BME100 f2016:Group15 W8AM L1

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OUR TEAM

Name: Shad Boswell
Name: Nathan Hui
Name: Carli Winchester
Name: Melissa Amaro
Name: Adam Akkad


LAB 1 WRITE-UP

Health Care Issue

Degenerative Disc Disease (DDD) is better considered an aging process rather than a disease because of how many people the condition affects on a regular basis. The vast majority of lower back pain (LBP) or neck pain cases are diagnosed as instances of DDD. The clinical need for effective cures and solutions to DDD is immense: The Health Quality Ontario Institute claims that 40% of all people aged 40 suffer from DDD and 80% of all people above the age of 80 suffer as well. Moreover, only 20% of these victims have a mild-enough condition that can be treated therapeutically and without surgery (Health 1). DDD is the term used to describe the degeneration of one or more intervertebral discs. It is the leading cause of neck pain, back pain, motor debilitation, and spinal cord irritation.

A wide range of factors can cause a patient to develop DDD. The three most prevalent causes are traumatic compression injuries, old age, and heredity. Looking at the anatomy of the vertebral disc depicted below in figure 1, there are two important parts of the disc that deteriorate in cases of DDD: the Anulus fibrosus and the Nucleus pulposus. The Nucleus pulposus is the hydrated core of the disc that functions like a shock absorbing fluid similar to what is found in mechanical hydraulic system. The Anulus fibrosus is the fibrous tissue that surrounds the core and keeps it intact; this tissue is also stretchable and compressible. In all cases of DDD, one or more discs have diminished compression support for the two adjacent vertebrae due to a non intact Nucleus pulposus. This occurs when either the core has been dehydrated (usually due to old age or a hereditary condition) or the Anulus fibrosus has been badly damaged causing an unstable and weaken core (usually due to a traumatic injury).

Intervertebral-disc.jpg

Figure 1: A diagram from the eHealthStar institute describing the anatomy of the Intervertebral Disc (Modric 1)

Medical institutions like the Atlanta Brain and Spine Care Clinic have dubbed specific names to the various conditions that fall under DDD (refer to figure 2). A basic degenerated disc involves the accumulation of scar tissue on the Anulus fibrosus caused by repetitive minor injuries to the spine. A bulging disc involves the stretching of the Anulus fibrosus to a point where it makes contact with the spinal cord and/or surrounding nerves. A herniated disc involves the complete rupture of the Anulus fibrosus and the scattering of the inner core fluid tissue throughout the spinal cord's surrounding area, which is caused by a serious fall or other traumatic shock to the spine. A thinning disc involves the dehydration of the Nucleus pulposus, which is linked to old age and heredity. Lastly, degeneration with Osteophyte Formation is a condition where the spine adjusts to weakened thinning discs by building bone mass around the vertebrae to provide the spine with more support, which also causes great pain as bone gradually grown in the area surrounding the spinal cord (Benglis). All of these differing conditions have the same solution--vertebral disc repair.

Degen disc types label illus51.gif

Figure 2: A diagram from the Atlanta Brain and Spine Care Clinic depicting various instances of disc degeneration that would be diagnosed as DDD (Benglis)


Works Cited

Benglis, David M., Dr, and Roger H. Frankel, Dr. "Home." Lumbar Degenerative Disc Disease. Atlanta Brain and Spine Care, 2003. Web. 01 Sept. 2016. <http://www.atlantabrainandspine.com/subject.php?pn=lumbar-degenerative-disc-002>.

Health Quality Ontario. “Artificial Discs for Lumbar and Cervical Degenerative Disc Disease Update: An Evidence-Based Analysis.” Ontario Health Technology Assessment Series 6.10 (2006): 1–98. Print.

Modric, Jan. "Bulging, Herniated Disc and Pinched Nerve in Neck and Lower Back." Evidence Based Health Articles. EHealthStar, 17 Dec. 2015. Web. 01 Sept. 2016. <http://www.ehealthstar.com/conditions/bulging-herniated-disc>.




Competitors

Fusion, grafting of two or more vertebrae together to replace damaged vertebral discs, is currently the leading competitor in correcting degenerative disc disease (DDD) (Lee). This method has shown the most effective long-term results over other competitors such as disectomy/microdisectomy, arthroplasty and hybrid techniques (mechanical and hybrid implants), and non surgical methods such as physical therapy, physical supports, exercise, or pain medications. However, even fusion has many negative effects, such as limiting mobility in patients and increasing the risk of needing more surgery after the initial operation. The other methods are either not sustainable or simply prolong the time before corrective surgery is required.


Advantages
Adapting regenerative medicine to replacing degenerative or damaged discs has great potential to improve the sustainability and effectiveness of current competitors. Because the technology uses STEM cells harvested from the patient, this approach will be non-rejective, customized precisely for the patient's vertebrae, and is the most accurate, natural model of a intervertebral disc (Subach). The patient's damaged disc will be restored to a close model of the their original, healthy disc. Thus, this will also be much more sustainable (have the same capacity as a healthy spine at least for many years) and will increase the mobility of patients compared to all other competitors. Even relatively new approaches to degenerative disc disease such as arthroplasty and hybrid techniques will not allow the patient to have as much mobility because they cannot replicate the tissue material that give a disc it's malleability and shock absorbency (Lee).


Disadvantages
The technology for regenerative medicine is still relatively new. Its application toward degenerative disc disease has shown much progress, as seen by advances in 2013 when ISTO Technologies inc. identified NuQu, a STEM cell-based therapy for treating DDD (Subach). However, it is still in the testing and development process. Because of the recent the technology is, research, testing, and initial treatment will be quite costly, at least more expensive than a current fusion treatment, which is about $90K (Nordqvist). The expenses will need to be applied not only toward the development and treatment but also toward the replacement of new technologies in clinics and training physicians to correctly apply the treatment. From a patient perspective, one disadvantage is that the process and surgery required to regenerate disc tissue requires a longer recovery time and likely more hospital visits to monitor recovery.


Works Cited
Heindel, P and Tuchman A, Hsieh PC, Pham MH, D'Oro A, Patel NN, Jakoi AM, Hah R, Liu JC, Buser Z, Wang JC. "Reoperation Rates Following a Single-Level Lumbar Discectomy." PubMed, 2016. http://www-ncbi-nlm-nih-gov.ezproxy1.lib.asu.edu/pubmed/27548580 Accessed August 31, 2016.

Lee, YC and Zotti MG, Osti OL. "Operative Management of Lumbar Degenerative Disc Disease." Asian Spine Journal, vol. 4, pp. 801-19. http://www-ncbi-nlm-nih-gov.ezproxy1.lib.asu.edu/pubmed/27548580 http://www-ncbi-nlm-nih-gov.ezproxy1.lib.asu.edu/pubmed/27559465. Accessed August 31, 2016

Nordqvist, Christian. "What is Degenerative Disc Disease?" Medical News Today, 26 Sep 2014. http://www.medicalnewstoday.com/articles/266630.php

Subach, Bryan. "Breakthrough Cell-Therapy for Degenerative Disc Disease Sufferers." Virginia Spine Institute: Spine MD, 3 Oct 2013. http://www.spinemd.com/news-philanthropy/breakthrough-therapy-shows-promise



Customer Validation

Patient
Implanting tissue engineered intervertebral discs would be preferable for patients because current methods of treating this disease, such as surgical fusion of the spine, leads to further damage to the spine. Surgical fusion typically results in the patient suffering from reduced range of motion in the spine while regenerative therapy would return the spine to its previous performance ability. This would be preferable to patients who do not want to continue to suffer from back problems after the surgery. On the downside, the surgery is extremely expensive and would not be covered by insurance considering DDD is prevalent in the vast majority of the elderly population (Insurance). Moreover, tissue regeneration is a long process of growth and maturity, which would would likely result in an extended recovery period for patients.


Payer
Treatment methods would not actually affect most insurance companies as most do not cover spinal fusion surgery or most other solutions to DDD. The few that do cover it, only cover the repair of a single disc (Insurance). This means that the patient would be paying the full price for the treatment out of pocket. Due to the fact that it would be experimental treatment and new, it would cost the patient a very large quantity of money, at least $90,000 (the approximate cost for spinal fusion surgery), which is already an established treatment method. However, in the long-run, a one time payment to have a disc regenerated is more economically sound than paying for a rudimentary procedure like fusion or mechanical disc replacement considering DDD is less likely to emerge again with a tissue engineered solution.


Physician
Physicians would have interest in disc engineering because it is a set procedure, so they would only have to learn a single method instead of multiple. However it would still require a large amount of training due to how complicated the procedure would have to be in order to utilize STEM cells to regenerate parts of the spine in a scaffold in the spine. In addition to this being a set procedure, the procedure is all non-rejective because the disc replacement would be grown in the patient and from the patient's own cells. Rejection is a major issue that most other disc replacement methods face because of how invasive most implants are nowadays (Health).


Provider
This technology would be good for medical providers as it would give them an opportunity to gain recognition in the medical community for developing and providing ground breaking technology. Consequentially, this would also greatly increase their profit margins if they were able to advance their research beyond other institutions and become recognized for it. That being said, the hospitals would either have to pay for the training of their surgeons and support staff that would be involved with this procedure, or have to hire new staff, which would put a significant dent in their budgets.


Purchaser
Purchasers would be interested in this procedure because they could possibly generate a very large amount of money from the hospitals if the procedure could be marketed and optimized enough for the hospitals to pursue further research on the regenerative solution. That being said, because it is a procedure rather than a consolidated product, it would be very difficult to effectively market the technology without human trials that would require hospitals to already be authorized to use it. This means they would lose some money up front but in the long run could be involved in a very profitable market.


Works Cited

Health Quality Onario. "Artificial Discs for Lumbar and Cervical Degenerative Disc Disease-Update: An Evidence-based Analysis." Ontario Health Technology Assessment Series 6.10 (2006): 1-98. Print.

"Insurance Covering Total Disk Replacement ? - Health Insurance Issues." Spine Health. N.p., n.d. Web. 02 Sept. 2016.

IP Position=

Patent Landscape: Currently, there are various methods and patents for treating Degenerative Disc Disease, repairing intervertebral discs, and even completely replacing them. Almost all of the latest patents involve the regeneration of the intervertebral discs through the use of biological material. A patent has already been filed and granted for the repairing of intervertebral discs by introducing stem cells to the already existing intervertebral disc. This patent is considerably the closest to our method. What separates our method from this one though is that we aim not to introduce stem cells to an already existing intervertebral disc, but rather to produce a completely new intervertebral disc from adipose tissue stem cells, coupled with a scaffold that will allow for the continuing growth and strength of this intervertebral disc. Using this newly made disc and scaffold, the damaged intervertebral disc can be removed and replaced with a brand new artificial one.

IP Risks: As this method introduces an entirely new disc into the body, the biggest risk we face is getting the method and product approved by the FDA.


Relevant, already existing patents include :

1. Patent #US20040193274A1

2. Patent #US20080045949A1

  • Title:Method of treating degenerative spinal disorders
  • Summary: "A method of treating a degenerative intervertebral disc disorder comprising implanting a disc stabilization device into a subject suffering from the disorder and administering at least one therapeutic agent which promotes healing of the disc to the subject such that treatment of the disorder occurs" (2)
  • Filing date: June 19, 2006. Published on February 21, 2008
  • https://patents.google.com/patent/US20080045949A1/en?q=regenerative+intervertebral+disc+implant&q=stem+cell
  • No Image of Method Provided

3. Patent #US20050149046A1

Screen Shot 2016-09-01 at 10.18.56 PM Figure 1:Image depicting method for Patent 3 (Friedman)

4. Patent #US20050069571A1

Screen Shot 2016-09-01 at 10.23.09 PM Figure 2 (above) and 3 (below) :Image depicting method of treatment for Patent 4 (Slivka) Screen Shot 2016-09-01 at 10.23.17 PM


Works Cited

1. Trieu, Hai, Trieu Hai H., and SDGI Holdings Inc. "Materials and Methods for Augmenting And/or Repairing Intervertebral Discs." US20040193274A1. US Government, 30 Sept. 2004. Web. 02 Sept. 2016.

2.Hunt, Margaret, David Hooper, Alain Meunier, James Jara-Almonte, Hunt Margaret M, Hooper David M, Abbott Laboratories, and Zimmer Spine Austin Inc. "Method of Treating Degenerative Spinal Disorders." US20080045949A1. US Government, 21 Feb. 2008. Web. 02 Sept. 2016.

3.Friedman, Craig, Arindam Datta, and Friedman Craig D. "Repair of Spinal Annular Defects and Annulo-nucleoplasty Regeneration." US20050149046A1. US Government, 7 July 2005. Web. 02 Sept. 2016.

4.Slivka, Michael, Hassan Serhan, and DePuy Spine Inc. "Method for Treatment of Defects in the Intervertebral Disc." US20050069571A1. US Government, 31 Mar. 2005. Web. 02 Sept. 2016.



Fundability Worksheet Scores

Competitors
The score for competitor criteria will be a two--although we have existing competitors, some of those competitions are still finding improvement (for example, arthroplasty and mechanical implants are increasingly mimicking a natural disc model). We also do not know the actual long-term risks regenerating disc tissue may cause once it comes to human trials. Also, because it requires more advanced technology to regenerate disc tissue, it will be more expensive than other competitors.

Customer Validation
Customer validation criteria will be scored a one because regenerative disc tissue will be more expensive for customers. However, there is potential interest because it will come with greater long-term benefits. Because regenerating disc tissue has not yet been introduced to the market, we do not have any feedback from customers.

IP Position
IP position was scored a two because there are patents similar to regenerative disc tissue but none that take it as far as our unique approach, which is to create an entirely new disc using regenerative medicine.