• Have A Profitable Medical Device Idea?

  • When an individual has an idea for a product that meets a need in the marketplace and has the potential to be profitable, they want to get it on the market as soon as possible.  Design it, manufacture it, pack it up and ship it out.  For most products that is totally feasible. Some planning typically goes into it first, such as market research to determine if it is likely to be a profitable endeavor. However, with medical device the planning should include regulatory considerations.

    Have A Profitable Medical Device Idea?

    By the FDA’s definition and guidance, a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:

    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

    Sometimes it’s hard to know for sure if your product is a medical device.  If it is an item or software, even an app, and it is meant to affect how someone feels or affects their body in any way then you should find out for sure.

    What Classification Is Your Medical Device?

    If you are in the United States, or plan to market your device in the U.S., then FDA regulations need to be considered.  When MedTech Launch does this, we start with the client’s idea and how it’s supposed to be used.  FDA device classifications are risk based, so we determine which classification the device is likely to be.  Class I is the lowest risk, and Class III is the highest.  Over 80% of devices are either Class I or Class II.

    Most Class II devices and some Class I need premarket notification clearance from the FDA., and that comes in the form of a 510(k).  A substantial amount of resources goes into the preparation for submission of a 510(k), so knowing if this is a requirement is critical to the successful launch of your product.

    In nearly all cases the FDA requires a medical device company to have some systems in place to ensure safety.  This could be complaint systems or full quality systems.  Sometimes these systems can be large and require customization to your business in addition to training and evidence that the system is effective.

    Many devices have to meet certain performance standards.  These standards are often created by organizations such as ISO, ANSI, and ASTM.  Some standards are very specific to the device.  Others are more general, such as standards for biocompatibility, sterilization, and packaging.  Application of these standards is always specific to the device, so planning how to meet these requirements is important.

    Regulatory Considerations Report

    If you already have started development, or are almost ready to launch, it’s not too late to create a regulatory considerations report. It’s still important to know whether or not your product is a medical device and what FDA requires if it is.

    At MedTech Launch, we create these reports for our clients as early as we can.  It helps them better plan how long it will take before they can start seeing revenue, how much money to invest, and how much regulatory burden they are taking on.  All of this helps them be better informed about their business risks.

    Have a medical device idea you would like to discuss with our team? Connect with us at 317-482-4250 or via our contact form.