Orthoses for neonates with cranial deformity

Claudia Villalobos

Just over a decade ago, the lack of orthoses to correct cranial deformities in newborns, as well as the high costs of these devices outside of Mexico, served as the starting point for two young students of Biomedical Engineering at the Instituto Politécnico Nacional (IPN) to develop a corrective helmet to enhance the quality of life for infants by preventing them from aesthetic issues due to the abnormal shape of their heads, orthodontic and ocular alterations, among other complications.

The commitment and desire to provide a solution to this issue led Lucero Rosas Camacho and Julio César García Vázquez to the National Institute of Pediatrics (INP), where they received support from specialists in pediatric neurosurgery to initiate the project that, as students of the Unidad Profesional Interdisciplinaria en Ingeniería y Tecnologías Avanzadas (UPIITA), they saw as their undergraduate thesis, but they never imagined it would become their way of making a living.

Favorable Pause

Under different circumstances, Julio and Lucero would not have paused their studies, but they decided to do so when faced with the dilemma of either failing to fulfill their commitment to the INP or modifying their thesis project to meet institutional requirements. By choosing the former alternative, they were able to enhance their innovation, and upon resuming their academic studies, they developed a mathematical algorithm to identify cranial deformity zones in babies and implemented this tool in the orthosis design, enriching the process and contributing to the creation of an innovative product.

The young polytechnic students named their nascent company Fix You, which was due to the treatment itself. Once incubated and with the purpose of consolidating the corporate image of their business, they renamed it JuluMed.

For a neonate with cranial deformity, time is of the essence, as in the first months of life, the skull bones are more flexible.

Entrepreneurial Patience

Establishing a reputation as entrepreneurs has involved a series of challenges for Lucero Rosas and Julio García, whose secret to facing them has been patience. Initially, their monthly production was two or at most three helmets, in addition to reviewing some patients. Nevertheless, their progress was slow but steady, as they promoted the patent registration of the filling system, which allows easy modification of the device according to the patient's improvement and cranial growth.

One of the goals of the young entrepreneurs is to offer quality treatment at a low cost since in countries like the United States and Spain, the device and treatment are very expensive. "We designed the orthosis with the idea that parents only invest in one helmet, which we modify according to the personalized needs of each baby," Julio emphasized categorically.

For these polytechnic graduates, being entrepreneurs does not mean just selling things but offering a quality service to the customer. Therefore, the company focuses on safeguarding the health of babies, being very careful in all its processes.

To maintain the quality of their product, it has been fundamental to have descriptive manuals. "It is very important that those who start a project prepare from the beginning for success. And, no matter how simple their procedures are, they should always document them in a manual, which is very useful when the company begins to grow; it is necessary to train the personnel who will participate in the production," Rosas Camacho pointed out.

Orthoses are produced for neonates with cranial deformities at low cost.

Time is of the Essence

The graduates of UPIITA explained that cranial deformities or flattening can originate from different reasons, one of them being positioning, which can occur due to multiple pregnancies or after birth. For example, when premature newborns remain for some time in the Neonatal Intensive Care Unit (NICU), it is common for them to present deformities due to continuous posture, as their skull is even softer than that of a full-term baby.

For a neonate with cranial deformity, time is of the essence, as in the first months of life, the skull bones are more flexible and are separated by spaces called cranial sutures, but as time passes, these sutures harden, and the difficulty of shaping them increases.

Although Lucero and Julio have patients from four months onwards, the ideal age to adapt the orthosis is from six months onwards, due to the head support they already have. The deadline to start treatment is at 18 months since at two years old, the skull of all individuals becomes hard, and the separations between the bones that make up the skull are closed by 80%, making correction impossible at later ages.

Postural or Mechanical Cause

The flattening or deformities treated by the young entrepreneurs have their origin in postural or mechanical causes; however, the most severe cases that compromise normal brain growth can complete their correction with the helmet, but they must undergo neurosurgery beforehand.

Depending on the initial cranial deformity and the patient's age, treatment can last between six and eight months; once started, the helmet must be worn for 18 to 23 hours a day. Every six to eight weeks, a follow-up plan is made to take different measurements, and depending on the evolution, the decision to modify or not the interior part of the helmet is made; likewise, the patient's recovery is evaluated, which depends on adherence to treatment.

Process

To ensure the success of the treatment, the polytechnic graduates work hand in hand with specialist doctors (pediatric neurosurgeons), who determine whether the baby is a candidate to use the orthosis or not. However, when it is not possible to have the support of an expert, especially when the patient resides outside of Mexico City, the helmet production is carried out based on the review and information extracted from a tomography or radiography of the patient.

With a medical evaluation in place, the manufacturing process begins with the measurement of the baby's head circumference, then a plaster mold impression is taken, from which other necessary measurements are extracted. Manufacturing using synthetic fibers and resin ensures the hardness of the device. The filling is protected with hypoallergenic EVA, and modifications to it are made according to the evaluation determined by the new measurements taken with a cranial meter.

When the company began offering its services to the public in 2014, it only had designs of pink or blue helmets. Currently, a plastic artist who is part of the team decorates the helmet by hand and creates personalized designs at the request of clients. The Pillow

After several years of experience in the treatment of cranial deformities and flattening, Rosas Camacho and García Vázquez determined that in mild cases, the use of an orthosis to correct the problem is not necessary. So they resorted to their inventiveness to develop an orthopedic pillow, whose early use combined with physiotherapy avoids the use of the helmet or shortens the treatment time with it.

With this, JuluMed opens up alternatives for faster and lower-cost treatments, as proud graduates of the Politécnico, one of their policies focuses on the well-being of patients and offering affordable prices, thereby seeking to give back to society some of what this educational institution invested in them by providing them with an excellent free education.

Growth

After nearly 10 years of starting their activity and to bring their benefits to a greater number of people throughout the national territory, the company of polytechnic origin currently has four service points, the headquarters is located in Mexico City, another one in Morelos, a third in Puebla, and another in Querétaro.

Amid the Covid-19 pandemic, IPN entrepreneurs initiated a new mode of care. In this way, it is now possible for parents from anywhere in Mexico to communicate with them through a video call to resolve doubts about the treatment and clearly explain the entire procedure they must follow, with a previous evaluation through a tomography or radiography; based on the studies, it is determined whether the baby is a candidate for helmet use, and the process can be started semi-presentially. It is important to emphasize that the patient must maintain follow-up with their family doctor or pediatrician.

In the United States, this type of treatment is very expensive, and sometimes insurance does not cover it. The young polytechnic graduates have developed orthoses for patients whose parents are undocumented and therefore do not have sufficient resources to attend to their little ones in that country.

After counting helmets made in the first few years with droplets and considering the possibility of abandoning the project if sales did not grow, Lucero and Julio currently do not know the number of orthoses they have made. "We can proudly say that we have at least made one helmet for each state in the country," Lucero pointed out with a smile, while estimating that they have a monthly production of between 20 or 25 helmets, in addition to the care and follow-up of new patients and those undergoing treatment with cranial orthosis or with physiotherapy and pillow.

She emphasized that their company is inclusive, as they have sought to incorporate single mothers into their work team, with the purpose of offering them a flexible schedule that allows them to be attentive to their children, a situation valued by the workers who perform their activities with great commitment.

Future Goals

As part of their future goals, García Vázquez informed that they will seek to reduce the delivery time of the devices and will venture into 3D printing of these. "We have always put all our effort and energy into our product, as if it were a child, and we are very proud of what we have achieved. However, we must always think about improving both the service and the quality," he added. Both young people showed great pride in being polytechnic graduates and acknowledged that if they could go back in time, they would undoubtedly repeat the same path of being entrepreneurs to have the same life story.

Awards and Recognitions

• Recognitions in 2013, 2014, and 2016 during the Entrepreneur Week of the IPN.

• Special award at the Ibero-American Innovation and Entrepreneurship Awards in 2013.

• Second place for entrepreneurship project, awarded in 2014 by the Higher Education Business Foundation.

• Second place in the Santander Award for Business Innovation 2014, in the category of Business Idea with Social Impact.

• National Youth Award 2016 in the Entrepreneurial Ingenuity category.

• Smart Money 2016 Recognition, conferred by Red Emprendia.

• National Youth Award in Mexico City 2017.

Selección Gaceta Politécnica #170. (January 31st, 2024). IPN Imagen Institucional: Read the full magazine in Spanish here.