Michael Barbella, Managing Editor04.21.20
It will be different next time. Much different, hopefully.
Future pandemics are unlikely to resemble the disjointed patchwork of COVID-19 mitigation efforts implemented worldwide by lawmakers and health officials. Instead, they possibly will involve more coordinated responses and widespread testing, as well as technological innovations inspired by design thinking.
Such thinking could result in redesigned public spaces that double as treatment areas during an outbreak and airports with more security screening lanes. Hospitals are likely to rethink conventional schematics too, potentially employing such pandemic-busting features as negative pressure zones, special patient evaluation areas, telehealth centers, and flexible-use rooms (i.e., those easily modified between acute care and ICU).
With the COVID-19 threat unlikely to abate in the fore- seeable future, design thinking could potentially become a powerful tool in helping to better manage and control forthcoming pandemics. The approach is already being used to improve healthcare equity and spawn creative solutions to medicine’s most pressing dilemmas.
MPO’s January/February feature, “Inventive Interaction,” explores the various forces at play in medtech R&D. Maciej Jakucki, medical device manager at Element Materials Technology., was among the various experts interviewed for the story. His full input is provided in the following Q&A.
Michael Barbella: Where are companies spending their research dollars now—on incremental improvements to existing devices, or game-changing innovation?
Maciej Jakucki: Incremental changes will always be a part of R&D and I think it depends on the amount of risk that a company is willing to tolerate. In orthopedics, two innovative areas are additive and robotics and they continue to drive the growth in the industry—focusing on replicating existing product lines with additive manufacturing, but then also leveraging those unique capabilities to improve geometries. All of the largest companies have invested in robotics to improve patient outcomes, and new robotic technology continues to be developed. Is this expensive? Yes. Is it game changing and does this functionally change the industry right now or prove better patient outcomes? I think it has the potential to, but in my opinion, it is still several years away from being game changing. When you look at life saving product development in the diagnostic or cardiovascular segments, companies are more likely to spend their R&D dollars on introducing game changing innovation using technology such as wireless, imaging, augmented reality, machine learning and artificial intelligence—especially if the market growth continues. Many of the cardiovascular medical device projects we see are brand new device designs or solutions for complex problems. Looking into 2020, there is potential for more innovation and introduction of game changing technology; however, with MDR, the upcoming political election and uncertain tax legislature, there is potential for companies to reduce spending dollars as they protect themselves from risk.
Barbella: How is value-based healthcare shaping the kinds of medical devices/technology being developed?
Jakucki: If we could measure what comes out of the body, then we could improve and better understand what to put into our bodies. With value-based healthcare, healthcare delivery systems, device and health feedback models and patient monitoring are critical to success. This will continue to drive software advances alongside of medical devices. If you couple that data with predictive analytics, you can impact it even more and start closing the loop. The question really becomes: “Which metrics?” The explosion in cloud computing, predictive AI, and data analysis software will result in medical technology of the future communicating and predicting health patterns, as well as provide updated training based on real time events. A heavier industry focus on clinical results and making data available will spill over into all of the regulatory environments. The industry is also seeing more “non-medical” companies use their expertise to align and partner with the traditional medical device companies or even strike out on their own. Imagine companies not only being in the business of developing and selling medical devices, but also then selling the data they have obtained which in turn will be used to drive new technology development.
Barbella: Please discuss the importance of university/academic partnerships in developing cutting-edge medical devices.
Jakucki: Partnership with academia is critical for development of future devices. In my mind, there are two main areas where this is applicable. The first is training new talent and routing into the industry hotbeds. I came through Drexel University where I spent time in pharma, power, and medical device industries as a co-op and expanded my worldviews in each. I still remember differences that have influenced decision making because of the exposure I received. Active co-op and internship programs offer accelerated ramp-up time so new graduates hit the ground running, especially if afforded the opportunity to have interned at medical device companies. Your new employee starts with two years of experience at your company already. Second, if those universities are also performing both basic and applied research in relevant medical device technology where they can drive talent into specific fields, those perspectives and relationships can help drive new innovation at the industry level. A results-oriented, collaborative approach helps discovery on both the academic and industry level. Academia needs to solicit and engage with industry to go from concept to market, and industry needs to be in better touch with the new talent and opportunities across the board, not just in the medical space, but also in other cutting-edge industries to bring new perspectives.
Barbella: Are startups better suited than their mid-size or large OEM cohorts to develop medical technology that addresses value-based healthcare solutions? If so, how? (Or, if not, why not?)
Jakucki: Absolutely. The large OEMs have a significant amount of talent to deliver truly innovative ideas, but the business impact of having to report quarterly profits and the risk of a negative press release by an unproven technology is a concern. I wonder how many ideas don’t get pursued. It is typically better for a large company to incrementally develop and then either acquire or partner with a smaller, more nimble company, essentially outsourced the innovative R&D. That way, the risk can be assumed separately and then once vetted, bring the best technology internally surrounded by large OEM expertise. Speaking of developing medical technology, with the ability to stay connected through social media, crowd funding, and the venture capital money available, I think there is opportunity for grassroots problem solving to start developing new technology to disrupt common thinking. In terms of value-based solutions, it can be difficult for a large OEM to stay connected on the patient ground level to the same extent as a smaller company. If a disruptive technology can be developed and then combined with the resources and expertise available at the large company level, then value-based care can really be improved.
Barbella: Can a company effective tackle a healthcare need/problem and devise a solution based on its own internal R&D? Please explain.
Jakucki: I think innovation and problem solving follow the ability to think across industries and solicit ideas from people that don’t think like you. One of the developments in healthcare that excites me is to see companies like Google, Amazon, Apple, and Facebook—non-traditional medical companies—dip their toes into the medical space or partner with medical companies to drive ideas forward. I see this progress every day in our product testing laboratories. There are innovative medical device companies that are able to devise solutions through their own R&D, but most are adding a “me too” device or relying on a very niche market. If game-changing innovation is the target, I think this is difficult to perform internally.
Barbella: How can companies “innovate the process of innovation” to achieve more transformational products through R&D?
Jakucki: Coming from a testing company with a global presence in medical, aerospace, automotive, energy, etc., it is really interesting to see how each industry is different and I think medical would benefit substantially by cross pollinating and bringing different skills from other industries. I keep hearing comments about how small the medical device industry is, and the same people just move around from company to company. While this is great for incremental improvement, can you really drive development of transformational products by thinking the same way?
Barbella: How will AI, big data, and digital health affect the R&D process going forward?
Jakucki: Transformative. It challenges contemporary analytical techniques and creates new models that were previously unable to factor in different variables. To be able to use past, present and predicted data also transforms the way R&D functions. Instead of targeting a specialty skillset, integrating advanced backgrounds in statistics or computing will be necessary to keep up with your competition. As new data models are created and become readily available, the ability of R&D to pivot will become critical as the current models can lock in on a target and miss the signs along the way to make an adjustment. Data-hungry processes will also force increased collaboration with different industries
Barbella: What is driving the need to outsource medtech R&D? Does the R&D process even need to be outsourced?
Jakucki: I mentioned that R&D expands and contracts with business needs. If you diversify your product portfolio, it can be a challenge to use the same team and, depending on your growth, to keep that team engaged. It is also expensive to hire specialized talent, and that talent has be able to grow and pivot with the company. For a smaller company, they can’t necessarily afford to bring on all the necessary experts so they have to decide on what is least prohibitive. Increase the timeline? Risk adding the expertise? Hire temps or partner with someone who can provide the resources so the business can focus on their core strengths? It also depends on the technology you are pursuing and how long it will take to implement. In our testing business, we have seen some customers increase their R&D outsourcing over the last year. It is also becoming more common for services like quality and regulatory to be outsourced as well. With upcoming increased regulation, the political and tax environment, and the uncertainty of the future economy, outsourcing some or most of your R&D seems like an appropriate option.
Future pandemics are unlikely to resemble the disjointed patchwork of COVID-19 mitigation efforts implemented worldwide by lawmakers and health officials. Instead, they possibly will involve more coordinated responses and widespread testing, as well as technological innovations inspired by design thinking.
Such thinking could result in redesigned public spaces that double as treatment areas during an outbreak and airports with more security screening lanes. Hospitals are likely to rethink conventional schematics too, potentially employing such pandemic-busting features as negative pressure zones, special patient evaluation areas, telehealth centers, and flexible-use rooms (i.e., those easily modified between acute care and ICU).
With the COVID-19 threat unlikely to abate in the fore- seeable future, design thinking could potentially become a powerful tool in helping to better manage and control forthcoming pandemics. The approach is already being used to improve healthcare equity and spawn creative solutions to medicine’s most pressing dilemmas.
MPO’s January/February feature, “Inventive Interaction,” explores the various forces at play in medtech R&D. Maciej Jakucki, medical device manager at Element Materials Technology., was among the various experts interviewed for the story. His full input is provided in the following Q&A.
Michael Barbella: Where are companies spending their research dollars now—on incremental improvements to existing devices, or game-changing innovation?
Maciej Jakucki: Incremental changes will always be a part of R&D and I think it depends on the amount of risk that a company is willing to tolerate. In orthopedics, two innovative areas are additive and robotics and they continue to drive the growth in the industry—focusing on replicating existing product lines with additive manufacturing, but then also leveraging those unique capabilities to improve geometries. All of the largest companies have invested in robotics to improve patient outcomes, and new robotic technology continues to be developed. Is this expensive? Yes. Is it game changing and does this functionally change the industry right now or prove better patient outcomes? I think it has the potential to, but in my opinion, it is still several years away from being game changing. When you look at life saving product development in the diagnostic or cardiovascular segments, companies are more likely to spend their R&D dollars on introducing game changing innovation using technology such as wireless, imaging, augmented reality, machine learning and artificial intelligence—especially if the market growth continues. Many of the cardiovascular medical device projects we see are brand new device designs or solutions for complex problems. Looking into 2020, there is potential for more innovation and introduction of game changing technology; however, with MDR, the upcoming political election and uncertain tax legislature, there is potential for companies to reduce spending dollars as they protect themselves from risk.
Barbella: How is value-based healthcare shaping the kinds of medical devices/technology being developed?
Jakucki: If we could measure what comes out of the body, then we could improve and better understand what to put into our bodies. With value-based healthcare, healthcare delivery systems, device and health feedback models and patient monitoring are critical to success. This will continue to drive software advances alongside of medical devices. If you couple that data with predictive analytics, you can impact it even more and start closing the loop. The question really becomes: “Which metrics?” The explosion in cloud computing, predictive AI, and data analysis software will result in medical technology of the future communicating and predicting health patterns, as well as provide updated training based on real time events. A heavier industry focus on clinical results and making data available will spill over into all of the regulatory environments. The industry is also seeing more “non-medical” companies use their expertise to align and partner with the traditional medical device companies or even strike out on their own. Imagine companies not only being in the business of developing and selling medical devices, but also then selling the data they have obtained which in turn will be used to drive new technology development.
Barbella: Please discuss the importance of university/academic partnerships in developing cutting-edge medical devices.
Jakucki: Partnership with academia is critical for development of future devices. In my mind, there are two main areas where this is applicable. The first is training new talent and routing into the industry hotbeds. I came through Drexel University where I spent time in pharma, power, and medical device industries as a co-op and expanded my worldviews in each. I still remember differences that have influenced decision making because of the exposure I received. Active co-op and internship programs offer accelerated ramp-up time so new graduates hit the ground running, especially if afforded the opportunity to have interned at medical device companies. Your new employee starts with two years of experience at your company already. Second, if those universities are also performing both basic and applied research in relevant medical device technology where they can drive talent into specific fields, those perspectives and relationships can help drive new innovation at the industry level. A results-oriented, collaborative approach helps discovery on both the academic and industry level. Academia needs to solicit and engage with industry to go from concept to market, and industry needs to be in better touch with the new talent and opportunities across the board, not just in the medical space, but also in other cutting-edge industries to bring new perspectives.
Barbella: Are startups better suited than their mid-size or large OEM cohorts to develop medical technology that addresses value-based healthcare solutions? If so, how? (Or, if not, why not?)
Jakucki: Absolutely. The large OEMs have a significant amount of talent to deliver truly innovative ideas, but the business impact of having to report quarterly profits and the risk of a negative press release by an unproven technology is a concern. I wonder how many ideas don’t get pursued. It is typically better for a large company to incrementally develop and then either acquire or partner with a smaller, more nimble company, essentially outsourced the innovative R&D. That way, the risk can be assumed separately and then once vetted, bring the best technology internally surrounded by large OEM expertise. Speaking of developing medical technology, with the ability to stay connected through social media, crowd funding, and the venture capital money available, I think there is opportunity for grassroots problem solving to start developing new technology to disrupt common thinking. In terms of value-based solutions, it can be difficult for a large OEM to stay connected on the patient ground level to the same extent as a smaller company. If a disruptive technology can be developed and then combined with the resources and expertise available at the large company level, then value-based care can really be improved.
Barbella: Can a company effective tackle a healthcare need/problem and devise a solution based on its own internal R&D? Please explain.
Jakucki: I think innovation and problem solving follow the ability to think across industries and solicit ideas from people that don’t think like you. One of the developments in healthcare that excites me is to see companies like Google, Amazon, Apple, and Facebook—non-traditional medical companies—dip their toes into the medical space or partner with medical companies to drive ideas forward. I see this progress every day in our product testing laboratories. There are innovative medical device companies that are able to devise solutions through their own R&D, but most are adding a “me too” device or relying on a very niche market. If game-changing innovation is the target, I think this is difficult to perform internally.
Barbella: How can companies “innovate the process of innovation” to achieve more transformational products through R&D?
Jakucki: Coming from a testing company with a global presence in medical, aerospace, automotive, energy, etc., it is really interesting to see how each industry is different and I think medical would benefit substantially by cross pollinating and bringing different skills from other industries. I keep hearing comments about how small the medical device industry is, and the same people just move around from company to company. While this is great for incremental improvement, can you really drive development of transformational products by thinking the same way?
Barbella: How will AI, big data, and digital health affect the R&D process going forward?
Jakucki: Transformative. It challenges contemporary analytical techniques and creates new models that were previously unable to factor in different variables. To be able to use past, present and predicted data also transforms the way R&D functions. Instead of targeting a specialty skillset, integrating advanced backgrounds in statistics or computing will be necessary to keep up with your competition. As new data models are created and become readily available, the ability of R&D to pivot will become critical as the current models can lock in on a target and miss the signs along the way to make an adjustment. Data-hungry processes will also force increased collaboration with different industries
Barbella: What is driving the need to outsource medtech R&D? Does the R&D process even need to be outsourced?
Jakucki: I mentioned that R&D expands and contracts with business needs. If you diversify your product portfolio, it can be a challenge to use the same team and, depending on your growth, to keep that team engaged. It is also expensive to hire specialized talent, and that talent has be able to grow and pivot with the company. For a smaller company, they can’t necessarily afford to bring on all the necessary experts so they have to decide on what is least prohibitive. Increase the timeline? Risk adding the expertise? Hire temps or partner with someone who can provide the resources so the business can focus on their core strengths? It also depends on the technology you are pursuing and how long it will take to implement. In our testing business, we have seen some customers increase their R&D outsourcing over the last year. It is also becoming more common for services like quality and regulatory to be outsourced as well. With upcoming increased regulation, the political and tax environment, and the uncertainty of the future economy, outsourcing some or most of your R&D seems like an appropriate option.
