Over the course of his career, industrial designer Michael DiTullo has designed everything from consumer electronics to soft goods, from toys to automotive work and, in his time at Nike and with the Jordan Brand, plenty of footwear for famous basketball players. But a year or two ago, he found himself designing an unusual piece of footwear without a well-known athlete's name attached:

That is—or ultimately would become—the Foot Defender. Technically speaking it's a revolutionary piece of medical kit, and one that could save tens of thousands of people from having their foot amputated each year.

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If we're talking target markets, you might struggle to think of what a professional basketball player has in common with a diabetic that's developed DFU (Diabetic Foot Ulcers). After all, elite ballers earn their living on two feet; people suffering from DFU have a 24% chance of having one of their lower extremities amputated within 6-18 months.

What they have in common is a need for precisely-designed footwear. Elite athletes with sponsorship deals get that attention, with footwear designers crafting signature shoes featuring support or flexibility in the areas preferred by the athlete. Those with DFU could use that same design attention, but until a certain Dr. Hanft came up with an idea, they had not received it.

To explain, when someone has diabetes, they can sustain nerve damage that prevents them from feeling foot pain. When someone without diabetes develops a blister, cut or scrape on their foot, they can feel it and take care of it, taking it easy on that foot. But a diabetic often can't feel that injury, and what started out as a treatable blister can turn into an ulcer. Then, the reduced blood flow that diabetics experience in the lower extremities slows the rate of healing, and that ulcer can become infected. If that infection spreads to the bone, it can lead to an amputation.

So how often does that actually happen? "Every 20 seconds someone loses a limb due to complications with diabetes, a condition that is 100% preventable," says DiTullo. "From 2009 to 2015, lower extremity amputations for diabetic patients increased by 50%.... This is unacceptable." The American Diabetes Association estimates these amputations to number from 80,000 to 100,000 each year.

DiTullo learned of the issue after being contacted by Dr. Jason Hanft, a Florida-based expert in lower extremity medicine and surgery, limb salvage, wound care and clinical research. Years ago he himself had suffered a grievous foot injury, and "As part of his treatment, Dr. Hanft was required to wear the same medical devices he prescribed to his patients, giving him first-hand experience with the pain points of each device," writes the company he founded, Defender. "From here, Dr. Hanft was driven to create a better healing experience with Defender's suite of foot care products."

You might wonder why an in-demand and practicing doctor--one who's today regarded in his industry as a foremost expert on foot injuries--would attempt to divide his time with starting a product company. The answer, paradoxically, is time; Dr. Hanft can only see one patient at a time, and the power of mass production is multiplication.

"As many professionals do, once you become competent at your profession you try to find ways to reach or help more people," Dr. Hanft told Core77. "My reach was limited to the hours I had to work. By actually solving problems and launching a business, you exponentially expand your reach. Addressing the issue of the utilization of protective devices seemed only natural after years of work in wound care."

Dr. Hanft had learned that the number of amputations among diabetics was rising each year; investigating why, he learned that patients with DFU typically didn't like wearing the supposedly corrective devices they were prescribed, which were just generic, bulky and ineffectual foot-covering objects designed for catch-all foot/ankle injuries. He then developed an idea for purposefully-designed medical footwear that people would want to wear, and that could help prevent amputations among those with DFU.

Dr. Hanft reached out to a local investment firm for help. They weren't interested in pursuing the project, but the firm's principal had seen DiTullo's work, suggested the two of them talk, and put them in touch. Given DiTullo's credentials--his designs had graced the likes of elite basketball players like Carmelo Anthony and Dwyane Wade--Dr. Hanft was initially skeptical that this was up DiTullo's alley, but luckily he was wrong. "From our first conversation," Dr. Hanft says, "it was clear Michael was like-minded in trying to help people and use his skills to improve others."

After Dr. Hanft explained the problem, DiTullo looked at the existing protective boots prescribed to those with DFU, and found this:

DiTullo signed on to the project, excited, as he saw "a massive opportunity to bring a product that someone would actually be proud to wear to a space that's highly stigmatized."

The goal: "Let's make a protective boot that performs better, is easier to put on properly, and aesthetically is something a person would actually want to wear."

DiTullo started out with gestural concept sketches that envisioned a piece of footwear with rigid side bracing:

Eventually the design evolved into the concept below, which featured an "injection-molded bucket," as DiTullo describes it, to cradle the foot:

But prototype after prototype, in testing, were not delivering satisfactory results. "We still were getting too much motion" from the test wearers, DiTullo recounts.

"And then like in so many projects, there's just a simple breakthrough that comes from frustration," DiTullo says. In a meeting with Dr. Hanft, DiTullo suggested "Why don't we stop trying to make this like a medical device, and start making it a lot more like a shoe? We're trying and failing so much with these molded components; let's do a simple, very durable rubber cup sole, a textile and leather upper, like a sneaker, and that will allow us to experiment below the skin [of the shoe] and tune everything exactly the way we want it."

With Dr. Hanft signing off on the new approach, DiTullo sketched this:

Gone were the rigid sides, replaced by more sneaker-like outer materials, with the intent of adding inner materials that would do the heavy lifting. DiTullo continued evolving the design, but spotted a new problem: Getting the shoe on and off. To counter this, he designed a removable spat for the front, with a carbon-fiber insert that maintained the curved shape and offered protection, while also providing an easy-grab surface than even someone with limited mobility or limited fingertip sensitivity could get ahold of and remove.

With the outer surface of the shoe established, extensive prototyping and testing began on the all-important unseen internal parts that would be doing the protective work inside the shoe. DiTullo drew on his footwear experience to create a cocktail of materials distributed in different locations: Some soft EVA here, medium-density foam there, high-compression foam here, some Absorbium (a visco-elastic polymer) there. Add a pneumatic system so users can dial in the fit to perfectly suit their foot. Shake. Serve. Test. Revise.

And DiTullo, of course, wasn't working in a vacuum: There was a lot of back-and-forth between Dr. Hanft, former Nike developer Drew Linth, podiatrists, surgeons, biomedical engineers, movement experts, material scientists, production specialists, not to mention the feedback from Dr. Hanft's thousands of patients.

Drew Linth and Michael DiTullo keep it rolling during the pandemic

Dr. Hanft, right, and a patient wearing the Foot Defender

Finally--after 39 iterations--they achieved the testing results they were looking for, which demonstrated a clear advantage:

When stacked up against the competition, the Foot Defender, as the new product was christened, reduced pressure across the foot by up to 50%. "Whether standing or walking," Defender writes, "Foot Defender outperforms alternatives through innovative design resulting in a first-rate healing environment for the foot."

"The Foot Defender is specifically designed to reduce pressure on the bottom of the foot through a combination of locking the ankle at a specific angle, negative heel drop raising the balls of the feet, and a proprietary viscoelastic material under the foot called Absorbium. In addition to being functionally superior, the Foot Defender is easy to put on properly and take off due to its unique removable spat design."

"The Foot Defender looks more like an athletic shoe and less like a medical device to reduce the visual stigma of needing to wear the product. Unused products fail 100% of the time so we designed the Foot Defender to be acceptable to be worn daily until the patient is healed."

All told the entire process took over five years. DiTullo even went the extra mile after seeing the user manuals for competing products, which looked like "something typed up on Microsoft Word and shoved into a polybag." Instead DiTullo used visuals to create a more easily comprehensible guide:

He also designed eye-catching packaging to communicate the design difference of the product. (From an efficiency standpoint, note that the shapes can be nested for palletization and shipping.)

Foot Defender finally hit the market late last year, and is already in use in diabetes clinics across the country.

DiTullo is used to seeing sketches on paper turned into real-life production models, but Dr. Hanft was not. Upon seeing the finished product, "My thoughts were amazement," he says, "that our team and a large group of caring consultants had actually taken our ideas and turned it into a reality."

"The Foot Defender has the potential to help millions of diabetics every year."

DiTullo, too, is stoked: "I feel like I got to use my decades of footwear design experience for something really good and helpful."