Handling regulations

The medical industry is heavily regulated. That’s because bugs that kill people are to be handled with definitely more care than bugs that force a web page to reload. But guess what ? That’s good for established manufacturers – barrier to cheap and fast new entrants. Stop complaining about regulations, adapt to them, take advantage of them.

Carefully study regulations, norms and standards. They change all the time. New countries write their own (Anvisar, CFDA…). Worldwide manufacturers must infer from them a meta-regulation that bundles the worse (i.e., the more stringent) of them all and that is relatively unstable, because it changes when any underlying regulation changes. Usually, organizations set up RA (Regulatory Affairs) teams for that purpose.

But don’t let specialized quality teams write procedures. Procedures must be written by the people who execute them (with proper RA supervision) if you want the interpretation of norms to be productive (fast to execute, lean, no waste) and adaptive (changing frequently). It’s easy to ask for a stupid, lengthy, repetitive task when you’re not going to do it yourself.

regulations

Having a 6 months approval procedure for procedure changes with 10 senior managers involved will definitely discourage change. The procedure for writing procedures must enable evolution and empowerment.

Challenge regulations. Sometimes they can be interpreted in a variety of forms.

  • Take for example NF EN 62304, that presents software development activities in a numerical order, subtly implying you should follow the evil waterfall model. But it is not explicitly written. It took AAMI TIR45 to explicitly legalize Agile.
  • Regulations never talk about the amount of work to be done. 2 pages or 200 for a document ? Challenge your impulse to be thorough. From what I’ve heard, auditors get mad when something is totally missing, but are open to negotiation when it’s small. You can be lean by providing the bare minimum if you don’t find the activity really useful – but a have a rationale ready to justify your priorities.
  • Challenge RA people. When they say developers should add a best practice because of « regulations », ask to read the text of the article of the regulation that really puts a constraint. Always come back to the text – it’s the core principle, it’s the real constraint. It’s too easy to invoke a hazy « regulations » to justify any excessive demand. If it’s not mandatory, if we’re talking about best practices, then it must be decided by the development team. Best practices are only known by people who practice. Just to bring the point home: whenever you feel something brought up by “regulations” doesn’t feel right, always come back to the test, and challenge its interpretation.

Rules_and_Regulations

Remember, regulators don’t want you to drown in papers – they want medical devices to be safe, and incidentally their design to be auditable. They are reasonable people. If something seems completely silly, there must be a more sensible interpretation.

One useful technique my teams use is to write regulations as a spec, and trace its implementation to our specs and risk mitigation measures. Works well for technical guides such as CLSI AUTO9 and CLSI AUTO11. Going fully traceable by writing procedures as specs as seemed a little excessive to us, but why not? The good thing about this technique is you can challenge any legal obligation, and it can help you in case of an audit, by capturing your decisions towards regulation implementation, and by showing off how organized you are towards them.

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