Richard Hausmann is the CEO of Elekta, a firm focused on precision radiation medicine and the combination of science, technology, and clinical intelligence to revolutionize cancer care.
Eric Kolb, MS, is the CTO and co-founder of Elidah. The company designed and manufactured the Elitone, the first externally worn treatment for stress urinary incontinence cleared for over-the-counter use.
Ken Londoner is the chairman, CEO, and co-founder of BioSig Technologies, a medical device developer for the electrophysiology market.
Misha Rakic is the CEO of Xoran Technologies, a pioneer of low-dose radiation, cone beam CT scanners for use in-office and operating rooms.
Richard Vincent is the CEO and co-founder of FundamentalVR, a company that created a professionally accredited VR education platform to establish a safe, realistic, measurable space for physicians to learn and develop skills.
Sean Fenske: Overall, is the medical device industry heading in the right direction?
Richard Hausmann: I do believe it’s moving in the right direction, which, to me, means it is responding to the real clinical, operational, and economic needs of the customers and patients it serves. The medical device industry does seem to be focused on efforts to expand global access to better healthcare, whether technology and training is needed in rural parts of mature markets or the first technology for a specific disease is introduced into a country in need.
Elekta is not only focused on global access to radiotherapy, we also work with healthcare professionals to design and bring to market technologies that make a difference in how patients with cancer and neurological diseases are treated. We do this through consortiums and other collaborative research platforms and by building value-based medicine into our products and digital solutions.
While there are challenges, including evolving regulatory landscapes and reimbursement models, I am optimistic about the industry’s ability to meet those challenges and address what’s vital to society—achieving better outcomes and lowering the cost of healthcare.
Ken Londoner: We strongly believe the medical device industry is heading in the right direction. We are seeing growth in all areas of medtech—from innovations in artificial intelligence to triumphs in bioelectronic medicine. In particular, we are seeing heavy investment in bioelectronic medicine. For example, Alphabet (Google) is making strides in the medical device industry with a recently announced partnership with iRhythm to bring attention to arrhythmias. Heart rhythm disturbances is our top focus at BioSig and it is excellent to see our peers as well as companies such as Google recognize the unmet need in this segment. The future is bright for the medical device industry and we plan to continue innovating to provide superior products to health professionals.
Richard Vincent: Overall, the medical device industry is heading in the right direction, but I believe the pace of change is moving too slowly. This assessment is based on a culture of risk averseness. Much of this is understandable and, of course, patient safety is paramount, but innovation needs to be given some space so change and improvements can be made.
Fenske: Are market forces impeding innovation, enhancing innovation, or is it somewhere in between?
Hausmann: I would say somewhere in between. It is said necessity is the mother of invention, and this certainly holds true in the current healthcare market. Value-based healthcare demands medical device manufacturers look more broadly at the landscape in which our products are used and adapt our development processes to ensure we are not only improving some aspect of patients’ health, but doing so in a way that is cost-effective and benefits everyone involved in care delivery.
Elekta solutions are simplifying patient data collection and reporting requirements—big drivers for innovation of digital solutions that reduces the time and cost of delivering care. To enhance innovation, we see more of a need for precision radiation medicine that gives each patient personalized therapy—the right treatment at the right time.
Eric Kolb: Elidah develops products in an exciting space at the junction of wearable tech and women’s health. It’s an area seeing tremendous growth and innovation, which I expect to continue for several years.
Misha Rakic: Within the markets we engage—specifically neuro, spine, and ENT—we’re seeing a trend toward acquisition and consolidation. This trend represents challenges and opportunities. As always, Xoran starts with its motto: Xoran makes the complex simple.
In the operating room (OR), surgeons want technology solutions that work seamlessly together. The trend toward minimally invasive surgery means neurosurgeons need advanced imaging, surgical navigation, robotics, and other visualization assists. What large organizations are doing to respond to this trend is to merge or acquire the technologies they don’t otherwise have.
Xoran is a nimble organization where innovation is our core competency. Our contribution, therefore, will be fundamentally innovative. We have leveraged our knowledge of cone beam computed tomography (CT) imaging and designed the truly mobile CT—xCAT IQ—for both brain and bone imaging. Now, with the announcement of our $8M of matching grant funds from the NIH/NCI and Decathlon Capital, Xoran will be able to bring to market a combined technology solution—imaging with surgical navigation in one product. Our plan to develop a spine CT solution means we will have both cranial imaging and spine.
This means in the OR, a patient will not need to be transported down to radiology to have an intraoperative scan. The xCAT IQ can be rolled quickly into place during surgery, and the patient’s scan images are available within minutes. In the future, with the combined navigation and imaging solution, the surgeon can have the CT images registered with the navigation system seamlessly, potentially reducing costly OR time. Having access to intraoperative imaging may also help ensure surgical completeness, possibly improving outcomes.
Vincent: Market forces are impeding innovation. The old adage, “Everyone wants to innovate, but no one wants to go first,” is ringing loud and clear. Much of this stems from risk of failure driven by a culture of unsupportive behavior. In simple terms, much of the human capital in healthcare, particularly at the patient interface, is pressured in a way that means there is little time to experiment or trial, or explore and fail. Everyone wants certainty. Old protocols of validation and research (while still important) simply cannot keep pace with the speed of innovation and, as a result, many innovations are reduced to the slowest moving component.
Fenske: If you had to pick the most significant, what issue truly keeps you up at night?
Hausmann: My biggest concern is the challenge of access to effective cancer care. And there isn’t a single solution to this because different countries have their own unique challenges, such as high cost to individuals or unacceptable wait times for cutting-edge treatments. And in resource-constrained economies, some treatments simply aren’t available.
Elekta is committed to offering a portfolio of solutions from linac-based, brachytherapy, radiosurgery, and MR-Linac systems that can enable improved care and outcomes while meeting the economic, cultural, and regulatory needs of individual countries. We are leveraging big data and artificial intelligence to innovate software solutions that automate processes, increase productivity while giving clinicians more time with their patients, and reduce costs. This is key in a world in which radiation therapy is becoming more personalized for each disease site and I believe there is sufficient passion and scientific innovation to continue improving both the outcomes and costs of cancer care.
Vincent: Error in the delivery of healthcare is what keeps me up at night. The human cost is ridiculous. In fact, Johns Hopkins suggests 400,000 people die each year from medical error, which is the third leading cause of death in the U.S.
The financial impact of these mistakes runs into the billions! Errors must be surfaced, understood, analyzed, and reduced. Creating safe places for healthcare practitioners to learn, continuously practice, be tested, and accredited is long overdue. The technology is there; what is needed is the political and institutional will to change.
Fenske: Should tech industry leaders (e.g., Google, Apple, Samsung, etc.) be viewed as frightening competitors to device manufacturers or potential partners who offer unique benefits?
Hausmann: I believe the tech and medical device industries have more to gain from working together than competing against each other. The tech industry brings new perspectives, technologies, and software to the table, but they generally lack experience dealing with health regulatory agencies, designing and implementing clinical trials, and marketing to the healthcare community. Medical device companies know how to address these issues, and this will be important if tech companies really want to break into the medical marketplace rather than selling apps and devices for consumer use.
I also believe the resources of both the medical device and tech industries will be needed to address many of the challenges in today’s healthcare environment, including increasing efficiencies, reducing errors, mining data to glean new insights into which treatments are most efficacious in particular patient populations, and ensuring the cybersecurity of internet-enabled devices.
Kolb: Those companies don’t have a monopoly on innovative ideas or on relationships with clinicians/patients, or the capacity to pursue the incredible breadth of medical technologies that comprise the medical device sector. Their entry into the space simply offers exciting possibilities for future innovation.
Londoner: We applaud these companies for taking the vital steps needed to help combat health problems around the world. Google, Apple, and Samsung have resources available to them that enables these companies to innovate by partnering with medtech- focused companies such as BioSig. We look forward to seeing our category grow with the large tech industry leaders coming on board.
Vincent: They absolutely should be considered partners! Healthcare must learn to free its data, expose its flaws and failings, and learn from them. Tech leaders have the ability to aid this progression.
Fenske: As the industry moves to a value-based reimbursement model, does it open the door to device makers to become true partners with care providers?
Hausmann: We believe it does. The days of medical devices being stand-alone products is over. The medical device industry must be laser-focused on creating practical solutions to the real challenges that exist today in healthcare. This includes considering how the end user will interact with a device, the clinical workflows in which it will need to be integrated, and the treatment paradigms in which it will be used. This approach to development can succeed only with a true understanding of how customers operate and how patients move through the care pathway. The shift to value-based reimbursement models has only reinforced the growing need for customer collaboration and patient centricity.
Value-based reimbursement is making it easier for customers to adopt Elekta’s cutting-edge technologies by reimbursing for a complete episode of care (from diagnosis to the end of therapy) rather than for individual office or clinic visits. This creates a very powerful incentive to utilize more efficient treatments, which is particularly beneficial in radiation oncology as a growing body of data supports the clinical benefits of hyperfractionated regimens in which higher doses of radiation are delivered over a fewer number of treatment sessions. These regimens can also increase access to care and reduce patients’ indirect costs of radiation therapy by reducing the number of times they need to undergo treatment, which may impact travel costs, time off from work, child care costs, etc.
Close collaboration among device manufacturers, care sites, physicians, patients, and payers is essential for making value-based healthcare standard practice. And we have to make it standard practice because the current healthcare economic landscape, especially in the United States, is simply not sustainable.
Kolb: Yes, and this is in part evidenced by ongoing market consolidation and the ever expanding breadth of products and services offered by the top tier medical device companies. What is equally interesting is how device makers will grow their relationships with the patients. In the wearable health technology space, companies frequently market directly to patients and promote value-based messaging to consumers who pay out of pocket for their healthcare. These companies also spend heavily on engaging their customer base and enhancing user experience, much like consumer electronics companies.
Londoner: I believe it does. In our example, working with physicians enables us to continuously innovate our core product—the biomedical signal processing and analyzing platform PURE EP System.
By putting our product through rigorous pre-clinical and, later, observational clinical studies, we were able to receive tremendous feedback from top electrophysiologists across the nation. Working directly with physicians—future users of the technology—enables companies to hear first-hand feedback in real-world scenarios to position the company for a strong commercial launch. Ultimately, we are looking to serve patients and doctors, and to do so, companies must put forth only the very best medtech products.
Rakic: Xoran has embraced value-based reimbursement from the beginning. Since Xoran’s inception in 2001, we have understood ear, nose, and throat (ENT) practices want a turnkey solution. Our MiniCAT—a point-of-care CT designed for ENT and allergy—allows surgeons to image their patient in the office and devise a treatment plan quickly and efficiently.
Fast and efficient healthcare is at the heart of MACRA and MIPS. Reducing time to treatment, ensuring accurate and timely diagnosis, increasing patient access to care—these are all goals that align closely with the MiniCAT value proposition.
Xoran’s MiniCAT has always been at the heart of that solution—ENTs need a sinus CT as a key diagnostic tool. By placing the CT at the patient’s point-of-care (i.e., where they are seeing their surgical specialist), three appointments could be reduced to one appointment. What’s more, the ENT can review the treatment plan with the patient, ensuring increased compliance.
Vincent: Yes! This exciting change is an opportunity to redefine the relationship between the parties. It will challenge device, pharma, and insurance alike, but it is an essential progression.
Fenske: Given the numerous changes to regulatory oversight in a variety of locations around the world, is the environment becoming more or less restrictive?
Hausmann: This isn’t an issue for Elekta. We believe every country has the right to regulate as it believes appropriate to protect the health of its citizens, and we adhere to the relevant regulations in the countries in which we operate.
Kolb: The increasing levels of standards harmonization is making the process of bringing products to market more predictable and efficient, but with it comes increased complexity, making it ever important to hire talented people who understand high-level regulatory strategy while simultaneously being able to sweat the details.
Londoner: Although the environment is becoming more restrictive for device manufacturers in other countries, we welcome the regulation as it can only push companies to produce products of the highest caliber. Over the last decade, the FDA has worked hand-in-hand with many of the companies in our industry. We tip our hats to the FDA as the organization provides valuable guidance to the companies aiming to address unmet clinical needs in healthcare while ensuring patient safety and efficacy.
Fenske: Do partnerships with academia/universities present a “win-win” opportunity for medical device firms to “outsource” R&D while providing a real-world learning experience for the students?
Kolb: Through the years, I’ve not had great success with outsourcing R&D to academia, largely due to a too infrequent communication between the firm and students and a lack of continuity from one academic semester to the next. I’ve found internship and co-op programs to provide a better “win-win” opportunity. The students obtain real-world experience while the industry sponsor benefits from having the student under their direct supervision as well as identifying the most talented students to hire upon graduation.
Vincent: In most cases, the opportunity to partner with passionate experts, in world-leading institutions, is a win. It provides medical device firms with even more industry expertise and knowledge to develop and expand technologies. Finding true win/win opportunities can be challenging, but with effort and understanding on both sides, it is possible.
Fenske: Does your company partner with any academic institutions or universities on such an agreement? Can you share any takeaways/benefits/challenges of the arrangement?
Londoner: We partner with several universities each summer for our rigorous intern program, which offers summer internship opportunities in clinical, biomedical engineering, and business fields. This year alone, we employed 10 students from Lafayette College, Bates College, Union College, and the University of Delaware. Our company benefits tremendously from working with them on several important initiatives. These students are our future, and we feel it is our duty to help them get ready to be the next leaders in the medical device industry.
Rakic: Xoran has a long-standing history of collaboration with academic institutions. We have key opinion leaders in leading academy institutions and health system organizations throughout the U.S. and internationally who provide input and feedback on our systems. Because our products are innovative and our customer service excellent, our provider partners are generally more than happy to discuss with us their thoughts on whatever new product or service we are currently working on.
Vincent: Yes, we are partnering with institutions including (but not limited to) Harvard Medical School, Mayo Clinic, and Sana Klinken (Germany). Each relationship is unique in objective and outcome, but what unifies them is that once the common understanding has been gained, there is genuine ongoing commitment to achieving our common goals. From these relationships, we’ve improved our product as well as conducted validation and research on current and future product and technology initiatives.
Fenske: What are your opinions of innovation competitions? Should industry support these ventures or do they result in new competitors, which could be viewed as a negative?
Hausmann: Elekta absolutely believes innovation is essential for improving patient outcomes, increasing access to effective healthcare, and enabling value-based healthcare paradigms that achieve these goals in a cost-effective manner that benefits patients, physicians, and payers. We welcome innovation regardless of the source and look for opportunities to collaborate with others who share our vision of improving cancer care.
As an example, PalabraApps developed a cutting-edge voice recognition technology that was specifically designed for use in patient documentation. Our partnership allowed their technology to be part of Elekta’s MOSAIQ electronic health record. Similarly, Elekta believes artificial intelligence (AI) and the use of big data are absolutely essential for improving healthcare outcomes and reducing cost and inefficiency. We have a robust internal effort focused on AI, machine learning, and advanced data analytics. Yet we also partnered with several external experts in AI to capitalize on their leadership. This allowed us to provide our customers with new solutions sooner than we could have using only our internal capabilities.
Kolb: They are a great way to get multiple eyes looking at problems industry isn’t actively tackling, and the ideas generated can serve as great launching points for new projects or ventures. That said, companies may be better served by fully leveraging the innovation potential within their own organizations. Are all employees tasked with developing innovation solutions? Are they presented opportunities to innovate outside of their immediate scope of work?
Londoner: Our first product—the signal processing technology PURE EP System—is designed to work in parallel with other equipment in the electrophysiology lab. Our goal is to improve the overall performance in the electrophysiology lab by improving signal clarity and not to appear as a competitive force. If more innovators create sustainable and effective medical devices, we only see it as a positive effort in transforming healthcare.
Vincent: Innovation cannot be restricted, and new competition is good for the market. My view is well-run ICs are extremely positive for all.
Fenske: How is the friction with China regarding trade impacting the medical device manufacturing industry?
Kolb: We’re working closely with our supply chain to minimize the impact. There are certainly financial concerns related to unit cost increases that must be absorbed or passed along, but as a small business, we worry more about volatility in component availability and lead times. Industry buying patterns have become erratic, which makes management of supply chain a more challenging and important task.
Fenske: Is outsourcing of medical device design/development/manufacturing growing for your company?
Hausmann: Elekta takes an “outside-in” approach to new product development in which we collaborate closely with physicians, physicists, dosimetrists, and those who treat cancer every day to innovate new concepts and prototypes. We also work with external designers to ensure new products meet the physical, emotional, and occupational needs of the patients and clinical staff who will ultimately use our products. This approach has been tremendously successful for Elekta.
For example, we worked with a multi-disciplinary, global consortium of leaders in radiation therapy, medical physics, and clinical research to develop Elekta Unity, the world’s first high-field magnetic resonance radiation therapy (MR/RT) system. As we worked on the technology with this international consortium, we also worked with DCA Design International to ensure the system had a patient-centric design and was optimized for clinical workflow and operational efficiency. Elekta Unity won several design awards, highlighting the benefits of collaborative development.
Kolb: I don’t foresee a significant change over the next several years. We try to be smart about which tasks we outsource and which we undertake internally. Hopefully, we continue to improve in this decision making process. What is growing is the ease with which companies can identify outsourcing partners, particularly for short-duration projects with clearly defined deliverables.
Fenske: What trend(s) in medtech are most interesting to you and/or will be following over the next few years?
Vincent: Building a company in immersive technology, I find this space most interesting. My team and I are constantly looking for new ways to expand and innovate in immersive technology. Additionally, I closely follow innovation in robotics, which presents great opportunities and challenges for all working in the space.
Fenske: Do you have any other thoughts, comments, or ideas you’d like to share?
Hausmann: Over the last 20 years, advances in radiation therapy have been accelerated by the development of new technologies such as the MR-Linac. Today, it is increasingly becoming more similar to minimally invasive surgery, providing increased precision through optimized image guidance and reduced toxicities. With these new technologies, radiation therapy offers new ways of treating oligometastatic disease with better outcomes and lower burden to the body—even compared to traditional surgery—and has the potential to enable new therapeutic approaches. Given these advances, I believe we are closing in on a future in which radiation therapy will compete more with surgery, particularly high-precision robotic surgery technologies.
Londoner: We recently announced a new licensing agreement with Mayo Clinic. The new agreement aims to develop a new product pipeline to support some of the more advanced features of BioSig’s first product, PURE EP System. The development program will be run under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic’s vice-chair of innovation and medical director, Electrophysiology Laboratory. We are continuously innovating by looking for new, innovative ways to significantly advance the current arrhythmia treatments.
In addition, BioSig was recently added to the Russell 3000 Index and allowed 33 patent claims covering its PURE EP System.
[Editor’s Note: Are you an executive at a medical device firm willing to share your perspective on topics such as these? Reach out to firstname.lastname@example.org.]