Megan Ray Nichols, Science Writer; Editor, Schooled By Science05.30.19
Technological advancements are changing the world over, altering the way many modern industries and fields work. Medical device manufacturing is no different, and it sees regular interference in terms of how equipment is designed, developed, and distributed. Particularly, the emergence of new, smarter devices has become more common and it’s not just shaping the way the equipment is made, but also how it’s used by medical professionals.
Medical device manufacturers and end users alike—in this case, many medical professionals—must keep an eye on current industry trends. This will allow everyone to prepare and adapt to what’s on the horizon.
1. Minimally Invasive Will Be the Primary Focus
Thanks to the widespread advancement and miniaturization of technology—for example, the supercomputer you now carry in your pocket—the market focus will shift to minimally invasive solutions. The smaller the better, because smaller devices improve the doctor-patient experience and minimize a lot of the risk involved. Working with a minimal footprint inside the body means there’s a lot less room for error.
The minimally invasive devices market is expected to grow at a CAGR of 8 percent by 2024. It may not seem like much, but that’s a significant boost, especially for something just starting to see more frequent adoption.
2. Complex Medical Device Software Is Coming
As systems and devices in use become more advanced, their software and, by proxy, controls, also grow complex. This translates to a few different scenarios, the most obvious being advanced software will be embedded within the devices themselves, as opposed to a network or cloud system. This also means medical professionals will need further training to work with these tools, devices, and equipment.
Some of the things medical professionals must understand include troubleshooting, risk management, and cybersecurity. This stretches the necessary skills and expertise beyond anything medical professionals have dealt with in the past.
Device manufacturers will also need to focus on the same software elements, but also design control. As new software or firmware is released, there is a higher risk for defects and bugs, which may even surface late in the production process. It calls for ongoing product and service support as well as consistent, yet thorough testing practices.
3. Compliance and Regulation Will Evolve
Many of the more advanced devices don’t just rely on dedicated or local software—there are remote apps used to interface and control the equipment. This has led to a surge in healthcare-related apps, many of which fall under the purview of the FDA.
Medical equipment and operation tools now require proprietary apps. Hospital management and planning tools interface with mobile devices. Even accessibility equipment such as weight scales, chair and exam tables, and patient lifts have all been upgraded to offer mobile support.
As the FDA learns to deal with these new solutions and systems alongside the greater medical field, we will see many new compliance and regulation processes come to fruition. The agency must honor the same risk-based assessments to ensure the safety and efficiency of mobile apps and software in the medical industry.
4. Rise of the De Novo Classification
The two most common premarket submissions when dealing with the FDA and new medical devices are the 510(k) classification and the PMA approval. There is a third called the de novo classification or pathway, but it’s rarely used, at least until recently.
The FDA has since streamlined the application process by eliminating the need for a 510(k) and NSE determination. What that means is more and more providers are going through the de novo pathway because it’s relatively faster and more efficient. It does come with high risk, however, so it’s best suited for new technologies with either a low-risk environment or solutions where the provider can mitigate all known risks.
Either way, de novo classification is on the rise and it may be the more viable solution for many new technologies coming to market.
5. Robust Contract Manufacturer Support
Medical device manufacturers have relied more and more on third-party services and providers in recent years. It’s happened so often that the services offered by these third parties have also grown more complex and functional. Contractual parties are now involved with and can support much more, including supply chain management, conceptual design, and early development, as well as specialized manufacturing.
The result is a much more capable system that boosts productivity and efficiency alike, resulting in faster time to market and much more capable products. This trend will likely continue into the future, becoming not just more widespread but also an incredibly common and (possibly even ideal) way to deal with the changing market.
6. More Diversified Personnel
This might seem unrelated, but is going to be quite impactful for the device manufacturing industry in terms of capability, efficiency, and available talent. The entire talent pool is growing much more diverse, but so are the rosters of manufacturers in general. A rising demand for more robust and skilled professionals has led to the recruitment of women and veterans alike, a previously untouched talent pool.
As of 2016, the entire manufacturing workforce was only comprised of 29 percent women. But that number continues to grow as manufacturers realize the full potential of a more diverse and capable staff.
Veterans especially come equipped with a robust selection of skills and talents that can prove valuable to the medical device industry.
Change Is Coming
Over just the past few years, the state of the medical device industry has changed considerably. When you look at the devices themselves, there’s a growing demand for smarter, more connected technologies. This also breeds the development and usage of more nuanced software, including mobile companion apps.
Alongside those more device-focused changes is the rising need for minimally invasive gear, more efficient and capable manufacturing processes, and new regulation and compliance requirements.
It’s safe to say these trends will play a considerable role in the future of the industry, which means medical device manufacturers would do well to acknowledge and understand them.
Megan Ray Nichols is a science writer and the editor of Schooled By Science. Her work regularly appears on Real Clear Science, Manufacturing.net, and Astronaut.com. Keep up with Megan by following her on Twitter.
Medical device manufacturers and end users alike—in this case, many medical professionals—must keep an eye on current industry trends. This will allow everyone to prepare and adapt to what’s on the horizon.
1. Minimally Invasive Will Be the Primary Focus
Thanks to the widespread advancement and miniaturization of technology—for example, the supercomputer you now carry in your pocket—the market focus will shift to minimally invasive solutions. The smaller the better, because smaller devices improve the doctor-patient experience and minimize a lot of the risk involved. Working with a minimal footprint inside the body means there’s a lot less room for error.
The minimally invasive devices market is expected to grow at a CAGR of 8 percent by 2024. It may not seem like much, but that’s a significant boost, especially for something just starting to see more frequent adoption.
2. Complex Medical Device Software Is Coming
As systems and devices in use become more advanced, their software and, by proxy, controls, also grow complex. This translates to a few different scenarios, the most obvious being advanced software will be embedded within the devices themselves, as opposed to a network or cloud system. This also means medical professionals will need further training to work with these tools, devices, and equipment.
Some of the things medical professionals must understand include troubleshooting, risk management, and cybersecurity. This stretches the necessary skills and expertise beyond anything medical professionals have dealt with in the past.
Device manufacturers will also need to focus on the same software elements, but also design control. As new software or firmware is released, there is a higher risk for defects and bugs, which may even surface late in the production process. It calls for ongoing product and service support as well as consistent, yet thorough testing practices.
3. Compliance and Regulation Will Evolve
Many of the more advanced devices don’t just rely on dedicated or local software—there are remote apps used to interface and control the equipment. This has led to a surge in healthcare-related apps, many of which fall under the purview of the FDA.
Medical equipment and operation tools now require proprietary apps. Hospital management and planning tools interface with mobile devices. Even accessibility equipment such as weight scales, chair and exam tables, and patient lifts have all been upgraded to offer mobile support.
As the FDA learns to deal with these new solutions and systems alongside the greater medical field, we will see many new compliance and regulation processes come to fruition. The agency must honor the same risk-based assessments to ensure the safety and efficiency of mobile apps and software in the medical industry.
4. Rise of the De Novo Classification
The two most common premarket submissions when dealing with the FDA and new medical devices are the 510(k) classification and the PMA approval. There is a third called the de novo classification or pathway, but it’s rarely used, at least until recently.
The FDA has since streamlined the application process by eliminating the need for a 510(k) and NSE determination. What that means is more and more providers are going through the de novo pathway because it’s relatively faster and more efficient. It does come with high risk, however, so it’s best suited for new technologies with either a low-risk environment or solutions where the provider can mitigate all known risks.
Either way, de novo classification is on the rise and it may be the more viable solution for many new technologies coming to market.
5. Robust Contract Manufacturer Support
Medical device manufacturers have relied more and more on third-party services and providers in recent years. It’s happened so often that the services offered by these third parties have also grown more complex and functional. Contractual parties are now involved with and can support much more, including supply chain management, conceptual design, and early development, as well as specialized manufacturing.
The result is a much more capable system that boosts productivity and efficiency alike, resulting in faster time to market and much more capable products. This trend will likely continue into the future, becoming not just more widespread but also an incredibly common and (possibly even ideal) way to deal with the changing market.
6. More Diversified Personnel
This might seem unrelated, but is going to be quite impactful for the device manufacturing industry in terms of capability, efficiency, and available talent. The entire talent pool is growing much more diverse, but so are the rosters of manufacturers in general. A rising demand for more robust and skilled professionals has led to the recruitment of women and veterans alike, a previously untouched talent pool.
As of 2016, the entire manufacturing workforce was only comprised of 29 percent women. But that number continues to grow as manufacturers realize the full potential of a more diverse and capable staff.
Veterans especially come equipped with a robust selection of skills and talents that can prove valuable to the medical device industry.
Change Is Coming
Over just the past few years, the state of the medical device industry has changed considerably. When you look at the devices themselves, there’s a growing demand for smarter, more connected technologies. This also breeds the development and usage of more nuanced software, including mobile companion apps.
Alongside those more device-focused changes is the rising need for minimally invasive gear, more efficient and capable manufacturing processes, and new regulation and compliance requirements.
It’s safe to say these trends will play a considerable role in the future of the industry, which means medical device manufacturers would do well to acknowledge and understand them.
Megan Ray Nichols is a science writer and the editor of Schooled By Science. Her work regularly appears on Real Clear Science, Manufacturing.net, and Astronaut.com. Keep up with Megan by following her on Twitter.
