Yordan Iliev, CEO of MY Synergy, on the application that helps manufacturers and distributors of medical devices to comply with EU regulations and provide quality
A healthcare system without inequalities, where all services and products are consistent, intelligently budgeted and dedicated to the patients' comfort: value-based healthcare sounds like a utopia. But it is possible, with the right combination of policy changes, visionary healthcare stakeholders and smart technological solutions that enable the needed transformation. MY Synergy is an award-winning health-tech company headquartered in Bulgaria and focused on transforming the healthcare system for better patient outcomes. Its latest solution, HealthData Box, helps manufacturers and distributors of medical devices and IVD medical devices to comply with the EU regulations 2017/745 and 2017/746. The CEO of MY Synergy, Yordan Iliev, elaborates.
The Bulgarian healthcare system is far from perfect. Is it possible for it to become more value-based?
One of the key challenges that we see in the healthcare system is overcoming the existing inequalities and access to high quality healthcare services regardless of one's social and economical status or geographic location. Currently, health services with high added value are concentrated in the big cities, while whole regions are deprived of proper access to healthcare. Healthcare services are also organized based on quantity: the hospital performs a number of procedures to a number of people, it reports them to the National Health Fund and is then reimbursed.
The idea of value-based healthcare shifts the focus on delivering positive patient outcomes while optimizing costs. The integrated models of care that coordinate the services between healthcare service providers and the ability to track the results of the activities in time, are a predisposition for sustainable high quality of treatment in different healthcare facilities.
Of course, this cannot happen overnight. It is a slow transformation that requires commitment from all stakeholders, including the patients whose feedback is instrumental for this change. The three main pillars of value-based healthcare are quality and outcome metrics, patient experience and costs. The quality and outcomes metrics include clinical and patient-reported outcomes. The first are collected by healthcare providers, which are focused on disease management. The patients, on the other hand, are focused on both disease management and quality of life. There are a lot of disease areas where patients' feedback is crucial to manufacturers and policy makers. The patient is the only one capable of reporting their experience – without this proper evaluation of quality of services and their effects is impossible.
Value-based healthcare does not mean that services should be cheap. Analyzing real-world data could show that some services are expensive but give excellent results, that some cheap services also have great results, and that some expensive services yield no results. The capability to evaluate these services in relation to quality and overall added value for the patient is crucial for selecting the investments and expenses with high added value.
Where is the place of MY Synergy in the value-based transformation of Bulgarian healthcare?
Since its very beginnings MY Synergy has developed products and services with added value for the healthcare system.
HealthData Box is a modular application for market analysis and cost-effectiveness of medical devices and IVD medical devices. HealthData Box was developed in collaboration with the Center for European Health Policies and is the logical answer to EU regulations that Bulgaria should abide from 2025: EU Medical Device Regulation 2017/745/EU and EU Medical Device for In Vitro Diagnosis Regulation 2017/746/EU. Until now, the market of medical devices was not regulated, every manufacturer or distributor could register a medical device without health technology assessment and with pricing decided on their own. These issues are addressed by the new regulations. They oblige all manufacturers and distributors to make a health technology assessment including all this data and to monitor the effect of the medical device and medical device for IVD according to the indicators previously set by them.
HealthData Box solves these fundamental challenges to manufacturers and distributors, provides comprehensive understanding of the business landscape and helps them growing their businesses.
Manufacturers and distributors need a product like ours because for them these regulations are something new and anyways, it is not their job to know modern IT technologies. We, at MY Synergy together with the CEHP, understand technologies in healthcare and know how to help companies collect relevant data, process it properly and offer the analysis to the stakeholders.
HealthData Box has six modules designed as a comprehensive and reliable solution for market analysis and addressing patient needs: analysis of market potential (market size and trends, infrastructure mapping, patient flow); analysis of competition (market share and participants, competition); value-based application with a detailed budget impact analysis and cost-effectiveness/cost-benefit ratios; market forecast; clinical trial data analysis of the methodology, design, and clinical evidence within the scope of EU Regulations 2017/745 and 2017/746; data analysis of indicators for tracking the effect of medical devices for in vitro diagnostics according to criteria/indicators previously set by the distributors/manufacturers.
As a company, we have a deep understanding of the specific needs of various stakeholders in the healthcare industry. We know how to measure the outcomes for them, identify the real-world data that needs to be gathered, and understand how to process and standardize this data for the analysis in support of the three pillars of value-based healthcare. This allows us to provide the information they need.
Who else can benefit from HealthData Box?
Our solution can also help healthcare providers to make informed decisions supported by exhaustive health data. HealthData Box can be used as well by healthcare policy makers as it helps development of effective healthcare policies.
What is the difference between MY Synergy and other companies that develop solutions and process data?
We have a deep understanding of healthcare data. With years of experience in the industry, we don't just process data – we also excel in standardizing and analyzing it to make it meaningful. Our tools are designed to help users understand and utilize data to achieve the best outcomes.
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