TITLE TITLE - Public Policy Forum

TITLE TITLE - Public Policy Forum

[PITCH TITLE] [One-line description] Innovation Centre at Bayview Yards, Ottawa June 1, 2018 The Pitch While should you care? - Mass industrial manufacturing - Globalization - Manufacturing coming back to patient bedsides

Gotta a basement, Gotta a 3D printer, Gotta an Email Account: Youre in business? [PROBLEM/OPPORTUNITY] Paradigm Shift: 3D printing allows for more specific point of care The spectrum between mix of care and fabrication becomes more blended Democratization of production processes

Challenge: What do we regulate? - Materials, Products, Software, Data, Practitioners [SOLUTION] Rethinking both basic regulator rules and how you show compliance; put the framework in place. For 3D printing, traditional regulation will be ineffective: - at product, at prohibition, at license

We have risks, potential oversight gaps are unknown Hypothesis: How Might AI and Big Data support new understanding of post-market monitoring? Making It Happen Next Steps The Process Process Mapping to see whether there are oversights and where those oversights may be

[Describe the steps with as much detail as possible: Device producers, sellers, practitioners What skillsets are needed? Which departments/decision makers need to be engaged? Does the project start small, with the ability to scale up? Which citizens/groups need to be consulted?]

[E.g., see slide 5 of sample deck (p. 13)] Co-Devenlopment The Ask [What do you need to make this proposal happen?] [Try to sell each point in the ask: Reiterate the problem/opportunity Connect each ask to the needs of the decision makers: - Their mandates

- Public perception of the project - Explain how the proposal aligns with other priorities (and why the proposal is a sufficiently high priority to act on now) [E.g., see slide 6 of sample deck (p. 14)]

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