Dr. Hans Frickel’s Post

🎸 Was haben 10 Jahre Bass und 30 Jahre Qualität gemeinsam? 🎉 Dieses Jahr markiert für mich ein doppeltes Jubiläum: Seit 30 Jahren bin ich in der Pharma- und MedTech-Branche aktiv, und seit 10 Jahren spiele ich Bass in der Progressive Rock Band Julia's Ghost 🎶💼. Dabei durfte ich immer wieder beobachten, dass Bassspielen und Qualität sehr wesentliche Gemeinsamkeiten haben. Beides kann man nicht unbedingt sehen, aber umso mehr fühlen. Man bemerkt eher, wenn es fehlt, als wenn es da ist. Und in beiden Bereichen ist Zuhören der Schlüssel. Ob in der Musik oder im Job – es geht darum, Timing, Dynamik, die richtigen Töne zu finden und aufeinander zu hören, um unterschiedliche musikalische Stimmen oder organisatorische Fachdisziplinen in Einklang und zur Entfaltung zu bringen.  Nur so entsteht Flow, ein harmonischer Groove, sei es zwischen Instrumenten oder Fachbereichen. Das Ergebnis? Ein tragendes Fundament, auf das man sich verlassen kann. Vielen Dank an alle, die mich auf diesem Weg begleitet haben – auf viele weitere Jahre voller Teamarbeit, Qualität und Bass! 🚀🎶 #Qualität #Pharma #MedTech #Teamwork #ProgressiveRock #Bass #Zuhören #Jubiläum

To all the introverts who are struggling with VUCA / BANI: keep faith, never give up. You’ll make it, no matter what 🎯💪. If you’re in love with music 🎶 same as I am, you may want to listen to the lyrics of Frost‘s song The Boy Who Stood Still. It’s about someone who feels isolated and immobile in an ever-changing world. The central theme of the song addresses isolation, the feeling of being stuck amidst progress and societal change, and the protagonist's inner journey as he grapples with his emotions and the world around him. The song reflects the challenges and the quest for identity and connection in a dynamic environment. Very relevant topic, isn‘t it? Very relevant to the current global situation. It’s not only affecting individuals like the boy in the song, but also Start-ups, small-sized, mid-sized and large organisations (which appears to be quite obvious, because they consist of individuals). Dynamic environments require cooperations. Across boarders. Across functions. Across organisations. Across silos. And across Egos. Let’s join forces and do what needs to be done. Transformation towards sustainability is showing the way.

Don’t do it alone… that’s perfectly true 🙏👍 Allow all your wits and fits to trigger all required teamplay to meet the sustainability transformation challenge. Movement of that change is exactly what needs to happen. Sustainability can never be reached without accompanying measures that consider organisational development, change management, integrated management systems, organisational development and transformational leadership 🚀💪🎯🏁. Not sure how to tackle that tremendous transformation? I’m there to support 💻 📞📧

Wer möchte sein Unternehmen nicht gerne auf Autopilot stellen? Klingt tatsächlich zu schön, um wahr zu sein. Warum? Weil bei der Frage ein wichtiges Element fehlt: wer möchte sein Unternehmen BEIM FLUG DURCH STURMTURBULENZEN nicht gerne auf Autopilot stellen? Klingt nicht mehr so schön, angesichts des nicht endenden Stroms von VUCA- und BANI-Wirbeln durchzogener Turbulenzen, die auf Unternehmer und Organisationen heutzutage von Außen und von Innen einwirken. Wenn man sich da entspannt zurücklehnt und autopilotiert fliegen lässt, wird man über Kurz oder Lang autofiletiert am Boden zerschellen. Also was tun? Nicht nur AM, sondern auch IM Unternehmen arbeiten und alle erforderlichen Stellhebel so reaktionsschnell und virtuos bedienen, dass trotz VUCA und BANI ganzheitliche, resiliente und nachhaltige Wertschöpfungen ermöglicht werden. Mit der richtigen Unterstützung kann man lernen, wie es funktioniert, die Kontrolle über das eigene Flugzeug zu behalten und ohne Autopilot durch die Sturmfronten in Richtung nachhaltiger Unternehmenserfolge zu fliegen. Wie? Ich bin da, um zu helfen.

R&D and GMP: integration at the right points in time is key to success 🚀!! In my previous post, I felt obliged to argue against startup companies´ apparent weakness to design processes without GMP in mind right from the beginning. During all my past assignments with multiple small and large companies in the pharma / healthcare sector since 2000, there was never any relevant need for R&D to run `quality management from Day 1´. Why? Because it would have killed innovation from Day 1. Particularly startup companies, by definition, are driven by coming up with something new, in case of disruptive innovations even without any existing frameworks for appropriate quality management or regulation systems. Quite many startups, like for example BioNTech or other ATMP / CGT inventors, would have never come that far, if they had not focused on nothing else than technical feasibility first, in order to then proceed with adapting their key core science & tech assets with QM and regulatory requirements underway. Still, it´s of course true that GMP development and manufacuring compliance requirements, as well as qualified materials & suppliers aspects, regulatory standards and data / documentation integrity need to be included as effective as possible, simply because these aspects contribute to overall timeliness and success in the end. So what? Forcing GMP into R&D is no solution, because it would cause harm to both. Magic starts to happen when suitable integrated `GRDMP` methodology approaches come into play, so that relevant strengths of both can spread their wings. And how? Careful. Considered. Targeted. If you´re unsure how to best tackle that topic in your specific case, feel free to contact me. I´ll be there to support.

Yes, antimicrobial resistance is indeed a growing and urgent threat to the health of global populations. Important to mention that the Ouroboros Diagnostics (OuroDia) team is developing a gamechanging diagnostic approach for mobile, modular, adaptable and affordable detection of antibiotic resistances, so that positive cases can be treated in a much more timely, effective and efficient manner. Thank you for tackling this threat with innovative features, dear Ouroboros team👍

Sorry to say, but I can’t agree to this comparison 🤔. During my 25+ years in Pharma / Healthcare, I’ve seen lots of companies die away, because they had been trying to - or have been forced to - consider everything everywhere all at once. That’s particularly overwhelming innovative startup companies, because that `day 1` approach is essentially killing innovation ☠ . There are two main reason why innovation needs to remain the predominant core of innovation, most particularly during early stages: 1. You need to start with Why, and then proceed to build the How and What around it. ⛅️ 2. Form follows function. Sometimes even regulations are following innovations, like e.g. those following all those ATMPs that have been developed during the past 5-10 years. 🏛️ Therefore, young biotech companies just need to make sure that the right step is done at the right point in time 🎯🚀. It’s okay not to try and find solutions to all relevant obstacles at the very beginnings.

That’s a nice graphic representation of Q-uality M-anaged S-olely, or S-tepwise. One step forward, two steps back. This is why INTEGRATING is much more important than Educating, Communicating, Understanding and Acceptance. If Q is not integrated into an organisation to widest possible extents, Q-uality cannot be M-anaged S-ustainably the way it should be. And it’s that integrated sustainability aspect that an efficient & effective QMS is all about.