3D Medical Printing and the Lack of Feedback for the FDA Administrator
Medical printing allows companies to boost economic value and enhance clinical outcomes in the health care industry. 3D medical printing can help clinics test devices on realistic anatomical models which are clinically relevant, enabling them to release goods to market sooner and complete revisions in faster time periods. However there is a lack of feedback for the FDA administrator, which means approvals take a long time for medical devices. Thankfully it is possible to get devices approved faster via third parties.
Restrictions of the Traditional Approval Process
On average, approval for medical devices and pharmaceuticals can take 12 years and cost US$350m. The laboratory testing period normally lasts around 3 years, followed by an application for the FDA which typically includes a 100,000 page report. Only then will the process of testing on humans begin. Only a small fraction of those put forward will make it to the human testing phase of development, and during this phase the drug company will report on reactions to the trials and feed back other data to the FDA.
Benefits of 3D Printing
3D printing for a new type of pill was approved by the FDA in 2015. 3D printing has previously been used for prosthetics and similar devices, but the new approval for the pill form epilepsy drug Spritam has opened the door for other pills to be developed via 3D printing. These pills dissolve and act in the same way as a regular pill.
3D printing for medical purposes can also help develop effective bionics and orthotics with improved fit, form and function, so it makes sense to help these vital medical developments get to sale as quickly as possible without wasting precious time on lengthy FDA approval processes.
Speedier Approvals Using a Third Party
At the moment drugs and prosthetics take so long to get approval that many people are missing out on these important developments. There are, however, ways to get FDA 510k clearance submission organised much more quickly and they involve third parties, such as http://www.fdathirdpartyreview.com/, who know the medical industry inside out.
Using a third party to gain approval can cut the time it takes by an average of 100 review days. Companies can also often skip the FDA MDUFA fee by submitting their 150k via a third party service.