title: Improvisation in implantable medical devices: a Gordian knot.
authors.forename: M H
authors.initials: MH
authors.lastname: Lehmann
authors.forename: S
authors.initials: S
authors.lastname: Saksena
mesh_terms: D017147:Defibrillators, Implantable / Q000592:standards; D004059:Diffusion of Innovation; D004867:Equipment Design; D006801:Humans; D013673:Technology Assessment, Biomedical; D014481:United States; D014486:United States Food and Drug Administration