Schedule

Tuesday, April 03
7:15 AM - 6:30 PM

  • Tuesday, April 03, 7:15 AM - 6:30 PM

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Tuesday, April 03
8:15 AM - 10:15 AM

  • Room:   Workshop Room C/D
  • Tuesday, April 03, 8:15 AM - 10:15 AM
“The FDA gives you permission to sell your technology, but it doesn’t give us a single reason why we should buy it.” – An official from the Centers for Medicare and Medicaid Services (CMS) Innumerable medical devices and diagnostics make it all the way through proof-of-concept, venture capital funding, patenting, and...
Speaker
Beth Brooks

President
Decision Driver
Speaker

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  • Room:   Workshop Room A/B
  • Tuesday, April 03, 8:15 AM - 10:15 AM
The revised ISO 13485 standard expects you to apply a “risk based approach” to all of your organization’s QMS processes, specifically stating you’ll need to apply risk management methods and techniques to every single QMS process, including outsourced processes as well. This presentation will give product developers and manufactures a thorough...
Speaker
Jon Speer

Founder & VP of QA/RA
Greenlight Guru
Speaker

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Tuesday, April 03
10:30 AM - 12:30 PM

  • Room:   Workshop Room A/B
  • Tuesday, April 03, 10:30 AM - 12:30 PM
Everyone wants to get their device to market as quickly as possible, but the biggest delay is not 510(k) clearance. If you complete the required testing before you submit your 510(k), your 510(k) should take 90-120 days to receive clearance. Typically the testing required for submission will take equally long –...
Speakers
Elizabeth Fitzgerald

Director, Regulatory Intelligence
Right Submission
Co-Speaker

Jon Speer

Founder & VP of QA/RA
Greenlight Guru
Co-Speaker

Juan Serna

Co-Founder
Right Submission
Co-Speaker

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  • Room:   Workshop Room C/D
  • Tuesday, April 03, 10:30 AM - 12:30 PM
“We don’t innovate enough." “Our idea of innovation is adding a button or changing the color.” “Even if we did innovate, our biggest competitor would copy us almost immediately.” Serial entrepreneur and medical device inventor Jeffrey Carlisle has heard it all. He’s watched companies kill innovation very effectively. Yes, every device can “add...
Speaker
Mr.  Jeffrey Carlisle

Chief Executive Officer
Pneuma Systems
Speaker

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Tuesday, April 03
12:45 PM - 2:45 PM

  • Room:   Workshop Room C/D
  • Tuesday, April 03, 12:45 PM - 2:45 PM
The introduction of the MEDDEV 2.7/1 Rev. 4, in June 2016, is part of the significant changes happening across the medical device regulatory landscape. This particular change is connected to introduction of the EU MDR enacted in 2017 and will significantly impact the procedures surrounding post-market clinical information, device equivalence, and...
Speakers
Anne Leijsen

Medical Writer
Factory CRO
Co-Speaker

Christine Zomorodian

Innovative Consultant
Gish Consulting
Co-Speaker

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  • Room:   Workshop Room A/B
  • Tuesday, April 03, 12:45 PM - 2:45 PM
For medical device companies, ineffective communication with FDA often leads to time-consuming and costly delays. Manufacturers may assume a classification or regulatory pathway for a new device – only to learn later that FDA disagrees. Unfortunately, most of these delays are completely avoidable! The ‘pre-sub’ program – an expansion of the...
Speaker
Michael Drues

President
Vascular Sciences
Speaker

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Tuesday, April 03
3:00 PM - 5:00 PM

  • Room:   Workshop Room A/B
  • Tuesday, April 03, 3:00 PM - 5:00 PM
Uncovering User Needs for any Medical Product is now an important aspect for the FDA. However, for a typical startup, this means balancing the technology with usability. There is an increased demand for new devices ranging from combination products to medical devices. Products are crossing boundaries from pharmaceutical and biologic...
Speakers
Bobby Boyer

Senior Mechanical Engineer
HS Design
Co-Speaker

Tor Alden

Principal
HS Design
Co-Speaker

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  • Room:   Workshop Room C/D
  • Tuesday, April 03, 3:00 PM - 5:00 PM
Participants will receive valuable material regarding Exit Strategy including: • When do I start thinking about an exit strategy? • What are the best ways to maximize value in my business? • What are the exit options available to me at different stages: early, commercialization, mature • What is the current state of obtaining...
Speakers
Dave Sheppard

Principal
MedWorld Advisors
Speaker

Florence Black

CEO, President and Founder
MedWorld Advisors
Speaker

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Tuesday, April 03
5:15 PM - 6:00 PM

  • Room:   MDTX Exhibit Hall
  • Tuesday, April 03, 5:15 PM - 6:00 PM
MDTX thanks their inaugural exhibitors for their participation and support.

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Wednesday, April 04
7:30 AM - 6:30 PM

  • Wednesday, April 04, 7:30 AM - 6:30 PM

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Wednesday, April 04
7:45 AM - 8:25 AM

  • Wednesday, April 04, 7:45 AM - 8:25 AM
Manufacturer attendees registered for "The Works" package receive complimentary breakfast served in the Exhibit Hall. Paid concessions are available for all other attendee and exhibiting participants.

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Wednesday, April 04
8:25 AM - 8:30 AM

  • Wednesday, April 04, 8:25 AM - 8:30 AM
Speaker
Joe Hage

Conference Host, MDTX
Leader, Medical Devices Group
Master of Ceremonies

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Wednesday, April 04
8:30 AM - 8:55 AM

  • Wednesday, April 04, 8:30 AM - 8:55 AM
What you need to know about recent FDA guidance regarding: Real World Evidence, reporting age-, race-, and ethnicity data in clinical studies, drug/device classification issues, the pre-submission process, De Novo submissions, the Breakthrough Devices Program, submission involving cybersecurity, and deciding when to submit a new 510(k) for changes to an...
Speaker
Bob Marshall

Chief Editor
Med Device Online
Speaker

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Wednesday, April 04
8:55 AM - 9:20 AM

  • Wednesday, April 04, 8:55 AM - 9:20 AM
• Getting cost-effective access to new product ideas from individual physicians and university tech transfer offices• Determining the main issues/difficulties in working with physicians• Illustrating what physicians really want and need when working with engineers
Speaker
Dr. Howard Levin

President & Chief Scientific Officer
Coridea
Speaker

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Wednesday, April 04
9:20 AM - 9:45 AM

  • Wednesday, April 04, 9:20 AM - 9:45 AM
Collaborating with your customers AND internal stakeholders (e.g., sales, marketing) is absolutely essential to creating delightful user experiences for your products and services. Within the field of User Experience Design, there are a myriad tools and techniques available to us to allow for participatory feedback throughout the design process.This session...
Speaker
Lorraine Chapman

Senior Director of Healthcare
Macadamian Technologies
Speaker

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Wednesday, April 04
9:45 AM - 10:00 AM

  • Wednesday, April 04, 9:45 AM - 10:00 AM
Three-minute introductions from five of our most innovative exhibitors that will highlight some of the can’t-miss stops in the exhibition floor.

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Wednesday, April 04
10:00 AM - 5:00 PM

  • Wednesday, April 04, 10:00 AM - 5:00 PM
Visit the Exhibitors. Exhibits showcasing new technologies, resources, and materials you didn't know existed and meet the companies who can help you grow your business.

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Wednesday, April 04
10:30 AM - 10:55 AM

  • Wednesday, April 04, 10:30 AM - 10:55 AM
More medical device manufacturers have stepped up to 3D printing than you might realize. In fact, medical devices comprise 20-25% of speaker Rick Gillespie’s business.In this timely session, Rick will cover how 3D printing for medical device companies:• Reduces costs, improves patient care and/or increases speed and accuracy of product...
Speaker
Rick Gillespie

Healthcare Business Development Manager, 3D Printing
Fisher Unitech LLC
Speaker

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Wednesday, April 04
10:55 AM - 11:20 AM

  • Wednesday, April 04, 10:55 AM - 11:20 AM
The medical market has evolved over the past several years and is facing unprecedented challenges. Increased government regulation, heavy cost pressures from local competition in emerging markets, and increased public pressure to achieve sustainability are challenging companies to drive operational efficiency and revisit material selection in order to succeed in...
Speakers
Allen Kesselring

Founder
EKG Labs
Speaker

Jason Spencer

Director, Market Development
Henkel Health & Wellness, Medical Device Manufacturing
Speaker

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Wednesday, April 04
11:20 AM - 11:45 AM

  • Wednesday, April 04, 11:20 AM - 11:45 AM
Patients are driving the miniaturization on ambulatory devices with increased emphasis on more functionality, more comfort, portability and self-powered devices. This growing trend towards making devices smaller allows for less invasive procedural techniques and helps reduce the length of hospital stays which reduces costs.With the development of smaller components and...
Speaker
Carsten Horn

Business Development Engineer for Medical Applications
Maxon Precision Motors
Speaker

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Wednesday, April 04
11:45 AM - 12:00 PM

  • Wednesday, April 04, 11:45 AM - 12:00 PM
Three-minute introductions from five of our most innovative exhibitors that will highlight some of the can’t-miss stops in the exhibition floor.

...read more...


Wednesday, April 04
12:00 PM - 1:00 PM

  • Wednesday, April 04, 12:00 PM - 1:00 PM
Manufacturer attendees registered for "The Works" package receive complimentary lunch served in the Exhibit Hall. Paid concessions are available for all other attendee and exhibiting participants.

...read more...


Wednesday, April 04
1:00 PM - 1:25 PM

  • Wednesday, April 04, 1:00 PM - 1:25 PM
A case study will be presented that visually demonstrates how upstream contextual inquiry maps user experience to robust device requirements and design inputs resulting in a dynamic trace matrix. This case study demonstrates how to effectively apply a usability design process, employing human factors engineering methodologies (including task analysis and...
Speaker
Philip Remedios

Principal
BlackHägen Design
Speaker

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Wednesday, April 04
1:25 PM - 1:50 PM

  • Wednesday, April 04, 1:25 PM - 1:50 PM
In his talk, Ames Gross will share case studies and discuss: • When sourcing and manufacturing in Asia may be worth your consideration • Best strategies to source in India’s medtech market • How to set up a greenfield medtech manufacturing facility in China and India • The most effective...
Speaker
Ames Gross

President and CEO
Pacific Bridge Medical
Speaker

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Wednesday, April 04
1:50 PM - 2:15 PM

  • Wednesday, April 04, 1:50 PM - 2:15 PM
This is a case study which couples together technical theory of operation with applied human factors. While usability testing is a strong topic of conversation due to FDA human factors guidance, the application of HF principles is implemented in the initial product design.This presentation will delve into the process of...
Speaker
Mary Beth Privitera

Principal
HS Design
Speaker

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Wednesday, April 04
2:15 PM - 2:40 PM

  • Wednesday, April 04, 2:15 PM - 2:40 PM
Since Bitcoin was first released in 2009, it and other cryptocurrencies have surged in popularity, eclipsing a combined value of $300B in November, 2017. Bitcoin’s major innovation was the utilization of a cryptographic, immutable, distributed ledger, known as a “blockchain,” that is used to keep track of all bitcoin transactions....
Speaker
Jad Mubaslat

Founder
BitQuick
Speaker

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Wednesday, April 04
2:40 PM - 3:20 PM

  • Wednesday, April 04, 2:40 PM - 3:20 PM
Create your own sundae or select a childhood ice cream truck favorite! This is the perfect time for a little sugar-infusion.

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Wednesday, April 04
3:20 PM - 3:45 PM

  • Wednesday, April 04, 3:20 PM - 3:45 PM
Walt Maclay will discuss the issues involved with bringing wearable medical devices from an idea to FDA approval based on his firms many experiences. He will discuss areas including user interface issues, battery life, different sensing technologies, data security, and verification to meet FDA and CE requirements.
Speaker
Walt Maclay

President
Voler Systems
Speaker

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Wednesday, April 04
3:45 PM - 4:10 PM

  • Wednesday, April 04, 3:45 PM - 4:10 PM
We are seeing explosive growth in wearable health monitors for healthcare and fitness applications. Many of these devices stick to the skin. This talk will explore the challenges of the skin as a substrate, and considerations for selection of the proper adhesive. In addition, Dr. Lawson will discuss the challenges...
Speaker
Del Lawson PhD

Laboratory Manager
3M Critical & Chronic Care Solutions Division
Speaker

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Wednesday, April 04
4:10 PM - 4:35 PM

  • Wednesday, April 04, 4:10 PM - 4:35 PM
When designing and developing a medical device, companies often consider labeling down the road, but they shouldn’t. Labeling can involve a variety of ways a medtech company markets a product. What presenter Michael Drues calls high-level labeling – indications for use, intended use and label claims – drives to the...
Speaker
Michael Drues

President
Vascular Sciences
Speaker

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Wednesday, April 04
4:35 PM - 5:00 PM

  • Wednesday, April 04, 4:35 PM - 5:00 PM
Medical device designs are becoming complex in nature with combined elements of electrical, mechanical and material sciences. The innovative functionality, ease of use, safety and manufacturability, are given importance in the early stage of design process. With the initial focus on design and functionality, testing requirements are not given the...
Speaker
Hitesh Mehta

Researcher and Innovator, R&D Engineer III
Integer Holdings Corp. (formerly Greatbatch Medical)
Speaker

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Wednesday, April 04
5:15 PM - 6:00 PM

  • Wednesday, April 04, 5:15 PM - 6:00 PM
There is an influx of medical devices entering the global market, expected to reach $343 billion by 2021. The increased availability of healthcare and the ageing population contribute to this growth, along with the promise of better outcomes enabled by Internet-connected devices. And we hear it all the time: devices “breaking...
Speaker
Nersi Nazari

Chief Executive Officer
VitalConnect
Keynote

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Wednesday, April 04
6:00 PM - 8:00 PM

  • Wednesday, April 04, 6:00 PM - 8:00 PM
All are welcome. Eat, drink and mingle after the Keynote Presentation. 

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Thursday, April 05
7:30 AM - 3:00 PM

  • Thursday, April 05, 7:30 AM - 3:00 PM

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Thursday, April 05
7:45 AM - 8:25 AM

  • Thursday, April 05, 7:45 AM - 8:25 AM
Manufacturer attendees registered for "The Works" package receive complimentary breakfast served in the Exhibit Hall. Paid concessions are available for all other attendee and exhibiting participants.

...read more...


Thursday, April 05
8:25 AM - 8:30 AM

  • Thursday, April 05, 8:25 AM - 8:30 AM
Speaker
Joe Hage

Conference Host, MDTX
Leader, Medical Devices Group
Master of Ceremonies

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Thursday, April 05
8:30 AM - 8:55 AM

  • Thursday, April 05, 8:30 AM - 8:55 AM
Medical Device Manufacturing has many requirements, including regulatory constraints, standardized practices, identification and precision. In the future, we’d want even shorter runs of specialized devices, customized to patient needs. The use of IoT and Edge Computing will allow sensory systems, strategically implemented in the manufacturing chain to develop a feedback system...
Speaker
Srihari Yamanoor

Mechanical Engineer
Stellartech Research
Speaker

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Thursday, April 05
8:55 AM - 9:20 AM

  • Thursday, April 05, 8:55 AM - 9:20 AM
Is printing a knee really any different than printing a drug? The regulatory strategies are exactly the same! Interested in 3-D printing applications in medicine, not just what we are doing today but what we could be doing in the future and how do we get there? For example, can...
Speaker
Michael Drues

President
Vascular Sciences
Speaker

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Thursday, April 05
9:20 AM - 9:45 AM

  • Thursday, April 05, 9:20 AM - 9:45 AM
Details to follow.
Speaker
Jon Speer

Founder & VP of QA/RA
Greenlight Guru
Speaker

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Thursday, April 05
9:45 AM - 10:00 AM

  • Thursday, April 05, 9:45 AM - 10:00 AM
Three-minute introductions from five of our most innovative exhibitors that will highlight some of the can’t-miss stops in the exhibition floor.

...read more...


Thursday, April 05
10:00 AM - 4:00 PM

  • Thursday, April 05, 10:00 AM - 4:00 PM
Visit the Exhibitors. Exhibits showcasing new technologies, resources, and materials you didn't know existed and meet the companies who can help you grow your business.

...read more...


Thursday, April 05
10:30 AM - 10:55 AM

  • Thursday, April 05, 10:30 AM - 10:55 AM
Having been on both sides of the supplier selection process in large and small companies, Mark learned many pitfalls and rewards in selecting the right suppliers.There are many factors besides cost that need to be determined when assessing a new medical device manufacturing partner.In this session, you will learn methods...
Speaker
Mark Rutkiewicz

Vice President, Quality
Innovize
Speaker

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Thursday, April 05
10:55 AM - 11:20 AM

  • Thursday, April 05, 10:55 AM - 11:20 AM
The concept of Procurement Excellence has been gaining more attention recently and is on the verge of becoming a mainstream capability. Procurement organizations are asking themselves how they can apply manufacturing based lean methodologies into their own day-to-day service processes. It is not clear that anyone fully understands what Procurement...
Speaker
Carlos Soares

Managing Director
The Prokur Group
Speaker

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Thursday, April 05
11:20 AM - 11:45 AM

  • Thursday, April 05, 11:20 AM - 11:45 AM
All sterilization methods have pluses and minuses and any given sterilization method is the best option depending on type of material or medical device. In this session, Jeff will address the primary terminal sterilization methods of Ethylene Oxide, Gamma, E-beam/X-Ray as well as emerging sterilization technologies. This will include the drawbacks and...
Speaker
Jeff Sauter

Director of Business Development
Steri-Tek
Speaker

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Thursday, April 05
11:45 AM - 12:00 PM

  • Thursday, April 05, 11:45 AM - 12:00 PM
Three-minute introductions from five of our most innovative exhibitors that will highlight some of the can’t-miss stops in the exhibition floor.

...read more...


Thursday, April 05
12:00 PM - 1:00 PM

  • Thursday, April 05, 12:00 PM - 1:00 PM
Manufacturer attendees registered for "The Works" package receive complimentary lunch served in the Exhibit Hall. Paid concessions are available for all other attendee and exhibiting participants.

...read more...


Thursday, April 05
1:00 PM - 1:25 PM

  • Thursday, April 05, 1:00 PM - 1:25 PM
Healthcare is moving out of the hospital, meaning that medical devices need to be connected to the internet. Since many patients have smartphones in their pocket at all times, device manufacturers can easily use Bluetooth to send data from their device to a smartphone app, and then to a cloud...
Speaker
Mike Kijewski

Chief Executive Officer
MedCrypt
Speaker

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Thursday, April 05
1:25 PM - 1:50 PM

  • Thursday, April 05, 1:25 PM - 1:50 PM
Intellectual property rights and attendant issues may arise at many stages of medical device development. Both the internal and external landscape of IP rights are critical drivers in medical device, research, design, development and commercialization. We will explore the nature and role of IP counsel in identifying IP rights, navigating...
Speaker
David Rosenbaum

Chairman & CEO
Rosenbaum IP, P.C.
Speaker

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Thursday, April 05
1:50 PM - 2:15 PM

  • Thursday, April 05, 1:50 PM - 2:15 PM
Data Science has been the buzzword for the past few years, but many companies are still struggling on how to effectively use it in their products. We will discuss a few examples on how companies are integrating data science outcomes into their products and help you formulate strategies on how...
Speaker
Sean Otto

Vice President, IoT and Analytics
Cyient Insights
Speaker

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Thursday, April 05
2:15 PM - 2:40 PM

  • Thursday, April 05, 2:15 PM - 2:40 PM
As medical device development complexity and regulatory requirements increase, the timeframe for development and the budget to complete the work struggle to maintain pace.  Additionally, evidence-based medicine requirements increase the need to quickly and clearly convey complex physical interactions to non-technical audiences in an environment of constant distractions.  Computational modeling...
Speaker
Arlen Ward

Medical Device Simulation Principal
System Insight Engineering LLC
Speaker

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Thursday, April 05
2:40 PM - 3:00 PM

  • Thursday, April 05, 2:40 PM - 3:00 PM
Sweet and/or salty choices for your afternoon pick me up break on the Exhibit Floor. Beverages also served.

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Thursday, April 05
3:00 PM - 4:00 PM

  • Thursday, April 05, 3:00 PM - 4:00 PM
At this exclusive 10x Workshop, you will get a private lesson from one of the world’s best marketers in healthcare. In two hours Mike Sperduti will present a consolidated version of the 7-Step Sales Program. This course teaches effective and straight-forward strategies for every step of the sales process. Students...
Speaker
Mike Sperduti

Principal
Emerge Sales
Speaker

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Thursday, April 05
4:00 PM - 4:05 PM

  • Thursday, April 05, 4:00 PM - 4:05 PM
Closing Thoughts
Speaker
Joe Hage

Conference Host, MDTX
Leader, Medical Devices Group
Master of Ceremonies

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