Opal Medical Devices Summit – Minneapolis 2017

The Commons Hotel, Minneapolis, MN
June 26, 2017 - June 27, 2017

93 days left

In today's highly regulated environment, medical device and combinations product manufacturers cannot ignore even the smallest challenges at every stage of development--or during use in healthcare and clinical settings. Fortunately, Opal Group's Medical Devices Summit Midwest is here to provide a platform for a bench-to-bedside discussions every medical device and combination product professional needs.

The Medical Devices Summit Midwest attracts professionals from Medical Device, Pharma, Biotech and Drug Delivery who will learn new strategies for concept development, navigating the regulatory landscape, and managing risk and maintaining quality throughout the product life cycle.

Current as of March 17, 2017

7:00am

Exhibitors Setup

7:30am

Continental Breakfast & Registration 

8:15am

Chairman’s Welcoming Remarks

9:30am

Cyber Security—End User Expectations
FDA’s 2015 warning on remotely controlled infusion pumps and recent MedStar Health breach are a grim reminder of institutional vulnerability. How does the institutional vulnerability affect device security and the future of connectivity? Our esteemed experts will explore the security of connectivity.

Moderator

Art Manion, Senior Vulnerability Analyst, CERT

Panelist

Andrew Bomett, Manager, Product Cybersecurity, Boston Scientific

Panelist

Kevin McDonald, Director of Clinical Information Security, Mayo Clinic

Panelist

Ryan Winn, Director Information Systems, Munson Healthcare

10:30am

Morning Coffee Break – Meet the Panelists of the Cyber Security Discussion

10:50am

Cyber Security– Regulation
Do we understand FDA’s direction on cyber security—regulation vs recommendation. What cultural changes does a medical device manufacturer need to implement to give their developers a chance to incorporate strong cyber security during the ever-present drive to the market. How to minimize your organization’s exposure to future liabilities caused by the hacking incidents.

Moderator

Carl Anderson, Vice President, Van Scoyoc Associates

Panelist

Suzanne Schwartz, Associate Director for Science and Strategic Partnerships, FDA

Panelist

Steven Abrahamson, Senior Director, Product Cyber Security, GE Healthcare

Panelist

Jim Jacobson, Chief Product and Solution Security Officer, Siemens Healthineers

Panelist

Beau Woods, Deputy Director, Cyber Statecraft Initiative, Atlantic Council

11:40am

Requirements for a Strong Design Control Process (With a Software Twist)
Recognizing and mitigating software risk by implementing risk analysis of the systems at the early stage of design. What processes and policies can be implemented to prevent costly corrections?

12:30pm

Lunch

1:30pm

Medical Device Innovation and Manufacturing
From a startup to a large organization, our expert panelists will discuss challenges of moving from early stage development to manufacturing, including strategic approaches to developing and protecting your intellectual property, overcoming technical and regulatory hurdles, and navigating through the intersection of innovation and law.

2:30pm

Effective Supplier Management for the Medical Device Industry
How to choose and manage vendors with time, cost and quality in mind.
What are the complexities of establishing and maintaining procedures to ensure FDA’s Title 21 820 compliance. Are ISO standards enough? Should we involve the supplier in design process to establish quality requirements and improve retention?

3:20pm

Exploring the Challenges and Opportunities in Developing Pediatric Medical Devices
With Pediatric Device Consortia Grant Program in place the FDA has awarded 3.535 million dollars in 2015. Albeit awareness campaigns why don’t we see more of much needed development in this difficult to navigate space?

Angel Adams, Chief Executive Officer, Catchwind Pediatric Innovations

4:05pm

Device Connectivity – Internet of Health
The benefits of going wireless are tremendous and when paired with the new wave of wearables these solutions will revolutionize care and treatment.
To successfully implement wireless technologies developers have to choose the right approaches-solutions and understand the options for wireless.
Successful implementation has to address the security concerns.

4:50pm

Day One Closing Remarks

7:00am

Continental Breakfast & Registration 

8:15am

 Chairman’s Welcoming Remarks

8:30am

Full product Lifecycle Traceability: The Golden Key to Proof of Compliance
As medical devices grow more complex, demonstrating regulatory compliance requires advanced analysis of device design, manufacturing quality and risk management. Join us while a panel of industry experts discuss traceability best practices for compliance to ensure business and engineering alignment, information management and contextualized communication from start to finish.

9:15am

Protecting and Licensing Inventions Developed from Government Funded Research
Funding from U.S. Government sources like the NIH is vital to innovation of pharmaceuticals and medical devices.  Funded research may complicate how rights to inventions made with the help of Uncle Sam can be used.  The conflicting demands of research and the patent law can sometimes put scientific work at odds with effective patent protection.  We will discuss issues faced by government agencies, academic institutions and potential industry partners that are considering licensing rights to inventions developed from government funded research.  We will discuss how such funding affects the right to exploit and to license IP.  We will look at what government agencies and academic institutions could do to effectively secure IP rights that not only serve the public good but that are also attractive to investors, therefore increasing the likelihood of commercialization success.

10:05am

Human Factors Awareness:
Human factors validation testing covers a broad spectrum of devices.
What are good human factors practices in the design of medical devices.
Can human factor awareness lead to a more user friendly safer products?

10:50am

FDA Presentation

11:20am

Funding Early Stage
Funding for early stage development has been drying up in recent years. Who is currently funding and what are some of the innovative options. What are some of the regulatory milestones that make your company more attractive to the investors.

Panelist

Shoshana Friedman, President and CEO, ProMedoss

Panelist

Sergey Sirotinin, Chief Executive Officer, Dbaza Health

Panelist

Cameron Plummer, CEO, Innurvation

12:00pm

Combination Products Realm
One of the challenges of combination products is to create processes that will deal efficiently with the unknown. What are some of the solutions for dealing with the unknown? What are some of the compliance requirements in combination products when dealing with pharma?

Giridhar Thiagarajan, R&D Engineer, CR Bard

Charles Ledonio, Director of Spine Research, University of Minnesota

Tieming Ruan, Principal Engineer, Biogen

12:40pm

Closing Remarks

1star
The Commons Hotel, Washington Avenue Southeast, Minneapolis, MN, United States


Registration Pricing

Earlybird Rate (expires 4/26/17) Standard Rate
Employees of Medical Device Manufacturers , Government and Academic faculty* $195 $495
Service Providers $795 $995

*Excluding contract manufacturers and other service providers.
Subject to Opal Group's approval. To qualify you must be currently employed by a non-vendor company. Eligibility will be verified by Opal. Opal reserves the right to allocate places and to refuse applications or to charge a normal attendance fee once the number of complimentary places has been exceeded.

Sponsorship, Exhibition & Speaking Opportunities 212.532.9898 info@opalgroup.net