Last week, I interviewed Todd Buchheit, the Compliance and CSV Services Director of CGMP Validation, L.L.C. our partner company in the US.

Get inspired about the upcoming challenges in the medical device industry / Parma industry in the USA in the new podcast episode.

I have worked with Todd for many years and can recommend his company for all services related to medical device consulting.

If you want to know more, just contact me below in the comments.

Enjoy!

A few days ago I did an interview with a good colleague of mine. Aaron and I were talking about topics like problem solving and process optimization. Since Aaron is an expert in these areas, he was able to bring many exciting aspects into the conversation that were also very interesting to me personally.

One topic we talked about, for example, was how high processes should be set so that they can still be understood and executed by everyone. This topic is also very interesting for people involved, as there are always difficulties in the area of process implementation.

Aaron revealed a lot of exciting information that I'm sure you´ll find very interesting as well.

I would also like to know from you how you deal with processes in your company or whether you use processes at all in your company. Maybe the interview with Aaron and me will help you.

Why are problems so often only recognized as such when it is actually already too late? I have been dealing with this question for years with various customers. Again and again, we come to the answer that the problems are often not recognized as such and, above all, not accepted as such.

It is exactly this denial and refusal to accept the existing problems that is the real problem. If one recognizes inconsistencies or difficulties in one's own company, then these problems should be recognized and addressed in a structured manner. Otherwise, it is often already too late and the customer or your own job are gone in the worst case.

In the new episode of the podcast you will learn how to recognize problems and how you manage to deal with them.

Learn more about the forecast estimation on medical device consumes for 2022.

Interventions declined by ca. 40% due to the pandemic situation in 2020. If this trend stays up until September 2021 in Germany, this is a huge backlog …

This will provide an increase in the need for having some medical devices and a ramp-up of interventions in 2022.

This positive outlook - especially for manufacturers of surgical consumables or disposable products - is dampened by the general shortage of nursing and technical staff in hospitals. In this respect, the backlog is likely to be reduced only slowly. Nevertheless, we can expect an increased demand of about 20% for the post-pandemic phase, which we should see in 2022.

Digitization is on everyone's lips these days. Everyone wants to digitize processes and I keep hearing about how difficult the transformation is. Of course, it's all about making processes more efficient and then automating them.

What is often forgotten is that I need a solid foundation before I can even begin.

A foundation of processes, structures, input-output definition and of course the most important: the right people for this journey.

Listen to my new podcast episode to hear what can happen when the second step is taken before the first.... It all comes crashing down like a house of cards.

it is so ridiculous, it seems that we are never coming to a common decision.

I see people struggling with the decision making itself, because they are using a lot of excuses for something not to do.

Whenever there is a decision to make most people hide behind stories and things like: I don’t have the ressource, I only can make it within a project, I will get no funding for it, we are already overloaded with the daily tasks we have to deliver and so on and so forth.

This is the direct way down the drain.

Imagine you would implement those decision making points with all the core values of the company. Wouldn’t that be worth working for? Wouldn’t that be worth fighting for? Wouldn’t that be a great world?

Listen to my latest podcast episode on how decision making can be done ….

Warum sollte das funktionieren das Thema mit den Prozessen?

Die Leute halten sich doch sowieso nicht daran, sie halten sich ja auch nicht an meine mündlichen Wünsche oder Anweisungen. Manche Dinge habe ich bestimmt schon tausend mal erwähnt und sie ändern sich doch nicht.

„Eigentlich“ ist eine hervorragende Ausrede nichts zu tun!

Den Status Quo zu akzeptieren ist nicht nur „eigentlich“ schlecht, sondern es ist die direkte Fahrt in den Abgrund, nur dass er unter Umständen nicht so schnell geht, sondern schleichend von statten geht.

In dieser Klitsche hier brauchen wir so etwas wie Prozesse nicht.

Diese und ähnliche Einstellungen verhindern häufig die Einführung von Prozessen oder die wirklich gelungene Umsetzung und Anwendung. Solange wir die Arbeit nicht ernst nehmen, die wir zu erledigen haben und solange wir nicht einsehen, dass unser Beitrag wichtig ist, solange werden unsere Ergebnisse eben auch klein und unbedeutend bleiben.

In this episode Malte Stöckert speaks about the right understanding of roles. This Podcast is a part of an online event called Trust the process that was hosted by StingOrg GmbH.