Over the past 50 years, the advancement of technology has been beyond incredible. Although, we are not zipping around in flying cars, fearing the dreaded encounter with a hoverboard gang, or living amongst cyborgs, we are witnessing things never before thought possible. Such innovations include robotic performed surgeries, implantable drug-eluting stents (DES), and the ability to “print” skin grafts.
The medical device industry has consistently developed ingenious products that uniquely bring healthcare and technology together, especially within the past half century. Technology seems to always evolve; a result of this evolution is the “emergence” of nanotechnology and how it will come into play with the medical device/med-tech industry.
Nano-what? Nanotechnology - it is not in the realm of the once popular 90’s virtual pet (I confess that I did have a virtual pet and I still cannot shake the slight association between the two)! This nanotechnology is a vast term, which describes the use of incredibly small materials in an extremely broad range of applications. Coupled with medical devices, nanotechnology has the potential to be developed on a molecular level with application in diagnostics and utilization of nanomaterials in devices. This technology has great promise and may bring macro change to the medical device industry (but not without new regulations).
The recently passed FDA Safety and Innovation Act (FDASIA) may help fuel or hinder the development of nanotechnology for medical devices. FDASIA allows FDA to collect user fees to fund reviews on innovator/generic drugs, medical devices, and biosimilar biologics. Interestingly, FDASIA includes a section pertaining to nanotechnology and instructing the Secretary of Health and Human Services to “intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act[.]”
What innovative medical devices will the decade of 2010 bring? Are there any predicate devices that have yet to be fully explored and could be improved through the utilization of nanotechnology?
I want to hear your opinion and thoughts!
^_^ Rebecca
For more information regarding FDASIA and how it will affect Medical Devices:
1. FD&C Act Chapter V: Drugs and Devices
2. FDASIA
3. Medical Device Registration & Listing
Sources
1. http://www.greatachievements.org/
2. http://www.thedailybeast.com/articles/2009/12/03/the-21-biggest-medical-breakthroughs-of-the-decade.html
3. http://www.uclahealth.org/body.cfm?id=26
4. http://www.mddionline.com/article/30-years30-devices-1979-1980s-1990s-2000s-older-technologies?quicktabs_2=2