#323 The Combination Products Handbook - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers
from 2023-06-15T23:05
Combination products are a difficult niche because they combine so many different elements. However, today’s guest literally wrote the book on the topic, and she’s joining the podcast to share her insights. In today’s episode, Susan Neadle and I spoke on the topic of Combination Products, and specifically how she recently wrote the Handbook on this topic, with many co-authors from FDA.
Susan is a recognized international Combination Products and Medical Device expert with over 30 years of industry experience. Her FDA peer-reviewed book, “The Combination Products Handbook: A Practical Guide” is available for purchase through CRC Press. Listen to the episode to hear about her past experience and how she ended up in products, how the different chapters of her book came to be, and how her collaborators were involved.
Some of the highlights of this episode include:
- Susan’s past experiences in the industry
- How Susan got into the combination products space
- Specific examples of the multilingual approach Susan had to take
- How the different chapters in Susan’s books evolved and who collaborated with her
- What it was like to work with so many different professionals on the book
- Thoughts about challenges that may be addressed in the future
- How to harmonize language differences in the glossary
- Overcoming the challenge of being a niche within a niche and juggling multiple fields
- How industry knowledge interacted with FDA knowledge
Memorable quotes from Susan Neadle:
“It was really a great adventure, being there right at the ground level when it all started.”
“If people aren’t able to use the product effectively, they’re not going to take their drug, which means all sorts of other ramifications.”
“It’s important to understand what are the combination inspection product criteria.”
“It was great, although it would have been much easier if I was trying to write the book by myself, because I have control of my own timelines.”
Links:
20% Discount for The Combination Products Handbook
Combination Products Consulting
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