What claims can you validly make for a product? Neil R. Armstrong of MeddiQuest looks at what the regulatory environment means for medical device marketing, and how changing your message can impact on the status of your product.

Forgive me if I start with a short tale from a bygone era…

Developing a medical device

For some years now, I have concentrated almost exclusively on new medical devices and new technologies. Frequently I visit a new potential customer who shows me their prototype product and asks me: “How will this be regulated?”

I always have to give the same answer: “Show me the whole product, including the labelling. Show me the indications for use. Show me the claims you intend to make. Then I’ll be able to tell you.” How a medical device will be regulated is not based simply on the physical device, but also on the words we put around it:

• What procedure(s) is it meant to be used in?
• What patient population (e.g. adults, children) should it be used on?
• How invasively should it be used?
• How long should it be used for?

The blacksmith in the story let his enthusiasm run away with him when he was in ‘sales mode’, and needed the apprentice to point out to him that his words had fundamentally changed the nature of the product. Listen to a modern hospital sales representative, let alone the owner of a business describing his new product, and you will discover that the same mistake persists to this day.

When we are designing and developing a medical product, we need to take a holistic stance and develop the ‘whole product’ together, including the promotional materials, the website, the instructions for use and the packs, boxes and labels. Only then can we be sure that we understand ‘what the product is’.

Following the label

Once we have determined the product and sought regulatory sanction to market it, we have essentially fixed the allowable use and claims. Many salespeople forget this, start promoting off-label uses in their enthusiasm to get a sale, and cause major problems for their organisations as a result.

Imagine an inexperienced sales representative confronted with a famous senior surgeon praising the product and keen to demonstrate exactly how he uses it. On his next call, the representative is keen to drop the surgeon’s name and endorsement into the conversation… and by accident the company has started endorsing an off-label use.

Another common problem is a lack of internal communication. Frequently the manufacturer goes for a limited (use or claims) approval in order to get the product onto the market quickly, expecting to follow up later with a more complex regulatory submission – but this is not communicated effectively to the sales force. Then there’s the over-zealous creator.

Frequently I deal with a product’s inventor who believes passionately in it. He is convinced that the product has another use or that he can make another claim for it, and he is determined to include this in the regulatory submission. However, the marketing team know this claim will be of no interest to a clinician, particularly if it is technological in nature and not outcomebased – and the regulatory team know it will be a nightmare to prove.

Approval and value

It is increasingly important to demonstrate the health economics advantage of a new device or new technology. However, this is separate from the performance and safety issues that need to be demonstrated to gain regulatory sanction for a product.

If clinical trials are required to gain regulatory approval, it is common sense to structure these in such a way that they also provide health economic evidence. However, if this means additional patient trials, it will be better to seek regulatory sanction without any health economic justification and then to demonstrate the latter with legally market product, at a fraction of the cost and complexity of a clinical trial.

The global market

Today, due in large part to the Internet, even the smallest single-product companies tend to think of themselves as players on a global stage. But there are many pitfalls for the unwary in international trade. Commercial laws, particularly those concerning the advertising of healthcare products, vary markedly from one country to the next; and increasingly, governments are assuming extra-territorial positions when it comes to Internet marketing.

The lure of export sales can seduce a business into international trade, but for the medical technology company it is essential always to check the basics:

• Are the translations really accurate?
• Does the clinical practice differ?
• Will a local partner take as much care of your legal and regulatory duties as they do of their own?

There is a great temptation to rely on a local partner to translate literature, develop contracts or terms and conditions of sale, train and manage their own sales force, and even manage regulatory submissions – but many organisations have paid a high price for such abdication of responsibility.

Keep it real

The spoken and written words that a company puts around its medical device are frequently a larger part of the whole product than the physical device itself. We need to control the evolution of the words just as much as that of the physical product.