I recently experienced facing a regulatory change which affected the type of clinical testing and labeling for our products. The 2016 SMBG FDA Guidance made the packaging requirements more stringent for blood glucose meters. The label of the products need to prominently display the their accuracy of their blood glucose results. The updated FDA Guidance affects all products that will be launched into the market post it’s release. Fortunately it didn’t require companies to update the labeling and packaging of product that is already in the market. To develop and update the artwork of the packaging for a medical device takes an incredible long time and a lot of money, especially for global products because things such as translations, graphical representations, registration numbers and addresses, country distribution list, which all need to be approved by each country individually. For products that will be launched in the market post the FDA Guidance will need to comply to the requirements, providing their patients awareness of the accuracy differences in the products that are commercially available.

To go back to amin-sadig’s point, I am not sure about products that are in the middle of development, specifically in the middle of a clinical trial where the protocol has already been approved and initiated. I believe it should be the same, where if it hasn’t launched yet the product needs to meet the regulation standards. Unfortunately at that point, the company will have to weight the project’s product portfolio influence, priority, and return on investment to determine if the project will continue and meet the requirements or be terminated. Larger decisions such as these are approached to the product design committee by the project management office, where the description the project’s status and a request for an increase in budget and an extension in schedule are presented. Then the committee will review the project’s overall importance and decide to conduct the additional tests needed or cancel the project. And if the project is further along in the development process, I don’t think a company would suggest ending the project since so much time and money had already been invested into it.

I don’t believe any medical device should ever cut the corners just to make it into the market. The biggest advantage in becoming a competitor in the medical product industry is to aim to have the highest quality and performance. Referencing back to my experience, knowing that you need to represent accuracy in your labeling for a blood glucose meter, you wouldn’t want to cut corners in the reliability tests when those results will have to be displayed on your product. Clinical trial data becomes public once completed. These results would be used by competitive marketing departments to compare and promote their own products compared to yours. You wouldn’t want your product to be the least accurate one in the market, then you wouldn’t be making any profit and it could potentially harm the company reputation. I think if there is the potential to make a statement of equivalency to save time and money when situations occur like this, that should be the line. Otherwise, the new tests should be done, and completed to the highest standards.