Medical Device vs Non-Medical Device

Unless the intended use clearly indicates that a product is a medical device, some products can be positioned as either a medical device or a non-medical device. This decision requires consideration from multiple perspectives. Here, we examine it from the standpoints of product strength, economic viability, and buyer psychology.

• Product Strength
  • Is the product excellent as a product? Does it have high clinical utility?
  • If the intended use that maximizes the product's value is the treatment, diagnosis, or prevention of disease, then classifying it as a medical device is clearly the only option.
  • If the product is groundbreaking, pursuing medical device classification may maximize returns.
  • If the product's characteristics suggest that healthcare (non-medical) applications would maximize its value, choosing to position it as a non-medical device is often the better option.
• Economic Viability
  • Does a medical device or non-medical device classification offer a better balance of cost and return?
  • Does a medical device or non-medical device classification offer a better balance of price and performance? This requires analysis from the perspective of purchasers and users. For example, if the product must be priced high to recoup substantial development costs as a medical device, will buyers actually pay that price?
• Buyer Psychology
  • This must be examined from the perspective of both the purchaser and the end user.
  • To meet their needs, should the product be a medical device or a non-medical device?
  • Related to economic viability, the products that fulfill a given need are often not fixed. For example, someone may really want wine but decide to have beer today instead. In other words, if the need is to enjoy an alcoholic drink, the choice is not limited to expensive wine — a slightly cheaper beer could also work, or even a more affordable low-malt beer. The implication is that even if products do not offer identical functionality, they can still compete if they are nearly the same or similar. A product's competitive advantage must be scrutinized with substitutable alternatives in mind.
  • If a medical device does not receive insurance reimbursement pricing, is there enough benefit for buyers to pay out of pocket? This also ties back to product strength and economic viability.

Thinking about how to position a product to maximize its value is one of the key practices in marketing. Take the time to consider it carefully from various angles.
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For products that could functionally qualify as either a medical device or a non-medical device, a two-stage strategy may be worth considering. This involves initially selling the product as a non-medical device, accumulating data and capital, and then exploring medical device classification in the future. This approach allows startups and SMEs to generate revenue while keeping initial investment and risk low, making it well worth considering.