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Lotta Ljungberg

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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.

Energizing Sustainability at Elos Medtech

Working strategically toward a more sustainable medtech industry

Last year, 2016, we published a blog article about our continuous work with Corporate Social Responsibility (CSR) at Elos Medtech. We also introduced our initiative “Energizing Sustainability” which is a part of our efforts to step up our sustainability work. The aim is to provide more value to our customers while minimizing our environmental footprint at the same time. A lot has happened this past year through this initiative. Amongst many other activities, we have established a new vision & mission, which is the basis for our sustainable work.

Vision and mission for more innovative and sustainable medical device products

Taking responsibility for people, environment and society are anchored in Elos Medtech’s way of working and emphasized in our guiding principles and the heart of our culture. Corporate responsibility reflects our vision, mission, and values and supports Elos Medtech’s leadership positions and the broader responsibility that comes with it – responsibility to our customers, to our employees, to business partners, to society, to the environment and to our shareholders.

Corporate responsibility and sustainability involve all parts of a company’s operations. The concepts need to be a guiding principle in every choice made and that requires ongoing investments. Therefore, Elos Medtech has developed a sustainability strategy that is closely aligned with our business strategy. The new vision & mission describes what we strive to achieve and under what guidance we will operate and seek future growth. Our vision of “Transforming Medical Technology and Advancing Quality of Life Worldwide” describes our focus and will for making meaningful changes in the way we do business and in the lives of the people we touch.

The vision goes hand in hand with our new 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.” Sustainability, partnership and excellence are main elements of the mission. And also important parts of our business strategy. To create more value for our customers, it is essential to ensure product quality, compliance, improving cost efficiency as well as providing more innovative and sustainable solutions.

3 focus areas for a sustainable organization and customer-oriented business

We have identified several success factors for how to contribute and achieve long-term sustainable solutions for the environment and for our business. These can be summarized in three focus areas: Care for our People, Care for our Business and Care for our Responsibilities.

Care for our People

Care for our People means that we strive for building a culture that promotes our values, relationships and excellence. At Elos Medtech, our people are our greatest asset. They are the ones that make it possible for us to live by our values. Therefore, we are in the midst of an initiative where we are collecting information regarding employee engagement, health and safety at our workplaces, labour practices, diversity and human rights. This information will lay as a foundation for further analysis to identify success factors and objectives to ensure sustainability in this area.

Care for our Business

We are committed to offering innovative and sustainable solutions to our customers. Satisfied customers and lasting customer relationships are essential aspects for us. Being a customer-oriented business helps to create a financially sustainable organization. As a reliable and strategic development and production partner we aim to enhance existing business relations and create new business opportunities. One initiative related to this is to evaluate our customer surveys to ensure that these capture as much valuable feedback as possible. Also, we will put a lot of efforts in turning the customer feedback into positive changes in our solutions and products.  

Care for our Responsibilities

As a global contract & development manufacturing organization (CDMO), Elos Medtech has responsibilities that go beyond supplying high-quality products to our customers. We need to continuously work with aspects such as ethics, compliance and anti-corruption. Also, we have a responsibility toward the environment with regards to our transports, water and energy consumption, the chemicals we use and the waste that we produce. Internal and external communication is another important part connected to this focus area. An example of this is that we will publish our first Sustainability Report for 2017. Elos Medtech will publish a sustainability report during spring time next year, 2018.

We also have a social responsibility for the communities where our facilities are situated. For instance, our subsidiary Elos Medtech Onyx is engaged in various charity activities, internship programs and building a training center to support medical device professionals. We will post more blog articles regarding these activities later on. Stay tuned for that on our Knowledge Blog!  

I hope you enjoyed reading about our latest sustainability efforts. We will be posting more blog articles on the subject ahead. In the meantime, also visit Elos Medtech’s website for more information about our current work with sustainability and the responsibilities we take.

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.

IQ, OQ, PQ - Validation Process in the Medtech Industry

IQ, OQ, PQ – A Validation Process in the Medtech Industry

Do you get confused with medical terminology that sometimes sounds like mumbo jumbo? You are not alone! What do these abbreviations actually mean? This is something that everyone working with manufacturing or production in the medtech industry needs to know. I will guide you through it.

A process to fulfill US regulations and ISO

Regulations and ISO standards applicable for medical devices require that validation of a manufacturing process shall be performed. In fact, both the U.S. Quality System Regulation 21 CFR Part 820 and ISO 13485:2012 have explicit elements requiring the manufacturer to perform tasks associated with IQ’s, OQ’s and PQ’s, Note that these explicit terms are not found in either  the regulations nor the ISO standard, but the requirements are clearly stated. A GHTF guidance, which is an internationally harmonized document recognized by both the US FDA and ISO clarifies how to act*.

The purpose is to establish documented evidence that all necessary production equipment are present, connected to appropriate utilities and are performing according to the approved specifications, and to demonstrate that the process under normal operating conditions will consistently produce products in compliance with product specifications.

There is a need to validate every manufacturing process for production of medical devices where the result is not verifiable by subsequent monitoring or measurement. For each manufacturing process, a validation plan shall be established. The validation plan shall define the validation approach for the manufacturing process in relation to the IQ/OQ/PQ elements. The approach should be risk based to secure that the critical product parameters or specifications are adequately taken care of.

Installation is key for manufacturing equipment to deliver a desirable result

IQ stands for Installation Qualification. This is the first step in the validation process to ensure that the manufacturing process will live up to its expectations. In this phase you verify the equipment’s design features and make sure it was installed correctly. Often the basis for IQ is the design specification with the installation requirements. Therefore it is of high importance to verify that all necessary documents, drawings and manuals are available. During installation qualification, equipment maintenance and calibration schedules and procedures should be established. Equipment should be calibrated before and after process validation to determine whether the equipment remained in calibration during the entire process validation study.

Test runs determine the operational qualifications

OQ stands for Operational Qualification. In this phase you want to verify that the manufacturing process is achieving its operational requirements. Test runs will determine the highest, lowest and medium operating parameters. You will use the process parameters to set control limits and action limits. They help you ensure the process is reproducible. You will “challenge” the process by using “worst case” conditions. If the Operational Qualification is successful, it validates that process control limits and action levels result in product that meets all predetermined requirements.

Functions will be challenged under normal conditions

PQ stands for Performance Qualification and is the last phase of the validation process. Here, the equipment will run several times under normal operating conditions and its functions will be challenged. The purpose with the PQ is to demonstrate that the process, under anticipated conditions, consistently (long term runs) produces a product which meets all predetermined requirements for functionality and safety.

IQ, OQ, PQ the ideal way to guarantee absolute quality of medical devices

In each phase of the process, documents are compiled with detailed results of each qualification test and a judgement if defined acceptance criteria were met. Only after performing IQ, OQ, PQ successfully with a desired result and established documents that verify each phase, the production can get underway. This defined discipline for process validation has proven to be the ideal way to guarantee the best quality of products, constantly over time.

Validation process to prevent human injury and product recall

A well planned and performed process validation is an important work to ensure that you have a well-controlled manufacturing process consistently producing conforming products. Non-conforming products could lead to human injury or result in costly product recalls.  By implementing a successful validation process, medical device manufacturers can improve productivity, reduce recalls and consumer complaints and also reduce the burdensome process of investigations.

Do you want to learn more about IQ, OQ, PQ? Don’t hesitate to contact me. Please stay tuned for more interesting articles and topics on our Medtech Blog.
*GHTF/SG3/N99-10:2004 (Edition 2), Quality Management Systems – Process Validation Guidance