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Why China is a lucrative market for dental implant manufacturers

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The Chinese dental implant industry has shown strong growth in recent years, and the trend is expected to continue. As the Chinese population is experiencing increased upward mobility, more people can afford dental care, and the demand for restorative dental services is increasing. As a result, China has become a lucrative market for dental implant manufacturers.

A glance at the dental implant market in China

The Chinese dental implant market size is expected to grow and reach a valuation of nearly $680 million in 2027. The expected market increase is setting the stage for lucrative opportunities for dental implant manufacturers.

The proportion of dental implant procedures performed in private dental clinics is much greater than that of government-owned public hospitals in some regions. However, this split differs between Northern/Southern and Eastern/Western regions. On average, across China, the total number of dental implant procedures performed in private clinics versus public hospitals is almost fifty-fifty.

With an almost equal distribution of procedures taking place in clinics compared to hospitals, it would seem logical to deduce that clinics and hospitals are equally desirable for implant manufacturers to focus on. However, this is actually not the case. 

Private dental clinics versus public hospitals

Public hospitals are a much more lucrative segment for implant manufacturers to target to substantially grow their business in China. Public hospitals are considered the most reliable and qualified treatment centers among patients and the prime segment for premium foreign brands today. Consumers have greater confidence in public hospitals, and the best dentists want to work for public hospitals – not private clinics.

More than 50% of dental implant sales today already target hospitals as their prime segment. This market is estimated to win an even greater market share from private clinics in the future. Furthermore, most dental implant companies are persistent enough to put in the effort to succeed in public hospitals due to their strong influence, academic status, and better gross profit margin.

Foreign versus domestic dental implant brands 

It is also key to know that Chinese patients prefer foreign brands over Chinese brands. In fact, more than 90% of dental implants in China are provided by foreign brands today. Furthermore, Chinese consumers prefer American and European brands over all others as they are known to be market leaders in the dental industry with safe, high-quality performance.

The high trust in foreign brands means excellent opportunities for dental implant manufacturers in the Chinese market. However, as a foreign brand in China, you need to understand the regulatory challenges and new policies to compete.

Regulations for dental implants in China

The NMPA (National Medical Products Administration) has launched new medical device regulations that pose threats to foreign dental implant manufacturers.

In early 2021, a proposal was submitted to the National People’s Congress mentioning the high cost of dental implants for the first time at the national level. Later that year, a notification was issued by the Pharmaceutical Equipment & Procurement Service Center of Sichuan Province. It stated that information collection of high-value medical consumables in the dental category would take place. This included dental implants, repair abutments, prosthetic products, and other medical consumables that constitute dental implant systems.

In 2022, an executive meeting of the State Council was held to deploy and accelerate the major projects identified in the outline of the 14th Five-Year Plan, covering the years 2021-2025. At that time, it was announced that dental implant systems would be included in the program of volume-based procurement on a national level.

State order 739 is the approval for the new Regulations on the Supervision and Administration of Medical Devices, which is now publicized and took effect as of June 1, 2021, with an enforcement date of January 1, 2022.

Classification is key to the Chinese dental market

Although the official reasoning behind the new policy is a reduction in the cost of the medical burden on patients, Elos Medtech assesses that the policy will be much more detrimental to foreign dental implant brands sold in China than meets the eye. The new policy incentivizes the protection of domestic brands in China, the localization of dental products, and the development of China’s technical knowledge in the dental implant industry.

Our assessment of the new policy’s regulations is that it is becoming imperative to become classified as a domestic brand in China, acting as a Legal Manufacturer to be able to sell dental implant products in public hospitals in the future.

And in the most recent move, on August 18, 2022, the Chinese National Health Care Insurance Association solicited public comments on the Notice on Carrying Out Special Governance of Oral Implant Medical Service Charges and Consumables Prices. This notice regards the pre-stages of the procurement of implantology. It shows that the government is working swiftly to accelerate the implementation of its implantology plan. Notably, this notification relates to both public and private clinics.

Opportunities for dental implant manufacturers

It is vital to act quickly to avoid being left out of such an important market, and Elos Medtech can help. For more in-depth information and strategies to help ensure your brand’s success in China, visit Elos Dental, where you can also download our eBook.

Yes, I want to enter the lucrative dental implant market in China!

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!

Sustainability Report Elos MedTech

Sustainability – A look at what we achieved in 2017 and our focus for 2018

Beginning of April, we released our very first sustainability report. The report describes our work to make the development and manufacturing of medical technology more sustainable. In this blog post, I will summarize our sustainability highlights of 2017 and introduce you to the activities we are focusing on this year.   

Responsibilities beyond providing high-quality medical device products

In previous blog posts, we have described Elos Medtech’s strategic work toward a more sustainable medtech industry. As a global contract development and manufacturing partner (CDMO), we have responsibilities that go beyond providing our customers with high-quality medical device products. Working with economic, social and environmental aspects is equally important and we have strategic targets to ensure that we are continually improving in these areas.

A few of our sustainability highlights from 2017

During our previous years in business, customer relationships and sustainability work have been equally important but mainly managed by our local subsidiaries. Since we are now in the process of consolidating our whole organization into one Elos Medtech, we are also going for a more unified approach to sustainability. This is reflected in the priorities we set up for last year, 2017: to launch our new vision and mission, formalize a Code of Conduct and continue our sustainable growth.

So, how did we do?


Conducted a materiality assessment to define our most important sustainability aspects

To reach a more unified approach to sustainability, we needed to determine where to focus our efforts and resources, and what activities that matter the most from a sustainability perspective. To determine this, our Sustainability Project Group conducted a comprehensive materiality analysis which resulted in a list of eleven materiality aspects. Some of these aspects are: Customer satisfaction, Product performance and excellence, Empowering people, Healthy and safe workplace, Ethics and compliance and Energy management.

Launched Our Way; a new vision, mission and revitalization of our values

As a way of clarifying our role in the medical device market, what we strive to achieve and under what guidance we create sustainable value, we launched a new vision and mission:

Vision: “Transforming Medical Technology and Advancing Quality of Life Worldwide”

Mission: “In partnership with our customers, we provide sustainable, innovative products and supply solutions for the global medical device market. Building profitable, long-term partnerships and striving for excellence in everything we do, our goal is to help people to live rich, active and fulfilling lives.”

Developed a Code of Conduct

In order to live and fulfill our vision, mission and values, everyone at Elos Medtech must represent the company in a way that meets ethical standards. To facilitate this, we have developed a Code of Conduct. The guidelines form the basis for our entire culture and include our stands on issues such as compensation, terms of employment, freedom of association, equal opportunity and non-discrimination, as well occupational health and safety.

All employees have undergone training in compliance and our values

During 2017, all employees have been trained in medical device regulations and Elos Medtech’s established quality and environmental management system. It has also been an emphasize on our core values during the roll out of the new vision and mission for all employees.

Significant reduction of energy consumption

Reducing the climate impact of our operations is a long-term commitment that involves many parallel activities. We aim to invest more than five percent of our investment budget in projects that improve our environmental performance. Two initiatives from last year were installing LED lights in our factories as well as a new cooling system at Elos Medtech Pinol in Denmark. The cooling system will reduce the site’s energy consumption with ~200,000 kWh per year.

What sustainability efforts are we focusing on in 2018?

We are excited about our achievements during 2017 as well as to enhance our efforts even more through our goals for this year:

  • Implement a new program for measuring and monitoring customer expectations and satisfaction.
  • Carry through the Employee Engagement Survey program throughout the organization.
  • Reduce the usage of energy from non-renewable sources and convert to energy from renewable sources where possible. The target is a five percent increase of the renewable energy ratio in 2018, compared to 2017.
  • Reduce scrap costs by at least 20 percent.
  • Roll out the Code of Conduct through local training sessions. By year’s end, all employees shall have participated in the training session and signed off the Code of Conduct.
  • Secure sustainable investments which improve our environmental performance corresponding to at least five percent of the agreed investment budget.

In other words, we are in the middle of a busy year and are looking forward to report on further achievements in upcoming reports and blog articles! If you want more in-depth information regarding our sustainability work at Elos Medtech, read the full report or contact me with questions.

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Safe and effective digital dentistry products on the US market

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Premarket Notification, also known as the 510(k) process, is one of several controls to ensure that all medical devices that enter the American market are safe and effective. In this blog article, I will introduce you to two of the most common regulations as well as describe Elos Medtech’s journey towards bringing our full range of digital dentistry products to the US.  

Regulations to ensure safety and effectiveness of medical devices

There is an extensive system to regulate which products enter the US medical device market. United States Food and Drug Administration (FDA) is responsible for promoting and protecting the public health by ensuring effectiveness and safety of medical devices. The agency is also responsible for promoting innovations that improve medical devices as well as helping the public access scientifically based information about the products.

FDA divides medical devices into three different classes, based on the level of control needed to assure safety and effectiveness. This is dependent on the device’s design complexity, characteristics of use and the risk of harm if it is misused. Medical devices that belong to Class I, such as elastic bandages and examination gloves, are subject to the least regulatory control. Class II and Class III medical devices include products that are subject to more controls and approvals to ensure safety for the user and patient.

Premarket Approval vs. Premarket Notification

There are two major processes by which medical devices enter the US market after review by the FDA. The first one is the Premarket Approval (PMA). This process evaluates Class III medical devices that support or sustain human life, that are of great importance in preventing impairment of human health or present a potential, unreasonable risk of illness or injury. Examples of Class III medical devices are implantable pacemakers and pulse generators. Because of the risks associated with Class III medical devices, the PMA is the most stringent pathway of the two and it generally takes clinical trials to ensure the devices’ safety and effectiveness.

The other and most common way of bringing a new medical device to the American market is the “Premarket Notification” process which applies when a PMA is not needed. Premarket Notification, also called the 510(k) process, requires that a new medical device is compared to another already lawfully marketed model. The parameters that are compared are for example indication for use, material, chemical composition and design. The new device will get a 510(k) clearance by going through general controls, tests or literature search that show FDA that the device is at least as safe and effective as the predicate device it was compared to. This, in turn, means that the medical device manufacturer or their contract manufacturer can legally market and sell the device in the US.

A 510(k) clearance as a first step towards the complete digital workflow

Elos Medtech has been offering scanning abutments and model analogs on the US market for many years. Since they are categorized as Class I medical devices they do not require 510(k) clearances. The products are included in digital dentistry but they do not alone enable a complete digital workflow. For our customers to experience all the possibilities and benefits that digital dentistry has to offer we have been working on bringing more of our Elos Accurate products to the US market.

Just recently, we got a 510(k) clearance on our first Abutment Blank after a process of clinical testing and literature search. This does not only mean that the product itself is proven safe and effective, it also has a bigger meaning. Even though this is merely one step on the journey towards offering our full range of products for a digital workflow, it is a step that will pave the way for the next ones. Since we can now use the Abutment Blank as our predicate device in the Premarket Notification process it will accelerate the process of bringing our other products to the market. Next, we will focus on making our titanium bases available in the dental libraries for our American customers.

Meet up with Elos Medtech at LAB DAY Chicago

For the seventh time, Elos Medtech will exhibit at LMT LAB DAY Chicago, the largest international gathering of the dental laboratory community in the US. Between February 23-24 you can meet us at the event to get to know more about our upcoming product launches and developments. We are looking forward to seeing you there!

I hope you enjoyed reading this blog article about our ongoing work to provide dental professionals in the US with more of our digital dentistry products! For more information and news from the dental industry and Elos Medtech, visit our Dental blog!  

OMTEC 2017 Elos MedTech Onyx

Elos Medtech is the Proud Premier Sponsor of OMTEC 2017

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The annual Orthopedic Manufacturing & Technology Exposition and Conference is at the door. Elos Medtech is very happy to be the premier sponsor of this year’s event! OMTEC is the world’s only conference exclusively serving the orthopaedic industry. The event takes place June 14-15th in Chicago, USA. Will you be there? We hope so!

Meet professionals from the orthopedic manufacturing community

OMTEC is an important hub for various professionals from the orthopedic manufacturing community. With twelve years under its belt, OMTEC is recognised as an international conference that facilitates dialogue and partnerships among suppliers, service providers, and orthopaedic OEM (Original Equipment Manufacturer) professionals. The target audience of the conference is procurement, supply chain, operations, R&D (Research & Development), and executive-level participants as well as business development, regulatory, quality, and clinical affairs professionals.

Explore the medical fraternity and emerging orthopedic trends

OMTEC is directed towards exploring the medical fraternity and emerging trends in the orthopedic sector. Visiting the event, you will experience an environment that educates, connects and empowers you: 147 exhibiting companies from 13 countries will be on hand to help you. 28 speakers will bring you how-tos, lessons learned, and future outlooks through workshops, keynotes, sessions, tech presentations, and surgeon-hosted knowledge pod discussions. It is a great event for joining forces with your peers and strengthening your knowledge and network!

Elos Medtech is a global solution partner to the orthopedic industry

Elos Medtech is not only the premiere sponsor of OMTEC 2017, but we will also exhibit as a global solution partner to the orthopedic industry, sharing our knowledge and insights. Our main message for OMTEC 2017 will be “Our world continues to change – our passion remains the same”. This means that we are dedicated to innovation and committed to continuous improvements. Our solution offerings are based on our extensive know-how that is up-to-date with the orthopedic trends. We believe in building great partnerships and have been serving the orthopedic industry for many years now, and made the strategic decision to acquire U.S. based Onyx Medical to further increase our presence and offering in the orthopaedic market.

Onyx Medical is specialized in making a complete line of wires, guide pins, half pins, drills and screws utilising the latest in process technology, and partnering with the world’s leading orthopedic companies. The 53,000-square-foot, ISO-certified and FDA-registered facility located in Memphis, Tennessee, USA is strategically positioned for unparalleled global supply, together with our facilities in Sweden, Denmark and China.

We look forward to seeing you at OMTEC 2017

We are always delighted to meet our customers, partners, distributors, and anyone interested in orthopedics and the medical device industry. We hope that our participation at OMTEC 2017 will provide many interesting and fruitful discussions as well as the opportunity to exchange ideas and experiences with our customers and colleagues. We are very excited for OMTEC 2017 and hope to see you there!

For more news and updates from the medtech industry and Elos Medtech, visit our medtech Blog. Also, read:

Orthopaedic Device Mark

3 Top Trends in the Orthopaedic Device Market

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The medical device market is large, complex, competitive, and growing. As a global development and production partner for the European, Asian and US markets, we strive to remain aligned with the latest market developments. In this blog article, I will take a closer look at the orthopaedic device market and describe three of the top trends as well as speculate about what the future might hold.

1. Cost control: Commoditization of the orthopaedic device market

The first big trend I see is that the orthopaedic device market – in many ways – is becoming more commoditized and there is a larger focus on cost-reduced implants, instrumentation and delivery systems.  This is the result of the combined effect of ongoing pricing pressure and growing demand for procedures in the market – medical device companies must find ways to reduce the cost of getting their products into the hands of the people who need them around the globe.  Cost controls are becoming even more important because expanding regulatory requirements are generating increased expense which erodes margins even further.  As a result, medical device companies have to work really hard to eliminate non-value added cost drivers and mitigate supply chain and regulatory expense.

We focus on building effective and sustainable quality and regulatory processes

At Elos Medtech, we recognize that by investing time and resources early in the project, there is a greater opportunity to develop a compliant and cost effective design and supply chain from the very beginning.  Furthermore, we are continuously working to increase internal efficiency, improve production techniques and utilize technology advances to support our customers’ ongoing cost containment activities. Aside from the design, manufacturing and logistics processes, we understand that one of the greatest cost drivers of any project or product is the ever escalating regulatory compliance aspect. At Elos Medtech, we are highly knowledgeable of the requirements and capable of full compliance in a cost effective, value added manner. We truly believe that companies who are able to comply in a simple and efficient way will have a serious competitive advantage.  This is why building effective and sustainable Quality and Regulatory processes is a large focus for our group.

2. Product innovation: Improved patient outcomes, reduced surgical time

Improving patient outcomes and reducing procedure time is also becoming increasingly important in healthcare.  And within the orthopedics market, we have an ageing population that is going to need more procedures. It is actually expected that there will not be enough orthopaedic surgeons to meet the growing demand.  Device companies are going to have to produce medical devices and tools that allow orthopedists to perform more surgeries, which in turn also reduces cost. Medical devices need to be simpler and more user friendly with less likelihood of error.  But they cannot cost more, and this is also a challenge. Most products on the market today are generally sufficient. So unless a new product can reduce the surgical time or improve patient outcomes or differentiate itself in some meaningful way, hospitals are typically unwilling to pay more. A large challenge lies ahead for the medical device companies to effectively compete and meet the demands of the market.

We collaborate closely with customers to improve performance, cost and quality

In close collaboration with our customers and their development teams – and within our niche areas of expertise – we use our deep knowledge to help design and deliver products that will perform better and which will meet the surgeon and patients’ needs. Understanding the specific surgical application and the associated challenges along with the market requirements of the customer is essential to our process. The earlier our team can be brought into the commercial, design and R&D process, the more opportunity we will have to provide suggestions for improved performance, optimal cost control and advance consideration of quality compliance requirements.

3. Technology advances: Robotics, computer-aided surgery, 3D printing

Today, we are seeing a number of technology advances in the orthopaedic device market.   We definitely see more emphasis on minimally invasive, computer aided and robotically assisted surgery with the goal of improving accuracy, precision and patient outcomes. Over time, this may help create a higher and more replicable standard of care and perhaps one day help to achieve the broad goal of reducing surgical time and the total cost of care.   As the technology moves forward, the orthopaedic supply chain needs to keep pace.  In the end, one thing remains constant. When it comes to orthopaedic procedures, there will always be the need for medical devices and tools that can cut, shave, and make holes in bone.

Another technology that is a subject on everyone’s lips right now is 3D printing. Even though not widespread, we are starting to see 3D printing in orthopaedic procedures and manufacturing for prototype, custom and low volume solutions. One of the greatest advantages of 3D printing is that implants can be completely adapted to the patient, and delivered with a very short time frame. But because the implants are patient-specific, and quite expensive to produce, this technology targets a smaller niche market.

We develop our knowledge with 3D manufacturing techniques continuously

We are already helping to develop and deliver many products in support of robot assisted and computer assisted surgery (such as for fixation and bone cutting,) and working with customer design teams to develop products to support their growing needs within this surgical area. It is a natural fit for our specialized expertise.  We are also working to apply 3D manufacturing within our groups. Currently, our efforts are focused on supporting production innovation and process improvement activities but we are continuously developing our knowledge and experience with 3D manufacturing techniques to evaluate applications that could be directly applied to the products we deliver in the future.

The US orthopaedic device market and the future

So what does the future hold for the US orthopaedic device market? This is always a difficult question to answer, but I definitely think that the market will only continue to experience steady development as the population continues to grow and to age and the demand for orthopaedic devices increases. One of the biggest challenges ahead will probably be for the companies to differentiate themselves. As to the technology advances, they are not likely to slow down. On the contrary, new innovations will go hand in hand with the need for improving patient outcomes, reducing surgical time and hopefully also the total cost of care. And while the US has heavily dominated the global market for some time now, companies that are able to compete in a cost effective way and deliver innovative and regionally tailored solutions will have a competitive advantage.  Ultimately, technology is and will continue to be one of the key drivers for overall growth within the orthopedic market.

What do you think of the US orthopaedic market and the future? Which trends do you see? Please, let me know in the comments! For more info about how Elos Medtech can help and support you to develop and manufacture trauma, extremities and spine products, visit Elos Medtech’s website. Also, visit our Knowledge Blog to read Onyx Medical – A leading Supplier to the Orthopaedic Market as well as OEM’s Choice of the Right Contact Manufacturer.

Energizing Sustainability Elos Medtech

Stepping up our Sustainability Actions at Elos Medtech

Today, there are ongoing discussions about the need to achieve sustainable development in the world. Elos Medtech is a company with high awareness about the global environment and a commitment to contributing to a more sustainable future. We have been working with Corporate Social Responsibility (CSR) for a long time, but recently, we established a workgroup to step up our sustainability activities and environmental focus. This new initiative is called “Energizing Sustainability” at Elos Medtech.

Establishing the “Energizing Sustainability” workgroup

The name “Energizing Sustainability” reflects the high importance of sustainability and a new drive into the area. We have established a workgroup to set the scope and main activities. The workgroup will be expanded by topic experts from all parts of our organization whom will be involved and contribute to the new sustainability initiative at Elos Medtech.

What does sustainability mean to Elos Medtech?

Sustainability can be described in several dimensions such as ecological, economic and social sustainability. These three dimensions are all considered in our business and operational processes at Elos Medtech. Our current CSR will be further developed within these areas. We believe efficient processes intended to create customer value, also contributes to minimizing waste. Customer-oriented business development helps to create financially sustainable organizations. Job satisfaction, commitment, and motivation are positively affected when employees are involved in, and  actively working with, sustainability on various levels in the organization. All these aspects are strongly linked to quality focus in everything we do and continuous improvements.

Sustainability is our guiding principle for every decision we make

As an international organization, we are aware of the need for sustainability focus and the many benefits that follow. Our performance in relation to the society, in which we operate, as well as our impact on the environment, are critical parts of measuring our overall performance in continuing to operate efficiently. We operate in a manner that meets – or exceeds – the ethical, legal, commercial and public expectations placed on our business operations. Sustainability is our guiding principle for every decision we make, in every area of our business.

A new sustainability report initiated by the European Commission

Reporting on non-financial information issues including risk management and sustainability has gained in importance over the years. An updated European Commission directive regarding reporting of non-financial information for listed companies is expected to enter into force December 2016. The requirement states that an annual Sustainability Report shall be issued with start 2017. This is applicable for Elos Medtech since our corporate governance is based on Swedish legislation for listed companies.

Stepping up our sustainability actions through this new initiative is both exciting and a challenge for us. But moreover, it is a contribution to a sustainable world and, hopefully, our customers are as dedicated as we are to this commitment.

This is only one step in our long-term sustainability strategy. We will be posting more blog articles on our sustainability actions ahead, how sustainability is connected to our business as well as the medtech industry in general. Keep an eye out on our Knowledge Blog! In the meantime, also visit Elos Medtech’s website for more info about our current CSR and what we aim to do.

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.

Meeting Quality Requirements in the Medtech Industry

The Importance of Meeting Quality Requirements in the Medtech Industry

When choosing a development and production partner to manufacture medical devices, there are certain areas that must not be compromised with. You should look for a partner with a quality mindset, that focuses on patient safety, product quality and compliance. According to us, to comply with applicable rules and regulations goes without saying.   

What does insufficient quality mean for the end user/patient?

Every day, numerous medical devices are used in health care facilities, and elsewhere, all over the world. Most devices are quite simple, while others are complex and combine different technologies. Defects or disturbances in the functions of medical devices may expose patients to serious risks. This is particularly true for devices which transfer energy or pharmaceuticals to patients, e.g infusion pumps, or devices which sustain or support vital functions, e.g pacemakers. Nonetheless the safety standards must be high for all medical devices. The devices shall be safe and reliable and well suited for their intended purposes.

Medical device having defects or malfunctions could lead to severe consequences

Deviations from expectations and claims could be a threat to patients’ health in terms of dissatisfaction, pain, discomfort and suffering. It could also lead to more serious consequences, such as injury, sickness and death. A structured and controlled way of designing, producing and distributing medical device products is a must. This is to ensure that the products are safe, and by that said, free from unacceptable risks for persons, property or environment. This structured way of working is described in several laws and regulations, as well as standards and guidelines.

The medtech industry is subject to extensive rules and regulations

To avoid accidents and risking the patients’ health, there are a number of different standards and regulation systems to follow. U.S. Food and Drug Administration (FDA) has implemented Quality System Regulation, (QSR) to ensure product performance and safety. Europe’s regulations are published in the Medical Device Directive. The aim of these rules, as regulations, is to ensure a high level of protection for human health and safety. In Europe, the standard ISO 13485 complements the Medical Device Directive, and describes the requirements for a comprehensive quality management system for the design and manufacturing of medical devices.

The regulations exists primarily for enabling patient access to high quality, safe and effective medical devices, and restricted access to those products that are unsafe or have limited clinical use. When appropriately implemented, the regulations ensures public health benefit and the safety of patients, health care workers and the community. Additionally, there are several recognised guidance documents published that support the medtech industry to comply with the rules and regulations.

High demands on development and production partners

When working in the medtech industry, it is important to choose a development and production partner that live up to the high demands that are required. A development and production partner needs to be aware of all the various applicable laws and standards, and manufacture the medical devices accordingly. Policies and procedures shall be established in line with the defined rules and regulations, and employees shall follow these policies and procedures.

In my opinion, working with medical devices is a trusted job that all must take “pride” in. To have a quality mindset is the prerequisite for patient trust, which includes patient safety, compliance and product quality.

Our values at Elos Medtech

At Elos Medtech, our commitment is to never compromise on safety, compliance or quality, of our products and services. This requires everybody to be engaged, to understand their responsibility in achieving our quality objectives and to be empowered to take action in order to protect our patients and customers. Our founded values at Elos Medtech help us to keep our promises and be precise in our work; passion, trusthworthy and result-oriented are words that describe our way of thinking and acting in everything we do.

Elos Medtech ensure quality to meet the expectations and needs of all stakeholders

This means that we will;

  • Never compromise on patient safety and quality
  • Respect and comply with all statutory and regulatory requirements or other provisions applicable for our operations
  • Continuously challenge ourselves through the review of our quality management system, quality objectives and results, to sustain a high quality and to make improvements when needed
  • Promote quality awareness throughout the company and the entire supply chain

I hope you found this article rewarding. Please don’t hesitate to visit our website or contact me with any further questions.