The need for safe medical devices is mounting. These marvels of modern science and engineering, ranging from prosthetics to implants to diagnostic devices and software, are depended on by billions of people to live a long and healthy life.
According to Nasdaq reports, the medical device industry is going to experience healthy growth over the next decade. Estimates show that demand for such devices will increase 4.5% annually through 2030, with the United States being the largest market where current spending exceeds 180 billion USD annually. As aging populations drives demand for medical devices, developing nations, where which life expectancy is increasing rapidly, will experience the most growth.
While demand is growing, there are many obstacles that companies face when developing medical devices. Due to the life-dependent nature of these products, the industry is highly regulated. In the United States, the Food and Drug Administration (FDA) oversees these products under a bill passed in 1976 named the Medical Device Amendments (MDA). Many of the devices in development today are still grounded in the regulations set by Congress some 43 years ago.
The Regulatory Landscape is Changing
As consumers’ preferences are moving towards greater knowledge of the products they use, including medical devices, previously established regulations are coming under the spotlight. For instance, scrutiny over the 510(k) process in the US, an expedited pathway to market, has led to the FDA announcing plans to modify this process. These amendments juristically effect both developmental costs and manufacturing costs.
In Europe, the recently passed European Union Medical Device Regulation and In-Vitro Device Regulation are having massive effects on their respective industries. As the amount of documentation almost doubled over the previous regulatory requirements, so has complexity. Consequently, companies now spend more resources and time to both understand these documents and ensure that these life-dependent devices comply with the regulation.
RegTech – Smart Technology Aiding Compliance Work
To cut down on these costs, companies are employing labor-aiding technology, often powered by AI-based methods, to do the menial tasks that are critical for compliance. RegASK is leading this adoption in the pharmaceutical and medical device industry by applying technologies including artificial intelligence (AI), machine learning, natural-language-processing and semantic-graph-engines to a wide range of tasks. Specifically, these solutions allow customers to look up relevant regulatory information and be forewarned of any potential regulatory changes. As such, companies are better prepared for the future by cost-effectively mitigating the risk of noncompliance.
In a heavily regulated yet booming industry such as the medical device industry, it is critical to know how current and future regulatory changes will affect products. With medical recalls growing by over 39% in the last 4 years and increasing demand for regulatory amendments, it is difficult to know how the development of such life-critical products will be affected. RegTech solutions from RegASK enable companies to cut down on time navigating and understanding relevant regulatory information, ultimately leading to safer products and lower development costs.