Starlight Cardiovascular

Overview

Starlight is designing a set of devices specifically for newborns and babies with congenital heart disease.

The Issue

A surprisingly underserved population, about 1 out of every 100 babies born in the United States has a congenital heart defect. Currently, the standard of care is either two or three surgeries in the first year of life, or – if successful – a hybrid approach where the first surgery is replaced by an adult stent implanted using a microcatheter. The issue with the hybrid approach is that it’s not successful about half of the time; either because the device is designed for adults so it does not sit properly, or the microcatheter (also designed for adults) is too difficult to use because of the length.

Approach

Starlight has two potential devices to mitigate the issue. The septal conduit is specifically designed for complex congenital heart defects and is sized for newborns. The pediatric microcatheter is also sized for newborns and can be used in all percutaneous cardiovascular procedures.

MTM Student Engagement

Our team was focused on helping assess whether Starlight should proceed with the septal conduit or the pediatric microcatheter. We compared multiple factors such as the business plan, reimbursement, regulatory strategies, market assessment, unmet needs, and more to thoroughly understand which device Starlight should focus on first. Each category was weighted and then graded by the MTM team, resulting in a scored outcome.