What If Engineers Could Innovate Instead of Wasting Time on Documentation? | Karl J. Larsson

If you’re a MedTech company looking to make your devices more sustainable, let’s talk :
👉 https://lucaspianegonda.clickfunnels....

Up to 50 percent of medical device development time is spent writing and maintaining technical documentation. Not engineering. Not innovating. Just boring paperwork.

In this episode, Karl J. Larsson*, co-founder of *Aligned , joins Lucas Pianegonda to break down why MedTech companies are drowning in documentation inefficiencies and how shifting from Word and Excel to a design-control–centric software system dramatically accelerates innovation, market access, and audit readiness.

Karl explains why most companies underestimate the true complexity of technical files, how inconsistency stalls submissions for months, and how restoring confidence in documentation has a direct financial impact. He also shares why enabling engineers to focus on engineering (instead of paperwork) is the fastest path to more innovation, better devices, and a more sustainable MedTech ecosystem.

Timestamps :
01:15 – Why documentation takes 50% of MedTech development time
02:00 – The hidden risks of Word- and Excel-based documentation
06:19 – How Aligned extracts design controls from existing documents
11:15 – What automated traceability and consistency checks unlock
13:28 – The “audit anxiety cycle” and why companies lose confidence
19:41 – Why innovation dies when change control becomes too painful
27:05 – The training, mindset, and culture shift required
28:37 – How documentation confidence fuels sustainability and change
39:33 – Karl’s journey from engineer to co-founder of Aligned

Connect with Karl J. Larsson :
Website: https://www.aligned.ch
LinkedIn:   / karl-johan-larsson-bab4312  

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📩 Work with Lucas and the team: [email protected]

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