By Raymond Miller, Barry Boise, Jessica Rickabaugh, Megan Bowers and Pierre Queiroz de Oliveira ( September 8, 2017, 12:05 PM EDT) -- Patent protection can be critical for health care products, including medical devices, prescription drugs, dietary supplements and software as a medical device (SaMD). Although a precise regulatory pathway is not always clear, innovators' initial development choices may influence how the product is regulated and protected. Innovators must decide whether to spend the tremendous time and money required to bring a drug or device to the market as a regulated product — as opposed to a dietary supplement, cosmetic or unregulated consumer product. The product's marketing plan could impact both regulatory and exclusivity strategies. Innovators should consider how they will position their product in the market and whether their exclusivity strategy aligns with their marketing strategy....