Presenting on tele-otology at the AAO-HNS Academy

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We recently presented the data from our study on use by parents of the CellScope iPhone Otoscope at the annual meeting for the Academy of Otolaryngology Head and Neck Surgery.

Overall, the study showed that more research is required on whether parents can reliably use tele-ENT devices to help diagnose their own children. In trained hands, however, it appeared to provide images that are suitable for diagnosis by other physicians. In the future, devices like these could be used as low-cost methods of avoiding unnecessary consults, or providing telemedical access to ENT specialists for specific otological questions in rural area

Above, I have posted the slides from the presentation, and the text of the presentation has been posted below.

 

Academy presentation

*None of the researchers have any disclosures or ties to the product being discussed. CellScope, Inc. provided the device for this study. 

In areas with limited access to otolaryngologists, tele-otology, or diagnoses based on video recordings of the tympanic membrane, has been validated as a reliable method for remote tympanostomy tube surveillance and diagnosis of otologic diseases.

Based on this concept, a company called CellScope has released an attachment that is able to turn an iPhone into an otoscope, which allows parents to record videos of their child’s ears and send them for remote diagnosis by a physician. This device is available in all 50 states and offers to save time by bypassing a pediatric visit. All of the prior studies validating tele-otoscopy, however, have been based on images recorded by trained professionals. Our study aimed to assess whether tele-otoscopy was reliable for diagnosis when parents took videos, instead of health professionals.

This prospective, randomized, blinded study was conducted at a tertiary academic children’s hospital. To simulate parents using the device at home, parents of children ages 1 month to 17 years were placed in an exam room and given the entire Cellscope box. They were allowed time to set up the device and to watch the company’s tutorial videos. They then used the device without any outside help.

With the attachment device, they attempted to record videos of their child’s ears. To tease out whether reliability was based on the user or the device, a physician subsequently used the device to record the same ears. Finally, the child was examined by the gold standard of pneumatic otoscopy by a pediatric otolaryngologist.

Later, a pediatric otolaryngologist attempted diagnosis based only on the videos. To avoid bias, the pedi-ENT was blinded as to whether the recording was obtained by a parent or a physician. The agreement between video diagnosis and original diagnosis on pneumatic otoscopy was recorded, as well as the number of objective landmarks visualized on each recording.

Overall, eighty ears were enrolled. Using a kappa value to measure inter-rater agreement, we found that there was low agreement between the remote diagnosis based on videos taken by parents and original diagnosis by a pediatric otolaryngologist with pneumatic otoscopy. In contrast, there was high agreement, kappa of 0.71, between diagnosis based on videos of ears taken by a physician and diagnosis by pneumatic otoscopy. There was also nearly no agreement between the number of objective landmarks identified when a parent recorded an ear versus when a physician recorded the same ear

100% of parents watched the tutorial, and 87.5% of parents reported experience using an iPhone. Still, a majority of parent videos provided a limited view of the tympanic membrane landmarks. Many recorded only cerumen, making diagnosis impossible, even when diagnosis had been possible with pneumatic otoscopy.

Based on this poor agreement, we feel further studies are needed to ensure there is no significant risk of missed diagnosis or inappropriate antibiotic prescriptions when parents utilize this service. Furthermore, it is possible that the parent tutorials need improvement.

On the other hand, when used by trained physicians in this limited study, it provided high-quality videos of the tympanic membrane, which other smaller studies have noted as well, and at a price of $79 it is relatively low cost, especially when compared to previously used endoscopes for tele-otoscopy. In the future, ACOs or healthcare systems could potentially utilize tele-otoscopy by frontline providers for tympanostomy tube surveillance to diminish unnecessary specialist consults or avoid missed diagnosis. As we strive towards cost-saving measures, we believe further research on the utility of smartphone otoscopes for tele-otoscopy should be conducted.

*The full manuscript for this paper is currently being prepared for submission

Surgeon Workflow Matters in Device Design

This post was originally posted on the Device Talk blog for Medical Drug and Diagnostic Industry Online. You may find it here: http://www.mddionline.com/blog/devicetalk/surgeon-workflow-matters-device-design-07-28-16

Engineers, take note: paying attention to how a clinician operates can lead to a well-designed device that enjoys widespread adoption.

Manan Shah, MD and Timothy O’Brien, MD

Processed with Snapseed.

In print, Sept. 2016 edition

As clinicians, we know that surgical devices need to fit into the flow of a procedure in order to be used frequently. A key example of this is the coblator device, which is used during tonsillectomies. The coblator demonstrates how one company’s solution to a simple surgical design problem resulted in widespread adoption despite other potential drawbacks.

Tonsillectomies are one of the most common procedures performed by otolaryngologists. Despite the frequency of the procedure, the authors of a recent study from Michigan State University pointed out that there “is no consensus regarding optimal surgical technique or instrument selection.” The most common technique involves the use of a monopolar electrocautery, which applies energy directly to tissues to generate heat and burn the tissue. A newer technique uses the coblator device, which employs low-temperature radiofrequency ablation to break molecular bonds in the tissue. The coblator is used by many otolarygologists even though it costs more than monopolar electrocautery and the data on its benefits are mixed.

Why Do Surgeons Use the Coblator?

The key to grasping the coblator’s popularity is understanding the steps of a tonsillectomy surgery. The coblator device, offered by Smith & Nephew, was designed to combine a suction tool, an ablation tool for dissection, and coagulation tool to control bleeding. This combination fits ideally into the tonsillectomy workflow because surgeons often switch between two tools to achieve all of this during the procedure. From a surgeon’s perspective, the engineers of the coblator were able to combine two separate instruments that surgeons often use successively during a tonsillectomy.

A monopolar cautery burns in a thin line, like a knife. It is a fine instrument that assists in dissecting the tonsils out of the mouth while leaving the throat muscles untouched. But each tonsil has a number of blood vessels that connect to it and supply the tonsil with blood. When the surgeon inevitably comes across one of these vessels, the thin, knife-like burn of the monopolar cautery is often not enough to stop vessel bleeding. As a result, blood quickly fills the mouth, obscuring the surgeon’s view. The surgeon is forced to quickly switch to a suction cautery to remove the blood, regain visualization of the vessel, and then use a more diffuse cone of cautery to coagulate the vessel.

The required switch between the monopolar cautery and the suction cautery takes time, and vessels bleed quickly. While surgical assistants are fast, the surgeon must wait—hand outstretched—for the next device, while watching the patient’s mouth fill with blood. In contrast, with the coblator, the suction cautery is already built into the device, so surgeons can simply move their foot to a different controller pedal in order to activate the coagulation tool and stop the bleeding, without ever removing the instrument from the patient’s mouth. The coblator allows surgeons to single-handedly control the vessel bleed more quickly, decreasing time and blood loss.

Because of how the monopolar electrocautery works, it cannot simply be combined with a suction cautery, which is why a new device was developed. The designers of the coblator understood the workflow of a tonsillectomy, recognized the need for a combined excising and coagulation tool, and were able to produce a new tool that streamlines the workflow and makes the surgeon more comfortable when performing a tonsillectomy.

What Does the Data Say?

The data on the benefits of coblation are uncertain. The concept behind coblation is that using a lower-temperature method to remove the tonsils should lead to less collateral damage to surrounding tissues. The hypothesis is that decreased collateral damage leads to decreased post-operative pain and better healing. Many surgeons adhere to this line of logic and believe that decreased pain to the patient is worth the extra cost of using the coblator device.

Studies using tissue samples have confirmed that there is decreased depth of tissue injury using the coblator compared to the monopolar cautery. However, a number of studies have also found that there is no significant difference in post-op pain survey scores between the two techniques. Some surgeons argue that the pain-survey results are due to poor study design, and a Cochrane review of studies on coblators cites a lack of strong studies as a potential cause of the uncertainty over the outcomes of the two techniques. Further recent studies still have not settled the debate on post-op pain benefit. Accordingly, the comparative data remains unclear as to how the outcomes of the two techniques compare.

While many surgeons assert that they use the coblator with the intension of decreasing post-operative pain for the patient, a review of the literature suggests that there is also a more visceral reason for their preference: the lack of switching tools gives a sense of decreased patient blood loss. But the data is mixed. While some studies show a significant difference in blood loss, others do not, and there are even concerns raised about higher risks of post-operative bleeding. Additionally, while some argue that surgeons use coblation simply to save time, studies fail to show any significant decrease in operative time.

The coblator device costs more than a traditional monopolar electrocautery. While both devices require a stand-alone controller unit, most hospitals already stock the monopolar cautery controller units, because monopolar cautery devices are used in a number of different surgeries. In contrast, the coblation device requires the purchase of an entirely new controller not typically stocked by hospitals. On top of this, the disposable unit for each procedure costs more for the coblator than for the monopolar cautery. The Thottam et al. study from Michigan State University estimated that the average overall combined cost of both the instrument and the anesthesia for the coblation technique amounted to $244.32 per procedure, versus only $30.04 per procedure for the monopolar electrocautery. It is important to understand that the reimbursement for a tonsillectomy is the same, regardless of which device is used. Because neither the hospital nor the surgeon is paid more to use the coblator device, facilities may actually incentivize surgeons to avoid using the coblator to save the hospital money.

Overall, there is not yet an obvious consensus among surgeons over whether to use the coblator or the traditional monopolar electrocautery. Until more conclusive data can be obtained, each surgeon must ultimately utilize the device that they feel provides the best outcome for their patients. An ideal device would have strong clinical data and save our healthcare system resources. However, even with equivocal data and higher costs, the coblator has gained support among surgeons because of its ability to seamlessly fit into the tonsillectomy workflow and address perceived risks by the surgeon.

Personally, I am more familiar with the monopolar electrocautery device, so I prefer using that tool and my patients do well. Still, whenever I run into a case that requires frequent switching between the monopolar electrocautery and the suction cautery, I can’t help but think about the coblator. It is a great example of how engineers understood the needs of the surgeon and developed technology to improve surgical workflow.

Medical device designers and engineers need to understand exactly how a surgeon will interact with their device. For innovators, observing procedures and discovering points of inefficiency, like the tool switching moments in a tonsillectomy, can provide opportunities for improvement. Overall, understanding how to make the healthcare team more comfortable can increase efficiency, and most importantly, benefit the patient.

Manan Shah, MD is a biomedical engineer and current resident in Otolaryngology at the University of Connecticut

Timothy O’Brien, MD is a board certified Otolaryngologist and an assistant clinical professor at the University of Connecticut School of Medicine

The authors have no financial ties, royalties, or relationships with any of the companies or devices in this article.

Interview with a Medical Device Venture Capitalist, Darshana Zaveri, on Physician Entrepreneurship

Darshana Zaveri of Catalyst Health Ventures

As physicians become increasingly interested in entrepreneurship, it is important that they first understand the different elements of the entrepreneurial ecosystem. Recently, I had the opportunity to sit down with Darshana Zaveri, a partner at Catalyst Health Ventures, a Boston-based fund that invests mainly in medical devices and recently made an investment in the Otolaryngology space. Darshana discussed her firm’s role in the start-up life cycle and was kind enough to offer advice to physician entrepreneurs on approaching venture capitalists for funding and avoiding common pitfalls that physicians often make.

Manan Shah:  Tell me about Catalyst Health Ventures and what types of investments you make. 

Darshana Zaveri:  Catalyst Health Ventures is an early-stage healthcare venture capital fund that focuses on technology solutions that solve large problems in healthcare. We work with lots of physician entrepreneurs, many of whom are surgeons. Our particular interest is mechanical solutions to mechanical problems, so we invest predominantly in medical devices. Our expertise is in assisting to develop the design and engineering of a device. We also will invest in diagnostics, which make up about 20% of our current portfolio, and we sometimes invest in research and development tools for scientists. We have been investing in healthcare for 14 years now through 3 funds, the last of which we just closed last December. Josh Philips and I source and manage all of the deals and opportunities, and we have about $100 million under management.

Manan ShahWhat are your thoughts on physician involvement in healthcare entrepreneurship?

Darshana Zaveri:  I think physicians should absolutely be involved. There is a lot of emphasis on savings and money in the healthcare system today, but at the end of the day, it should be about the patients, and most physicians truly care about and understand their patients. They know what the clinical needs are and should be involved in finding solutions. In fact, whenever we see an area where a physician has jerry-rigged a solution to make a procedure work, it is a sign to us that it would be a great area to invest in. When we are considering a new device investment, a large part of our due diligence is discussing the concept with physicians we know and trust.

Manan Shah:  When is the right time for physician entrepreneurs to approach early angel or venture funds? 

Darshana Zaveri:  There is no easy answer to that, and there’s a lot that rolls into what makes for an attractive investment opportunity. At Catalyst, we are willing to start the dialogue early, and I mean as early as just having a concept and a PowerPoint, as long as the concept is innovative, feasible, and most importantly, it must improve clinical outcomes and reduce cost. In terms of clinical outcomes, it cannot just be that your imaging technology provides two times more clarity than what is out there; in order for us to want to invest, you have to fundamentally change the clinical paradigm. Most physicians are able to articulate this clinical value, but one area where we see a lot of entrepreneurs stumble is articulating the economic value.  You do not need to have an Excel model, but you do have to have a back-of-the-napkin idea of how much your innovation will cost, how much it will save the system, and how many people it will help.

On the other hand, you do not need to have nailed down every part of your business plan, or have all the answers to the FDA regulation, and the right team. Part of our job is to help you put those pieces together. The most important thing is the concept, and the product has to be cost saving and very innovative.

Manan Shah:  What are some other common pitfalls that physician entrepreneurs make?

Darshana Zaveri:  We are based here in Boston, which is a Mecca for doctors, and we are lucky to interact with extremely bright physicians. One common frustration I have is when a brilliant clinician brings on a subpar CEO, or worse yet, brings on a good CEO but does not allow that CEO to direct the company. When we take meetings with them, it is hard for us to determine who is driving the company, and that uncertainty concerns us. Often, entrepreneurs make the mistake of just partnering with a hired gun, or any MBA, because they think they cannot attract someone better at this stage. This isn’t true; in the same way you need to convince investors to provide VC dollars, if the concept is strong enough, you will be able to attract strong teammates, and then you have to let them execute. Sometimes these quick partnerships make things worse; if we find a great clinician with an innovative concept without a team, we can find a strong CEO to partner with, but it is much harder to get rid of somebody than to find somebody else. Partnering with someone in a business, be it a CEO, a technician, or a researcher, is like a marriage, and it is a good idea in business to date a lot before getting married.

Manan Shah:  Do you think physicians should be CEOs of their own companies? Or do you think our training of ‘trusting no one and double-checking everything ourselves’ hinders us?

Darshana Zaveri:  While there are definitely exceptions, I think it is not always the best idea for physicians to be the CEOs, because sometimes that culture of certainty, particularly with surgeons, prevents you from seeing pitfalls. And it isn’t just physicians, in general, being a CEO is a very tough position, and very few people are good at it. It requires a special mix of personality, experience, and a characteristic that I can’t put my finger on, but I know it when I see it.  I think it is far better to make sure you hire the right people, and, once you do, let them do their job effectively.

Manan Shah:  You recently invested in a medical device in the Otolaryngology space, the Lantos Aura 3D digital ear scanner. Could you tell me a little about the device and how it is as an example of what you would consider a strong investment?

Darshana Zaveri:  I think the hearing aid space is ripe for innovation and currently is dominated by a few key players. We have seen a few companies entering this space; one had to do with disposable hearing aids, another was an online hearing test, and the direct-to-consumer companies are popular now as well. In general, we are leery about technology that leaves the physicians or audiologists out of the loop, because they should be the ones disseminating the technology, and we want them to be our champions.

We were the lead investors in a company called Lantos, which created a device that uses 3D scanning to measure the ear canal and improves the process of creating custom ear buds and fitting hearing aids. As an investment, first off, it completely shifts the paradigm, and the hearing aid field is ripe for innovation. The current technique uses silicon putty placed into the ear to create molds, and many audiologists are hesitant to measure deep in the canal for fear of damaging the tympanic membrane. This technology allows for deeper measurement of the canal, and there is a lot of innovation going on for deep-in-the-canal hearing aids. Also, the silicon putty method takes 10 to 15 minutes to fit, whereas the Lantos technology only takes 30 seconds. More importantly, that computer scan can be sent directly to manufacturers, avoiding the time to mail a mold back, so it decreases the time to production and saves the customer time. Lastly, it improves the function of the product itself because it allows for dynamic measurement. Since the ear canal changes shape with movement, the Lantos technology allows manufacturers to see which areas are constant with movement, allowing for a better-fitting ear bud. Ultimately, this allows you to get increased performance and battery life, since you have less sound loss and require less volume. The technology came out of a group of clinicians working with researchers out of MIT, and all the clinicians we spoke with wanted a digital scanner, which we knew was a strong sign.

What we also liked about Lantos was there was a consumer angle to it. Audiophiles and musicians use custom ear buds, and companies like Logitech and Skull Candy are interested in driving and expanding the custom ear bud space, so we think there are multiple markets that this one technology can address.

Manan Shah:  Thank you very much for sharing your time and for the insightful advice.  If readers have questions for you, is there a way they can contact you? 

Darshana Zaveri:  Sure. They can visit our website and contact me through there.

Learn more about Catalyst Health Ventures and Darshana here: http://catalysthealthventures.com/

New Article in the Academy of Otolaryngology Bulletin: Developing Digital Health Technology

I had the pleasure of publishing an article this month with the AAO-HNS Medical Devices and Drugs Committee on developing digital health technology. The article outlines advice for entrepreneurs interested in creating digital health applications or technology.  

It was an honor to work with the chair of the committee, Dr. Anand Devaiah, as well as the esteemed Dr. KJ Lee, who is not only a key opinion leader in our field, but whose textbook nearly every ENT resident reads. I’ve posted screen shots here, but academy members may read the full article at www.ent.org/bulletin. Special thanks to Shameet Luhar of Vheda Health and Kyle Samani of Pristine whose start-ups I am a big fan of.

Screen Shot 2015-08-11 at 10.25.27 PM Screen Shot 2015-08-11 at 10.26.49 PM Screen Shot 2015-08-11 at 10.27.10 PM

Medical Device Venture Investment Spikes; Trends in 2015

Medical device, diagnostic venture investment at $2.7B, highest since 2008

See article above: Excited to see that medical device venture investment is picking up. It has been a big month for the space after the end of the JP Morgan Healthcare Conference and a number of new Lifescience investments have been announced (ex: Obalon Therapeutics $20M, Apama Medical $11M; and of course Moderna Therapeutics’ historic $450M financing).

One area that I think is exciting is the neuromodulator space. It has been growing, and in my time in VC, I saw a company working on a diaphragmatic stimulator for ALS, just last year the FDA approved the Inspire device for stimulating the hypoglossal nerve for sleep apnea, and recently the FDA approved a neurostimulator device for obesity, the Maestro system.

What is interesting to me is the market and physicians are willing to utilize implants for increasingly less dangerous diseases. No one batted an eye at pacemakers because they are a life-saving device. When the lap-band debuted there was market hesitation because it was an implant for a purely lifestyle disease, but it gained acceptance quickly, and I think part of what sold consumers is that it is an easy to understand mechanical device that works by limiting gastric expansion. What is different about the Inspire hypoglossal nerve stimulator device for sleep apnea, and the recently approved Maestro obesity neuromodulator device, is that they act electronically on significant nerves and alter neurophysiology in complex and not fully understood ways. Also, this is for diseases that can otherwise typically be cured by lifestyle modifications. This suggests that device makers assume consumers are interested in tech implants that don’t just save their life, but make it better, and I think this is related to the trend towards wearables.

The development of these devices signals that the technology for biologically compatible electrodes/sensors is rapidly improving. A clear example are electrodes in the cochlear implant space; where we could once only fit a handfull of implants into the tiny human cochlea, now we can fit in 20 and a 50 electrode model is in the works

The implications of this are twofold: 1) entrepreneurs are increasingly less limited by technology, and instead can focus more on finding/solving significant clinical needs 2) the lines between tech innovation, wearables, and medical device innovation are increasingly blurred. Entrepreneurs will need to diversify their teams accordingly, and more and more software and hardware backgrounds are relevant to life sciences and this is supported by Google X making large inroads into medical device.