OUR TEAM
LAB 1 WRITE-UP
Health Care Issue
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
- Valeant Pharmaceuticals (contact lens manufacturer)
- Novartis (contact lens manufacturer)
- The Cooper Companies (contact lens manufacturer)
- X-Cel Specialty Contacts (contact lens manufacturer)
- Metro-Optics
- Dr. Shannon L. Steinhäuser
- American Academy of Optometry
- Pearson Eyecare Group: Dr.Kerry Pearson
- GP Specialists
Competitors
| Companies
|
Advantages
|
Disadvantages
|
| Johnson and Johnson
|
Changes color to let user know when it expires.
|
Astigmatism models, Presbyopia models
|
| Acuve
|
Changes color to indicate the lense is inside out
|
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.
Works Cited
(2015, January 27). Retrieved January 25, 2017, from https://www.cdc.gov/contactlenses/bacterial-keratitis.html
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
Enerson, B. D. (n.d.). Patent US8113654 - Contact lens with visual indicator. Retrieved January 25, 2017, from https://www.google.com/patents/US8113654
Glacial Multimedia. Optometrists. Retrieved January 25, 2017, from Southwestern Eye Center, http://www.sweye.com/optometrists.htm
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
NICHOLS, J. J. (2017). CONTACT LENSES 2016. Contact Lens Spectrum. Retrieved from http://www.clspectrum.com/issues/2017/january/contact-lenses-2016
Rare-Earth Metal Long-Term Air Exposure Test. (2007, November). Retrieved January 25, 2017, from http://www.elementsales.com/re_exp/
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
Wagner, H. et al (2014, March). Age, Behavior, Environment, and Health Factors in the Soft C... : Optometry & Vision Science. Retrieved January 25, 2017, from http://journals.lww.com/optvissci/Fulltext/2014/03000/Age,_Behavior,_Environment,_and_Health_Factors_in.3.aspx?trendmd-shared=0
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BME 100 Spring 2017
