A disciplined focus on patient care and innovation means that today, nearly 50 years on from developing our first humidifier, we help in the care of an estimated 13 million patients in 120 countries each year.
As a world-class company on a global scale, we value focus and discipline, and have a clear pathway to sustained growth over the coming decades.
We recognise our responsibility to be a sustainable, long-term partner for the many patients, doctors and nurses who we impact every day. We also have a business responsibility to our employees, suppliers, investors and other stakeholders to be clear on where the coming years will take us.
By taking a measured approach to achieving our long-term aspiration, our strategic plan and technology development framework is structured to deliver continual and sustainable growth.
Achieving this will rely on us extending our presence across the globe; designing even more effective products and technologies; and working with healthcare providers to develop new therapies that change clinical practice and reduce costs to healthcare systems.
We build on what we know, but look to the future too: a future where we believe we can help over 50 million patients throughout the hospital and in the home, every year.
'Our innovative medical devices assist healthcare providers to deliver outstanding patient care.'
As healthcare systems strive to balance the need to provide excellent patient care with the growing costs of caring for ageing and growing populations, we will continue to support them with our technology innovations.
'Optiflow therapy is being used to treat a broader range of patients with respiratory complications.'
Our outlook is exciting as we look forward to another year of positive growth. We are well positioned to meet the growing demand for our products from an increasing investment in healthcare across the globe.
We have a long-standing approach of striving to design better products, change clinical practice, expand our global presence and deliver sustainable, profitable growth. This consistent growth strategy has served us well and will continue to drive momentum for the long term.
Increase our presence around the world
We work with thousands of healthcare professionals, including doctors, clinicians and nurses, giving them the products and tools they need to deliver the best possible care. This year, we estimate our products were used to care for over 13 million patients in more than 120 countries around the world.
We are headquartered in New Zealand. Our largest markets (in order of size) are North America, Europe and Asia Pacific, and around half of our products are sold in North America. 99% of our revenue is generated offshore.
Each year, we continue to expand, train and strengthen our sales teams so they are well equipped to explain the clinical advantages of our products and encourage a change in clinical practice. Building trusting relationships between our people and our customers is a critical part of our sales approach, right around the world. We now have almost 1,000 people in our sales and marketing teams in 37 countries.
Utilise our expertise to develop new therapies and reduce costs to healthcare systems
With the healthcare device industry regulated worldwide, the ability to meet stringent standards is vital to ensuring market acceptance of our products. We comply with these standards by operating a quality management system certified to a range of international standards which apply to both our manufacturing facilities and our sales network.
As manufacturers of medical devices, we are required to comply with a wide range of country-specific regulations and are routinely audited for compliance to the applicable regulations. Our products destined for the United States must comply with the US Food and Drug Administration Quality System Regulation and require market clearance prior to commercialisation. Similarly, our products destined for the European Union, Canada or Japan must comply with the European Medical Device Directive, CMDCAS and JPAL respectively and require country-specific market clearance prior to commercialisation.
During the year we continued to invest in, and further develop, our quality management systems to ensure that our processes and procedures meet both our business needs and changing international regulatory requirements. Continuous improvement ensures that our products and services meet the highest possible quality standards and surpass our customers' expectations.
TUV Group, a European notified body, audits our New Zealand and Mexico facilities annually. This is required to maintain the certification that allows us to place a CE mark on our products which is necessary for entry into European Union markets and to meet Canadian, Japanese, Australian and other regulatory requirements.
The company has in place formal procedures to ensure that the International Conference on Harmonisation Good Clinical Practice (GCP) standards are adhered to during all clinical investigations carried out by Fisher & Paykel Healthcare. GCP standards cover the design, conduct, recording and reporting of clinical investigations that involve the participation of human subjects.
Our procedures have also been compiled based on the ISO 14155:2011(E) standard for: Clinical investigation of medical devices for human subjects – Good clinical practice and the EU Medical Devices Directive.
These procedures are designed to ensure that the data and reported results of all clinical trials are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.
The clinical studies we are involved with need to follow these procedures and fall within the scope of regulatory body audits.
New research has been published in the prestigious New England Journal of Medicine that shows significant benefits of Optiflow nasal high flow therapy for pediatric patients requiring respiratory support.
The Pediatric Acute Respiratory Intervention Study (PARIS) was conducted by the research team at Lady Cilento Children’s Hospital in Brisbane, Australia, led by Ms Donna Franklin and Dr Andreas Schibler. The study is the largest nasal high flow (NHF) randomised controlled trial to date, aiming to investigate if the early use of NHF in less intensive settings can prevent the need for treatment escalation.
The video above shows the team at Lady Cilento Children's Hospital discussing the use of Optiflow NHF therapy in their hospital.
Continuously strive to improve our products
Our product development approach is underpinned by a philosophy of always doing what is best for our patients. By focusing on developing products that better meet the fundamental needs of the patient, we are also developing devices and systems that become products of choice for clinicians and healthcare providers.
For more videos on design thinking and other ideas in health and technology, please visit our BluePrints page.
The foundational requirements for our product design are that it must be safe and effective. Through all stages of the product development process, the potential for risk is assessed. Risk management processes, product validations and manufacturing process validations are conducted to ensure that quality products are consistently manufactured. Through rigorous controls and testing, we achieve a high degree of confidence that our products and processes are stable and meet customer requirements.
Our product design process includes inputs and collaboration across many internal functions. R&D engineers, quality engineers and manufacturing personnel are co-located and are all involved in the stages of the design and manufacture of our products.
We have a skilled team with expertise specific to medical devices, and we actively recruit from around the world. There are currently over 200 people in our quality and regulatory team.
We work closely with universities, schools and community groups to attract the best graduates for our teams. Our graduate programme is a 12 month schedule that incorporates business awareness, mentorship, feedback sessions, internal and external training and team building events. For roles requiring more experience or specialised skills, we search across the global employment market through targeted recruitment campaigns. We take a proactive approach to finding people whose individual values match with ours.
In New Zealand, we host a five day literacy and numeracy programme that aims to increase the capability and confidence of our manufacturing employees in communication, team work, continuous improvement and health and safety. Tailored for the specific needs of our employees and aligned with our company values, the programme has been running for two years and over 100 people have taken part.
Our learning and development function runs development programmes for our people, supported where necessary by third party providers. We provide different levels of learning and development for people at different levels within the organisation, and leadership training for those in management positions.
We have support processes for succession planning through identifying experiences employees should have to develop the knowledge and skills to progress within the organisation. We view success planning like a chess board so we can understand the implications of one move on another. This allows us to be deliberate in providing opportunities for people to develop the future skills they need through initiatives such as secondments, project assignments, job enrichment and enlargement. We aim to develop people through work experience combined with coaching and learning.
Ensure our growth is managed in a sustainable way
When we think about sustainability in the context of financial performance we are referring to the ability to grow our business profitably at a rate that can be maintained into the future. Given the long-term commitment required to effect changes in clinical practice, we look to manage all aspects of our business in a sustainable way, including our financial performance. If we do this we think we will be well-positioned to assist in improving the lives of tens of millions of patients over the long term.
For nearly 50 years, we have iterated, crafted and improved healthcare technology to support patients around the world. Every day, our team of over 500 engineers and scientists strive to find new, better ways to improve healthcare outcomes for patients in surgery and in respiratory distress. Our culture of continuous improvement is supported by a consistent investment in R&D of between 9-10% each year.
This long-standing investment in R&D needs to be protected. We have an in-house team of intellectual property (IP) specialists who ensure our exclusive legal rights to commercialise our innovative product designs, software and manufacturing processes are secured, as well as monitoring and responding to competitor filed IP.
The team identifies, captures and protects our IP, actively manages IP litigation risk, detects and responds to competitor IP and IP strategy and enforces our IP where necessary. We have policies in place and support from our Executive Management team and the Board of Directors.
IP protects our ability to manufacture and sell products that improve care and outcomes, and the availability of our products to our patients who rely on them for their care.
Fisher & Paykel Healthcare takes a proactive approach to risk management. We have integrated business continuity practices across our global business to reduce the likelihood and impact of a threat and provide us with the ability to respond and recover from incidents should they arise.
In the past financial year, we have conducted an impact analysis focused on identifying, understanding and quantifying the impact of a material disruption to a key facility, location, supplier or business process, and prioritising the most significant potential exposures to the business. As an outcome of this work, we have put in place mitigation strategies and plans which are integrated into the business units and tested to establish confidence and continuous improvement of recovery capabilities. Crisis management plans exist, and regular simulations will be conducted to prepare the company for effective and timely communication to our stakeholders.