According to the Food & Drug Administration, 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 it’s 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.”
They make is sound rather complicated, but basically it is anything, excluding drugs, used to treat, diagnose or affect the human body. The gamut includes everything from tongue depressors to MRI machines to hip implants. The FDA separates medical devices into three categories or classes by risk: “Class I includes devices with the lowest risk and Class III includes those with the greatest risk.”
Why does this matter if you are a medical device sales rep or marketer?
You could say that the classes in some way correlate to the level of product knowledge and skill required by the sales representative or marketer, as well as the level of responsibility and commitment required. Class III medical devices, subject to the most stringent review and controls, are designated as such because the failure of these products could seriously injure a patient or perhaps even lead to their death. Surgical implants of all varieties fall into this category. Whenever there is an incident of injury or, heaven forbid, death attributable to a medical device, a formal Medical Device Report must be completed and submitted to the FDA. Of course, the regulatory system has numerous safeguards intended to prevent unsafe products from ever being sold. Still, even with safe products, things can go wrong.
That’s worth stopping to think about a moment, isn’t it?
It really takes the idea of a “consultative approach” to a whole new level, doesn’t it?
Being a sales representative in the OR is exciting and rewarding, but it also comes with tremendous responsibility: To the patient, the surgeons and their staff. To recommend the right product for the particular need. To always be more than prepared. To uphold the highest ethical standards.
If you decide to pursue medical device sales or marketing, especially if you are dealing with Class III devices, be sure to keep this in perspective. It’s not like selling any other product. Have respect for the learning curve. There’s a lot to learn when you first get into the industry in order to be an effective representative. What’s more, you must continue to learn to keep your knowledge current and skills sharp as you progress in your career.
Lisa McCallister specializes in recruiting for medical device sales and marketing positions with an operating room focus, such as orthopedics, electrosurgery, endoscopy and a wide range of surgical specialties. She has recruited two Rookie of the Year award winners. Connect with her on LinkedIn or check out her blog, MyJobScope.com.