Thanks to the ongoing advancements in standards of care and gradual improvements in more targeted therapeutics, some argue that cancer is slowly turning into a chronic disease, and with it bringing about a host of new challenges for oncology care. These challenges are also opening up a variety of new opportunities for technical innovations that would mediate the load on already heavily burdened healthcare systems.
One of the leaders driving the development of end-to-end (from diagnosis through to remission and/or palliative care) oncology care technologies is product design and development firm Cambridge Consultants. Medgadget had the chance to sit down with Harshal Shah, the head of Oncology Drug Delivery at Cambridge Consultants, to chat about the current status of the field and where medical technology innovations in oncology are poised to be in a few years.
Mohammad Saleh, Medgadget: Tell us about Cambridge Consultants and your role as Head of Oncology Drug Delivery.
Harshal Shah, Cambridge Consultants: Cambridge Consultants has been in business for more than 50 years, primarily doing product development for some of the leading names in multiple industries. We have a large team of about 750 scientists, engineers, and physicists. We now work across various industry sizes and segments. We don’t just work on medical devices, but we have dedicated divisions around consumer products, oil, gas, & energy, as well as satellite phones & wireless communication devices. You can pretty much think of any innovative product area and we’ll have our fingerprints on it in some way or another. We’ve spun off more than 20 startups, and some of the innovation to come from our labs has gone on to become billion-dollar businesses.
We have three groups that we’ve structured around medical technology innovation, focusing on diagnostic, surgical, and drug delivery systems. As head of Oncology Drug Delivery Systems, my primary interest is in innovation in the area of modern delivery devices such as patch pump connected devices, micro-dose delivery systems, and auto-injection systems. I also closely collaborate across the MedTech groups who are focused on surgical and diagnostic innovations within oncology as well. Oncology is a unique area where all three are intertwined and closely integrated.
We are continually investing a lot of resources into internal research and identifying unmet needs so we can do something innovative and revolutionary. Since we have groups focused on other industry segments as well, we learn a lot about innovations in those industries too, and we’re constantly thinking about applying them in a cross-functional manner for medical applications. We’re also always looking into external partnerships to work with pharmaceutical companies and help them get ready for the evolution that oncology care is undergoing.
Medgadget: You mentioned particular technologies like patch delivery and auto-injectors. Could you comment on some of the recent advancements in the oncology medtech space? How have recent advances changed oncology care?
Shah: If you think of the latest drug innovations in immuno-oncology or targeted therapy to treat cancer, they’re becoming much more effective, leading to higher cure rates and much longer progression-free survival. Patients are increasingly living near-normal lives for much longer periods than before. The direct effect of this change is that patients are now expecting to live a relatively normal life once they’ve passed through the acute treatment phase after diagnosis. If their prognosis is improving, their expectation evolves into “If I’m not feeling sick and my doctor doesn’t need to see me, and if a diabetic can take a drug at home, why can’t I?” If the patient is in a healthy condition and it’s just a matter of taking a regular dose, then going to a hospital and occupying an IV-infusion chair is a loss of efficiency for the overall system. Taking the drug in a non-hospital setting would be much more economical.
So there’s now a trend for a lot of these drugs that were traditionally developed as an IV to switch to subcutaneous administration. Some of that work is on reformulation, but putting those drugs onto pumps has provided increased convenience and is changing the caregiving model for some of these oncology drugs. Before this becomes a mainstream care model, there are challenges that need to be addressed, though. Some of the more complex drugs require consistent monitoring of vitals before, during, or after the drug administration so that treatments can be stopped or adjusted if need be. The normal patch-pumps that were designed for diabetes and then cross-leveraged for oncology drugs need to become much smarter for them to be a mainstay in oncological applications.
What we’re doing right now is creating a smart pump that is connected with a number of peripheral devices. For example, if a drug requires monitoring of heart rate and oximetry throughout administration, your pump could be a closed-loop system that talks to such monitors. We’re generating an ecosystem around these patches, rather than having them do the measuring. Why re-invent the wheel and re-engineer a measurement device when you could link-up with existing technology?
Another example of these challenges is that some drugs require a patient to lie down at a 45-degree angle to ensure that the drug flow to the brain is not excessive. You could imagine using gyroscopes and proximity sensors to make sure that patients are adhering to the proper guidelines. You can’t just mention in your instructions that this is a requirement – you have to ensure that this is actually adhered to so they don’t put themselves in harm’s way. As long as your systems are validated and you have appropriate measures in place, you can design a sufficiently fool-proof system. There’s always room for error, be it through human or machine involvement, but as long as these systems are engineered reliably, they should be safe for deployment. You could even have certain parameters fixed into the system itself – for example, if you pass a certain threshold of heartbeats, call 9-1-1 automatically. Those are the kind of features that will ensure translation to the home.
Medgadget: You touched on current inefficiencies in clinical settings. How are these technologies affecting the economics of cancer care?
Shah: Everything hinges on health economics. How can you build a case that your innovation is going to decrease the overall cost of care? Most of these innovations attempt to fulfill an unmet need, change the current standard of care, or have a cost-saving proposition. In terms of drug delivery, any medication that is mandated to be administered to a relatively healthy and mobile patient in an infusion center or hospital is an inefficiency in the system that could easily be addressed by self-administering pumps. Let’s say a drug dose costs $5,000 and administering it in a hospital setup costs another $3,000. Putting the same drug on a high-end $300-500 smart pump saves at least $2,000 per dose to the care-delivery model. These innovations can dramatically reduce the cost of care and offset the increasing costs of these drugs. New checkpoint blockade, CAR-T, or cancer vaccine therapies are all very expensive to manufacture, distribute, and set up. Smarter drug delivery regimens, along with better and earlier diagnostics, will go a long way to decrease overall costs. Similarly, in surgical care, technologies to accurately identify tumor margins and more precise surgical interventions will decrease chances of relapse and the need for repeated surgeries.
Medgadget: You identified a couple of trends such as the move to home-based systems or making them smarter and safer. Could you comment on upcoming R&D trends that promise to revolutionize the industry over the next few years? What do you envision the clinical oncology pipeline to look like in the future?
Shah: Something that I’m really passionate about, and more on the futuristic side of thinking, is the continuous monitoring of vitals and digital biomarkers in a broad sense. We know that early diagnosis of cancer can help improve prognoses and cure rates. How early can you possibly detect it? In most cases, the cancer is detected when it’s already in maturity, or is at least late enough to be classified as a Stage I tumor. Are there any vital signs or bodily changes that are worth monitoring on a constant basis, at least in groups that are at high risk of developing cancer?
An example of Cambridge Consultants’ cross-disciplinary expertise is their development of the Cyto-Mine® dispenser for Sphere Fluidics. This technology combines microfluidics, optoelectronics and engineering proficiency to develop a single cell analysis instrument capable of dispensing single picodroplets on demand.
Current monitoring devices are stand-alone technologies, and that’s the reason why we fail to collect high-quality data from digital biomarkers. The way I envision this evolution is perhaps, ten years down the road, products will mingle into the environment surrounding people – things like smart offices or bathrooms with sensor-equipped mirrors or toothbrushes that can test your saliva to alert you if something is wrong. These will enable early diagnosis and prevention of cancer to save billions of dollars spent on cancers that reach late stages. With increasing use of big data and massive computing power, we can link health conditions with particular signals. Mapping these patterns will lead to an evolving understanding of these biomarkers, allowing us to adjust our screening algorithms accordingly. Any change in your body is in response to something. It may not necessarily need medical intervention, but your device could perhaps suggest alterations in your diet or lifestyle.
That way you don’t have to worry about whether patients will remain engaged with these devices – they naturally fit into the day. The reason some people lose the motivation to remain engaged with current devices is that they’re designed in isolation. Every device needs its own charging and has its own data with no way to integrate or look at them holistically. Industry standardization and some cool innovations have to happen so that these no longer remain “stand-alone” devices. When these smart devices become an integral part of your daily lifestyle, we’ll be able to truly achieve real-time continuous monitoring for high-risk patients.
Medgadget: Any other trends or areas of research in oncology care, beyond generating diagnostic eco-systems, that excite you?
Shah: On a shorter timescale, there are two promising fields: palliative care and surgical oncology. Historically, palliative care has largely been ignored because the US healthcare and reimbursement systems were designed to consider that stage of disease progression as a “lost cause.” Obviously, at that stage, the intent is not curative but rather managing the symptoms to give patients as much quality life as possible. There are some very quick innovations that can be leveraged in palliative care to help ease and improve these patients’ lives. I’m interested in pain management drug delivery pumps that would be controllable by caregivers in hospice care settings. The pain is often so acute that it’s not well managed through opioids or other medications. Implantable pumps exist now, but patients in palliative care have highly complex conditions – so implants come with a high risk of infection. Other complex challenges also exist around administration, flow, and device control, especially if patients have lost dexterity or part of their memory. That, again, is where connected and smart systems come into play – a caregiver should be able to monitor these factors from a central station and take care of multiple patients at the same time. That also justifies the cost and investment – we’d be helping patients as well as reducing the healthcare cost. The same rationale applies to all sorts of drugs and technologies that go into palliative care. On the side of surgical innovations, there are a number of implants and aids that help patients in an acute health state to manage their breathing, and intake of food or water. Those technologies were cross-adapted from cardiology and endocrinology and have seen very little change since.
Developed in partnership with Cambridge Consultants in 2014, the ClearCell® FX System is able to isolate and capture circulating tumour cells (CTCs) from a blood sample – even at concentrations as low as one in a billion blood cells.
Medgadget: What technologies that are currently being developed come to mind for their promise to be game-changers in the field?
Shah: There are a number of startups that seem quite promising, but it’s always very hard to gauge their real potential and the state of the technology’s development. Nice concepts on paper don’t always translate to successful technologies.
That being said, I’m a fan of Counsyl’s technology. They offer rapid and automated DNA testing for a variety of diseases and genetic disorders at early stages to allow for informed decisions. I see that kind of technology being very valuable if it becomes mainstream, because it could help classify patients on a massive scale and narrow down who needs critical monitoring or closer surveillance.
Medgadget: The need for innovative technologies to better understand and treat cancers has trickled down to other areas of investigation. For example, single-cell sequencing developed for heterogeneous tumors is now being applied in rapid diagnostics. Do you predict any current/upcoming technologies having similar impacts?
Shah: Mass spectroscopy is making its way in to the surgical field with early research in using the technology to analyze cancer tissues in real-time during surgery. The entire industry of wearables built around consumer health is priming the ideas around early diagnostics and continuous monitoring – digital biomarkers, so to speak. Precision microchip manufacturing technology is being implemented in dispensing aerosolized medication, for example, in Respimat Inhalers, as well as for designing long-term micro-implants. All of these examples support the idea of the trickle-down effect of innovations in other industries or other parts of medical sciences into cancer care.
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