The most significant dynamic in the cost of new product development is time to market, because development requires significant expenditures without the benefit of revenue from sales. Depending on the nature of the device, the “design-build-test-redesign” cycle can take two to three years, and can easily consume $10-$20 million before the device is ready to be submitted for Food and Drug Administration (FDA) approval. Depending on the nature of the device, FDA approval can take several months to several years. Package development is a critical element in moving a device to market and needs to be considered concurrently with device development.
Because of this long, arduous and extremely costly process, it is important to have considered package design well before the device is submitted for FDA approval. Concurrent device and package design allows sufficient time to consider options such as custom or stock packaging, the degree of product protection required and other vital factors, without unnecessarily extending time to market.
Medical devices are regulated in the United States by the Center for Devices and Radiological Health (CDRH) of the FDA. Its mandate is to promote and protect public health by making safe and effective medical devices available in a timely manner. The standard for demonstrating safety and effectiveness is determined in part by the risk associated with the device in question. Devices are classified according to perceived risk, using a three-tiered system: Class I, II, or III.
Class I devices are the lowest risk and require registration and device listing, but usually do not need formal FDA approval. Class II devices are higher risk and may also require FDA clearance of a Premarket Notification Application, called a PMA or 510(k), before the device can be marketed. This requires the device manufacturer to demonstrate that the new device is “substantially equivalent” to a legally marketed device, which can add to time to market.
Class III devices, such as heart valves, pacemakers, implantable defibrillators and coronary stents, pose the highest potential risk and require FDA approval of a PMA before they can be legally marketed. Approval of the PMA generally requires clinical data demonstrating reasonable assurance that the device is safe and effective for the target population. It is estimated that such clinical studies in the United States can add three to six months to the device development process. In addition, subsequent review by the Institutional Review Board (IRB) at the clinical site can add another three to six months to this timeline.
Unfortunately, companies have no direct control over the precise time required to obtain FDA approval. By beginning package design at an earlier stage however, these companies can significantly mitigate time used before FDA approval to their product launch timelines, and the associated costs.
LPS Industries frequently works with medical device manufacturers early in the development process to ensure that time to market is not unnecessarily extended by delaying the package specification, testing and selection process.