Neurosurgeon Dr. Thomas Melin's been frustrated for about 25 years in practice — with expensive and inefficient bone grafting surgeries.
Until recently, it has been a very messy business. It is not uncommon to fund surgical teams, who perform around 500,000 bone grafts each year in America, struggling to collect by hand or even through coffee filters, bits of valuable, real bone.
For one thing, synthetic bone costs about $900 for just 1 cubic centimeter, according to Hensler Surgical. Not to mention the patient's risk that the body can reject it.
Which is why North Carolina-based Dr. Melin and his longtime friend and physician assistant, Sean Hensler, conceived of and launched the "Hensler Bone Press," which filters bone and compresses it so that it may be immediately used for grafts and returned to the body.
The simple device could also save hospitals a bundle. "The manufacturer's cost to the hospital for an average lumbar spine surgery is between $3,000 and $5,000," said Dr. Melin.
The Hensler Bone Press is for sale on Henslersurgical.com for $350.
Notably, the medical duo created the product without the help of dominant medical manufacturers. Players like Medtronic and Allergan , each with multi-billion dollar market caps , manage much of the market for neurological and spinal therapy devices.
"I'm not sure large manufacturers would want this to go to production. We're competing against their products," explained Dr. Melin. "We know it works, and it's a good idea, but if we went to the main medical suppliers, we were concerned they would just kill it."
That's not to say Melin and Hensler didn't need help. They got it from friends and colleagues.
"People came forward and wanted to invest in the idea. We received support from medical staff who saw how much impact this could have," said Melin.
All in, for testing, development, and production, the team raised about $300,000. These funds enabled the Hensler team to hire an FDA-registered manufacturer — just a relatively small one.
Medical Murray detailed the regulatory requirements for the bone press, and is now manufacturing it. They say in the grand scheme of medical devices, the bone press is as about as inexpensive a product to make as it gets.
"This device doesn't require clinical trials. You simply have to register the product with the FDA, because it doesn't pose much risk," said Tanner Hargens, a senior biomedical engineer for Medical Murray.
In FDA terms, the device is considered "510k exempt" (not requiring testing) because it is similar enough to others which have already gone through the 510 process. If a medical device does not have this exemption, however, "FDA testing can run anywhere from $20,000 to $150,000, depending on the product," says Andy Leopold, vice president of Medical Murray.
That said, the Hensler team has opted to go through a round of FDA testing, to be on the safe side.
"It still makes sense to conduct testing, and demonstrate that the device is truly safe," said Hargens. As the manufacturer who ultimately registers the product with the FDA, Medical Murray's "biocompatibility," "sterilization," and "specialized controls" testing, all add up to about $50,000 of certainty that this product will not harm the body.
For the Hensler Bone Press, this entire process is taking only three months — much shorter than many innovators experience when attempting to gain approval from the FDA regulators, who can change their mind about approval decisions and timing at any point.
Regulatory approval is only the first step. The hard part is distribution.
"In order to be used, it needs to go through purchasing groups within huge hospital networks, who may already have a contract with a large suppliers. Access to those groups may be limited for small companies," noted Leopold.
For Hensler's innovators, selling the bone press online is possible, but is unclear how many hospitals could buy the product there.
On the other hand, Matt O'Brien, medical analyst at William Blair, says Hensler's chances are "fairly good."
"It's an interesting product, because it appears to make spine surgeries much faster, and anything that does that will probably get good traction," said O'Brien.
In his assessment, the Hensler Bone Press shortens the time needed to separate grafting material by about half an hour. In general, bone graft surgeries take four to five hours.
"They say that every minute in the [operating room] costs $50. So, 30 minutes is about $1,500 bucks in indirect costs saved," he said.
That said, he doesn't this is an industry game-changer. "It won't change the way surgeries are done; it just helps technicians separate bone faster."
No matter the scale of sales, the Hensler Bone Press exists, and is available for use. This means marketing and sales may become the next hurdle for the Hensler team, as they try to gain access to larger markets.
"It's a really simple product; it's advantages are intuitively obvious, and it simplifies the procedure," concluded Leopold.