Our Journey

Importance of Customer Discovery and Pivoting

Originally started as a graduate level class project, VasSense initially explored methods of performing ABI (ankle brachial index) at home on peripheral artery disease patients post-surgery. However, after extensive customer discovery it was recognized that the problem we initially thought was secondary occlusion due to lack of ABI was actually due to lack of monitoring at home and post surgery in general. Main findings that guided this pivot was based on customer feedback regarding the challenges of ABI. First, there is a lack of doppler equipment on the hospital floor, as well as lack of staff with expertise in listening for the waveforms when often PAD patients' reduced blood flow makes the signal minimal. The second main finding we made was that ABI is not a procedure that is typically done post surgery. For many reasons, but the first being that for patients who have undergone surgical intervention for PAD, it is unwise to put pressure on the vasculature with the inflatable cuff. That being said- flow checks post surgery are often done by hand because the restored blood flow is more easily detectable than presurgery. Another rationale for not conducting ABI post surgery is that since it is assumed that surgical intervention reduces the severity of disease, it is often used more as a pre surgery diagnostic tool than post. It may be performed by doctors at follow-up appointments but is not vital for a patient's initial recovery monitoring.

This led to the pivoting of ideas away from monitoring ABI in post surgical patients, to monitoring of patients with a much more critical issue in mind- secondary occlusions.

Narrowing the Focus: Surveillance Challenges

Patients who receive surgical intervention for PAD are typically only in the hospital for a few days at most. One of the biggest challenges during this recovery period is the lack of available staff to perform Q-15 or Q-hour pulse checks while patients are still in the clinic. Once they return home, the risk becomes even harder to manage—particularly when it comes to identifying secondary occlusions.

Many PAD patients have additional conditions that make symptom detection difficult. For example, patients with diabetes or hypertension often experience reduced sensation in their lower extremities. As a result, they may not feel the early signs of numbness that could indicate a developing blockage. PAD symptoms also tend to appear only after walking a certain distance and then go away with rest, which can delay detection. By the time complete numbness sets in, blood flow is often severely reduced. At that point, tissue and vascular damage may already be occurring and if left untreated, can lead to irreversible damage and even amputation of the leg.

Another major gap is the lack of consensus on post-intervention surveillance, both in terms of timing and methodology. Right now, methods like ABIs and duplex ultrasounds are used to check for restenosis, and while both are accurate, they’re done at inconsistent intervals and require patients to return to clinic or hospital. These tests are also expensive and time-consuming, both for patients and providers.

Rural populations and people with multiple chronic conditions are especially at risk. Rural patients often don’t have access to nearby follow-up care and for patients already dealing with lower extremity pain, it’s hard to recognize when PAD symptoms are getting worse—especially when those symptoms overlap with what they’re already used to feeling.

Considering Market Size & Financials

One of the main components to consider when developing a device is not just how well it works or how well it solves a problem. It also is vital to consider the financial aspects of the device and how the consumers, in this instance how the hospital, can bill patients and receive insurance reimbursement. Insurance reimbursement is vital for a device's integration into clinical care.

Although we could attempt a direct sales model (B2C) , we can leverage the fact that hospitals can get reimbursed through the CPT code. Specifically, since this device is a non-invasive monitoring system CPT codes related to non-invasive vascular studies, such as 93922, 93923, and 93924 could potentially be used.A physician will take a code and submit it for billing. The insurance then looks at the billing and establishes if the CPT modification is valid. Hospital Intermediaries will also be the middleman (to reduce incidence of fraud) to determine if physicians are billing properly. However, since it is not legal to advise hospitals on how they should be billing- this information could be used to inform angel investors on routes for reimbursement. Based on CPT code research Medicare could reimburse up to $ 86.91 per day. Since the use case for VasSense is 10 days of wear post surgery- $860.91 can get reimbursed.

*It is important to note that this section is not intended to provide billing guidance or dictate CPT code usage, but is solely included for market analysis and informational purposes. *

VasSense 2025

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