yes it it´s; costs and others factors can always be used a justification for not using a technical solution to a risk control measure. However, this is true when you have the option of choosing more than onw technical solution. In the case of regulation which prohibit, for example, certain material, yoou do not have this option because doing so would mean you would be against the regulation.
I would agree that that's a state of the art response, but I would also note that it rests on multiple subjective judgements on the part of the participants in the decision process and their auditors.
In the present phthalate instance, one interpretation of the rule is that phthalates may be used in regulated instances if a sufficient rationale is presented. Could such a rationale rest on an economic argument?
I.e.:
1. Provision of health care is a social good.
2. Health care of course must be paid for, and society has limited resources.
3. Quantity of health care able to be provided by society is dependent on costs including device costs.
4. Phthalate-plasticized-PVC technical solutions are substantially lower in cost for a given clinically adequate level of mechanical performance.
Is such an argument precluded on its face, and a manufacturer duty-bound to ignore social good and just obey orders?
And on the other hand, if such an argument may be allowed, how can regulations be implemented in an objective manner, and who shall make the needed judgements?
Perhaps those who formulate and adopt directives and standards are responsible for such value-balancing judgements, so that they do not have to be made in multiple individual instances. One problem with this is that history has shown that the process for creating such directives and standards is slow and ponderous, and sometimes results in outcomes that are non-optimum in regard to social healthcare economic goals but benefit the particular participants' commercial needs.
As I suppose this discussion reveals, I regard the balancing of small probabilities of substantial harm with certainty of increased cost, in an era of social inability to pay for an adequate amount of care, as one of the more subtle and difficult aspects of risk based device manufacturing.