Biology

Why Medical Devices are not for Kids but should be

Why Medical Devices are not for Kids but should be

There is a scary fact about our medical system.  It is not equipped to serve children; at least not unilaterally and with the latest technology.  Barring specialized childrens’ hospitals (like the one seen in the above video) that are few and far between, most hospitals are specifically geared to deal with the ailments of the adult population.

The area of weakness that is most troublesome is Medical Devices.  As a medical device specialist myself, I have seen multiple cases where doctors were forced to use a device off-label and left to there own devices to jury-rig a solution for their pediatric patients.  While these doctors are incredibly effective at coming up with solutions, it would be much more ideal for these patients to have specified implants for their bodies.

My speciality is trauma orthopedics (plates, screws, and rod implants to fix broken bones), so when a child breaks a bone bad enough to require an immediate surgical fix, I receive a call from the surgeon.  In trauma situations, there is no time for special ordering pediatric implants or designing a new implant for the patient.

“This patient needs to be fixed now.”

And so, the doctor and I come up with a plan to treat the patient with the tools we have available.  This usually means we are using a plate designed for a adult’s forearm in a child’s leg or some screws typically used in a adult’s hand for a child’s ankle.  Basically we are using items designed for the smallest bones of a adult to fix the child’s fracture.  There are some devices called “flexible nails” that can be effective for pediatric large bone injuries.

CHild pacemaker

Image of a pacemaker implanted in a child’s chest cavity. Notice the bulky size of the device when first implanted and the slack left on the lead for growth over time.

But orthopedics isn’t the only specialty in need of better devices for children.  Other areas lacking pediatric options outlined in this story are cardiac care via pace makers to large for a child’s chest cavity and prosthetic limbs that cant grow with a patient.

The problem with children and medical devices is simple, they’re small and they don’t often require devices. (in orthopedics, less than 1% of cases)

So there is very little incentive for a hospital to purchase devices to have readily available for children, and this in turn disincentives medical device companies to spend the time and money to create pediatric products and have them approved for use by the FDA.  That is the strange thing about medicine, people often forget it is a business and governed by the same supply and demand principles as other businesses.

However, unlike other businesses, people’s lives are at stake.  And so the government jumps in to make sure those people are being protected.

This is both a good and bad for children in need.

It is good because the government has strict guidelines that ensure these medical devices are safe and effective.  But since the FDA is so strict with regulating medical devices, companies are even more hesitant to put out a pediatric product and deal with the hassle and financial investment to get approval for use.  Due to this, most pediatric medical devices are about 10 years behind the curve with advancing medical technology.

So what is the solution?

One solution could be government incentives for pediatric devices.  The only real way to change a business is with money.  But this might just be a quick fix and another burden on our government.  Much more interesting is a fix through technology.

What if medical devices for children could be made locally, instantly, and on demand?

3d arms Little girl

3D printed exoskeleton helps child draw for the first time.

3D printing is ushering in a new age of consumer products and the medical device industry is already taking charge by using the advantages of these machines to manufacture better devices.  If these same devices were placed local to hospitals, they could manufacture, on site, any device that these pediatric patients might need specific to their exact size.  With new imaging technology like CT scans and MRI, these devices could quickly use patient data to design a specified implant for the patient.  The video above showed how this technology could design a airway splint that literally gave three children life when death was imminent.

And why stop with pediatrics?  There are all sorts of applications for this technology for patients with unique anatomy or specialized injuries.

Whatever the fix, the honest truth about the medical field is that healing patients needs to be profitable.  In order to ensure that our brightest minds keep working to fix people, they need to be incentivized.  And to keep the medical system afloat we need to use new technologies to improve efficiency and be creative to reach every patients needs.

 

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