BME100 s2017:Group8 W8AM L2

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Name: Meghan Rasmussen
Name: Salma Leyasi
Name: Nicholas Chung
Name: Michelle Loui
Name: Nicholas Sora
Name: Ezekiel Mendoza


Device Image and Description

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The bioabsorbable screws and anchors take the design of generic tools used in Anterior cruciate ligament reconstruction. What sets them apart is the bioabsorbable osteoconductive material it is made from, that will prevent further surgeries due to the screws. The material can be used in a variation of ligament surgery screw and anchors, to fit their need.

Technical and Clinical Feasibility

Technical Feasibility
1) What are the technologies needed?
The technologies needed to make a bioabsorbable screw is a bioabsorbable material that is osteoconductive. There are many different sorts of viable biomaterials that can make the screw the most common one being poly lactic-co-glycolic acid (PLGA).

2) What are the challenges?
The biggest problem, from a technological standpoint, will be making sure the screw bio absorbs into the bone while making sure it can maintain an effective level of stability for the ACL to reattach itself. If it absorbs too fast, the ACL can not repair properly, and if it absorbs too slowly, than it may cause an unnecessary level of discomfort in the patient.

3) What could go wrong?
Technologically, the biggest risk that is currently known to us is that the screw doesn’t bioabsorb and cause pain in the patient and then the patient is forced to have another surgery to remove the screws.

Clinical Feasibility
1) Will it work in the clinic?
Yes, there are a couple of clinical trials going on right now and one study has been completed. The completed study had no significant findings, but shows there is potential for rapid improvement.

2) What are the clinical risks?
Risks that come with testing our product is the degradation of the screw and no bone growth occurring. Also with any foreign material that gets inserted to the body, there is the potential for rejection and to the newly anchored ACL being released and having a patient go to another surgery and repair the damage once again.

3) Have similar products been in a clinical trial? How long was the trial?
There has been one completed study done with bioabsorbable screws which went on for four years. The outcomes of the study were not promising and did not show any reason to use bioabsorbable screws as opposed to metal screws. The bioabsorbable screws used in the study did not show any bone and one of the two screws started to show signs of degradation.

Market Analysis

Value Creation
Our prototype creates a quicker return to normal activity for the customer. One of the primary complaints about traditional metal screws used today for ACL reconstruction surgeries is the discomfort caused by them when patients return to their normal activity level. Depending on the level of discomfort felt by the patient, additional surgery is required to release the pressure around the metal screws in hope to alleviate the discomfort. With our bioabsorbable screws, patients won’t have to worry about discomfort from metal screws. They can return to their everyday life faster and with less complications.

Manufacturing Cost
The cost to make the screw, not including labor, will be around fifty dollars per screw. We took the density (1.34g/cm^3) of the material we were using, multiplied it by by the area of the screw (0.92 cm^3) and then multiplied it by the cost of our material per gram (around $40/g). Including labor, we speculate that our cost will be around $125-$150 per screw.

Sales Price
The anticipated average sale price would be between $225-$250 for each screw, with the price ranging depending on the size of the screw. Currently, metal screws used in ACL reconstruction can range up to $900 [3]. By making our bioabsorbable screws less expensive than the traditional metal screws, more patients will be willing to ask for them in their reconstruction surgery.

Market Size
The average cost of a screw used in an ACL reconstruction surgery is 208.633 Euros, which is approximately 223.25 US dollars (1). The average cost of a suture anchor used in this surgery is $1000. In the US, 100,000 of these surgeries are performed annually. By adding the average cost of a screw and suture anchor ($1223.25) and multiplying by the number of surgeries performed annually (100,000), the market size for ACL reconstruction materials in dollars per year can be calculated ($122,325,000).

Fundability Discussion

Score Criteria 0 1 2 3
1 Customer Validation No customer excitement to purchase Hesitant interest to purchase or not enough customer feedback to-date Masses have expressed interest to purchase Significant customers have agreed to purchase and/or are willing to invest
1 Market Size (US only) Less than 80 million 80M-200M 200M-500M Over 500M
2 Competition Single dominant competitor or value proposition insufficient to compete Crowded market space. Differentiation will be difficult Competition exist but clinical improvements are still being made Value proposition will easily displace any competition
3 IP Position No patentability or freedom to operate No or weak patent applications or provisionals only Non-provisional(s) filed and pending or issued patents, but weak Strong, issued patents
2 Technical Feasibility Physics would have to be bent Will require large investments/research, development will be cost prohibitive Some challenges but will be overcome with time and within a reasonable cost. Simple and straight-forward design with known materials and methods
3 Regulatory Pathway Unclear regulatory pathway PMA 510K - clinical data needed or De Novo 510K - No clinical data needed. Exempt
2 Clinical Feasibility Clinical success unlikely. Others have tried and failed Clinical success is unclear. Large patient volumes or long time-frame trials required Clinical success is likely but will require special expertise and/or research Clear path to clinical success. Others have been clearly successful
2 Reimbursement Reimbursement unlikely. No cash paying incentives New application to CMS necessary prior to any payments being issued Reimbursement could fall under an existing code but a new code will eventually need to be filed. Reimbursement readily accepted or patients are very incentivized to pay cash
144 Product Total

Justification for Scores
Customer Validation: To date, there is not enough feedback from prospective customers

Market Size: The average cost of a screw used in an ACL reconstruction surgery is 208.633 Euros, which is approximately 223.25 US dollars. (1) The average cost of a suture anchor used in this surgery is $1000. Annually, in the US, 100,000 of these surgeries are performed. ($223.25+$1000) x 100,000 = $122,325,000

Competition: Currently, there are many different companies that are selling their own type of screws for the surgery, so competition exists, but there are still groups that are attempting to make clinical improvements

IP Position: As of right now in the market, there are numerous strong patents that have been issued for this type of product.

Technical Feasibility: Since there are other reliable screws on the market right now that are being used in surgeries, extensive research and investments would not be necessary. Basic standards and parameters have already been set up and with time, we are hoping to only improve the quality of the product so that patients can be more comfortable. Challenges in making this product can be overcome with time.

Regulatory Pathway: Our product would be substantially equivalent to a predicate device, so no clinical trial would be required.

Clinical Feasibility: Some research would be necessary to ensure the quality of the screw, but not extensively, and clinical success is likely. Patient outcomes are likely to be positive.

Reimbursement: There are existing screws that are used in these surgeries already on the market, so initially, reimbursement could fall onto existing codes but new ones would most likely have to be filed at a later point.

Overall, based on the score of 144, funding for this prototype would be recommended. The benefits that would come from bringing this product to life outweigh the disadvantages. This product would enhance the quality of life for many future patients and improve patient satisfaction.