Design, Develop, and Market a Product: Heart Stents
Group Members: Ananya Somasekar, Amritha Somasekar, Natalie Mansergh, Emmy Nam
In this project, our goal is to develop an innovative and profitable product that can be marketed to the public through our own company." Similar to everyday life in the biotechnology field, scientists are trying to create products that will contribute to society as well as bring back revenue. We have to choose and design a product that encompasses an unmet need, uncured illness, needed technology, or needed project.
Exactly like in the real workplace, we will have to follow these procedures:
Exactly like in the real workplace, we will have to follow these procedures:
1. Initial Product Proposal
- Loan Application - Product Proposal - Resumes |
2. Marketing Plan
- Advertisement - Price - Audience |
3. Research & Development Plan
- Research - Materials - Procedure of Manufacturing |
4. In Silica Prototype
- Create prototype - Evidence |
Our Project Proposal:
I. Unmet Need:
Aneurysms are a prevailing medical issue across the globe. The heart is the human body's lifeline -- it is responsible for pumping blood, and the oxygen carried on it, every second of every day. This tireless responsibility can take a major toll on the heart, and in several cases, this causes the aortic wall to weaken. As a result, the aorta undergoes a balloon, bulge effect in order to combat the constant pressure of blood rushing in. This is called an aortic aneurysm, although this medical condition is not limited to the heart: it also occurs in other areas of the chest (thoracic aortic aneurysm) and stomach (abdominal aortic aneurysm). Diagnosis of an aneurysm is extremely serious: if it continues to swell and expand, it will eventually burst and cause extreme internal hemorrhaging that is most often fatal. Due to this, there is an undeniable demand for non-invasive, reliable, and long-lasting stents. In America alone, half a million people undergo heart stent surgery each year. The procedure for stent implantation is called either Percutaneous Coronary Intervention (PCI) or coronary angioplasty, and it is not without risk. Many of the immediate surgical risks include: bleeding/hemorrhage at the site of catheter insertion, damage to the blood vessel, arrhythmias (irregular heartbeat), damage to the kidneys, allergic reactions, and infection. More long-term, and equally serious risks encompass: restenosis (excess tissue growth over the stent), movement of the stent over time, damage to nerves (causing weakness, pain, or numbness), and blockage of the stent.
Aneurysms are a prevailing medical issue across the globe. The heart is the human body's lifeline -- it is responsible for pumping blood, and the oxygen carried on it, every second of every day. This tireless responsibility can take a major toll on the heart, and in several cases, this causes the aortic wall to weaken. As a result, the aorta undergoes a balloon, bulge effect in order to combat the constant pressure of blood rushing in. This is called an aortic aneurysm, although this medical condition is not limited to the heart: it also occurs in other areas of the chest (thoracic aortic aneurysm) and stomach (abdominal aortic aneurysm). Diagnosis of an aneurysm is extremely serious: if it continues to swell and expand, it will eventually burst and cause extreme internal hemorrhaging that is most often fatal. Due to this, there is an undeniable demand for non-invasive, reliable, and long-lasting stents. In America alone, half a million people undergo heart stent surgery each year. The procedure for stent implantation is called either Percutaneous Coronary Intervention (PCI) or coronary angioplasty, and it is not without risk. Many of the immediate surgical risks include: bleeding/hemorrhage at the site of catheter insertion, damage to the blood vessel, arrhythmias (irregular heartbeat), damage to the kidneys, allergic reactions, and infection. More long-term, and equally serious risks encompass: restenosis (excess tissue growth over the stent), movement of the stent over time, damage to nerves (causing weakness, pain, or numbness), and blockage of the stent.
II. Project Idea:
Our project idea is to create an innovated heart stent that will be less invasive, and less prone to slipping. We did extensive research on bio-compatibility. According to D. Mihov, who published an article through the Medical University of Sofia, biocompatible materials include: stainless steel, cobalt alloys, titanium alloys
One of the biggest problems with heart stents lies post-surgery. Many stents are drug-coated, but this also stimulates rejection of the stent, and chemical reactions within the body. In order to negate this, we wanted to create a heart stent that had a completely biocompatible structure: therefore, we will try to create a stent using titanium and a placenta covering.
Our project idea is to create an innovated heart stent that will be less invasive, and less prone to slipping. We did extensive research on bio-compatibility. According to D. Mihov, who published an article through the Medical University of Sofia, biocompatible materials include: stainless steel, cobalt alloys, titanium alloys
One of the biggest problems with heart stents lies post-surgery. Many stents are drug-coated, but this also stimulates rejection of the stent, and chemical reactions within the body. In order to negate this, we wanted to create a heart stent that had a completely biocompatible structure: therefore, we will try to create a stent using titanium and a placenta covering.
III. Materials: For our purposes, we decided to use titanium as the basis of our heart stent material. Titanium is stronger, more durable, less prone to degrading than stainless steel, and primarily non-corrosive. We would also like to use the human placenta as a replacement for the fabric covering: because it is actually a part of the human body, they are very biocompatible.
IV. Facility:
In order to create heart stents, we would need an isolated, sanitized lab complete with machinery and equipment to both create and test the stent. At Medtronic, a leading medical company, there were production facilities where the heart stents were manufactured. Then there was an entirely different section of the building that put the stents into sped up, real-life simulation of being inside a heart (fatigue lab). This allows for study of the stent, and direct feedback on its efficiency. This itself takes 3 - 6 months, even with a sped-up heartbeat.
In order to create heart stents, we would need an isolated, sanitized lab complete with machinery and equipment to both create and test the stent. At Medtronic, a leading medical company, there were production facilities where the heart stents were manufactured. Then there was an entirely different section of the building that put the stents into sped up, real-life simulation of being inside a heart (fatigue lab). This allows for study of the stent, and direct feedback on its efficiency. This itself takes 3 - 6 months, even with a sped-up heartbeat.
V. Budget / Cost Estimations:
1. Development Cost: - Fatigue & Development Lab: > 1785 square feet, Santa Rosa CA > $1.95/square foot/month > Ten year lease - Manufacturing Lab: > 850 square feet, Santa Rosa CA > $1.95/square foot/month > Ten year lease - Labor: > 2 cardiologists: $300,000 per year salary > 3 residency students: $42,700 per year salary > 2 bioengineers: $70,000 per year salary |
2. Material Cost: - Titanium ingot: $8.65 per pound - Placenta: [acquire from hospitals] - Fatigue Machine: $3,000 - $7,000 |
VI. Cost of Materials per Unit/ Cost of Development:
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VII. Timeline:
The first year, our aim is to simply set up the company fundamentals: we will set up the company base, hire professional staff, and apply for grants. In the following three years, we will develop a prototype and begin stress/fatigue testing on the stent. We plan to start off by manufacturing 100 heart stents, and implementing them in people with diverse situations who are both compatible and willing to try an experimental alternative for angioplasty. For the next couple years, we plan on monitoring the stents' behavior within the body. If the implementation is successful, our goal is to spread the stent to 500,000 people in the United States exclusively. This will make it easier to track the success rates within the country. Hopefully, if the turn out is positive, we will spread our market to the rest of the world. If the stent is successful, we hope to give out heart stents to second-world and third-world countries, where the procedure cannot be afforded.
The first year, our aim is to simply set up the company fundamentals: we will set up the company base, hire professional staff, and apply for grants. In the following three years, we will develop a prototype and begin stress/fatigue testing on the stent. We plan to start off by manufacturing 100 heart stents, and implementing them in people with diverse situations who are both compatible and willing to try an experimental alternative for angioplasty. For the next couple years, we plan on monitoring the stents' behavior within the body. If the implementation is successful, our goal is to spread the stent to 500,000 people in the United States exclusively. This will make it easier to track the success rates within the country. Hopefully, if the turn out is positive, we will spread our market to the rest of the world. If the stent is successful, we hope to give out heart stents to second-world and third-world countries, where the procedure cannot be afforded.
VIII. Sources:
- Material Used: http://blog.mediligence.com/2009/06/11/materials-used-in-stent-construction/
- Placenta: http://www.news-medical.net/news/20120519/Placental-stem-cells-with-key-therapeutic-properties-can-be-harvested-from-chorion.aspx
- People Who Need: http://well.blogs.nytimes.com/2013/08/15/heart-stents-continue-to-be-overused/?_php=true&_&_r=0
- Replacement Needs for Heart Stents: http://www.cardiachealth.org/ca-blog/how-long-does-heart-stent-last-do-they-need-be-replaced
- Fatigue Machine: file:///home/chronos/u-e460fb2338f5748a746faffa232e1813c6db6e08/Downloads/StentTesting.PDF
- Heart Failure (diastolic, systolic): http://www.mayoclinic.org/diseases-conditions/heart-failure/basics/causes/con-20029801
- Cost for Fatigue Machine: http://www.alibaba.com/trade/searchfsb=y&IndexArea=product_en&CatId=&SearchText=fatigue+testing+machine+price
- Medtronic: http://www.medtronic.com/patients/coronary-artery-disease/therapy/balloon-angioplasty-and-stenting/benefits-risks/
- Cost for Cardiologist: http://forums.studentdoctor.net/threads/what-is-the-average-fellowship-salary.32713/
- Cost for Cardiologist: http://www.glassdoor.com/Salaries/physician-interventional-cardiologist-salary-SRCH_KO0,37.htm
- Material Used: http://blog.mediligence.com/2009/06/11/materials-used-in-stent-construction/
- Placenta: http://www.news-medical.net/news/20120519/Placental-stem-cells-with-key-therapeutic-properties-can-be-harvested-from-chorion.aspx
- People Who Need: http://well.blogs.nytimes.com/2013/08/15/heart-stents-continue-to-be-overused/?_php=true&_&_r=0
- Replacement Needs for Heart Stents: http://www.cardiachealth.org/ca-blog/how-long-does-heart-stent-last-do-they-need-be-replaced
- Fatigue Machine: file:///home/chronos/u-e460fb2338f5748a746faffa232e1813c6db6e08/Downloads/StentTesting.PDF
- Heart Failure (diastolic, systolic): http://www.mayoclinic.org/diseases-conditions/heart-failure/basics/causes/con-20029801
- Cost for Fatigue Machine: http://www.alibaba.com/trade/searchfsb=y&IndexArea=product_en&CatId=&SearchText=fatigue+testing+machine+price
- Medtronic: http://www.medtronic.com/patients/coronary-artery-disease/therapy/balloon-angioplasty-and-stenting/benefits-risks/
- Cost for Cardiologist: http://forums.studentdoctor.net/threads/what-is-the-average-fellowship-salary.32713/
- Cost for Cardiologist: http://www.glassdoor.com/Salaries/physician-interventional-cardiologist-salary-SRCH_KO0,37.htm