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

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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Balance

on September 24, 2022

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.

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Customer-No-Service

on September 9, 2022

After some spam issues already with my first email SAAS (Namecheap) for diapason.consulting, I had moved my email services to my Google Workspace subscription, which I had upgraded to the second tier, including a supposedly professional level email server services. Several weeks of frustration later, after having setup SPF, DKIM, DMARC, with my emails still ending up widely in spams, I contacted google workspace support. The support chatbot questions, over a couple of minutes, led me to this point with a human support person.

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Workflows

on August 14, 2022

Workflows The invention and spread of writing did not turn everyone into a literary creator. Neither did the printing press, typewriters, home printers or word processors. The democratisation of home studios, electronic music equipment and pro-quality plugins did not turn every bedroom muso or DJ into Jean Michel Jarre or Deadmau5. Like Jordan Tanner @jrdntnnr explained to John Flowers, “having the latest, flashiest Nikon camera […] doesn’t automatically make you a professional photographer”.

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