Erika Schüttfort
Vorsa
Köln, Germany
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A European who has been lucky enough to have the opportunity to both study and work in various European countries. Long experience in the MedTech business and an eager driver for change to cease the immense opportunities to benefit customers and their patients.
Education:
MSc Engineering Physics Technical University Lund (Sweden)
PhD Materials Science University of Cambridge (UK)
Experience:
>10 years in medical device industry (BD, BSN medical) of varying leadership roles
1,5 years in Vorsa supporting agility & transformations in various businesses
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Case study: agile in highly regulated MedTech, the delecate balance of innovation and compliance
This talk will draw examples from case studies to exemplify how the journey towards business agility can look like when developing highly regulated software & hardware medical technology products. A huge challenge for this industry is how to ensure swiftness of innovation availability to help patients and yet ensuring that the products are compliant. There are great opportunities here to use agility to address exactly this challenge. We will highlight both how the compliance aspects and the HW development was addressed, what challenges we faced (such as varying regulations in the EU and the US) and how we tried to address them. Another factor that we want to share is how to drive change within a large corporate structure, the importance of working with agility of strategy and leadership simultaneously as various parts of the product development and what that can look like.
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