Diapason Consulting

Entrepreneurs

Entrepreneurs, it is never too early to integrate good design and development practices, quality management and ethics&regulatory considerations in your global strategy. It does not mean you need a certified QMS this week and a TGA registration tomorrow. You may not even need them at all if your product is not regulated. But now is the right time to understand whether you are regulated, and if so, what is the scope of these regulations. It is also the right time to design the next steps of your development and growth in a way that give investors confidence that you are on top of your strategy. Plan and manage not only the technical steps of your value proposition development - but also plan for your commercial, clinical and regulatory pathways

Manufacturers

Whether you are working on a new product submission, need a solid independent review of your processes or a formal internal audit, some help on a risk management committee, or are considering a significant transformation/growth project, we can help. Give us a call and we can discuss how I can either help you directly, or else introduce you to other experts in my extensive network

Investors

Medtech, digital health, wellness & wearables, mental health apps… These applicaitons are fast growing multi-billion dollars market, driven by mind-blowing innovations and the promises of a better health and wellbeing for billions of users and patients. Behind these innovations are talented entrepreneurs who repeatedly invent, build and test new solutions. What lies ahead of these entrepreneurs is complex. A good growth strategy needs to be evidence-driven, but evidence is expensive, more particularly in the regulated clinical world. Diapason can help investors in their risk assessment - pre- or post- investment - with a review of the founder’s plans and their early positions in terms of regulatory strategy, quality&compliance culture, evidence&documentation or process management excellence. Call us to discuss how we could participate in your due diligence exercises.

From our blog

Socratic Bot

on December 6, 2022

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.

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Chatbot consulting

on December 3, 2022

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”.

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Medical Devices Regulations 101

on November 13, 2022

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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Creative September

on September 26, 2022

Diapason creative - September Newsletter Diapason’s resonances this past month Wind of Change I rarely listen to multipart podcast series. I tend to binge rather than schedule, so this would be too competing with my workload. I stumbled though last month on Wind of Change from Patrick Radden Keefe. The song that gives it name to the podcast has been part of my teenage years - and this is when (teen+early adulthood) we forge our deepest sensory memories and tastes in music, as is known and used by music-based therapy for Alzeihmer patients.

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