1. What is a realistic timeframe for FDA approval?
Regulatory approval is critical for investors. If companies are seeking funding and do not have FDA approval yet, they will need to document the steps and projected timeline of their processes before approval is granted. The specific timeframe will depend on the individual company and product, and the process typically takes longer than companies anticipate.
2. Is there a clear path to cash-flow breakeven?
Investors are looking for companies with achievable goals. They want to see a company’s burn rate, a clear path to the breakeven point and a realistic timeframe of how long it will take to get there. A good number for companies to focus on is cash-flow breakeven or positive in two years, and they should determine how much capital they will need to reach that point. Companies should have enough cash for a two-year period.
3. Does the medical device technology have a market for high demand?
Covid greatly accelerated the trend toward digital health and the acceptance of medical technology. In a post Covid-world, patients want quicker diagnoses, non-invasive surgeries and procedures, access to remote monitoring and digital health tools. According to data from Statista, medtech revenue is expected to show a 5.95% annual growth rate, resulting in market volume of $768.80 billion by 2027.
4. How does a unique, transformational product can make the difference in success?
There are minimally invasive, non-invasive, robotic, telemedicine, remote diagnosis and quicker pathology technologies. We believe that medtech companies that are truly innovative and disruptive will be successful in securing funding, even in the current market.
5. Are there advocates in the medical field (doctors, surgical departments, etc.)?
Doctors, surgical departments, and hospitals want minimally invasive procedures and solutions that allow patients faster healing and recovery times and ideally, improved outcomes.
6. Can the product solution easily scale to market adoption?
The ability to scale for successful market adoption would be strategic to our assessment of a potential company for investment.
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