Plagiocephaly Preventative Mattress: Class 2 FDA Medical Device

Plagiocephaly refers to an asymmetrical head-shape deformity. This is an important issue to address as not only does it affect 47% of infants, but it has risen an astonishing 600% since 1992 in an attempt to reduce Sudden Infant Death Syndrome (SIDS). If left untreated, it can lead to cognitive and motor impairment, visual deterioration, and academic disadvantage in the future.

To solve this dilemma, other devices have been designed to remedy this. However, it has been found on more than one occasion that the current devices out on the market either do not adequately solve the issue at hand or act no better than giving a placebo effect to the concerned parent or guardian.

In response to this, we have chosen to design a novel device, named the Plagiocephaly Preventative Mattress (PPM), that through innovative design and use of modern technologies can prevent Plagiocephaly before it even begins. PPM needed to satisfy being safe for the infant by not causing any unnecessary hazards during use, being comfortable for the child as having an uncomfortable device would promote not falling asleep and fit inside a crib as that is where the device would be placed.

This design takes the form of a comfortable mattress topper that an infant can lay on top of while the operation gently turns the child automatically, relieving pressure from the center of the head and evenly distributing it.

The time frame that was given to our group was 9 months (August 2019 – May 2020) and despite many unforeseen circumstances that arose, we were able to complete to project to a level that the team members, sponsors and advisors were pleased with.

You can view our final presentation below.
Alternatively, you can click this link to watch directly on YouTube:
Plagiocephaly Preventative Mattress

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