I have previously posted on changes in the medical device clinical trial landscape noted at the MassMEDIC Annual Conference held May 7th at UMass Boston. Another area of discussion focused on financing emerging medical device companies.
It is no secret that the investment community has become much more risk adverse. It is necessary early on, even at the angel or A Round stage, to address matters that at one time were deferred for analysis at a later stage after technology was proven: cost of goods sold, pricing, reimbursement, designing a less expensive trial (perhaps utilization of statistical sampling to reduce onsite monitoring costs).
What are the current major investor touch stones? Reimburseability. Path to regulatory approval. Identifying a device that improves outcomes or saves money. Copycat devices, replacement designs of an existing device without palpable outcome improvement or demonstrable cost savings, are dead in the water.