Soft contact lenses (SCLs) are an increasingly popular method of vision correction. With this, younger and younger patients are beginning to wear soft contact lenses. Particularly with younger SCL wearers, improper use is rampant, with unsanitary behaviors including: not washing hands when inserting or removing lenses, sleeping in lenses, “topping off” lens cases instead of replacing solution, and reactive replacement of SCLs, that is, waiting for an issue to replace lenses rather than following the manufacturer's’ recommended time that lenses should be worn. “Approximately 99% of respondents reported at least one contact lens hygiene behavior previously associated with an increased risk for eye infection or inflammation” (CDC, 2015) “Nearly one third of contact lens wearers reported having experienced a previous contact lens- related red or painful eye requiring a doctor’s visit” (CDC, 2015) Bacterial Keratitis is an eye infection causing eye pain, redness, discharge, and other painful symptoms. “The largest single risk factor for microbial keratitis is contact lens wear.” (CDC, 2015) While daily-replaced contacts are popular, with 31% of wearers using them, 68% percent of contact wearers replace them monthly (44%) or every 1-2 weeks (24%). Our proposed technology is a dye or natural color that will degrade with exposure to oxygen (beginning at the time the SCL is removed from its sealed packaging) over the recommended month-long period of wear, notifying the user that it is time to replace the lens. This will reduce the likelihood of eye complications such as bacterial keratitis.
Customer Validation
Sheila Hickson-Curran, researcher for Johnson and Johnson visionwear
Dr. Ted Dryja, Global Head of Ophthalmology at the Novartis Institutes for BioMedical Research
Dr. Sheldon S. Miller, Scientific Director at National Eye Institute
John Reed (mesa optometrist)
Arizona Optometric Association
Timothy Sinek (southwestern eye center optometrist)
Jetal Patel (southwestern eye center optometrist)
Dr. Andrea P. Thau, president of American Optometric Association
Dr. Arthur B. Epstein
Air Optix Contact Lenses
Dr. A. Philip Aitsebaomo, National Optometric Association President
Does not tell any information about whether the contact needs to be changed
Air Optix
High oxygen permeability
Start to feel dry in 8-12 hours
Biofinity/Biomedics
Dry eye prevention, comfort, ease of use.
Color change
IP Position
IP Position: Perform a patent search and describe existing patents related to your device/technology.
Contact Lens with Visual Indicator: US 8113654 B2
Contact lens contains a visual indicator to help the user distinguish between the right and left contact lens. The indicator appears when the lenses are in contact with the contact solution and disappear when taken out of the solution.
https://www.google.com/patents/US8113654
Soft contact lens with contamination indicator: US 5598233 A
A contact lens that releases a visual indicator when contact lenses are contaminated, damaged, and old. Contact indicator is released via a small slit in the contact. Indicator releases once enough contaminants build up along the slit, causing the indicator to appear.
http://www.google.co.bw/patents/US5598233
Contact lens disinfector with temperature indicator: US 4251719 A
Contact contains a solution that when heated, sterilizes the contact. To heat the contacts, a heating case is provided that will heat up contacts that are not in use and allow them to be cleaned. The disinfecting solution within the contact is released when kept in the heated environment of the case.
https://www.google.si/patents/US4251719
Fundability Worksheet Scores
Competitors
Customer Validation
IP Position
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
3
2.Market size (US only)
Less than 80M
80M - 200M
200M - 500M
Over 500M
2
3.Competition
Single dominant competitor or Value proposition insufficient to compete
Crowded market space Differentiation will be difficult
Competitors exist but clinical improvements are still being sought
Value proposition will easily displace any competition
2
4.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
5.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
N/A
6.Regulatory Pathway
Unclear regulatory pathway
PMA
510k - clinical data needed or De Novo
510k - no clinical data needed Exempt
2
7.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
N/A
8. 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
48
TOTAL (product)
Customer validation: 1-- While a large portion of people wear contact lenses, there has never been an expressed need for contacts that tell the wearer when they should be changed.
Market size (US only): 3-- The total market size s almost 9 billion, and while this goes on paying suppliers, manufacturers, etc, there is still a large amount of people who would want a product such as this, and the amount would expand once it becomes apparent that even kids can use these lenses
Competition: 2-- There are a few dominant competitors in the vision wear, and specifically contact lens, industry. However, our product is somewhat unprecedented and it is difficult to tell how our product will fare in competition.
IP Position: 2 - there are currently a few patents that contain similar designs and technology, but these patents are either dated, expired, or not exactly the same as our product.
Technical feasibility 2-- There are various meals that oxidize and are safe to be in contact with the eyes, so long as it is not for too long of a time. These could be suspended on the surface or in the middle of the hydrogel that composes the lenses.
Regulatory pathway: N/A-- We lack the experience or expertise to determine this.
Clinical feasibility: 2-- Contact lenses are a well-established, noninvasive product and our additions will likely have little effect on their safety.
Reimbursement: N/A-- Without more expertise and experience in the medical device, and specifically contact lens, industry, this is difficult to determine.
Care, J. V. (2016, December 07). ACUVUE® brand contact lenses. Retrieved January 25, 2017, from ACUVE, http://www.acuvue.com
Cope, J. (2015, August 21). Morbidity and Mortality Weekly Report. Retrieved January 25, 2017, from Center for Disease Control, https://www.cdc.gov/mmwr/pdf/wk/mm6432.pdf
Haralambopoulos, C., Hara, A., & Gell, H. A. (n.d.). Patent US5598233 - Soft contact lens with contamination indicator. Retrieved January 25, 2017, from http://www.google.co.bw/patents/US5598233
Ryder, F. E., & Corporation, R. I. (n.d.). Patent US4251719 - Contact lens disinfector with temperature indicator. Retrieved January 25, 2017, from https://www.google.si/patents/US4251719
BME 100 Spring 2017
