Medical Device Product Manager and Marketing Strategy Questions

The single best step you can take to help your product succeed is to involve us in the product development process as early as possible. Additionally, it is helpful to enter the process with realistic expectations about the time required to obtain FDA approval, the product development and FDA filing processes.

"Almost two out of three 510(k) applications are cleared within six months. Although the FDA sets goals to review and respond to 510(k) submissions within 90 days, it is an uncommon occurrence thanks to the time required for you to respond to additional information (AI) requests...Plan on the process taking closer to six months." - Joel Lindsey, Med Device Online

The new product launch of a medical device takes time. While every case is unique, you can expect for the process to take at least several months. After going through the initial market analysis and product development phases, your 510(K) application must receive clearance, which can take months.  Allow yourself time to give input to your product manager on developing your medical device marketing strategy.

"A 510(K) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3).) that is not subject to premarket approval." - United States FDA

Every person who is interested in marketing a Class I, II, or III medical device is required to submit a 510(K) to the FDA. The only devices that are exempt from this rule are those that were deemed to be exempt from 510(K) requirements of the Federal Food, Drug, and Cosmetic Act.

Obtaining 510(K) clearance is a major accomplishment in the medical device marketing strategy and development process, because you can begin legally marketing your device once you receive clearance.

Absolutely not! In fact, you are welcome to present us with a sketch of your idea jotted on a cocktail napkin. We have years of expertise helping medical device innovators transform their sketches and ideas into state-of-the-art products. As your product managers we are here for you to guide you through the market strategy and to prepare you for your medical device’s new product launch. We encourage you to call us as early as possible after you come up with your idea so that we can help you succeed.

Developing the medical device iterations, the marketing strategy, and the introduction of a new medical device can be a complicated process. but with an experienced product manager, your medical device marketing strategy can help prepare you for  your new product launch. Here are just a few ways that CUBE Medical Innovations can help you bring your ideas to life:

• We provide guidance throughout the entire product development cycle.
• We help you get your device to market faster.
• We offer expertise regarding legal and regulatory requirements.
• We help you design a captivating product logo and marketing materials.