Regulation imposes a heavy burden, but it can also be a source of significant market advantage. The higher you set the bar for yourself, the tougher you make it for competitors to duplicate your success.
Regulatory strategy presents your best opportunity to unite compliance efforts with broader business goals. Developing a regulatory strategy is a key step in developing overall business strategy for any life sciences company.
There is no single regulatory pathway for IVDs. Early-stage choices made about intended use, product claims and partnerships can have a profound effect on both the regulatory process and the success of the product itself.
Determining the best pathway for a particular product will include addressing a number of questions, such as:
- Is it sufficient to have a “me too” intended use statement or do we need something that will set us apart from the competition?
- Is our product used in diagnosis of a disease or is it simply one piece of information that the physician uses in conjunction with others?
- Is there a way to get a basic claim now and then work to get and expanded claim once we’re already on the market?
- Have I considered how my regulatory choices may affect my prospects for reimbursement?