Managing a product in the healthcare space is quite different than most other industries. You need to have a thorough understanding of the following:
1. What is your target population? The candidate patient for your product needs to be well-defined. Usually, the more specific, the better (at least initially). This not only factors into your regulatory path but also reimbursement decisions, targeted healthcare providers and clinical adoption.
2. What is the regulatory path? Determining the regulatory route should be done early on in the product development cycle.
3. What are reimbursement practices of similar products? Payment for the product needs to be ironed out early on too. The product may need it's own CPT codes or can it rely on existing ones. If there's no reimbursement available, then other means of payment need to be determined (patient out-of-pocket, subscription-based, value-based proposition to healthcare provider, etc.).
Answered 2 years ago