Case stories of our work with sustainability
Circular approach to product design
"Imagine if, through our product design efforts, we could provide sustainable solutions that make a positive impact on the environment around us."
Nicklas Christian Funk
Circular Approach to Product Design
In our efforts to work towards a more sustainable future, Ambu has chosen to look backwards. In fact, all the way back to the beginning of a product cycle – namely, the product design. One of three sustainability pillars defined by Ambu concerns circular design and pertains to sustainability related to the choice of materials, parts, processing, modules, products, packaging etc.
“We want to make Ambu’s sustainability efforts grow and become more integrated in the company, and we want a circular economy mindset to lead this,” says Nicklas Funk, Sustainability Engineer at Ambu.
Six design principles
Nicklas Funk has focused on product design and created a guide setting out six principles that support the company’s innovation projects and guide towards more sustainable processes and outcomes. The principles raise important questions and provide solid advice on steps that can be taken to make a product development project more sustainable.
“It’s important for us to have these guiding principles as they help build internal skills, make sustainability an integral part of every project and put all the considerations behind our product innovations into a larger perspective. They also help us, as a company, to speak the same language when it comes to sustainability,” explains Nicklas Funk.
A time of opportunity
In light of the growth and expansion journey that Ambu is on, Nicklas Funk finds this to be the optimum time to invest in more sustainability in the company, and says:
“Right now, in Ambu, there is a lot of focus on innovation and ways of ensuring long-term growth for the company, and that also means that there is plenty of opportunity right now for embedding a thoroughly sustainable mindset into the company. At Ambu, our work is dedicated towards optimizing workflows and improving the quality of patient care. Imagine if, through our product design efforts, we could provide sustainable solutions that make a positive impact on the environment around us, as well.”
The importance of clinical trials
"Does the type of trial that we choose, match the outcome needed?"
Director, Global Clinical Affairs
The importance of clinical trials
For Ambu as a medical device manufacturer, clinical trials are an important part of bringing products to the market. Depending on the needed outcome, the clinical trials can involve manikins, cadavers, animals or lastly humans. The type of trial, the need for testing, and the potential outcome of the clinical trials are all factors which need to be carefully considered to ensure the right testing at the right time during the lifetime of a product.
“When bringing medical devices to the market, we need clinical data to substantiate that the products meet the relevant performance and safety requirements. However, there is always a balance to strike. We want to conduct the necessary clinical trials, but we do not want to subject patients to testing of our products if it is not deemed appropriate,” says Helene Gustafsson, Director, Global Clinical Affairs at Ambu, and elaborates:
“It’s important to consider the outcome of the clinical trials. Will a given trial only provide us with the relevant knowledge for bringing a product to market, or maybe prove real-world clinical performance, too? Does the type of trial that we choose match the outcome needed? These are all questions that we discuss every day in Global Clinical Affairs to assess the impacts of conducting any clinical trial.”
An ethical approach
As part of assessing the type of, the need for and the outcome of clinical trials, Ambu makes sure that the trials are conducted in accordance with Good Clinical Practice (GCP), which leads to a very high level of ethical standards. Ambu has established an internal ethical committee charged with assessing that our clinical trials are planned and conducted in accordance with applicable regulations and legislation, as well as advising on further ethical considerations.
“It’s a given that we comply with the regulations issued by the local competent authorities in the countries where we conduct clinical trials. On top of that, hospitals most often have an ethical committee of their own. However, we want to make sure that we address all ethical and clinical aspects internally before approaching the ethical committee of a hospital or a local authority. We – as a medtech company – have a responsibility for conducting only relevant and necessary clinical trials to support our products.”
Quality: Across the company, for the patients
"It is important that our customers can rely on Ambu products meeting specifications and quality."
Vibeke Lille Gadsbøl
Director, Corporate QA Systems
Quality: across the company, for the patients
“Meeting and upholding quality standards in our systems, processes and products is our licence to operate as a medical device manufacturer,” explains Vibeke Lillie Gadsbøll, Director Corporate QA Systems at Ambu, when asked about the importance of quality at Ambu.
Vibeke and her team are responsible for Ambu’s global quality management system – a structured system of procedures and processes that cover all aspects of Ambu’s operations, from management responsibilities, design control, risk management, process and production controls to product surveillance and more. Specifically, the team ensures that Ambu’s global quality management system is in compliance with applicable regulatory requirements, and that QMS certifications are continuously maintained.
A collaborative effort
Having a certified quality management system is just one piece of the puzzle. Before a medical device can be brought to the market, the product itself needs to meet certain requirements. The requirements and standards depend on the product type and the geographical market which the given product is entering. To accommodate this, close collaboration is required between departments like Innovation, Manufacturing, Marketing and Quality as well as regulatory experts.
Through Ambu’s quality policy, top management commits to ensuring compliance with regulatory requirements, to ensuring quality of our products and to ensuring an effective quality management system supporting this. The quality policy provides the framework for how we ensure quality across Ambu and supply safe and effective Ambu products for patients around the world.
“When you register a product on the market, you make a commitment to its functionality, quality and delivery, which is why we as a company put great efforts into meeting and upholding the quality standards for our devices, and why my team is required to work closely with all the relevant stakeholders in a product’s life-cycle,” says Vibeke Lillie Gadsbøll and continues:
“We do this not only because it’s necessary for us to get our products to the market but also because it’s the right thing to do. It’s important that our customers can rely on Ambu products meeting specifications and quality.”
Business ethics and compliance: An organizational virtue
"This is a responsibility we all carry as a part of Ambu
– from the Board, to the management, to the leadership, to the individual employees"
Casper Venbjerg Hansen
Director, Corporate Business Ethics & Compliance Officer
Business ethics and compliance: An organizational virtue
“Business ethics and compliance guide the company’s behaviour, relationships and growth. As we are a company on the path of expansion, and because we have a close relationship with our stakeholders, today more than ever, it is vital to promote business ethics and compliance and act with integrity,” responds Casper Venbjerg Hansen, Director, Corporate Business Ethics & Compliance, when asked about the importance of business ethics and compliance at Ambu.
As a global and growing company, Ambu must ensure adherence to national and international guidelines and standards, and several initiatives towards achieving this are already in progress.
“We’re working on building compliance programmes and ethical standards in relation to marketing materials, training for sales representatives and guidelines for interactions with healthcare professionals because we strive to have a large degree of transparency in our relationships with our customers and key opinion leaders in the industry. We are also increasing awareness on our Code of Conduct and whistleblower hotline so that even though the company grows, everyone is aligned on what is right and what is wrong in an Ambu context, and everyone knows where and how to report concerns,” explains Casper Venbjerg Hansen.
A compliance management system
Ambu is also in the process of implementing an overall compliance management system that incorporates different compliance programmes. The system provides a framework for compliant behaviour in terms of eight specific elements and acts as a tool for assessing the progress of these elements.
“Through the compliance management system – which contains elements like risk management, policies and procedures, and communication and training – we can measure our level of maturity. This allows us to continuously monitor and evaluate our compliance efforts,” says Casper Venbjerg Hansen and continues:
“Overall, through compliance processes, guidelines and our new compliance management system, we can ensure that we adhere to all the standards set for us in healthcare systems around the world and that there is consistency and authenticity in the way we work and what we provide. This is a responsibility we all carry as a part of Ambu – from the Board, to the management, to the leadership, to the individual employees. There is still much work to be done, but our ambitions are high, and we’re on the right track.”
"We verify and communicate the economic and clinical value that Ambu's products bring to our customers"
Director, Market Access
How many patients can you operate in a day? This question reflects a volume-based view of healthcare. How many patients can you operate in a day, while making sure that their quality of life improves? This question, on the other hand, shows a value-based view of healthcare.
Value-based healthcare is a holistic approach that shifts the focus from the volume of healthcare provided to the value of that healthcare.
“In our work, we listen carefully to our customers’ needs and industry trends through extensive research and fieldwork, then we bring that intel back to the drawing board in our R&D department, and then through health economic studies and academic articles that we produce in my team, we verify and communicate the economic and clinical value that Ambu’s products bring to our customers,” says Casper Barsøe, Director, Market Access at Ambu.
Measuring the value
The ‘value’ in value-based healthcare is derived from measuring the health outcomes for patients against the economic cost of bringing forth this value.
“We want to be able to continuously justify the value of our technologies, and through the health economic studies and article publications, validate the products we bring to the market and their pricing,” says Casper Barsøe.
With the health economic studies and articles as a foundation, Ambu’s Market Access team also invests their time in sharing their findings with clinical societies, procurement teams, reimbursement authorities, ministries and more. This is so that there is an aligned understanding amongst the various stakeholders of the value that the Ambu portfolio brings to healthcare systems. Casper Barsøe elaborates:
“As a supplier, it is our responsibility to bring value to the healthcare sector by providing cost-effective solutions and work with the other stakeholders in a healthcare system, so that the patient is properly cared for.”
A strong growth culture
"We have to dare to hire differently and to train our leaders to look beyond their own mirror images."
Christoffer Bjørk Petersen
Head of Business Partnering & Development
A strong growth culture
Ambu’s most important asset is its people. This financial year, approximately 1,000 new employees were hired into the company, which now has more than 4,000 employees worldwide.
“For us in Ambu’s HR departments, it has been a busy year bringing so many talents into Ambu. Being part of a company that works directly towards helping doctors and improving patient care is immensely gratifying, and that is one of the reasons many have chosen to join Ambu,” says Christoffer Bjørk Petersen, Head of Business Partnering & Development, and continues:
“Attracting and bringing in talent is one element. We also focus on ensuring that our people have proper onboarding and a structured lifecycle in the company in order to unlock their passion and potential and strengthen their performance throughout their time with Ambu.”
The Ambu culture and way of working aims to challenge and support the employees in their daily tasks. Graduate programmes, leadership development courses and networking groups are some of the many steps Ambu is currently taking to create space for talent to learn and grow in their roles.
Growing as individuals and as a company
“To make sure that we fully support our current growth strategy, it’s vital that we hand-pick the brightest minds, help them develop and integrate them properly into the Ambu culture,” says Christoffer Bjørk Petersen.
When new employees join the company, they are greeted by their colleagues and introduced to Ambu’s key functions, business and culture. From the very beginning, regular check-ins and alignment on objectives and time for feedback become the norm, and this continues well into the time employees become Ambu veterans. These efforts ensure that Ambu’s employees are given the chance to make themselves heard, develop their skillset and carry their ambitions forward, regardless of their location or position.
Dare to hire differently
Ambu is an innovation-driven company. Therefore, new ways of thinking, different perspectives and a strong culture that harmonizes it all, is key to Ambu’s success.
“We have to dare to hire differently and to train our leaders to look beyond their own mirror images. For instance, there has to be an even gender distribution amongst the applicants considered for each open position. In fact, we will halt a recruitment process to go back and ensure that we have a truly diverse pool of candidates. And thereafter, inside the company, we have to continue to foster a culture of inclusion. Ambu is a global company with a rich heritage and is growing exponentially, and our people, mindset and culture must reflect that,” explains Christoffer Bjørk Petersen.
A phthalate-free company
"We were not willing to compromise on the functionality, durability or longevity of the final products."
Head of Biosafety
A phthalate-free company
This financial year, Ambu reached its target of eliminating harmful phthalates from all products. Phthalates are most commonly used as plasticizers, which are added to plastics to act as a softener and increase the flexibility, transparency and durability of the material. Due to their chemical components, some phthalates can be harmful. As of 30 September 2020, Ambu has ceased to manufacture products that contain harmful phthalates.
“This is a target which has been in progress for almost ten years, and so reaching it now is a great milestone for us,” says Annette Bitz, Head of Biosafety at Ambu.
A complex process
The target was born from a customer need, and in order for Ambu to meet that need, the company was required to investigate which plasticizers could be used as a suitable substitutes, and only then could the project to have 100% phthalate-free products begin.
“From the outset, we shared with our customers that we were willing to listen to their need for phthalate-free products, but we also pointed out that this was far from an easy process. It wasn’t simply enough for us to substitute the phthalates. It was crucial for us to find the exact right substitutions. We were not willing to compromise on the functionality, durability or longevity of the final products. It was also important for us that the substitution did not impose a cost burden on our customers,” says Annette Bitz.
The project commenced with a substitution of phthalates in the Ambu face masks and laryngeal masks because these products are used in direct contact with patients. Initially, the phthalate target was intended to only cover medical devices, however, this was soon extended to include the full product portfolio, including training equipment such as the Ambu manikins.
A collaborative effort
“We had to ask all our suppliers to remove phthalates from their products, and then we had to test the products. It has been an immense collaborative effort amongst all the parties involves, and it’s wonderful to see that the effort has paid off,” says Annette Bitz.
This past financial year, Ambu worked on substituting phthalates in circuits and VivaSight products, and as this was successful, Ambu has now reached the target of phthalate-free products in the entire product portfolio.