How can medical device manufacturers deliver future innovation in medtech?

Roger Mazzella, Qt Company discusses developing and regulating innovative medical technologies of the future.

The medical device sector is an integral part of the healthcare industry, and has seen an unprecedented growth in innovative and improved technologies that delivers benefits such as reduced patient recovery time, lower cost of instruments, and more. The Internet of Things (IoT) is one of those technologies – and Gartner predicts that 8.4 billion connected things will be in use worldwide in 2017, and that total spending on endpoints and services will reach almost $2 trillion this year. Meanwhile, the Internet of Medical Things (IoMT) market, an emerging sub-sector of the IoT, stood at $22.5 billion in 2016, and is expected to grow at an impressive compound annual growth rate of 26.2% to reach $72 billion by 2021, per analyst and research firm Frost & Sullivan. 

The development of medical devices and accompanying technologies takes time and money, as many innovative products are new and need to go through the rigors of in-country certification and market clearance processes. These devices, such as the latest iterations of pacemakers, insulin pumps and blood pressure monitors, will eventually come into contact with patients and sensitive information – and, in severe cases, life-or-death situations – on a daily basis. As a result, there are regulations and processes to ensure these technologies reach consumers only after passing a rigorous battery of clinical trials – which is why healthcare is the second-most regulated industry around the world (aviation is number one).

However, new developments and the continued rise of new technologies like the IoMT have created more challenges than ever for medical device developers, bringing issues such as cybersecurity and data integrity to the forefront. Looking ahead, what can be done to keep the health and well-being of patients the top priority?

In the United States and the European Union (EU), strict compliance with regulations and guidance is a current solution, and many organizations (government, public and private) work together to make this happen. For example, the Advanced Medical Technology Association (AdvaMed) is a trade association that leads the effort to advance medical technology to achieve healthier lives and healthier economies around the world. The Massachusetts Medical Device Industry Council (MassMEDIC) is an organization of medical device manufacturers, suppliers and associated non-profit groups in Massachusetts and the surrounding region. AdvaMed and MassMEDIC work closely with national and international organizations such as the US. Food and Drug Administration (FDA) and the EU to advocate and promote policies directly from the medical community.

AdvaMed is currently involved with the FDA’s Digital Health Precertification (PreCert) Pilot Program. The impetus for this program is the fact that traditional regulatory processes for high-risk medical devices are slow and methodical. With the help of AdvaMed advisors, however, the FDA realized that this traditional regulatory approach for higher-risk, hardware-based medical devices is not well-suited for software products. Software evolves faster than hardware, and therefore has a more iterative design, development and validation cycle. The FDA PreCert Program will help better regulate these technologies by learning, adapting and adjusting key elements in real-time. The goal: to allow software iterations and changes to occur in a timely fashion, and ensure high quality medical products and software.

The IoMT is another new development that will impact the industry as a whole. Due to the requirements of this ecosystem, there are specific considerations, including cybersecurity and data integrity, that organizations such as medical device manufacturers should make – otherwise they not only could lose out on business opportunities, but could also put their customers at risk. To accommodate these considerations, the software powering medical devices has become more complex, hence the need for initiatives such as the FDA PreCert Program.

The medical industry is evolving rapidly, and Qt is at the forefront of industry professionals who aim to influence the direction of technology innovation, as well as the standards and requirements that govern the sector on every level: local, state, national and global.