How to reduce time to market for medical devices
Roger Mazzella, The Qt Company, looks at ways to address the lack of industry growth in the medical device sector.
According to market research firm Evaluate, the medical device and technology (medtech) market will be worth $500 billion by 2021, and the need for affordable and safe medical devices only continues to increase. This need is primarily driven due to population growth – the growth rate is 1% (approximate 60 million people) currently, and our global population increased from 1.5 to 6.1 billion between 1900 and 2000 alone. Another factor is the rise of new and developing diseases which require aggressive monitoring and treatment methods.
Given these realities, in addition to the rise in industry-wide adoption of present-day, high-tech developments like connected Internet of Things (IoT) devices and artificial intelligence (AI) software, the global medtech market should experience explosive growth – yet this is not the case. Although Evaluate predicts a 5% annual growth rate for the years ahead, many major players in this space had negative growth for the years previously. So what is the cause of this lack of industry growth and advancement and what role can we play to help solve it?
What is the problem?
The continued innovation and development of medical devices and accompanying technologies takes a significant amount of time, money, and resources. Additionally, these projects require various internal and external teams within software engineering, hardware engineering, product management, regulatory affairs, quality, marketing and other fields to work together simultaneously – which is not an easy task.
According to ScienceDirect, a platform for peer-reviewed scholarly literature covering healthcare and other science-related industries, the average time-to-market for a medical device falls between three to seven years; moreover, per a Stanford University study, the average cost of bringing an FDA-approved medical product from inception to release was $31 million. For high-risk medical products, the cost would run over $90 million.
Many of these inventive medical devices have no predicate device currently on the market for comparison; as a result, both the costs and go-to-market timeframe often surpass these averages. It is not the lack of technology or innovation that is holding back explosive growth in this market; rather, it is the time-to-market, and the associated costs, which are prohibitive.
How can we help solve this?
To accelerate the development and approval process of the devices, and speed their time-to-market, medical device manufacturers must immerse themselves in the current regulations practices to gather a clear understanding of the industry applications. Furthermore, manufacturers must stay abreast of changing regulatory practices, specifically those covering development, which can mature even on a month-to-month basis.
To successfully drive this initiative, medical device manufacturers should:
Implement better development approaches: Manufacturers need to leverage tools and techniques to develop their medical devices both faster and more efficiently while continuing to bring to market safe and effective products. Two key focus areas should be expediting the development process and making the iterative prototyping process easier and more useful.
Implement better regulatory and compliance strategies: Organisations that implement a strong regulatory and compliance strategy early in the development process will notice considerable gains once they submit their product to the various Ministries of Health (ie, FDA, EU, Health Canada, etc.) for consideration. A good regulatory strategy will allow you to properly assess the risk of your device, understand what is required of you based upon the risk assessment, and assemble the proper documentation and evidence needed to prove the device is safe for patients, doctors, nurses, and technicians, and is also effective in its intended use.
Partner with Industry Leaders: By merging technology expertise with regulatory best practices, medical device manufacturers can streamline the product development lifecycle. By working together, device creators and compliance experts can create diverse partner ecosystems that address resource limitations, navigate global compliance approvals, and elevate product development efficiency. The establishment of these ecosystems is a key step in accelerating time to market for medical devices.
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. Qt’s joined program with The Emergo Group supports major and emerging medical markets’ certification and compliance efforts, including the FDA, EU, ISO and IEC, and allows medical device manufacturers to align their product development cycle with the regulatory certification cycle, making their overall time-to-market process faster and more efficient.