Our Business Model
Össur develops, manufactures, and brings to market a wide range of prosthetics and bracing & supports solutions with high standards of quality. These high-end products are developed with the objective to improve the mobility of end-users. The products are delivered to the end-users through healthcare providers who specialize in assisting individuals who suffer from movement impairment. Össur’s products are in most cases reimbursed by public or private insurance. Every year, Össur makes a significant investment in research and development to further advance products and technologies for the benefit of all stakeholders.
End-users include lower and upper extremity amputees who have lost a limb due to, for example, vascular diseases including diabetes, trauma, and cancer. They also include individuals who require support as they may have, for example, developed osteoarthritis in knee or hip ligaments, incurred temporary immobilization, or require enhanced healing after surgery.
By collaborating closely with the end-users, Össur gains a better understanding of their needs and challenges. In turn, Össur improves their mobility by providing new technologically advanced products to achieve their goals. The involvement with the end-user is not limited to research and development as there is also an aim to provide quality services, directly through clinics operated by Össur or indirectly through customer service programs.
New major lower limb amputees per year
New upper limb amputees per year
of new amputees are fitted
with prosthetic solutions
is the average age
of the amputee population
Source: Össur Management estimates
Össur develops Prosthetics and Bracing & Supports, from an idea to a finished product. With every product, the aim is to deliver cost effective medical solutions that provide value for end-users and the healthcare system.
Research and Development
When a product is designed, Össur accumulates medical and biomechanical data during the development process to verify product safety and efficacy before the product launch. Also, to obtain independent clinical evidence for product outcomes as well as health economic data, Össur initiates and promotes clinical studies in cooperation with leading scientists, institutions, and healthcare professionals in the field.
Össur supports open collaboration within the industry and academia. An example of such an initiative is the collaboration between Össur and the Alfred Mann Foundation on the development and licensing of a myoelectric sensor system (IMES®). The solution utilizes implantable sensors that collect signals from the amputee’s muscles and translate those into prosthetic movements.
Manufacturing and Quality
Össur maintains a strong global manufacturing function. Manufacturing of advanced prosthetic solutions, including bionics, takes place in Iceland and Scotland. Manufacturing of other prosthetics solutions, components and premium bracing solutions takes place in Mexico. Össur outsources the manufacturing of soft goods to China. At Össur, there is a continuous strive for efficiency, which includes finding ways to optimize the manufacturing process.
Great emphasis is placed on quality, and it is an intrinsic part of our processes. Össur has had a certified Quality Management system in place since 1993 which is based on ISO management standards and complies with the applicable medical device regulations in the countries that Össur operates in. Össur is certified to the global ISO 13485:2016 Medical Device Standard and the Medical Device Single Audit Program (MDSAP).
The new European Medical Device Regulation (EU) 2017/745 (MDR) came into effect in late May 2021. The aim of the regulation is to ensure patient safety, increase transparency, and to enhance the quality of medical devices. Össur was well prepared and fully ready for the regulation to take effect. The Company’s extensive globally aligned quality management system has been updated to the MDR requirements and it has gone through a successful system audit by Össur’s notified body BSI.
Sales and Marketing
Össur operates within a highly specialized industry where the primary customers are specialized healthcare providers who provide and fit individuals with Össur products. In Prosthetics these customers are Orthotic and Prosthetic (O&P) clinics and in Bracing & Supports it is a combination of O&P clinics, hospitals, and surgery centers. In a few selected markets, Össur operates its own O&P clinics. Össur largely sells its products through its own direct sales network.
Prescribers, Providers and Payers
Prescribers include healthcare professionals who prescribe products based on the clinical indication of the end-users. These include orthopaedic surgeons, non-surgical physicians, and emergency physicians as well as other professionals providing medical diagnosis.
Providers are healthcare professionals who provide end-users with prosthetic and bracing & supports products, and related services. These include certified prosthetists and orthotists (CPOs) working at O&P clinics, durable medical equipment (DME) clinics, orthopaedic clinics, and hospitals. Many providers not only recommend specific products but also fit and tailor-make certain products. For non-reimbursed products, a provider can be a pharmacy or a sports store.
Payers include healthcare systems and insurance companies. In most cases, when an end-user has been fitted with a product, Össur’s customers claim reimbursement from the relevant public institutions or private insurance companies. Around 90% of Össur’s products are estimated to be reimbursed by a third party but reimbursement systems vary substantially between countries. In other cases, the end-user pays for the products out-of-pocket.