In this chapter, the specific challenges of device regulation are addressed with the suggestion that this analysis might be optimized by analogy to personalized medicine, now ascendant in molecular therapeutics. The challenge of device versus pharmaceutical regulation is made through the example of deep brain stimulation (DBS). Unlike drugs, devices are few in number, expensive to develop and administer, and require discrete medical-surgical interdisciplinary expertise. They are personalized in their scope, are therapeutic and investigative tools, and uniquely face barriers related to intellectual property exchange and conflicts of interest. The recent controversy over FDA’s Humanitarian Device Exemption (HDE) of DBS in the obsessive-compulsive disorder is offered as evidence of regulatory insufficiency and the failure to distinguish research from therapy due to the therapeutic misconception. An alternative fiscally and methodologically viable research pathway is advanced for quality DBS research. The conclusion is on a hopeful note, with the speculation that the advent of personalized medicine in other investigative realms may provide innovative solutions to regulation which promote scientific discovery and meet patient centered needs.
ASJC Scopus subject areas
- Arts and Humanities(all)
- Agricultural and Biological Sciences(all)
- Biochemistry, Genetics and Molecular Biology(all)
- Social Sciences(all)