast in the medtech industry. Since then, the Hansson Pin has gained further improvements, resulting in the Hansson Pinloc system. In this blog article, I will describe the Hansson Pinloc system and Elos Medtech’s involvement in the development process.  

Swemac offers solutions for fracture treatment and joint replacement

Swemac is a Swedish-based company, providing the medtech market with innovative and practical solutions for fracture treatment and joint replacement. The company dates back all the way to 1968 and has been developing and selling orthopaedic implants and medical equipment ever since. In addition, Swemac provides orthopaedic simulation training systems, as well as orthopaedic training programs that focus on surgical techniques and the characteristics of different orthopaedics implants. Swemac’s products aim to benefit the patients as well as professionals working with the implants. Quality, high performance and innovative competence were Swemac’s features in the past and most certainly will be in the future.

The Hansson Pinloc System is an evolution of the Hansson Pin System05

The Hansson Pin system was designed to offer secure, stable fixation for femoral neck fractures with reduced risk of healing complications, as well as to minimise surgical trauma to the patient. The Hansson Pin consists of two parts, an outer pin, and an inner sliding tongue. Fixation in the femoral head is achieved by pushing the inner sliding tongue out through the window of the outer pin. However, in some cases, the femoral head tilts back again to the same position it had during the fracture. This is the result of the screws not having the mechanical stability to allow the fracture to heal in its reduced position. To overcome the problem of fracture displacement after internal fixation, and still maintain the same features as the Hansson Pin System, Swemac designed the Hansson Pinloc System.

“When launching a new medical device, a successful cooperation with a development and production partner is crucial. To avoid bottlenecks and failure in deliveries, an optimal flow is required between the development phase, production phase and marketing phase. Basically, it all comes down to trust between the companies, says Lars Öster, responsible for Research and Development at Swemac.“  

High rotational stability with the Hansson Pinloc System

Skärmavbild 2016-11-24 kl. 14.48.15Swemac identified the need to further develop the Hansson Pin and make it even better, to provide the patients with even more benefits. Instead of the two isolated pins constituting the Hansson Pin, The Hansson Pinloc System consists of three Hansson Pins and a plate creating a dynamic unit, which has the ability to recreate the stability of an unbroken hip. The pins in the Hansson Pinloc System can not rotate in relation to each other, as often is the case when independent screws are used. This means that the femoral head can only rotate if the bone cuts through all pins simultaneously, which is very unlikely. Thus, the Hansson Pinloc System reduces the occurrences of complications during fracture healing and increases the quality of life for the patient.

Femoral neck fracture is a common fracture type,where around 30 to 40 % of the fractures are treated with osteosynthesis. The other 60 to 70 % are treated with arthroplasty. The surgery could result in symptoms like pain, limited ability to walk as well as tenderness. The Hansson Pinloc System aims to limit these symptoms to a minimum.

Elos Medtech started offering its expertise in the development phase

Swemac started collaborating with Elos Medtech early on in the development of the Hansson Pinloc System. Elos Medtech supported with production improvements to achieve an efficient and cost-effective manufacturing process. In addition, Elos Medtech was responsible for producing all the components, sterile validation, packaging and labelling the products. Elos Medtech was also Swemac’s development and production partner when manufacturing the Hansson Pin. Consequently, when manufacturing the Hansson Pinloc System, Elos Medtech contributed with an extensive understanding of the product, experience in producing similar devices as well as a unique know-how concerning the mounting, which was highly appreciated by Swemac.

Swemac puts high demands on a development and production partner

There were a lot of parameters Swemac took into consideration when choosing a development and production partner. High quality was on top of the agenda, as well as the prize, flexibility and delivery precision.

“I feel very safe letting Elos Medtech produce our products, and I have great confidence in them as our development and production partner. The manufacturing process was built on an open and tight dialogue between Swemac and Elos Medtech. Not all partners live up to the high level that Elos Medtech does, says Lars Öster, responsible for Research and Development at Swemac.“          

Elos Medtech is responsive to customer requirements

The medtech industry is characterised by tough competition and high-quality demands. Elos Medtech is an experienced and confident development and production partner, responsive to the customers’ requirements and market demands. On short notice, we manufacture products based on given specifications. We offer a unique flexibility during the design phase, which is highly appreciated by our customers. We provide valid and reliable instruments and products for clinical situations, and we take responsibility for your products throughout their entire lifecycles.

Are you more curious about the Hansson Pinloc System, or want to know more about Elos Medtech? Contact me directly or visit our website for more information. Don’t forget to visit Elos Medtech’s Blog for more interesting blog articles.

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.