Friday, November 3  | 7 am – 4 pm
The Grand America Hotel


Download Summit 2017 Printable Agenda Soon!



Frontiers of Innovations and Regulations
03 Nov 2017
7:00 am - 8:00 am

Registration and Check-in

8:00 am - 9:00 am

Breakfast Session

Welcome Address

Governor Gary Herbert

Breakfast Keynote

We will be honored to have Tom Polen, President of BD Medical, be our Breakfast Keynote.
Tom Polen
9:00 am - 9:30 am

Networking Break

9:30 am - 11:45 am

Morning Session

Medical Device Single Audit Program (MDSAP)

Understand the new requirements and benefits and risks associated with participating in the new single audit program

Clinical Needs Finding/Ethnographic Research

Before the development of any new solutions begins, must first identify and understand the opportunities that are associated with your strategic focus area.  The process of identifying opportunities requires you...
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John Langell, MD, PhD, MPH

Regulatory Basics

Regulatory issues play a critically important role in the ultimate success of a new technology.  Understanding the regulatory landscape early in the innovation process is essential.  Come get an overview...
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Spencer Walker, MSc

Stakeholder & Market Analysis

The stakeholder & market analysis, you systematically examine the direct and indirect interactions of all parties involved in financing and delivering care to the patient.  Including understanding which of their...
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Shawn Fojtik
11:45 am - 12:00 pm

Stretch Break

12:00 pm - 2:00 pm

BioUtah Annual Meeting Luncheon

Luncheon Keynote: State of Utah’s Life Science Industry

We will be honored to have Natalie Gochnour, Associate Dean, David Eccles School of Business and Director, Kem C. Gardner Policy Institute, University of Utah, be our Luncheon Keynote.
Natalie Gouchner
2:00 pm - 2:30 pm

Networking Break

2:30 pm - 4:00 pm

Afternoon Session

Quality Systems Basics

Understanding the key components of a quality systems (21 CFR 820 & ISO 13485) and why early implementation of certain subsystems is of strategic importance to managing a business.  Also...
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Spencer Walker, MSc

Product Reimbursement Fundaments

Understanding the reimbursement landscape early on in the development will help determine whether or not the existing healthcare payment infrastructure will accommodate a new solution to the clinical need it...
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John Langell, MD, PhD, MPH



The Grand America Hotel
555 South Main Street, Salt Lake City, Utah 84101

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225.00 USD

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Exhibitor Pass
1,050.00 USD

Includes 2 Summit Exhibitor entrances & a 6′ x 30′ skirted table

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Non-Member –  $1,050

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Who is BioUtah?

BioUtah is an independent, non-profit 501(c)(6) trade association serving Utah’s life science industry. Our primary members include organizations focused on research and development, manufacturing and commercialization or provide supportive services to life science technologies and treatments.

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What We Do

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Why us?

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