MEDICAL DEVICES

NO CLINICAL TRIAL FOR YOUR MEDICAL PRODUCT? NOT SO FAST!
By Chris Watts

Medical device manufacturers know the key to success is opening up as many international markets for their products as possible. But with international markets come the headaches of various regulations on product safety. Each country and region seems to have its own unique hurdles to clear to get a product on the shelves.

In Europe, the CE Mark certifies that a product has met EU safety requirements. The Medical Device Directive (MDD) sets these standards for medical devices, and its recent updating makes it more difficult for manufacturers to get their products approved for sale in Europe. Under the MDD, companies can provide data on their products in either of two ways:

• By conducting a clinical trial
• By using equivalent clinical data from a similar product (often called the Literature Route)

You can guess which method has been more appealing thus far. Who wouldn’t want to save time and money by avoiding a clinical trial and citing existing data from other products? But not so fast. The new MDD language makes it clear that clinical trials are now the preferred method for gathering data for certification and companies planning on using only the literature route may be setting themselves up for problems down the road.

“As a member of the EU working group that updated the Medical Device Directive, I can say that it’s tougher to use published data under the new MDD,” says Dr. John O’Dwyer, European Manager Medical Devices and Clinical Director of Medical Devices with the National Standards Authority of Ireland (NSAI), which is a Notified Body specializing in medical device certifications. (Notified Bodies are government-named organizations that assess manufacturers’ conformity with various directives.) “The new language clearly states that clinical trials for high-risk classifications shall be performed—unless duly justified.”

If you think about it, clinical trials make more sense. In order for a company to use existing data to support their product, the new product has to be significantly similar to the product from which the test data originated. In other words, the new product has to basically be the same as the existing product, and we all know that in the medical device marketplace, this is not always the formula for success.

“Novel and unique attributes of new products will now require unique clinical investigations,” says Claire McKenna, Medical Devices Program Manager with NSAI. “For example, one of my clients was trying to get a CE Mark for a product used to repair a knee joint damaged by osteoarthritis. They found a product was already on the market that also targeted knee joints damaged by osteoarthritis and figured they were all set. But on a closer look, the products were very dissimilar. For one thing, the new product anchored to the bones, whereas the device they cited required the physician to cut the bone. The systems were completely different, yet the company thought it was comparing apples to apples.”

Now this isn’t to say that using literature is now impossible. In fact, McKenna predicts that companies will still use literature, but only to supplement one of the three benchmarks in the CE Mark application:

Technical
“Is the physical makeup of the product similar to the cited clinical data?” she asks. “The technical data has to be very similar in order for the citation to work. The size, shape, the methods used to design it, how it is deployed, its color and durability—all need to
compare equally. If your product is close, but maybe 10 millimeters longer than the product you are trying to reference, the equivalency test may not work.”

Biological
“This is a critical area and covers how the product interacts with the human body,” says McKenna. “Are the product’s materials established and proven to be compatible with the human body? For example, if the product is made of titanium, your reference product must be also. However, if you’ve updated your product from titanium to a new polymer, you cannot go the
literature route and will need to collect new biological test data in a clinical trial.”

Clinical Equivalency
“Does your product have the same identified end users and same instructions, and is it used in the same anatomical area as the referenced product? Is it put in or on the body through the same access point? Are the physician instructions similar and is the product used in the same fashion? There are many areas where products can differ,” comments McKenna. “If your new product is made for children and the equivalent product is used by seniors, you may need to collect clinical equivalency data in new trials.” What this all boils down to is a company may be able to reference existing data for the technical and biological areas of equivalency, but may need to conduct its own clinical trial to gather data to satisfy the clinical part of the equation.

O’Dwyer says the best solution for a company wondering how to go about collecting data on its new device is to talk to its Notified Body early in the product development process. In fact, NSAI has been providing pre-submission regulatory guidance services to its clients for this exact reason. “Nothing is worse than a company’s managers thinking that they are only a matter of weeks away from a CE Mark utilizing data from another product, only to find that they need to collect additional clinical data, which may add a significant amount of time to get their product to market,” says O’Dwyer. “My advice is that if you’re in the process of developing a new product, start talking to your Notified Body and find out what data will meet the requirements of the Directive.”

Chris Watts is President of Precision Marketing, a company specializing in services for the medical device and manufacturing industries. He can be reached at chris@pmarketingllc.com.