MedTech Monitor: MEDevice Silicon Valley Edition
Welcome to a special edition of MedTech Monitor, dedicated exclusively to the MEDevice Silicon Valley show!
MEDevice is a one-of-a-kind expo and education event that unites engineers; business, technology, and cybersecurity leaders; disruptive companies; and innovative thinkers from startups and top medical device OEMs in a focused environment to enable hands-on product discovery, facilitate partnerships, and accelerate progress.
Johnson & Johnson, Flex to Keynote at MEDevice Silicon Valley on the Future of Technology & Security in Patient Care
By MD+DI Staff
MEDevice Silicon Valley returns to the Santa Clara Convention Center Nov. 20-21.
The show's lineup of keynote speakers will cover artificially intelligent (AI) and augmented reality (AR) driven Human Machine Interfaces (HMI) as well as a discussion on cybersecurity strategies, both top-of-mind critical tools designed to deliver easier, faster, and more reliable access to quality care.
Kicking off the event on Nov. 20, Jennifer Samproni, Chief Technology Officer of the Health Solutions business at Flex, keynotes on "Transforming the Future of Patient Care with Human Machine Interfaces", highlighting the growing role of HMI’s in the future of medical device innovation. Samproni will focus on medtech companies approaching progressive product design to remain competitive, how to create new medical devices that meet consumer expectations, as well as tools for managing the increasing demands of a healthcare system for the aging population.
Ashley Mancuso, Vice President, MedTech BISO & Product Security, Johnson & Johnson will present “Advancing Cyber Security in Supply Chain Operations”, diving into the critical understanding of proactive engagement with suppliers, partners, and stakeholders in the supply chain.
Presentation topics will include ways to embed cyber security principles into organizations, trainings to transform employees into vigilant defenders against cyber threats, and how to advance risk sensing techniques to identify potential risks in real-time.
“MEDevice Silicon Valley returns this year with a renewed focus on connecting the medtech community through the most up-to-date and actionable insights and education,” said Adrienne Zepeda, Group Event Director, Informa Markets Engineering. “Both of these globally renowned industry-leading speakers bring highly specialized and unique perspective to scale powerful technology, ultimately improving how we address complex organizational challenges, enhancing healthcare access for all. ?Silicon Valley is still the epicenter of North American innovation. We strive to create the most anticipated local platform for integral conversations that empower medical device manufacturers and designers with proven successful resources and data for implementation and sharp ingenuity.”
MEDevice Silicon Valley organizes more than 20 hours of education, presenting topics from 3D printing to AI, policy and regulations, design, development, and more. Nearly 90% of attending buyers are local to Silicon Valley, as the region's thriving technology sector continues to spark the in-person industry collaboration necessary for medical device manufacturers to harness the power of emerging digital-forward integration.
MEDevice Silicon Valley hosts over 175 exhibitors, featuring medical solutions and products including 219 Design, Accumold, Biocoat, Canon Medical Components U.S.A., Medbio, Nelson Labs, Qosina, Zeus Industrial Products, among many more.
5 Sessions You Don’t Want to Miss
By Omar Ford
Not sure what to check out during MEDevice Silicon Valley? Here's a list of sessions that are sure to pique your interest.
Protecting Supply Chain Operations With Better Cybersecurity Awareness
By Joe Darrah
As the rate of cyberattacks continues to increase worldwide, certain types of targets are becoming more attractive and lucrative to criminals. Among the more threatened sources today is the global supply chain and the collective software connected to it. Much like with the healthcare industry, the interconnected nature of the supply chain and an increasing collaboration with third-party vendors to meet the needs of customers provides a wealth of resources that are worth infiltrating.
This creates the potential to cause wide-ranging disruption when targets are compromised, resulting in opportunities to seek extravagant demands when victims attempt to recoup their losses.
According to Statista, approximately 183,000 customers were affected by supply chain cyberattacks globally in 2024 alone. As the ever-evolving landscape of supply chain operations continues to become more reliant on digital technology, it’s becoming more important for organizations to enhance their cybersecurity posture.
During the upcoming MEDevice conference in Silicon Valley, CA, Ashley Mancuso , vice president of medtech BISO and product security at Johnson & Johnson,?will provide one of the keynote sessions on “Advancing Cyber Security in Supply Chain Operations .”
Mancuso recently participated in a Q&A with MD+DI to discuss how today’s stakeholders in the medtech industry can play effective roles in protecting supply chain software from future attacks.
What are common examples of cyber threats today that particularly impact the medtech industry and the supply chain?
Mancuso: “Manufacturing is among the most targeted sectors by cyber criminals, with 55% of manufacturers in 2021 hit by ransomware attacks. The inherent complexity of ensuring robust cybersecurity across interdependent supply chains, which involve collaboration between operations, manufacturing, and distribution sites, presents challenges. However, there are ways organizations can strengthen their resilience. As companies build interconnected supply chains and often rely on a network of vendors for essential services, it’s vital to understand and align on the security protocols that each vendor follows. By fostering a culture of cybersecurity collaboration among vendors, organizations can collectively close the door on potential vulnerabilities that cybercriminals might exploit." “Moreover, the increasing incorporation of Internet of Things devices into supply chains, while beneficial, highlights the importance of vigilance. These devices can serve as potential entry points for cyberattacks. But by implementing strong security measures and adopting best practices, teams can help to mitigate the risks. Regulatory compliance is another critical area to reinforce cybersecurity efforts. By adhering to established standards, companies can not only protect themselves from threats but also can enhance their reputations and avoid financial penalties.”
What unique considerations are there today when it comes to fortifying defenses against cyber threats in supply chain operations and medtech?
Mancuso: “In modern supply chain environments, the growing demand for connectivity and data and analytics is driven by the need to proactively manage digital supply chain environments, such as with preventive maintenance. As supply chains become more digital, there should be a shift from the traditional model of segmentation towards more innovative approaches, enabling increased connectivity. Organizations must leverage advanced technologies to analyze data in real-time, enabling them to anticipate and address potential issues before they escalate. This transition not only enhances operational efficiency but also underscores the importance of creating agile and responsive systems that can adapt to changing conditions and improve overall supply chain resilience."
"The increasing digitization and operational complexity of medtech and supply chain, including intricate networks of suppliers and manufacturers, also underscores the necessity of more advanced security protocols. This requires a cyber strategy that safeguards physical assets, including unique operational technology, or “OT devices,” while ensuring the integrity and confidentiality of data and operational availability. Overall, companies should adopt a holistic approach to cybersecurity, incorporating continuous monitoring, real-time threat detection, and agile response mechanisms to adapt to emerging vulnerabilities.”
What are examples of innovative technologies and/or tools that can improve risk sensing and response capabilities today?
Mancuso: “Data and advanced analytics, pattern recognition, and automation capabilities of artificial intelligence (AI) are exciting areas of technology that can help enhance threat detection and response time. As a company, we are committed to keeping people at the center of our work – leveraging AI and digital technologies to help us work smarter and faster, but never removing the critical role of human care and intelligence.”
What are the best steps to implementing proactive engagement with suppliers, partners, and stakeholders? Mancuso: “It's crucial to engage proactively with suppliers, partners, and stakeholders. This involves establishing clear communication channels, conducting joint risk assessments, and implementing standardized cybersecurity requirements. Providing training and resources helps partners understand risks, while regular security audits ensure transparency and accountability. Collaboration on incident response planning and fostering a culture of security among all parties is essential. Additionally, monitoring for vulnerabilities regularly helps adapt to evolving threats.”
What does it mean for employees to be empowered to act as cybersecurity advocates?
Mancuso: “When employees are empowered to act as cybersecurity advocates, they become integral to the organization’s security framework. This empowerment involves providing them with thorough training on cybersecurity threats and best practices, which helps them to understand the critical role they play in protecting sensitive information."
"Empowered employees feel comfortable speaking up about potential security risks, and are given the tools and resources to identify and mitigate these risks, if and when they arise. They take ownership of their responsibilities regarding cybersecurity, understand policies, and taking part in organized trainings that reflect their real-world experiences. By creating a culture that recognizes and rewards proactive contributions to cybersecurity, organizations foster an environment where everyone actively helps safeguard the organization’s digital assets. Ultimately, this collaborative approach enhances security and reduces vulnerabilities across the board.”
Going Beyond The “Buzzword”: Bringing the Future Potential of AI into Better Focus
By Joe Darrah
Although the roots of artificial intelligence (AI) can be traced back through several decades and various iterations, its presence as a consistent part of everyday life is something that society is still learning to embrace.
When it comes to its role in healthcare, AI remains somewhat of a “buzzword” today, with its true meaning and implications often elusive, especially related to medical devices.
As AI’s capabilities expand beyond a mere feature of sophisticated technologies, these tools are reshaping quality standards across the board, from pre-market assessment to post-market surveillance.
As technology becomes more sophisticated, AI and machine learning will continue to transform diagnostic capabilities, predictive analysis, and overall med-tech innovation.
Impacts to safety and compliance will continue to deepen, and ethical implications will become more common. As such, it will be increasingly important for industry professionals to be more cognizant of how AI operates, how it differs from machine learning and generative AI, how it influences patient care, and how public perceptions compare to AI’s actual capabilities.
During his upcoming presentation at MEDevice Silicon Valley titled “QualitAI: How AI & Machine Learning Fit Into The Quality Future ,” Kellen Giroux, director of quality solutions at Network Partners Group, Warsaw, IN, will seek to empower today’s medical device company stakeholders on how the industry can collaborate to chart a more productive future by engaging in more open dialogue about AI’s impact on medical devices.
He will also discuss potential misconceptions and pitfalls as well as the potential for transformative benefits.
Giroux recently participated in a Q&A with MD+DI to discuss how various members of the medtech industry will have to come together to learn how to best integrate AI safely and effectively into various processes, services, and products.
When considering that AI remains a buzzword even within this industry, do you think most professionals “understand” how AI functions - or do you believe there remains a certain level of uncertainty and confusion?
Giroux: “I think there is definitely still a level of uncertainty and confusion. That is one of the primary goals of our [conference] panel - to educate and enlighten professionals regarding what AI actually is and how it functions. What they may deal with on a daily basis and may not realize, and how AI is being integrated into the medical device space. There are so many different types of AI (including machine learning, generative AI, and reactive machines), so it is difficult for people to understand what each one is and how they all function.
The saturation of the term AI and the vast number of different types has contributed to this confusion. Movies and Hollywood have also skewed how AI is understood. I have found the perception to be at both ends of the spectrum, where people either believe AI is a pipedream or that it could end the world tomorrow. The reality is that AI is somewhere in the middle (for now).”
Do you think the presence of AI will make it more challenging for manufacturers to adhere to quality standards?
Kellen Giroux: “Yes, absolutely. Quality standards are about ensuring medical devices are safe and effective. Validating, justifying, and qualifying AI to prove that they make devices safer and more effective is truly where the burden of the work lies. Because of the rapid evolution to the different types of AI, regulators are struggling to keep up as well. When the innovations begin to outpace the regulations, compliance becomes a major challenge, especially if [the regulations] don't yet exist. Again, I think confusion around AI clouds that issue. The misconceptions of what AI is capable of can influence how it is utilized and regulated. A lot of the AI in the life science space is based on machine learning, which requires good data to go in for the AI to put good data out. That inverse relationship has caused both manufacturers and regulators to simultaneously underestimate and overestimate AI.”
Moving forward, do you see AI having more influence on medical devices during pre-market processes or post-market process?
Kellen Giroux: “In the near term, the influence will be highest on the pre-market process. Most medical device manufacturers who are investing in AI are working to integrate it into their products and to develop AI-enabled interfaces. Right now, that is seen mostly in assisting with customer workflow, allowing the AI to anticipate needs and to make the device operation easier for the user. Eventually, with greater leaps in the AI learning process, the devices will begin to branch into the diagnostic space. We're not there yet for full diagnoses, but that is where many companies are trying to go. Conversely, I can foresee a heavier investment in the post-market phase in the not-too-distant future. The benefits of utilizing AI and machine learning to analyze field data, safety information, and customer experiences will greatly benefit how we investigate patient events and beyond. There are many companies developing these types of programs right now that can generate useful reports in this area, with some even able to offer predictive information so that organizations can anticipate issues, compliance gaps, and recalls. This will eventually feed into making better devices by organizing and predicting the customer needs. In the end, it will be a cyclical benefit.”
AI is progressing at such a rapid pace that the term “innovative” seems to be constantly expanding. What is that you think is truly innovative about AI in the medical device space as we get closer to the conference?
Kellen Giroux: “I think as we see more innovation in the diagnostic space, we are going to start to see some truly remarkable products that are able to determine patient symptoms and outcomes. As I mentioned, I have not seen devices that are really living in this space yet, but, with the proper database, I don't think we are too far off from this really taking off. The current capability that I believe is truly innovative is the ability of some post-market AI. There has always been a plethora of data available, but analyzing it, understanding it, and utilizing it has been difficult for experts and organizations to sift through. Some programs now can analyze public patient incidences and guide a company towards how best to risk assess the same hazard in their own devices, thus allowing organizations to be more proactive and to improve patient safety. I am working with such a company, and it is genuinely awesome to see in action!”
How has AI impacted the need for companies to invest in data and analytics? What is the significance of this type of investment in relation to the presence of AI in med-tech?
Kellen Giroux: “I have always been a huge advocate for data and analytics in the med-tech space. Not many companies truly invest in this area. I think the companies that do get a great benefit for their efforts. It allows you to see market trends and keep a finger on the pulse of how their devices are being utilized. It provides an amplification to the customer's voice. With the presence of AI in med-tech, these trends, signals, and data will be even more important to keep track of, otherwise the data feeding the AI brains will be incomplete. I can see companies investing more in data and analytics as AI in med-tech grows, especially if AI in data analytics continues to grow commensurately.”
Are there any common misconceptions about AI that you plan to address during your presentation that can be previewed here?
Kellen Giroux: “One of the most common misconceptions revolves around AI being objective and unbiased. With the current iterations of most AI, they are only as good as the data being fed to them. If the data has a lean to it, the AI output will as well. The ‘reasoning’ of AI is still very limited in that regard. For example, AI had recently been utilized by certain court systems to suggest sentencing recommendations. A study by Tulane University found that the sentencing recommendations by the AI were found to be prejudicial towards certain groups of people, suggesting longer and harsher sentencing guidelines. It was concluded that this was because the historical sentencing data used to ‘train’ the AI was also prejudicial in the same manner. Until biases can be removed, or data can be baselined, this type of output is still very likely.”
Can you provide a few insights about the differences between AI, machine learning, and generative AI that you intend to discuss more at length during your presentation?
Kellen Giroux: “AI is the overarching concept that describes this vein of technology in general, and this is where a lot of misconceptions come from. To some, AI can mean ‘artificial intelligence,’ aka a sentient being. To others, AI can mean a high-tech calculator. It depends on your experience. Machine learning is one of the most common forms of AI that people have interacted with. It focuses on learning from previous data. Generative AI takes that a step further and uses its data to create new things, rather than just a report or combination of the data it already has. We will be covering examples of these and how they are being utilized in med-tech [during the presentation].”
When you think about the future of AI in medical devices, what do you see as an example of the greatest benefits to manufacturers, providers, and patients. What are the most significant challenges?
Kellen Giroux: “Manufacturers will see significant benefits from AI in both the development of their products as well as in the products themselves. They'll be able to offer enhanced patient experiences and use AI to analyze them to create better products. Patients will see an even more comprehensive experience with their provider, who will be able to offer faster results, greater information, and cover more difficult procedures in the near future. As with most rapidly evolving technologies, the challenge for all will be when and how to utilize this powerful tool. Reliance on AI to perform things could result in negligent outcomes if these tools are implemented before they're ready or before the surrounding environment can adapt. Caution and strong risk assessments will be crucial in integrating this technology into the industry in both a safe and effective manner. In either case, AI in the med-tech space is inevitable, so guidance in this area will need to be collaborative as we all learn together the best paths forward.”
Have a Solution, Not Just an Idea, Expert Advises Medical Device Startups
With 30-plus years of experience in the medical device and IVD sector, President and Founder of Medicept, F. David Rothkopf, has seen many startups come and go. Most of the time failures for startups aren’t for the lack of a great idea, he said, but rather because the companies don’t build strategies that account for the regulatory, clinical, and reimbursement requirements their products will encounter on the way to market.
“What I see very often are really great ideas,” Rothkopf said in an interview with MD+DI, “like a robot that can manipulate around corners and see things, or an IVD that can detect a super rare disease.”
“But a big problem with a lot of startup companies is that they don't have an actual solution,” said Rothkopf. “You're coming up with a really cool new idea that you can do research on and get your PhD on,” he explained. “But that doesn't actually solve an actual problem that the doctor is having.”
In an upcoming session at Silicon Valley MEDevice , Rothkopf will advise startups on how to make sure that their products are good solutions to real problems. He will also discuss how to strategically plan ahead for other things that startups might not be familiar with, especially if they are new to the medical device and IVD industry.
Read on for a conversation MD+DI had with Rothkopf about his presentation, “The Do’s and Don’ts of Medical Device/IVD Sector Early Planning for Start-Ups.”
Can you tell our readers a little bit of what you intend to present at Silicon MEDevice?
Rothkopf: First, I’ll talk about having a solution, not just an idea. I'll give you an example of a medical company that’s been around for about 10 years or so. They’ve never made a profit. They’re a public company and they lose money every single year.
Why? They have an IVD that tests for sepsis. It seems like a really cool idea, but what is the solution? When someone is suspected of having sepsis, doctors just give them antibiotics right off the bat. But if you get the antibiotics, this IVD won't work.
So, the question is, what do you do? It's a really great idea. It costs a boatload of money—millions of dollars and then there's all the disposables. But the solution is, if you find out the person had sepsis in 20 minutes, fine we'll wait 20 minutes and then give you antibiotics anyway. But if I'm going to give you a test and you're not going to get a result for over five hours, well, then I'm going to give this person antibiotics now and I don't need your test anymore. So that's the difference between an idea and a solution.
So, should startup companies talk to doctors, hospitals, or focus groups first to determine if there is an actual need for their idea?
Rothkopf: Exactly. You have to talk to the doctors. And you can't just talk to one doctor because one doctor might have a great idea also and think it's the greatest thing since sliced bread. You have to talk to several doctors.
In one of the companies that I have right now, we have seven key opinion leaders (KOLs) that we talked to and all of them have different opinions, but they all believe that what we have is a solution that can actually reduce their pain points. They think that we could do a tweak here, a tweak there, but in the grand scheme of things, all seven of them think that the current methodology is not great and our solution actually will solve the problem.
So, first there has to be a problem to solve. Once that is figured out, what is the next step?
Building a strategy for regulatory and clinical and reimbursement requirements, and then going for the pitch deck. It’s all of those things combined.
A strategy is not a plan. A plan gives you resources, a strategy gives you a set of choices to lead to a plan. And what happens a lot of times is companies quickly come up with a plan and then go straight to a pitch deck. And what I'm saying is that a lot of investors, don't actually know the resources, the speed, and the timeline that you're going to need for a plan.
Are most medical device startup companies new to the industry?
Rothkopf: The majority of the NIH grant recipients and, and especially the ARPA-H individuals have never created a medical device company. They've done a ton of research, but they have no earthly idea about the regulatory environment or reimbursement.
Reimbursements are an enormous thing. We've got a client in Europe who came up with a really great prostate surgery product and they have no reimbursement. And thus, I think they sold four units last year because they can't get anybody to pay for it.
We had another client that came up with a pediatric EKG product, which is necessary, it actually is a solution. But the cost to make the product is way more than the reimbursement that a hospital would get, and there's a much cheaper way of getting the data. It's not a great solution, but it's cheaper. And thus, these guys can't even get out of the gate.
I've been in this industry for 30-plus years and I've seen a lot of great companies, a lot of great ideas, even some really good solutions never make it out the door because they didn't start with a strategy. They had a plan but the plan was not fully fleshed out. They didn't do the regulatory strategy, so they didn't know what testing they needed, they didn’t do a reimbursement strategy, so they didn't know who the customer was or if there was any reimbursement at all.
How would you suggest startups go about navigating the medical device world?
Rothkopf: They would attend the session that we're talking about! I would also say yes, a consultant is necessary, but you have to realize that a consultant, and I'm saying this as one, a consultant has knowledge but they don't necessarily have knowledge about everything.
If you talk to your investors, your investors are going to come back and say you’ve got to get this thing done yesterday. You got to get it out, get it out, get it out. If you talk to the regulatory people, they may say, ‘wait a minute, this may be a breakthrough designation and if you do that, you can get reimbursement much easier.’ You might talk to a clinical person and that clinical person might say ‘yes, you're going to have to run a clinical trial,’ but from a regulatory point of view you may not.
So, what you need is a band of advisors to ensure that you're getting accurate information and that all three of the strategies—regulatory, clinical, and reimbursement are cohesive and work together.
You don't necessarily need to hire people to get you this information, but you need to get the information and then be able to coalesce it into a strategy, which then can be moved to the plan. Again, the strategy is how are you going to do this or what are the choices I have and then that should lead to your plan.
You’ll also talk about mistakes to avoid. What are some of the “don’ts” you would advise companies against?
Rothkopf: Avoid overly complex designs. If you have a 510(k) me-too product, you're trying to say that your product is substantially equivalent to something that already exists. If you have too many bells and whistles—if you listen to seven different doctors and they all want seven different things (because they will) you're going to end up with this super complex product with a complex design, which is going to lead to a lot of cost overruns, a lot of additional testing, and a lot of difficulty to prove to FDA that your product is equivalent to the predicate.
Now, if you go for a very unique product, a Class 3 PMA product, or even a de novo device, the more complex you make your product outside of its core intended use, then the harder it's going to be for FDA to go over and prove it is safe and effective.
For example, a company I’m currently working with has a product that they kept listening to doctors about more and more and more, and now they have 98 alarms. 98 unique, individual type of alarms that can go off on their product. And FDA came back and said, ‘did you test all 98 of them individually?’ And no, they didn't. Because it would be really difficult for them to do it and it would cost them a lot of money and time. So, they have to go back and decide do we need all these alarms or do we test them all.
Also, a lot of times in order for companies to save money, they’ll go to a contract manufacturer or a contract design house. If you do this, it’s your responsibility to make sure that they do things correctly.
Another prime example is design houses. Many people, especially researchers, they'll take their idea, they'll put it on a napkin, so to speak, and send it to a design house. Well, many times that design person is not going to know all the regulatory requirements. They’re just an engineer and may not understand the whole ramifications of their product, of the design. So, it's the startup’s responsibility to make sure that the product is actually being designed correctly and consistently and to regulatory standards.
What are some holistic strategies that companies should bear in mind and how is this different from other industries?
Rothkopf: Start documenting a design early when dealing with a documentation-based agency like FDA. For example, we had a client that made video games and they wanted to gamify some health activities that would be considered a medical device. They didn't understand the medical software life cycle guidance document, which is how FDA determines if your software is acceptable. They were saying, ‘why can’t we just give FDA the software, let them play with it?’
The second thing that they didn't understand was that they couldn't just release a beta and let the world play with it. Find all the problems and then come back to them so they can make a final release of the product, which is something that high tech does all the time. It doesn't work that way with FDA. You can't do that because you're dealing with a human being.
Or they're in another industry and they realize they can make a lot of money in the medical industry and want to jump into it, but not understand the real regulatory costs that can be a barrier to entry.
Testing is expensive, regulatory is expensive, and design houses actively charge more money for medical device design than just designing a toy, even though the complexity of the toy might be exactly the same as a medical device. There's an additional cost that a company will charge you because of design controls or because they realize it's a medical device.
What’s the most important concept that you hope your attendees will come away with from your session?
Rothkopf: That they need a strategy. You can't just have a plan. Plans are good, but you really need a strategy before you even start with a plan. And you need this information before you work with your pitch deck.
Rothkopf will present his session, “The Do’s and Don’ts of Medical Device/IVD Sector Early Planning for Start Ups ,” at Silicon Valley MEDevice on Wednesday, Nov. 20, from 10:00 to 10:45 a.m., in Great America Meeting Room 1. He encouraged his attendees to come prepared with their questions.