During his Fellowship in Craniofacial Orthodontics in 2014, Dr. James MacLaine had the idea for a new device to improve on existing appliances for pre-surgical orthopedics. The purpose of this appliance is to reposition the gum segments of cleft infants. These appliances reduce the tension on the lip, which improves the initial lip repair by the Plastic Surgeon. Each of the two most frequently used methods, the Latham Appliance and the NAM technique, have inherent limitations. His goal was to create a device which would not ‘collapse’ the cleft gum segments but would position them according to more ideal anatomy. Dr. Shusterman, then still working, was very encouraging and supportive of the concept.

At that stage, Dr. MacLaine had some basic design skills but not enough to develop a prototype himself. With funds from a Boston Children’s Hospital grant, he engaged an outside company to develop a prototype. Unfortunately, they used most of the money but delivered a non-functioning prototype. Lesson Learned!

In 2017, the FFC gave Dr. MacLaine an additional grant to further develop the device. The most important thing about this grant was that the money could be used to buy equipment which he could then use himself to make prototypes.

Prototype MacLaine Appliance

By now he had mastered 3D CAD software and thanks to the ever-decreasing cost of technology, Dr. MacLaine was able to experiment with various desktop manufacturing techniques, primarily 3D printing, injection molding, CNC milling, and Arc welding. After many (~30) design evolutions, he has apparently found the right combination of function, size and robustness.

In the future, this appliance will hopefully be available to our families, after clinical trials to measure its performance. Dr. MacLaine reflects, “None of this progress would have been possible without the grant money from the FFC and I am very grateful for their assistance. It is my hope that future generations of cleft children – either directly or indirectly – will benefit from this investment. Hopefully very soon!”