I have a Medical Product idea – what’s it going to cost to develop it?

Now that you have a great idea for a medical product, how do you develop your product and how much is it going to cost?

By John Rodriguez

This is a great question, and unfortunately not a lot of thought is put into this by first time developers. The lack of preparation results in a huge surprise for the budding entrepreneur.Vice President of Compliance Engineering - Manufacturing

Fortunately, the team at Advantu is very experienced and has seen the eye-opening process that most first-time developers experience. We are here to guide you through this process and even prepare you for your first presentation in front of potential investors.

The path and cost for development of a medical product varies greatly and is dependent on several key factors. These factors include the technical complexity of the product, where the product will be marketed and sold, the regulatory path for the product, the clinical trials required, and of course the cost for all the development activities and preparations for manufacturing of the product. This could add up quickly and cost anywhere from hundreds of thousands to millions of dollars.

As a high-level summary, when planning for development cost, you need to consider the following:

Research and Development Cost:  Do you already have a functional device or does the product you envision need to be produced from concept? Complex devices can include software, electronics, and mechanical requirements. Each of these requirements adds a layer of complexity. Your basic team of engineers for such a task includes Mechanical, Software, Electrical, Quality, and Manufacturing Engineers. This product development team is responsible for not only developing a working prototype, but also conducting all the product qualifications needed to demonstrate that the product is safe and effective.

Regulatory Cost:  The cost for the regulatory pathway often is not considered and can add up. The medical classification of your device often provides insight on the projected time and cost for approval of your device. Classifications range from Class I to Class III, with Class I devices typically having the lower regulatory cost compared to a Class II or Class III device, which require a higher level of testing and documentation that leads to higher cost.Clinical Trials

Clinical Trials: Depending on your Regulatory path, your device may require clinical trials to demonstrate the safety and efficacy of your device. It is wise to consider the worst-case scenario when estimating your Clinical trial cost. Things to consider include, where your clinical trials will be conducted, how many trials will be needed, is your company focused on a single indication or multiple indications, and what duration is required for your trials to achieve the desired outcome. All these are key factors in determining both your cost and projected completion timeline.

Manufacturing: Have you considered how you will build your product? Is there automation or is your product labor intensive? What is the product forecast? What’s your ramp up rate?  What is the inventory needed for product launch? What equipment do you need for manufacturing? These costs can vary widely depending on the volume of units produced and the complexity of the manufacturing process. Without guidance from an experienced team, the questions can be overwhelming for a first-time entrepreneur.Manufacturing support

These are just a few of the items that should be considered when entering the product development and manufacturing world. Other areas of consideration include testing and certification of your product, marketing of your product, intellectual property, post market surveillance, plus overhead and administration cost. This can appear to be a daunting task of activities, and it is challenging to provide a specific cost figure without knowing the specific details of the medical device in question. Developing a medical device can range from hundreds of thousands of dollars for a simple Class I device to several million dollars or more for complex Class II or Class III devices.

Regardless of your product classification or complexity, everything begins with a concept, a plan, a project timeline, and a cost estimate. We are here to support you and your company in achieving your product goals.

If you have product development questions – reach out for a free consultation so we can answer your questions, and, discuss ways we can help you achieve your product development goals.

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