What is a Good Notification Period for Changes to Material Formulations?

On the fourth day of MD&M East, Thursday June 20, 2013, Vipul Davé, director of R&D for Johnson & Johnson’s global over the counter (OTC) technology division, will chair a conference called Medtech Polymers. The day will feature a number of interesting papers relevant to readers, including the following selected subjects: the future of biomaterials (Vascular Sciences), suture and fibre materials for cardiovascular device components (Teleflex), polymeric bioresorbable vascular scaffolds (Abbott), catheter development (Daikin), antimicrobial parylene coatings (Specialty Coating Systems), laser micromachining (Resonetics), MEMS intraocular drug delivery devices (Exponent).

Change control: fair notification for device manufacturers of formulation changes

An important issue for medical device quality control professionals is change control, also known as formula lockdown—the phenomenon whereby a supplier of a material agrees to provide a minimum period of notice before changing ingredients in a material formulation or making a material obsolete.

When an ingredient changes, a medical device manufacturer must inform regulators of those changes in order for the device to maintain its clearance in the market. A supplier who doesn’t tell its customers that it has changed one of its ingredients is at risk of making the manufacturer liable for any issues caused as a result of the change. By contrast, a supplier who agrees to give notice when changing ingredients gives its customers plenty of time to notify the regulators of the change and line up alternative formulations to maintain its compliance in the marketplace.

There are variations from one supplier to the next when it comes to change control policy. Some suppliers are helpful when it comes to notification of change control. These provide notice that they plan to change one or more ingredient in a customer’s device. The minimum requirement is that a supplier tells a manufacturer when they have changed an ingredient.

But smaller suppliers, perhaps new entrants in the medical device sector, may not fully understand the device manufacturer’s position with respect to what happens when an ingredient changes. When these companies don’t inform their customers that they have changed one of their ingredients, no matter how small, this can cause a problem for a device manufacturer.

Suppliers change formulations more often than one might expect, not realising the consequences further downstream. Even if the change does not have a noticeable effect on the properties of the end material, a change means a device manufacturer must requalify the material.

Medical device manufacturers will maintain very close relationships with suppliers to try and be aware of changes. Change control agreements place an obligation on suppliers to notify customers prior to making any changes to formulations and ingredients.

Medical Plastics News is in the process of canvassing opinion on what the best practice is in terms of how long materials suppliers should agree to give in terms of notifying customers before changing an ingredient, no matter how small. So far responses have ranged from 5 to 10 years in long term implantables and 18 months for products in contact with tissue for up to 30 days. The situation is complicated by the fact that an OEM may have up to three tiers of suppliers, all of which need to be on board with change control notification.

The issue of change control also affects manufacturers in other industries, including automotive, aircraft and consumer electronics manufacturing.