Question: Introducing medical devices to the market seems more complicated than product launches I’ve done in other industries. Why is that?
Answer: Medical device product launches have some rules that must be followed. In some ways they are similar to other industries and others are very specific to medical devices. As with many processes, sometimes it is the way things are implemented that makes it complicated, not the actual requirement.
Below, are some key parts of a medical device product launch along with how they compare to other industries.
- Regulations: Medical devices are regulated, meaning the product must follow a set of requirements or perform testing to ensure the product is safe and does what is claimed. This is not unique to medical devices. For example, consumer electronics need to follow certain testing regimens to obtain UL or CE Mark approvals. Cars need to meet certain safety and emission standards to be sold in various countries. However, for medical devices most countries also require that you obtain approval to sell, based on a review of a submitted product data package (e.g., 510k, technical file).
- Documentation: All the data which supports the regulations must be documented. Medical devices store that documentation in the design history file (DHF). The DHF must contain specific documents per the regulations. It can include all the actual reports or it can point to the locations for the approved records. The DHF is always checked to ensure it is complete. In other industries, the results of the tests also need to be stored at the company’s location for retrieval. While not always checked, a good engineering practice is to ensure all the records related to product development are stored and retrievable.
- Inventory Control and Distribution: Because medical devices must be cleared by the individual country prior to sale, inventory control is crucial. Often this approval is one of the last items needed for a launch. Most medical device companies develop strict internal controls to prevent any product from shipping unintentionally or to countries without approvals. For other industries, the inventory controls are not as strict since the supporting certifications are often done earlier in product development and no additional country specific approvals are needed.
- Advertising: Advertising for medical devices is different from many other industries. Specifically, advertising is generally treated by the regulatory bodies as labeling. Therefore, any copy or wording which states your product is better, faster, or provides a specific benefit must be treated as a claim and have data to support the claim. In addition, the timing of the information is also important. The FDA controls how the product is promoted. (Promoting Medical Devices Within FDA Law and Policy) As a result, firms apply stringent approvals to advertising copy. In contrast, other industries face fewer restrictions. For example, auto companies often advertise new models almost 1 year ahead of availability. Consumer products often claim their new product is “the best” or better than the competition with no additional data.
- Market Testing: There are two ways to do market testing for medical devices. The first method uses devices that may or may not be cleared and a clinical protocol to control how and where the device is used. This format is fairly structured, but may allow the company to gain additional information prior to full production scale-up and launch. Advantages of this method include early access to key opinion leaders (KOL) and testing sales approaches prior to generating full launch materials. The second method is a traditional market test. In this approach, the product has received clearance and the company is controlling market access of the full production product.
- Reimbursement: Medical device customers collect payment for the medical devices they use or sell. These payments are provided by a payer such as insurance or a government health system. Some products are directly reimbursed by the payer, for example diabetic supplies or a blood test for cholesterol. Others are bundled into the overall cost of a reimbursed service, for example a hip replacement or hospitalization for pneumonia. Still others are not reimbursed at all because they are part of the provider’s infrastructure, for example and x-ray machine or surgical tools. Reimbursement status affects product sales, therefore affecting the product launches. Reimbursement is unique to medical devices and many pharmaceuticals. It doesn’t generally apply to other industries.
Keep in mind, that medical device product launch includes selling a safe product that does what is claimed. The same is true for product launches in many other industries. However, there is more rigorous oversight of the process for medical devices because of the immediate harm that may be caused by the device.