Intellectual Property
We are basing our device based on technology developed at the University of California, Irvine. The university is the owner of this intellectual property and has a patent issued. We plan on acquiring a sublicense for this technology, as well as developing our own intellectual property.
Regulatory Strategy
Our device will be classified as an FDA class II device. Being a class II device we will have to perform a clinical trial and submit a 510K. We plan on doing a year long clinical trial to validate our device and use the results to get approval from the FDA to sell our device. We also plan on using a predicate medical device to fast track our 510K approval. We anticipate from the start of the clinical trial to approval of 510K from the FDA to late approximately a year and a half.
Market Strategy
The overall market size for dermatology devices is around 6 billion dollars and expected to grow to 11 billion by 2019. Our device will tap into this growing market and be used to help detect skin cancer. One in 50 americans will have some form of skin cancer. There is approximately 5.5 million skin biopsies performed annually in the United States. The cost of such a biopsy can cost anywhere between $150 to $1,000. A large number of these biopsies produce negative test results, meaning that there is no cancer. This is a big waste of money for insurance providers and our device could help reduce the number of biopsies that have to be read. Our device will be attractive to buyers because it will help reduce wasteful spending and help give dermatologist critical information much quicker.
After we have developed a working device, we plan to work with a manufacturing company that specializes in imaging to build our device. We also plan on companies specializing in sales, marketing, and distribution until we can create our own departments to help in these areas. Looking at the current competition, a device like ours would sell for around two thousand dollars. Based on cost of building and selling the device to be around $1,200, we are looking at a profit of around eight hundred dollars per unit. We also plan to sell disposables for our device and software upgrades. The disposables will be used on a single patient then replaced and software upgrades will try and be pushed out every year. We have not yet formed a for-profit company, but we do plan to do this in the future.
Competitors
Our device would be considered a digital dermatoscope and would be made for the use of dermatologists. The digital dermoscopy market has multiple companies in it and has diverse range of products. Companies such as 3Gen and Handyscope offer dermatoscopes that range between a couple hundred to a couple thousand dollars, and they just offer high quality images of the skin. We hope to sell our device to a price comparable to that of 3Gen in order to compete in the market.