Dawn A. Lissy, Founder & President, Empirical04.01.21
I miss 2020. For all of its slings and arrows, none of them landed in my back. I survived that freaky year and entered this one with the naïve notion that the worst was behind us.
Then the new strange pains in my legs got so bad, I finally went to a doctor.
“I don’t know how you’re still walking,” he told me as we reviewed my MRIs.
I couldn’t believe the images on the screen. That cramped, malformed lower spine couldn’t possibly be mine. I felt deeply betrayed by my own body.
I’ve spent most of my adult life considering the magical, complex series of bones and tissues that is the human spine. Early in my career, I worked at the Cleveland Functional Electrical Stimulation Center on a study that placed electrodes on various muscle groups of paraplegics to perform exercises and transfers. I hold an inventor patent on a stackable cage system for corpectomy and vertebrectomy. In the early days of Empirical Testing Corp., my company inadvertently developed a reputation for specializing in spine, even though we have always tested and consulted on a wide range of medical devices.
I find it particularly ironic that I am now pondering what steps to take and devices to consider for a series of spinal issues in my own body. The diagnosis caught me completely off guard: L4-5 spondylolisthesis, stenosis, degenerative, and herniated disc.
Of course, I understand the clinical definitions and what that means for the body. When I flex or extend, my L4 vertebral body rotates relative to my L5 vertebral body. This instability creates a contra-indication for many conservative treatment options. Stenosis means the narrowing of the hole for the spinal cord and nerves, which causes the pain that brought me in to the doctor’s office in the first place. The herniated disc’s outer sheath has weakened, so part of the disc bulges backward against the spinal cord, another source of pain. “Degenerative”—that just makes me feel particularly old three months before my 50th birthday.
No more skiing; a fall could cause further damage. I live in Colorado. We are a three to five ski trip per season family.
No excessive bending or rotation—that herniated disc needs to be coddled. This puts me in the “injury variation” section for Pilates and yoga.
No more golf—the extension-rotation motion of a golf swing could be crippling no matter how good or bad the swing looks. (This could very well save my marriage.)
No more burpees at the gym. OK, this is even better than no more golf.
I’ve never had to really consider planning my life around physical limitations. And I now understand why doctors and nurses are considered the worst patients. My companies have tested and reported on thousands of different implants and procedures over the past 23 years, a majority of them spinal implants. As the fog of shock cleared, I started quizzing my doctors on what types of devices they use and how they use them. With each option they offered, I rattled off additional concerns and considerations that stem from a career in the medical device industry.
What about adjacent disc disease, often an issue for younger patients? That’s when the disc above or below the fusion deteriorates over time, potentially creating the need for additional surgery. And when it comes to implants, which type of interbody fusion device (IBFD) should I go with? Titanium alloy? Polyetheretherketone or similar polymers? What about additive manufactured titanium? I know the pros and cons for all of these options. And if I have surgery, how do I keep up with my business and travel schedule, which is particularly heavy this fall because of industry trade shows stacking up after a COVID hiatus?
I’m likely looking at fusion—IBFD with screws and rods or other hardware for an adjunct to fusion application. This would replace the disc between L4 and L5 with bone graft and the IBFD, making this section one permanent, solid piece instead of three movable parts. I’d like to put this off as long as possible. The fusion would cause loss of motion and flexibility—both crucial for longevity and quality of life as I age.
I’m also researching options to delay the fusion. If it weren’t for the spondylolisthesis, I could consider a decompression and maybe an intra-spinous spacer. But thanks to “spondy,” that’s off the (operating) table.
I’m sorting through my list of contacts. I’m calling friends and colleagues to find out about various pending Class III devices and trials I might take part in. When I mentioned to my chiropractor it would be such a hassle to travel to the right treatment center given COVID protocols and the pace of my life, he offered a poignant reality check.
“You take your kid all over the country for care and drive up to Denver every week. This is the rest of your life. Stop being a dumbass.”
So I added that to my list of things to do.
I’m trying to not drive myself, my husband, and my doctors crazy. This is perhaps the biggest challenge. With so much competing and conflicting data, so many expert opinions to consider, my head hurts more than my back.
I know eventually this latest challenge will serve me well professionally and personally. But this middle part kind of sucks; particularly because I never know when that debilitating pain is going to strike.
For now, I’m committed to dropping some weight and strengthening my core with gentle, spine-safe training and physical therapy. At the recommendation of a surgeon friend, I’m reading “McKenzie Method, Treat Your Own Back” to learn some postural changes and exercises that may help. I’m also leaning into the nerd cliché to the point that I’m going to make a 3D model of my spine to better understand what’s happening and how different procedures might affect it. My doctor is joyfully geeking out with me on this project. He wants one for himself, too.
The downside to knowing so much about the spine is the sheer load of information I carry is so heavy, it’s more than a little overwhelming. The upside is I know so many brilliant, kind professionals already offering their expertise to help me navigate this latest challenge. The gratitude I feel for them outweighs the burden of my diagnosis, yet another reason I count myself very lucky to be a part of this community.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
For more information about Empirical Technologies Corp. visit www.EmpiricalTech.com
Then the new strange pains in my legs got so bad, I finally went to a doctor.
“I don’t know how you’re still walking,” he told me as we reviewed my MRIs.
I couldn’t believe the images on the screen. That cramped, malformed lower spine couldn’t possibly be mine. I felt deeply betrayed by my own body.
I’ve spent most of my adult life considering the magical, complex series of bones and tissues that is the human spine. Early in my career, I worked at the Cleveland Functional Electrical Stimulation Center on a study that placed electrodes on various muscle groups of paraplegics to perform exercises and transfers. I hold an inventor patent on a stackable cage system for corpectomy and vertebrectomy. In the early days of Empirical Testing Corp., my company inadvertently developed a reputation for specializing in spine, even though we have always tested and consulted on a wide range of medical devices.
I find it particularly ironic that I am now pondering what steps to take and devices to consider for a series of spinal issues in my own body. The diagnosis caught me completely off guard: L4-5 spondylolisthesis, stenosis, degenerative, and herniated disc.
Of course, I understand the clinical definitions and what that means for the body. When I flex or extend, my L4 vertebral body rotates relative to my L5 vertebral body. This instability creates a contra-indication for many conservative treatment options. Stenosis means the narrowing of the hole for the spinal cord and nerves, which causes the pain that brought me in to the doctor’s office in the first place. The herniated disc’s outer sheath has weakened, so part of the disc bulges backward against the spinal cord, another source of pain. “Degenerative”—that just makes me feel particularly old three months before my 50th birthday.
No more skiing; a fall could cause further damage. I live in Colorado. We are a three to five ski trip per season family.
No excessive bending or rotation—that herniated disc needs to be coddled. This puts me in the “injury variation” section for Pilates and yoga.
No more golf—the extension-rotation motion of a golf swing could be crippling no matter how good or bad the swing looks. (This could very well save my marriage.)
No more burpees at the gym. OK, this is even better than no more golf.
I’ve never had to really consider planning my life around physical limitations. And I now understand why doctors and nurses are considered the worst patients. My companies have tested and reported on thousands of different implants and procedures over the past 23 years, a majority of them spinal implants. As the fog of shock cleared, I started quizzing my doctors on what types of devices they use and how they use them. With each option they offered, I rattled off additional concerns and considerations that stem from a career in the medical device industry.
What about adjacent disc disease, often an issue for younger patients? That’s when the disc above or below the fusion deteriorates over time, potentially creating the need for additional surgery. And when it comes to implants, which type of interbody fusion device (IBFD) should I go with? Titanium alloy? Polyetheretherketone or similar polymers? What about additive manufactured titanium? I know the pros and cons for all of these options. And if I have surgery, how do I keep up with my business and travel schedule, which is particularly heavy this fall because of industry trade shows stacking up after a COVID hiatus?
I’m likely looking at fusion—IBFD with screws and rods or other hardware for an adjunct to fusion application. This would replace the disc between L4 and L5 with bone graft and the IBFD, making this section one permanent, solid piece instead of three movable parts. I’d like to put this off as long as possible. The fusion would cause loss of motion and flexibility—both crucial for longevity and quality of life as I age.
I’m also researching options to delay the fusion. If it weren’t for the spondylolisthesis, I could consider a decompression and maybe an intra-spinous spacer. But thanks to “spondy,” that’s off the (operating) table.
I’m sorting through my list of contacts. I’m calling friends and colleagues to find out about various pending Class III devices and trials I might take part in. When I mentioned to my chiropractor it would be such a hassle to travel to the right treatment center given COVID protocols and the pace of my life, he offered a poignant reality check.
“You take your kid all over the country for care and drive up to Denver every week. This is the rest of your life. Stop being a dumbass.”
So I added that to my list of things to do.
I’m trying to not drive myself, my husband, and my doctors crazy. This is perhaps the biggest challenge. With so much competing and conflicting data, so many expert opinions to consider, my head hurts more than my back.
I know eventually this latest challenge will serve me well professionally and personally. But this middle part kind of sucks; particularly because I never know when that debilitating pain is going to strike.
For now, I’m committed to dropping some weight and strengthening my core with gentle, spine-safe training and physical therapy. At the recommendation of a surgeon friend, I’m reading “McKenzie Method, Treat Your Own Back” to learn some postural changes and exercises that may help. I’m also leaning into the nerd cliché to the point that I’m going to make a 3D model of my spine to better understand what’s happening and how different procedures might affect it. My doctor is joyfully geeking out with me on this project. He wants one for himself, too.
The downside to knowing so much about the spine is the sheer load of information I carry is so heavy, it’s more than a little overwhelming. The upside is I know so many brilliant, kind professionals already offering their expertise to help me navigate this latest challenge. The gratitude I feel for them outweighs the burden of my diagnosis, yet another reason I count myself very lucky to be a part of this community.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
For more information about Empirical Technologies Corp. visit www.EmpiricalTech.com
