Regulations

Socratic Bot

This is a follow-up from my earlier post.

This is really entertaining. It is also depressingly addictive. Self-indulging as well: what a luxury it is to be able to engage in a polite, seemingly rationale discussion with s̶o̶m̶e̶o̶n̶e̶ ̶w̶h̶o̶ something that can reply almost instantly to each point, yet can wait with an infinite patience for my responses.

It also is a great support for fictional Socratic dialogues(*) - a very effective medium to convey philosophical ideas by guiding a student to reach the conclusion through their own reasoning. I used it with ChatGPT to talk about “regulatory narrow focus” which is an issue I have been looking in for a very long time.

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Chatbot consulting

Earlier this year, Diapason participated in the organisation of the CreativeAI_Sydney symposium. At this time, public attention on generative AI was growing exponentially, and focused very much on Dall-E2, Midjourney and Stable Diffusion (in the order they entered the spotlight), i.e. ‘prompt to image applications’. Most of our discussions gravitated around the this fundamental question: “Can AI be an artist (and therefore be a threat to existing artists) - or is AI only a tool that artists can use”. This question had been answered 5 years ago almost to the day in in the field of medical imagery AI with the idiom Rads who use AI will replace rads who don’t, although this is still open to interpretation.

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Medical Devices Regulations 101

Regulations are a complex topic. According to Feynman, the best way to master a complex topic is to:
(1) study it
(2) explain it simply
(3) fill any gap.

Here’s my 2cts at step 2, which I wrote for a collaborative project. Feedback welcome for step 3.

National or multinational (EU) regulations impose various requirements for the commercialization of medical devices within (or from) their jurisdictions, that consist in - roughly:

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Balance

A Quality Management System is often represented as a pyramid. Which is a relevant analogy. It has some “depth”, it is not a flat structure, and it matches well the hierarchical nature of many human thinking processes, of organisational structures, and of many information system paradigms (e.g. folders/subfolders).

Consultants and other experts who use this analogy typically describe from 3 to 6 levels. All these options are valid. A QMS does not have - by essence - 3 or 4 or 5 or 6 levels. It is a design decision, not an analytical result.

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Regulations never sleep

Regs never sleep. And they can wake you up early. Early in the day and early in the startups life-cycle.

When pitching for an early round, it’s tempting to think “Investors at this stage just need 1 slide or 2 to present our classification and a vague regulatory plan. In any case, they can always ask later, during the due diligence”.

Experience proves that investors have done their homework:

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Just guidelines

I posted this as a Linkedin article - after I started a post and was out of room. After several instances of being temporarily banned from linkedin, I decided to safekeep it here.

Nature is a continuous and multidimensional system. Any model based on a discrete classification will necessarily be a dimension-reducing projection, and will create arbitrary and energy-hungry distortions.

Justin Kunimune, CC BY-SA 4.0, via Wikimedia Commons

This article started as a comment to this post. I exceeded the character limit - so here’s my first ‘article’ here. The top comment on this post explains that “these guidelines are just that: guides. They are not rules or laws.” I disagree.

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Apple

Random Regulatory fact of the day:

Apple is the sponsor of four medical devices in Australia.

• As expected, two are the two features of the Applewatch that are medical devices in Australia (registered in February and March 2021).
• Two others are gloves and infrared thermometers that Apple registered as importer at the start of the pandemic in early 2020.

Technically, Apple started they #healthtech journey in Australia with thermometers and nitrile gloves.

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