2023年的夏天，斯蒂芬·史密斯（Stephen Smith）博士在圣母大学（圣母大学）校园北工程学院（Engineering North）的大楼里，面对面地坐在一个骨架模型前。

史密斯是印第安纳州南本德市中心灯塔健康系统纪念医院的一名神经外科医生，该医院位于大学校园西南约一英里处。 他正在与航空航天和机械工程教授瑞安·罗德（Ryan Roeder）谈论史密斯刚刚使用一种新型植入物进行的脊柱融合手术。 虽然他看到的是骨头，但很明显，在其他人看到死亡的地方，史密斯看到的是一个充满生命的系统。

“Bone is an active organ,” Smith says, “and it undergoes continuous remodeling.”

“Remodeling” is not just an apt metaphor; 这是一个技术术语，指的是由三部分组成的生物过程，即细胞消化旧骨，并沉积新的、硬化的骨骼作为替代。 Remodeling is a key word for this surgery, because for the surgery to be successful, bone has to fuse with an implant—a lifeless material that Smith must insert into the living system of vertebrae and nerves that make up the cervical spine.

Smith explains the spinal fusion surgery: “The entire procedure is done from the front of the neck,” he says as he shows how he makes a small incision and reaches past the trachea, the esophagus, and the jugular vein to access the spine. 在那里，史密斯使用一种被称为外科毛刺的精密钻头一次一毫米地移除骨头和椎间盘，然后将新的植入物插入旧组织。

种植体立即解除压迫，但愈合过程需要时间。 “We follow patients for a full year, taking periodic X-rays to ensure the graft is healing,” Smith says. “We are looking for bone growth. Once new bone shows up, you can be confident of a recovery.”

史密斯将这一过程与铸造断臂的过程作了类比。 The cast stops the bone from moving as new bone forms, but, Smith says, the cast is just an intermediate step: “The quicker the healing—the quicker there is a living part of you holding you together—the better.”

快速愈合也至关重要，因为重复手术的成功率较低。

“Your best shot is always the first time,” he says. “The second time, not only does that mean additional pain and recovery, but scar tissue has developed, and other complications can occur as well.”

所以史密斯表达了他的喜悦，因为这个全新的植入物有两个重要的特点。 首先，它的多孔结构允许骨头在里面生长，而不是在它周围生长。 其次，它对细胞友好的表面可以促进骨骼附着，从而形成更坚固、愈合更快的移植物。

Smith is also delighted that he was the first surgeon in the world to use the new material—one he and Roeder first discussed in a different meeting on 巴黎圣母院’s campus nearly two decades before.

脊柱护理的新方向

罗德和史密斯相识于2005年。 史密斯在圣母大学附近出生和长大，在完成田纳西大学健康科学系的九博体育研究后，刚刚回到该地区。 他开始与圣母大学的教职员工谈论医学上的创新，并被邀请在校园里演讲，解释他在九博体育研究期间学到的微创手术的新技术。

起初，他认为他的演讲失败了。 He recalls that after he spoke at length about the apparatus he used to connect to the body through small ports or slits in the skin, a student asked, “Dr. Smith, that’s very interesting, but how does the patient live with all this equipment attached to their back?”

“I guess,” he said, “I didn’t explain that I remove the structures when the surgery is complete.”

不过，还有其他问题，其中包括罗德的问题，他当时是一名新教员，他问史密斯用于脊柱移植的材料。

Smith’s answer was “PEEK”: polyether ether ketone. 在当时，PEEK是一种尖端产品。 它在2001年获得了FDA的批准，并因其在体内的强度和稳定性而受到重视。 As it turned out, though, Roeder and one of his graduate students had been working in their lab on a material they thought might be superior to PEEK—one that would combine the benefits of PEEK with an ability to interact with the living tissue of the bone to help the graft heal faster and remain stronger over time.

罗德和史密斯开始讨论他的实验室所做的改进是否会引起外科医生的兴趣。

“An engineer can develop new materials in the lab,” Roeder explained, “but you need someone to validate that it can solve a clinical problem. A clinician understands the problems patients face but needs an engineer with the technical expertise to develop a viable solution.”

根据他的经验，史密斯肯定罗德描述的材料可以带来真正的好处。 它可以做得足够致密以承受机械负荷，也可以做得足够多孔以允许骨头从头到尾生长并穿过它。 这种材料含有微小的棒状矿物结构，不仅可以加强植入物，就像混凝土中的钢筋一样，还可以促进新骨附着在植入物上。

Crossing the ‘Valley of Death’ to revolutionize spinal surgery

Getting the new material into the hands of surgeons was just a matter of time—and, of course, money.

“I often say to my graduate students in the lab that most of what we’re working on is at least 10 and maybe 20 years away from becoming a technology that is ready to become a product on the market,” Roeder said. “And that’s how it should be. 我们追求的想法是未经证实的，回报是不确定的。 No one trying to make money would invest that early on.”

进一步开发这种材料所需的资金很难找到。 罗德陷入了一个又一个死胡同。 联邦资助机构让他寻求企业资助。 当他接近公司时，他发现自己又被拒之门外。

“The consistent response when we pitched it to federal funding agencies was, ‘Somebody in industry should be doing that.’ When we pitched it to industry, we heard, ‘We’re not interested unless we can make money on the idea in the next three years. Someone else should fund that,’” Roeder said.

Roeder and Smith had entered a territory well-known to researchers and entrepreneurs—so well-known, in fact, that it has a name: the valley of death. 这是为新发现提供资金的公共投资与将这些发现转化为新产品的私人投资之间的差距。 许多伟大的想法、技术和突破只是在死亡之谷中停滞不前，从未触及那些本可以改善生活的人。

最后一条路出现了：罗德和史密斯可以通过自己成为企业家来跨越死亡之谷。

“We were what you might call reluctant entrepreneurs,” Roeder said.

“But we were just more reluctant to let the dream die because we so thoroughly saw how it would be better than what was available at the time,” Smith added.

对于大多数企业家来说，走出低谷通常包括完善产品、获得专利，以及找到一种方法，将实验室流程转化为商业规模，以便以经济有效的方式生产产品。 当产品与人类健康相关时，企业家面临的挑战就更大了。 医疗创新受到严格监管，获得美国食品和药物管理局（fda）等相关监管机构批准的过程可能漫长而艰难。

对于罗德和史密斯来说，将这种新型植入物商业化的过程还包括等待进入市场的合适时机。

“New ideas have to be ahead of their time; if they are not, they’re not new ideas,” Smith said.

在罗德的新材料的案例中，问题源于PEEK在21世纪头十年的日益普及。

“PEEK was new, and it was performing well in the market,” Roeder said. “The last thing companies wanted to do was change it.”

然而，在2010年代，由于3D打印技术的到来，市场开始发生变化。

“Suddenly, the hot new product was 3D-printed titanium,” said Roeder.

这一创新突出了多孔结构的优越性和PEEK的不足。

“The market was beginning to realize what we saw long before—that PEEK wasn’t perfect,” Roeder said.

但对罗德和史密斯来说，改用钛植入物是一种倒退。

“Titanium had been the standard before PEEK,” Smith said, “and many of the characteristics of titanium that had previously made PEEK a more attractive option were still true.”

For one thing, titanium was too rigid, “which is not the benefit that you might think,” Smith said. “It can present a problem because it can shield the bone from experiencing physical stress from the body’s movement. The physical stresses of tension, compression, bending, shear, and torsion actually stimulate bone growth.”

外科医生定期用x光来确定移植物是否成功融合，钛也带来了一个问题。

“Titanium implants are radiopaque, meaning they block X-rays and show up bright on a radiograph. 这使得外科医生很难评估骨头是否通过植入物生长； the titanium masks that,” Smith said. “But our material is radiolucent, meaning that you can see the healing happening in and through it on an X-ray.”

A “HAPPE” ending for spinal surgery patients

In 2018, Roeder officially launched his company, 哈佩脊柱, in partnership with Genesis Innovation Group, a technology incubator in Grand Rapids, Michigan, that accelerated the process to commercialize the material and implant with funding to get the product across the finish line. 史密斯继续为最终的植入物设计提供反馈。 罗德将担任哈佩脊柱的首席技术官。

During this leg of the journey, the team was awarded several patents, and Roeder 收到了 the 第一届资源银行商业化奖, which recognizes faculty from 巴黎圣母院 or Indiana University School of Medicine–South Bend for translating an exceptional research discovery into a marketable product or service.

2023年5月，哈佩脊柱的植入物获得了FDA的批准，首次进入市场。

史密斯在2023年夏天完成了第一次手术，他看到了新材料带来的不同。

“It went to work right away,” he said. “The porous surface drew in blood and growth factors. On X-rays, it immediately looked like living bone, and on the three-month follow-up, new bone was already present.”

The product was 被评为2023年最佳脊柱新技术 by 本周整形外科. By the spring of 2025, it had improved outcomes for more than 600 patients with 1,200 implants, and the company attracted a new round of investors—including 巴黎圣母院’s own Pit Road Fund, an investment fund launched by the IDEA Center to accelerate faculty, student, alumni, and community startups.

When asked what it has been like to take an innovative idea and see it through the long process of commercialization, Smith joked, “Mostly painful.” (“No pain, no gain!” 罗德说。)

Smith said the most satisfying part about finally crossing the valley of death is not just that it happened, but 在 it happened.

“It means a lot being from this city that this innovation happened here,” he said. “Others might view South Bend as a small town, but there is nothing about our skills, talent, or service that is small. I want to show my patients that they are getting better care here than they would get any在 else, and I’m glad this has been part of that mission.”