Neurotech Startup Positioned for Successful U.S. Product Launch

A South American neurotech startup that developed a noninvasive device to monitor variations in intracranial pressure (ICP) sought assistance in defining the market opportunity for a U.S. product launch.

The neurotech startup understood an experienced organization with broad industry and clinical expertise would be best equipped to identify, assess, and prioritize the U.S. market opportunity. Prior to its device launch, the company wanted to explore the:

• Realizable market opportunity in key identified use cases
• Value proposition in key patient segments
• Primary barriers to provider adoption

For answers, the startup turned to Guidehouse to conduct a strategic market assessment and facilitate leadership team alignment on a comprehensive plan to prepare for U.S. launch.

Challenge

ICP as a critical vital sign has been measured primarily in the context of neurotrauma in the intensive care unit (ICU), and current measurement techniques are invasive, costly, and present risk of infection to the patient (e.g., lumbar puncture).

In concept, this new device would allow for ICP monitoring across a much broader range of indications, benefiting patients who currently may not be indicated for invasive ICP monitoring, and increasing the potential to prevent adverse events in patients currently indicated for invasive monitoring techniques.

For example, beyond neurotrauma, other conditions such as liver failure and meningitis can cause a dangerous increase in intracranial pressure, which can subsequently result in neurological damage. Despite this risk, ICP is often overlooked in these patient segments due to the invasiveness and complexity of current ICP monitoring techniques.

Solution

The company’s research concluded that among certain patient segments, noninvasive ICP monitoring offered significant clinical benefits, even reducing mortality in some populations. Additionally, research indicated providers might consider using ICP monitoring to ensure that the brain is maintaining an appropriate level of volume and receiving necessary levels of nutrients. Further use cases included determining whether shunt treatment is properly draining excess fluid, ensuring patients are receiving correct drug dosages, or identifying whether a patient required a CT scan.

In addition to this research, the company identified several potential target indications in which the device offered clinical benefit to the patient, including hemodynamics management in ventilated patients, hydrocephalus diagnosis and management, and lumbar puncture decision and analysis. They theorized that these patients may not be indicated for ICP monitoring using current techniques due to the high-risk profile and cost, and, therefore, would stand to benefit from the company’s safer, noninvasive ICP monitoring device.

Within the target indications identified by the company, Guidehouse’s MedTech team conducted a rigorous literature review — more than 100 peer-reviewed articles — and leveraged Guidehouse’s proprietary National All-Payer Scale Model to procure age-controlled population and procedure estimates across U.S. commercial and public payers.

After conferring with the client and aligning on exclusion factors, i.e., age, skull fracture, craniectomy, the Guidehouse team filtered the found gross patient population via claims analysis — using both Medicare and commercial databases — to further understand the specific patient segments most compelling for device use and the sizes of each of those segments within the U.S. healthcare system.

Upon identifying key patient segments, the Guidehouse team outlined the primary challenges the company will likely face in launching the device in the U.S. and provided guidance on a successful product launch, including educating providers and establishing clinical guidelines around the utility of ICP beyond extreme neurological cases.

Impact

Guidehouse’s strategic market assessment helped the neurotech startup’s leadership team understand which patient segments have the greatest need for noninvasive ICP monitoring, which provider segments are most likely to adopt and champion the device, and which strategies should be pursued to resolve the major barriers the company will see prior to and upon U.S. launch.

As a result, the team is aligned on a roadmap and well-positioned for successful U.S. commercialization and widespread adoption.