The coronavirus outbreak has caused unprecedented levels of chaos and disruption around the world. As the global need for protective equipment, intensive care and infection prevention has grown exponentially, the medical device industry has become instrumental in the battle against the virus, while facing tough challenges itself.
Just like any other industry driven by innovation acceleration, medtech has been affected by impeded R&D, disrupted sales, manufacturing and supply chain processes, as well as reduced working hours and workforce.
To top these challenges, the industry is under the additional pressure of delivering effective diagnostic products and ultimately a vaccine that will contain the spread of the disease.
The rate of bringing new products to market has slowed down, and once the pandemic is over, the market itself will likely be different to what it used to be. What are the factors with the biggest impact?
Devices in high demand
All devices that have application in coronavirus-related therapy areas are now in high demand. These include: ICU devices such as ventilators and patient monitors; diagnostic tests and IVD kits; personal protection equipment (PPE) and disposables such as surgical gloves, face masks, hand sanitizers, etc. as well as hospital beds and other products needed for the hospitalisation of large numbers of patients.
In addition to COVID-19-related devices, the pandemic is facilitating the acceleration and adoption of several new technologies, too. For example, 3D printing is being extensively deployed in the mass-production of parts for ventilators and face shields.
Within the domain of telemedicine, video consultations, telepathology and teleradiology are growing in popularity. The digital health vertical generally is getting a good boost, with a variety of health apps, remote monitoring and other e-management solutions that utilise predictive analytics, telemetry, HD cameras, data visualisation and advanced reporting capabilities regardless of location.
Devices in low demand
As the global healthcare infrastructure is fully engaged in the effort to contain the spread of the virus, all non-COVID-19 devices fall into the low extreme of the demand spectrum. These include in particular orthopedic devices and implants involved in so called discretionary or elective surgeries such as joint replacements, as well as many non-urgent dentistry procedures.
Due to the halt on field engineering services at most hospital sites, capital equipment replacement cycles will prolong, whilst purchase and installation of expensive medical technology units such as MRI scanners and the like may get postponed.
New devices for diseases other than the pandemic are not reaching market as planned, which will have negative repercussions on patients and healthcare providers alike. Disruptions in supply chain, especially in Europe, are increasing already existing shortages of medical products. Production halts in China will have repercussions on export and therefore availability of wider varieties of medical devices, including generic products.
EU regulatory changes
Most Notified Bodies and other Quality Commissions have paused onsite inspections and audits until further notice. The EU MDR, which was supposed to come into effect on 26 May 2020 has been postponed by additional 12 months. The other important EU regulation anticipated by the industry, the IVDR, remains to be implemented on 26 May 2021. This means that alongside intense production rates during the crisis, IVD manufacturers are under the additional pressure to prepare for the transition next May.
Due to the extremely high demand, all imported PPE and related devices may skip regular CE marking in European countries. Notified bodies in the UK, Germany and France have temporarily relaxed rules on purchasing and importing of such goods from third country manufacturers under the condition that they have already obtained market approval under alternative regulations (US, Canada, Japan or Australia) and their instructions for use have been localised into the language of the receiving country. This relaxed regulatory climate opens an opportunity, albeit temporary, for companies to capitalise on sales and export of such products.
In addition, EU regulatory bodies have provided open access to technical documentation and standards for the local production of medical devices in high demand. Some manufacturers are also launching open source devices such as face shields to support frontline medical staff.
European companies that produce pandemic-relevant devices are now required to obtain authorisation in order to export outside the EU. However, this rule does not apply to Switzerland, Norway and Lichtenstein.
Clinical trials disruption
The medtech industry relies heavily on healthcare facilities for clinical trials. Most medical devices must undergo clinical trials before being made commercially available, followed by post-market follow-up studies. As a result of the pandemic, all these processes have been delayed or disrupted.
Hospital units typically used for monitoring phase-1 trial patients and volunteers are prioritised for the treatment of COVID-19 patients. Competent authorities and other relevant investigational bodies are now operating remotely, on often limited capacity, with focus on responding to the pandemic.
As a result, medical device manufacturers that need to conduct clinical investigations will have to adjust their timeframes as well as budgets on the go. The larger the company or product line, the higher the chance of product launches being affected, unless the device can be used against the pandemic.
Delayed or postponed studies have short-term implications not just on market access for various innovative, often life-saving devices but also on patients that could benefit from them. In the long run, clinical trial and post-market follow up disruptions may incur further costs for both patients and healthcare providers as well as result in loss of certificates for already established, generic products.
At Guided Solutions we have developed several tools in order to facilitate your hiring process during the pandemic.
If your medical device business requires support and assistance during these dynamic times, we are happy to talk and help you navigate successfully through the challenges ahead.