New Concepts and National Conferences

Our team’s pivot, strategy changes, and lessons learned from our conversations with the Hydrocephalus community

Anubhav Shankar
BerkeleyBIE
5 min readJun 30, 2020

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With the completion of the fourth week of the Biodesign Immersion Experience, our team has crossed the half-way point of the internship and is accelerating towards our final deliverables. We completed a series of interviews last week, each further strengthening or offering new perspectives on the various challenges of Hydrocephalus. Finally, the week culminated with our team attending the virtual Hydrocephalus Association Connect Conference — the 16th annual national conference for Hydrocephalus.

The Interviews

Our team’s goal from the start of the program has been to obtain the most interdisciplinary and multi-faceted understanding of Hydrocephalus by talking to a large number of stakeholders. This last week was no different, as our team got the chance to talk to more neurologists and neurosurgeons, the CTO of an existing biomedical device company, and a few more patients.

As our team nears the goal of 35 one-hour interviews, we have collected several opinions and perspectives surrounding hydrocephalus. The insights from these interviews have revealed multiple patterns and needs within this community, which inspired two “pivots” in our project idea. Now, with a much deeper understanding of Hydrocephalus than what we started with 4 weeks ago — barely knowing what the disease is — the team is exploring the field of non-invasive intracranial pressure (nICP) monitoring.

(Left) An External Ventricular Drain is often considered the gold standard intervention for high ICP due to its pressure monitoring ability and therapeutic option to drain excess CSF from the ventricle. (Right) The intraparenchymal bolt is a purely diagnostic tool with no therapeutic ability to remove excess CSF. Both are invasive procedures and bring risks for infection. (Adapted from La Fe University Hospital)

In our interviews with Dr. Michael Williams (Neurologist, UW Medicine) and Dr. Manish Shah (Pediatric Neurosurgeon, Children’s Memorial Hermann Hospital), we heard similar problems from our physician interviews from before. Currently, when the patient’s shunt is occluded and malfunctioning, and as CSF and pressure in the brain builds up, diagnostic tools are limited. Noninvasively, they may use serial imaging (via MRI or CT) or ShuntCheck (thermal dilution test) — although adoption is sparse and skepticism runs high. Alternatively, the more definitive tests are also more invasive, such as a spinal tap, nuclear dye imaging, or an intraparenchymal bolt/external ventricular drain (EVD) to measure pressure.

(Right) ShuntCheck system with an output device (tablet) connected to a thermistor sensor and an ice pack to cool the CSF. (Left) The use of the ShuntCheck test involves placing the thermistor sensor directly above the patient’s shunt and using the ice pack to cool the CSF in the shunt upstream of the sensor. A decreased temperature reading at the thermistor sensor is indicative of flowing CSF and proper shunt function. (Image source: NeuroDx)

The answers from our interviewees led our team towards the realization that existing technology does not allow for fast, easy, and accurate pressure monitoring at the bedside, and definitely not in the comfort of the patient’s home. Conversations with three more patients this week further confirmed a recurring desire within the community — the ability to quantitatively and accurately monitor their or their loved one’s condition at home. Despite the importance of knowing pressure levels, the invasive technology and procedures are left for emergencies and the operating room. The reason for the lack of development and new technology? Surgeons and company representatives in this field told our team that Hydrocephalus is a “sleepy” market — a small community that sees little representation or funding.

In spite of the challenges, the customers’ needs are clear. Patients and physicians want to be able to noninvasively and easily monitor intracranial pressure at the bedside and at home. According to Dr. Manish Shah, and many physicians we talked to earlier, a noninvasive pressure monitor would be the “holy grail of figuring out if a shunt is working or not.” Additionally, Hydrocephalus patients would not be the only group to benefit from such a device. Other indications (clinical problems) that require ICP monitoring include traumatic brain injury (TBI), subarachnoid hemorrhage (brain bleeds), idiopathic intracranial hypertension, Reye’s syndrome, and more — increasing the potential stakeholders and beneficiaries of this technology. Now, our team’s goal is to figure out how to bring physicians and patients that technology.

“A noninvasive pressure monitor would be the ‘holy grail of figuring out if a shunt is working or not.’”

Hydrocephalus Association Connect Conference

It is important to always find the silver lining of the worst situations, and this pandemic is no exception. Our team experienced this when we had the unique opportunity to virtually attend the 16th national Hydrocephalus Association Connect Conference this past weekend. From the comfort of our homes, we joined many Zoom panels with experts in the field of Hydrocephalus — many who we had the chance to talk to in our interviews earlier!

This year’s national Hydrocephalus Association (HA) Connect Conference was held over Zoom, an educational opportunity to patients and families to hear directly from the leading medical professionals and researchers in the field (Source: HydrocephalusAssociation)

Over the course of Friday and Saturday, our team listened to and took notes of neurosurgeons, neurologists and scientists explaining the various complexities of Hydrocephalus and developments towards solutions — both in biomedical devices and biomolecular research. We look forward to using what we learned to shape new questions for our future interview.

Next Steps

As we wrap up the internship, we are faced with an interesting challenge — a community that knows what they need, but science and technology that has not developed far enough to provide it to them. To date, our team was catching up on the past century of developments in hydrocephalus — learning about the disease and symptoms, the treatment options, and its challenges. Now, moving forward, we move towards the cutting-edge of research and science in Hydrocephalus. Our strategy for the coming days is to explore novel technologies such as Transcranial Doppler Ultrasonography (TCD) and talk to the pioneering teams that developed them to understand how non-invasive pressure monitoring can become a reality and the ideal solution that patients and physicians are looking for.

“We are faced with an interesting challenge — a community that knows what they need, but science and technology that has not developed far enough to provide it to them.”

Recap of Our Work

Here are some links to the work that led us to this point:

Week 1 — “Falling Straight Into the Lean Launchpad Model” — Elizabeth Wang

Week 2 — “‘Zooming’ Out of the Building” — Mitchell Tau Wong

Week 3 — “Reflections and Synthesis” — Mariam Ayrapteyan

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