MAJOR PLAYERS IN THE IVD MARKET
data from medical grade devices and provides an index which helps clinicians ascertain if a patient is going to have a health deterioration all within a secure network. This enables medical intervention in advanced of the patient being admitted to hospital. Hence improving patient clinical care, quality of life and also saving precious resources. Importantly, providing consumer confidence in personal data security is critical if we are to reach the full potential of this convergence” says Kuldeep Singh of Biofourmis.
He further says “Biofourmis is working to deploy remote clinical care services for patients post discharge from hospital. Patients are monitored utilising medical grade sensors and access their clinical care team through a mobile app. The care team themselves have a dashboard that provides them with ongoing physiologic data from the patient’s devices. Cost containment is being achieved through accessing telehealth revenue streams and measuring outcomes to prove these new services generate net savings and improve quality of life. Improvements in mobile infrastructure and high adoption of mobile devices has enabled the deployment of such care pathways.”
Growth in the future
Based on the emergence of new, more user-friendly tests, innovations and technologies, increasing access to healthcare, and the prevalence of several chronic and infectious diseases, the IVD market in APAC and around the globe is likely to remain vigorous.
“We see the industry moving towards a greater reliance on data, gathered in near real-time, to inform decision-making for products in market and predictive forecasts for market entry strategy. Additionally, the barriers to high-value design and manufacturing will be lowered due to advancements in bench-top simulation models and 3D printing using new mediums beyond polymers and alloys”, says Wilson Tan.
Harmonization across regulatory bodies on risk classifications and submission requirements is needed. This will create efficiencies in bringing new, innovative devices to market. Realizing better patient care from these new devices should not be hobbled by regulatory inefficiencies, especially when more and more health ministries themselves are providing seed funding to foster diagnostics development and growth.
“We are involved with the regulators to shape the regulations as technology is moving at such a fast pace that we believe that regulations and the providers of the technology and devices needed to work in tandem. There is still lack of mobile infrastructure in more remote areas of APAC. Consumer and provider confidence in provision of secure data networks,” adds Kuldeep Singh.
Alexis En adds, “Some emerging markets do not yet regulate the importation of home medical devices (such as home blood pressure monitors and nebulizers). This means that the market is flooded with low cost, but unvalidated products. This impedes consumer awareness of the need for accurate diagnostics and by extension better management of their health. Omron is making ongoing efforts with relevant authorities to improve regulatory frameworks and better protect and support the health of people in these areas of the world.”
Dr Sidney Yee, CEO, Diagnostics Development Hub (DxD Hub) and Executive Vice President, Incubation & Startup Management Division, Singapore says, “The importance of global regulatory harmonization in the field of diagnostics has long been acknowledged. However, the rapid technological innovation that characterizes the IVD industry is outpacing current regulatory frameworks. Safety to patients and evidence is crucial. While innovation is important, we probably also need to have a safety test of these innovations without having to be incumbent by a lot of these processes that have been put down by years. Sometimes, innovations disrupt the standard process. For regulators to deal with innovations, an innovation sandbox might be helpful which will also deal with the regulatory challenges.”
Emphasizing on the gradual shift towards early detection, thanks to sensor technology and wearables, Tan adds, “Current trends point toward a focus on oncology, cardiovascular disease and diabetes, with an emerging focus on mental health conditions. This will add to the deluge of healthcare data - which in turn will drive advancements and adoption of data science and artificial intelligence (AI) to organize and
glean actionable insights from the data. Ultimately this should benefit individual patients through faster diagnosis and targeted therapies based on their genetic makeup.”
“Medical diagnostics will become more consumer aka patient focus – and start incorporating the IoT into its delivery. We are also driving for AI to enhance what we have now alongside remote care models to realise better healthcare. Regulatory wise it needs to take the form of a governance structure which is still flexible enough to enable innovation to occur. Infrastructure is already making its ways into the further reaches of any geography with that the ability for patients to access care models not previously available. One of the biggest advances over the next decade will be achieving greater levels of diagnostic precision at the individual level by being able to capture and process multiple objectives and patient reported variables in the context of the environment in which the person lives using machine learning.
This will in turn give rise to the other significant advancements in the next decade. Also, the usage of diagnostic precision to generate personalised prescriptions of care that have a demonstrable health benefit. To scale these new advances, the medical diagnostic industry and its partners will need to compensate/incentivise and insure people for use of personal data and be willing to risk share for outcomes,” Kuldeep concludes.