Gold Sponsors

B Braun

Donatelle

Spectrum Plastics Group

Steri-Tek


Supporting Organizations

Colorado Advanced Manufacturing Association

Colorado BioScience Association

MDMA

Octane


Media Sponsors

Medtech Directory

Medtech Intelligence

Silver Sponsors

ARC Group Worldwide

Arthur G. Russell

Beaumont

Bentec Medical

Bihlermed

Biomedical Innovations

Cadence

Cyient

EG-GILERO

Eldon James

Forefront Medical Technology

IQMS

Isometric Micro Molding

Judson Smith

Laser Light Technologies

Medbio

MICRO

Micro Mold

MW Industries Medical Solutions

Parmatech

Plastikos

Qosina

Seisa

SigmaTron

Sparton Medical

Stradis Healthcare

STI

Tegra Medical

Teleflex Medical OEM

Trademark Plastics

Wytech


Bronze Sponsors

Eurofins

maxon motor

CNZFE

PMCF

QPC

 

Thursday, October 11
Location: Interlocken Ballroom, Omni Interlocken Resort
7:00-8:55 a.m. Registration & Continental Breakfast
Sponsored by:
Empirical
8:55-9:00 a.m. Welcome Address
Speakers:

    Howard Revitch, MPO/ODT Group Publisher
    Sean Fenske, MPO/ODT Editor-in-Chief
9:00-9:45 a.m. State of the Industry
A comprehensive analysis of the latest trends within the medical device manufacturing industry. M&A activity among both the medical device manufacturing firms and their supply chain partners will be a focal point. Also, concerns and considerations relevant to that OEM and supplier relationship will be discussed.

Speaker: Anthony S. Freeman, President, A.S. Freeman Advisors LLC

9:45-10:30 a.m. Regulatory Transitions—Navigating the EU MDR, Brexit, and More
Impending changes across the globe will increase the difficulty of navigating the regulatory landscape. When should companies start preparing for these changes? How can companies tailor their launch strategy to meet these challenges? This presentation will lay out major changes and a timeline of global regulatory changes, so senior management can appropriately develop their regulatory strategies to keep facilities in compliance and products on the market.

Speaker: Kim Trautman, Executive Vice President—Medical Device International Services, NSF International

10:30-11:15 a.m. Networking Break
Sponsored by:
BMP Medical
11:15 a.m.-12:15 p.m. ‘Part Process’ Development and Validation for Multiple Machines
A group of medical device original equipment manufacturers (OEMs) set out to discover a more efficient part process development and validation process for injection molding that can be transferable. They executed a real-world “proof of concept” event and formally documented their results. Traditionally, a part must be re-validated every time the mold is going to run in a different machine, especially in high-precision applications that are found in medical devices. This costs millions of dollars a year and sometimes leads to weeks or months of machine downtime, leading to lost revenue for both the OEM and molder. By creating a “Part Process,” molders are able to replicate transferable plastic conditions that eliminate the need to 100 percent re-validate the tool every time it is moved to a new machine. Using a reduced PQ verification run, molders can save millions and reduce risk based on the confirmation of repeatable statistical results. In preparation, click here to learn more by reading the MPO article and downloading the white paper at the end.

Presenters:

    Paul Robinson, Vice President of Operations, Quality Systems Consulting Services
    Matt Therrien, Business Development Manager—Medical, RJG Inc.

Moderator: Maureen Reitman, ScD, PE, Principal Engineer, Director of Polymer Science and Materials Chemistry, and Corporate Vice President, Exponent

Panelists:

    Rodney A. Brown, Senior Injection Molding Steward, Eli Lilly & Company
    Greg Lusardi, Worldwide Molding Leader, Becton Dickinson
    Scott Scully, Corporate Director, Terumo Cardiovascular Systems
    Ed Valley, Director of Engineering & Program Management, Nypro Healthcare
12:15-1:45 p.m. Networking Luncheon
Sponsored by:
Eurofins
1:45-2:30 p.m. Supply Chain Best Practices—Getting the Most Out of the Tools to Optimize the Process
Getting results out of your supply chain can be daunting. The agility to meet the ever-flexing customer demand, without excessive inventory, is key. Having that agility requires superior end-to-end supply chain management processes. This session touches upon best practices for a robust and agile SCM process. Topics will include developing the sales, inventory, and operations (SIOP) process; selecting and aligning the right KPIs; using tools such as 4DX and A-3 Thinking in a medical device world to improve supplier quality; implementing Lean and the Toyota Production System; consignment agreements; supplier rationalization; and more.

Speaker: Kenneth L. Ward, President and Founder, TeraSTRAT Consulting

2:30-3:15 p.m. ISO 13485:2016 Supplier Controls—Best Practices that Make Sustainable Change
The changes to ISO 13485:2016 have placed additional emphasis on Supplier Controls. As companies outsource more of their processes or become virtual, the expectation is that controls need to be implemented. What are the big problems found during the ISO audits?  What are the best practices? This presentation will review the ISO requirements and some of the best practices that are being used in industry.

Speaker: James Shore, Chief Quality Officer, Quality Lean Solutions

3:15-4:00 p.m. Networking Break
Sponsored by:
MTD Micromolding
4:00-5:00 p.m. Transforming the Services Relationship—Evolving from Supplier to Partner
Medical device manufacturers are no longer seeking out suppliers who offer transactional relationships. They want full-service solution providers who solve problems, eliminate challenges and reduce risk. They need partners who help get their products to market faster and at a lower cost. How do medical device manufacturers recognize these types of service providers and how does the supplier move their status into this direction? This panel will address this growing trend in the medical device manufacturing outsourcing community and discuss critical issues that impact it.

Moderator: Maria Shepherd, President and CEO, Medi-Vantage

Panelists:

    Elyse Blazevich, COO & CFO, Securisyn Medical LLC
    Thomas Burns, President & CEO, Resonetics
    Irena Cantrall, Principal, Red Line Consulting
    John Carlson, President—Health Solutions, Flex
    Palani Palaniappan, Ph.D., Exec. VP—Innovation & Development, Terumo BCT
5:00-7:00 p.m. Reception
Join attendees, speakers, and exhibitors for drinks and hors d’oeuvres during an evening reception. Take advantage of the setting for networking and conversation with peers within the medtech manufacturing industry.

Sponsored by:
SponsorName

* All session times, speakers, and content are subject to change.
Friday, October 12
Location: Interlocken Ballroom, Omni Interlocken Resort
7:30-8:30 a.m. Registration & Continental Breakfast
Sponsored by:
GL Chemtec
8:30-9:30 a.m. Secret Confessions of a Services Provider
Get a behind-the-scenes look at oversights made by OEM customers when working with a supply partner. Areas of discussion will include the RFQ process, contract negotiations, monitoring work progress and invoicing, managing conflict, and more. Hear from former insiders who have anecdotal examples of great and not-so-great ways in which clients negotiate with and manage external resources. Learn how to get the best results from outsource providers, while at the same time reducing the risk to the success of your project.

Moderator: David C. Robson, Principal, Robson Advisors

Panelists:

    David A. Durfee, Ph.D., CEO & Chief Scientist, Bay Computer Associates
    Christian L. Haller, Chief Executive Officer, The RavenOye Group
    Jake Rost, Principal, See Level Consulting
9:30-10:15 a.m. Verification and Validation: How Technology and Regulatory Trends Have Raised the Bar for Testing Medical Devices
Developers of medical devices are finding the testing needed to meet the requirements of design verification and validation is becoming increasingly challenging. As companies employ more sophisticated materials and designs, the testing to ensure safety and effectiveness often becomes significantly more complex. Additionally, the technical challenges of testing must be addressed within an ever-changing regulatory landscape where international standards are continually revised and government agency expectations are elevated. Successfully compiling the necessary test data to support a Design History File requires much more than in depth knowledge of the product being developed to ensure market approval.

Speaker: Christopher Scott, Vice President, Eurofins Medical Device Testing

10:15-11:00 a.m. Networking Break
Sponsored by:
BMP Medical
11:00 a.m.-12:00 p.m. When Rain Is All You Find at the End of the Rainbow—Moving on from a Project and onto the Pot of Gold
You are responsible for the next great product for your company and your team has spent a significant amount of time laying out milestones, creating relationships, and investing in tools, time, and resources. As you and your team are marching down the plan path, “if you build it, they will come” does not seem to be aligning with the created goals. How do you recognize when plans aren’t working and what are critical steps for correcting and/or changing the plan?

Moderator: Dawn A. Lissy, President & Founder, Empirical

Panelists:

    Natasha Bond, COO, Sana Health; Founder, Ikigai Medical Development
    Laura McGuire, Chief Operating Officer, VineaGroup
    Ben Walker, Executive Director—Life Sciences, Innosphere
    Craig Weinberg, Ph.D., President & CEO, BDC Laboratories
12:00 p.m. End of Conference
Wifi/Twitter provided courtesy of Maxon
* All session times, speakers, and content are subject to change.