Understand the population you are targeting and why. It may be preferable to define a narrower niche for your entry to the market.
Consider where your device/drug will be administered and by what means. This choice will greatly influence the preclinical and clinical development needs and strategies.
Most investors will want to see proof-of-concept (POC) data that extends beyond early discovery research. Provide evidence that your device or drug will be efficacious and can successfully make its way to the market by using a solid scientific foundation.
Be sure to describe the current physician practice/standard treatment and discuss how the new drug/device will be an improvement worthy of a change in the clinical setting.