World wide bone trauma

PD | Orthopedics

It was a long day in a cold lab. I was in scrubs. It was several hours into a working session with a set of surgeons and a large collection of frozen limbs. If you have not been to multi day long cadaver labs, then you should know that the mental image you have is accurate. The surgeons were repairing broken long bones using a variety of plates and screws I had printed out of titanium nearly a month ago. My job was to use the retractors to hold open the skin and muscle for them. Later, I'd be trying to perform parts of the surgery myself. My other job was to observe and ask questions.

 

I was leading new concept development and was in collaboration with the trauma team. Although trauma sales tend to be high, they still wanted to differentiate themselves somehow from the competition.

 

My role in the project was to research the current state of affairs in trauma surgery and find a place where new technology could fit. The trauma team knew they wanted to use 3D printed titanium, and my goal was to understand how. So there I was, in the thick of it, in my scrubs. The project itself lasted about a year with a majority of the time spent on passing FDA regulations.

Do you know how trauma surgeries are treated differently through out the world? If someone comes in with a broken bone that needs to be fixed, regardless a surgeon will use rods and plates to recreate their skeleton.

 

In the EU, these plates are going to be ultimately removed once the skeleton has healed.

 

In the US, the metal is left in the body.

 

So this radically changes how you design the trauma plates to fix the bones. US surgeons want something more binding that the bone can grow into, EU surgeons want something simpler akin to zip-ties. But from spending a lot of time in the cadaver labs with surgeons and seeing how the surgeons work, we had a great idea:

 

The design principle behind the idea was a trauma plate that must be modifiable during surgery. Basically, right up until a surgeon can see what they are working with and can allow them to change anything about the titanium plate at the last minute. Previously the design principles for trauma plates were very technical, in that they had to not mechanically fail, and fit the patient's anatomy in some way.

 

This was the first design principle that actually took the surgeon's work into account. This principle was from weeks spent collecting qualitative data and observations from surgeons in cadaver labs throughout the Northeastern quarter of the US and Western Europe.

 

So we invented a new plating system. The foundation was still a plate of metal, 3D printed out of titanium so that it could be strong and accommodate more types of patients. The trick was that it became a bed for totally new inserts. These little inserts were like small, titanium stamps that surgeons can mix and match, depending on the situation. Some are built flat, some are built with spikes that can grip the bone, and others are made from a titanium spongey surface that bone can grow into. The plate itself was built with grooves in case a surgeon wanted to ditch the inserts altogether and attach the bones together with wires.

 

The result was that this system paved the way for an entirely new, award winning product line that works globally and is fundamentally different than making US and EU versions of a set of traditional trauma plates. It was award winning because the patient outcome was fantastic, a surgeon could see more patients easily, and the company could manufacture these plates and stamps quickly.

 

Turns out that is possible to innovate on chunks of metal in an industry that is notoriously hard to change. The trick was to look outside of the technical specs for the patients and to consider the processes that the surgeons lived by.

 

The lesson I learned in this project that I keep in the back of my mind is that no group of people is ever isolated and designs never have a singular "user." Lasting change is created through designing for everyone involved in an elegant, cohesive way.

Footnotes:

>> You can find the patent for this design here.

>> My team also patented the method of 3D printing titanium that makes this design possible.

+ Role: User Research, Development, Testing

+ Basis for the VariAx 2 and AxSOS 3 systems