Nick Tippmann, CMO, Greenlight Guru07.08.22
True Quality 2022 felt like a time machine. We looked back on a storied path, with legends reflecting on their careers. We got an inspiring snapshot of the current state of MedTech from those in the trenches. And it also provided a glimpse into the future trends shaping the medical device industry and digital health at-large.
Let’s take a look at what True Quality 2022 expert presenters say is on the horizon for MedTech’s future.
“The digital transformation in MedTech quality is happening,” she said. “Any continuation of ‘the norm’ is already irrelevant.”
The rapid advances in technologies like AI and machine learning have made fertile grounds for innovation in MedTech. Patients have greater control over their data and treatment plans, providers have better tools for treatment, and healthcare organizations are reimagining what healthcare actually looks like.
However, that same pace of progress has also created a load of questions as to how the MedTech industry of the future should be regulated when it comes to things like SaMD. We’ve seen announcements of new regulations from the European Union, Canada, and the United States, and even more changes loom in the near future.
However, one thing is certain: companies now more than ever need to approach quality as being about more than compliance. For Sandra, that means creating adaptable regulatory strategies that are built to change with the times.
“You don't want to be behind the curve of the regulators when it comes to adopting technology,” she said. “If you’re not modernizing, you’re out of compliance, and you should get your digital house in order.”
While these changes may be the cause of headaches for burgeoning medical device companies anxious to get a breakthrough product to market, it’s a chance for the industry to remember why quality in device manufacturing is so important: improving the quality of the lives they touch. Sandra says this culture of continuous innovation is par for the course when it comes to the medical device world.
“We think of hand-crank bone saws they had before FDA as being so antiquated and cruel,” she said. “What will we see as cruel going forward? What will we think of CT-based software? Forward thinking is digital transformation. It’s acceptance of the future and enrichment of the present and past.”
While the medical device industry is ultimately more dedicated to patient care as opposed to consumer sales, device companies and healthcare organizations still must adapt to a new breed of patients who expect a voice and choice in a value-based care model.
Dr. Daniel Kraft, a renowned healthcare futurist, spoke extensively on this subject during his day one keynote presentation at True Quality 2022. He passionately connected the MedTech industry’s push for innovation as a matter of necessity in protecting public health.
“The new drug is the empowered patient,” said Dr. Kraft. “We all need to be exponential thinkers to provide them with the future of healthcare.”
That future, says Dr. Kraft, is one built on continuous care that meets patients where they are. And in a world still feeling the effects of COVID-19, that means providing the same level of care at home through telehealth technology.
“We practice not healthcare, but sick care based on that intermittent data that we get usually in the four walls of the clinic, and then eventually you might see it when you're face-to-face with a patient,” he said. “That’s a reactive sick care model. The idea is to move the needle from reactive to proactive to preventive to predictive.”
To do so, Dr. Kraft says the industry will need to move into a new age of device revolution and work on a more forward thinking, data-driven approach to public health. He noted how wearable devices and constant vital monitoring could give providers — and patients — a better chance at spotting life-threatening events before they happen.
“The smart phone is becoming a medical device,” he said. “We’re seeing development of apps to look at your pupils and diagnose a stroke. We already have AI stethoscopes that detect heart murmurs more effectively than cardiologists.”
Of course, healthcare is a bit different than shopping for a new car. Patients may have all the information in the world available to them, but even the most innovative medical devices should remain tools used by doctors who understand how and when to use them.
“What does this disruption mean for knowledge and misinformation? If we want to empower the patients, we need MedTech to empower the doctors in charge of keeping those patients alive.”
“We know a lot of these sound like buzzwords, and to an extent they are,” said Henry Peck, Director of Global Marketing at Altoida. “But the core technology here really represents a possible solution to future problems looming in MedTech.”
Omar M. Khateeb, Head of State & Host of The State of MedTech, agreed. “NFTs have the potential to solve various problems – giving the power of medical records back to the patient and streamlining the healthcare experience.”
The two panelists pointed to current clinical applications of blockchain technology, such as:
Authenticating pharmaceutical products to combat counterfeiting
Unifying patient data in a Patient’s Lifetime Medical Record (PLMR)
Protecting the privacy of patient data in wearable technology
Khateeb believes that NFTs, as well the cryptocurrency communities that surround them, could also present an intriguing new pathway for medical device startups, as well as young innovators looking for funding in their research.
“Getting funding as a scientist is incredibly competitive,” said Khatheeb in a recent blog post. “If you can’t get a grant, the other option is being supported by private funders. But most private funders like to donate to larger and more well-known institutions like Harvard, Johns Hopkins, and Stanford. What if you’re at an institute that isn’t a world-leading academic center?”
Even if startups instead turn towards pharma-infused capital from drug companies, there’s the inherent issue of bias, that pharmaceutical companies will give grants to fund specific studies and influence the accuracy of their findings.
This is where the idea of centralized-versus-decentralized funding comes into play. Rather than pursuing traditional funding routes, medical device startups could turn to a decentralized organization that funds research without any third-party interests interfering.
“MedTech needs community support for their scientific projects to reach their full potential,” Khatheeb said. “We should all stay open to new forms of earning revenue that exist outside of traditional grant applications.”
MedTech Lifecycle Excellence (MLE) is an approach for medical technology and device companies that focuses on delivering high-quality products to patients by connecting disparate teams, processes, and data throughout the entire product lifecycle.
Nick Tippmann is CMO for Greenlight Guru, a medical device quality management software (MDQMS) that provides an industry-specific solution to help device makers around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Nick is lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, Nick co-founded and led a media and event production company that was later acquired.
Let’s take a look at what True Quality 2022 expert presenters say is on the horizon for MedTech’s future.
The Digital Transformation of Quality Can’t Be Avoided
In Sandra Rodrgieuz’s True Quality 2022 opening-day keynote presentation, Behind the Research: Overcoming the Barriers to Improved Quality, the Senior Industry Analyst at Axendia, Inc, made certain to address one thing right away.“The digital transformation in MedTech quality is happening,” she said. “Any continuation of ‘the norm’ is already irrelevant.”
The rapid advances in technologies like AI and machine learning have made fertile grounds for innovation in MedTech. Patients have greater control over their data and treatment plans, providers have better tools for treatment, and healthcare organizations are reimagining what healthcare actually looks like.
However, that same pace of progress has also created a load of questions as to how the MedTech industry of the future should be regulated when it comes to things like SaMD. We’ve seen announcements of new regulations from the European Union, Canada, and the United States, and even more changes loom in the near future.
However, one thing is certain: companies now more than ever need to approach quality as being about more than compliance. For Sandra, that means creating adaptable regulatory strategies that are built to change with the times.
“You don't want to be behind the curve of the regulators when it comes to adopting technology,” she said. “If you’re not modernizing, you’re out of compliance, and you should get your digital house in order.”
While these changes may be the cause of headaches for burgeoning medical device companies anxious to get a breakthrough product to market, it’s a chance for the industry to remember why quality in device manufacturing is so important: improving the quality of the lives they touch. Sandra says this culture of continuous innovation is par for the course when it comes to the medical device world.
“We think of hand-crank bone saws they had before FDA as being so antiquated and cruel,” she said. “What will we see as cruel going forward? What will we think of CT-based software? Forward thinking is digital transformation. It’s acceptance of the future and enrichment of the present and past.”
Empowered Patients Are Expecting Empowering MedTech
The culture of digital disruption has created a seismic shift in how companies and consumers interact. Customers are highly informed and have equally high expectations, forcing companies to radically reposition how they do business regardless of industry, and MedTech is no exception.While the medical device industry is ultimately more dedicated to patient care as opposed to consumer sales, device companies and healthcare organizations still must adapt to a new breed of patients who expect a voice and choice in a value-based care model.
Dr. Daniel Kraft, a renowned healthcare futurist, spoke extensively on this subject during his day one keynote presentation at True Quality 2022. He passionately connected the MedTech industry’s push for innovation as a matter of necessity in protecting public health.
“The new drug is the empowered patient,” said Dr. Kraft. “We all need to be exponential thinkers to provide them with the future of healthcare.”
That future, says Dr. Kraft, is one built on continuous care that meets patients where they are. And in a world still feeling the effects of COVID-19, that means providing the same level of care at home through telehealth technology.
“We practice not healthcare, but sick care based on that intermittent data that we get usually in the four walls of the clinic, and then eventually you might see it when you're face-to-face with a patient,” he said. “That’s a reactive sick care model. The idea is to move the needle from reactive to proactive to preventive to predictive.”
To do so, Dr. Kraft says the industry will need to move into a new age of device revolution and work on a more forward thinking, data-driven approach to public health. He noted how wearable devices and constant vital monitoring could give providers — and patients — a better chance at spotting life-threatening events before they happen.
“The smart phone is becoming a medical device,” he said. “We’re seeing development of apps to look at your pupils and diagnose a stroke. We already have AI stethoscopes that detect heart murmurs more effectively than cardiologists.”
Of course, healthcare is a bit different than shopping for a new car. Patients may have all the information in the world available to them, but even the most innovative medical devices should remain tools used by doctors who understand how and when to use them.
“What does this disruption mean for knowledge and misinformation? If we want to empower the patients, we need MedTech to empower the doctors in charge of keeping those patients alive.”
NFTs Could Have Major Benefits for MedTech
For some, words like the blockchain or non-fungible tokens (NFTs) may conjure up images of influencers or finance-bros. But, after Wednesday’s True Quality 2022 panel, How NFTs Will Change MedTech, it turns out those NFTs may just be a little misunderstood.“We know a lot of these sound like buzzwords, and to an extent they are,” said Henry Peck, Director of Global Marketing at Altoida. “But the core technology here really represents a possible solution to future problems looming in MedTech.”
Omar M. Khateeb, Head of State & Host of The State of MedTech, agreed. “NFTs have the potential to solve various problems – giving the power of medical records back to the patient and streamlining the healthcare experience.”
The two panelists pointed to current clinical applications of blockchain technology, such as:
Authenticating pharmaceutical products to combat counterfeiting
Unifying patient data in a Patient’s Lifetime Medical Record (PLMR)
Protecting the privacy of patient data in wearable technology
Khateeb believes that NFTs, as well the cryptocurrency communities that surround them, could also present an intriguing new pathway for medical device startups, as well as young innovators looking for funding in their research.
“Getting funding as a scientist is incredibly competitive,” said Khatheeb in a recent blog post. “If you can’t get a grant, the other option is being supported by private funders. But most private funders like to donate to larger and more well-known institutions like Harvard, Johns Hopkins, and Stanford. What if you’re at an institute that isn’t a world-leading academic center?”
Even if startups instead turn towards pharma-infused capital from drug companies, there’s the inherent issue of bias, that pharmaceutical companies will give grants to fund specific studies and influence the accuracy of their findings.
This is where the idea of centralized-versus-decentralized funding comes into play. Rather than pursuing traditional funding routes, medical device startups could turn to a decentralized organization that funds research without any third-party interests interfering.
“MedTech needs community support for their scientific projects to reach their full potential,” Khatheeb said. “We should all stay open to new forms of earning revenue that exist outside of traditional grant applications.”
The Future Will Live in Greenlight Guru’s Medtech Lifecycle Excellence Platform
Though we may not know for sure what comes tomorrow, one thing is clear: Greenlight Guru aims to provide a solution that helps medical device companies all over. We need to embrace an entirely new approach and ecosystem, one which we humbly call MedTech Lifecycle Excellence.MedTech Lifecycle Excellence (MLE) is an approach for medical technology and device companies that focuses on delivering high-quality products to patients by connecting disparate teams, processes, and data throughout the entire product lifecycle.
Nick Tippmann is CMO for Greenlight Guru, a medical device quality management software (MDQMS) that provides an industry-specific solution to help device makers around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Nick is lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, Nick co-founded and led a media and event production company that was later acquired.
