Here’s how I came up with the intensities depicted.
FDA Approval. One of the most challenging steps of FDA regulation is securing premarket clearance or approval; there is no “beta testing” allowed in healthcare. You can’t offer someone the chance to sign up for a discount if they help you test the product first to see if it works as you intended. For an innovative device, that requires substantial effort to design and then test the device to ensure that it meets its intended use safely and effectively, and perhaps highly regulated clinical trials. In the diagram, I suggest that the effects of this requirement are felt as a part of validation and design controls, as well as in the regulation of the claims that can be made.
Marketing regulation. In addition to FDA rules regarding securing approval of specific claims, other federal and state regulators impose stringent requirements on the marketing function. Thus federal regulation is perhaps most intensely felt in the marketing function of the company. Again, this will feel quite foreign in Silicon Valley, where battles between “Marketectures” wage almost daily. “Cloud” pitches regulated by FDA would require detailed atmospheric reporting of the composite gases in the cloud, as well as an accurate forecast of how the cloud will impact the weather, good or bad.
In the postmarket servicing function, companies in the medical device field must adopt systems designed to vigilantly watch for and report any problems, and take perhaps significant corrective action when problems arise.
In the quality system area, companies that are certified to ISO standards will have the most new work to do in the design control and validation areas.
In the modest impact category, the quality system requirements will require that the device manufacturer take greater measures to assure the quality of inputs being supplied. This will include periodic auditing of suppliers to ensure their systems are robust enough. The wide spread decision to outsource and off-shore customer service functions, prevalent in IT, would have to be considered in light of these requirements. They could still be done, but doing so could take longer, be more involved, and actually end up costing more than keeping it in-house.
The changes necessary in the actual production of the products are perhaps least burdensome for a company that is ISO compliant.
In general, all of those measures:
Impose added cost.
Lengthen lead times in product development.
Add complexity.
Can be difficult to implement from a cultural standpoint for a company unaccustomed to that environment because they require discipline and rigor.
And of course multiply the paperwork.
In their analysis of the opportunity health markets present, many companies go no further than this. But this is exactly where some companies should persevere in their assessments, and consider the dynamics of the medical device market place.
Navigation: ( ←Previous | 1 2 3 4 5 6 | Next→ )