Improving Melanoma Screening: MELA Sciences

MELA is a start-up medical device company looking to develop a novel technology to help physicians diagnose a deadly skin cancer, melanoma. The case reviews the FDA medical device development process, the development path pursued by MELA, and the regulatory and business trajectory of the firm. In the end, MELA raised $100 million for the development of this technology, and had $1 million in revenue after launch. The case offers opportunities to have discussions focused on device development, market assessment, regulatory strategy, and launch strategy.