“Ediuska gave a guest lecture in my course on product development and regulatory requirements for medical devices. The students appreciated her real-world experience and she shared key learnings for students interested in pursuing careers in the medical device industry.”
— Katie Reuther, Senior Lecturer in Design,
Innovation, and Entrepreneurship, Columbia University
Innovation, and Entrepreneurship, Columbia University
POPULAR TALK TOPICS:
What Happens When You Don’t Know What They Know
New entrepreneurs don’t know what questions to ask, or how to even begin navigating regulation and medical device product development. How do you vet a regulatory plan? How will you assess suppliers? How likely is it that your Quality Management System will result in an FDA violation? (Answer: extremely likely!) Learn the essentials of what it takes to navigate this process the right way, the first time.
Theranos: Hay Dios Mio!
The signs were there all along, if only someone was watching. This talk takes you through the infamous product development and investment catastrophe, and what entrepreneurs and investors can learn from everything that they did wrong in their design-product development process.
The Sexiest Medical Device Product Development Presentation Ever
Learn from the Masters: Case Study of the product development of the Pediatric Mandibular Distractor and how you can use it to improve your own process.
Indications for Use: The Heart Of Everything!
The indication for use is critical and needs to be well crafted as it dictates the device’s risk classification and therefore establishes all the regulatory requirements that you need to follow. Yet few entrepreneurs even know what it is. Learn what it takes to do this right.
Keep Your V’s Straight If You Want FDA Approval: Verification vs. Validation*
People tend to get Verification and Validation (V&V) confused, especially if you are new. It is essential to have a strong V&V plan and execution as this is the information that will be submitted to FDA and evaluated for product approval. Gain clarity around these topics and what a strong V&V plan really takes.
Avoid The Recall: Design Specification & Risk Management*
75% of FDA recalls are due to design, in large part due to the confusion around user needs versus design inputs. This, plus an inadequate V&V, can not only lose you time and money, but can result in a business-crushing recall down the line. This talk breaks down the confusion and provides a roadmap to getting it right the first time.
Wake up your audience with a speaker who has an infectious obsession with the tedious topic of the regulatory process
