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

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.