Early Focus
To evaluate market readiness, look at whether there is already a market for your product or service. If you have to create a market, it may be too early.
Where does your product or service fit in existing systems, and can those systems be changed? For example, consider the life cycle of a medical procedure where a biomedical product would be used. Your medical device may solve a small problem in treating a particular illness, but does it fit into the protocol for the treatment? Will it change the standard of care?
If you are joining an existing market, get to know your competitors well. Don’t give up just because you discover someone else is already addressing the problem. For instance, is your solution more scalable to the size of the market at a more reasonable price?
Fully understand that in medicine and healthcare, there are often multiple parties or stakeholders. Be sure to research the needs and interests of each group. Will you be able to produce the product or deliver the service for what they are willing to pay?
If all research looks favorable but you need more resources than you can access, consider whether it is better to license your product to a bigger company that has the business resources and testing ability to ensure that the product succeeds. This commonly happens with pharmacological products.
Later Focus
Consider your ability to meet market demand and compare it to both the initial market size and the adjacent or “follow-on” market size, which is the market that becomes interested in your product or service once you succeed with the initial market. How large of a follow-on or adjacent market are you prepared to manage if your product or service takes off? Some businesses have failed due to being unable to scale up and meet demand.
Know your customer and other stakeholders well. Differentiate and consider the needs and interests of the different stakeholders: influencer, economic buyer, and user.
Consider product label requirements before you do clinical trials. If you hope to claim on your product label that the product works, you must gather the data supporting that claim during your preclinical and clinical trial research phases using instruments that are accepted as valid.
