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


Exhibitors Setup


Continental Breakfast & Registration 


Chairman’s Welcoming Remarks


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.


Art Manion, Senior Vulnerability Analyst, CERT


Andrew Bomett, Manager, Product Cybersecurity, Boston Scientific


Kevin McDonald, Director of Clinical Information Security, Mayo Clinic


Ryan Winn, Director Information Systems, Munson Healthcare


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


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.


Carl Anderson, Vice President, Van Scoyoc Associates


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


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


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


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


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?




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.


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?


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


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.


Day One Closing Remarks


Continental Breakfast & Registration 


 Chairman’s Welcoming Remarks


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.


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.


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?


FDA Presentation


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.


Shoshana Friedman, President and CEO, ProMedoss


Sergey Sirotinin, Chief Executive Officer, Dbaza Health


Cameron Plummer, CEO, Innurvation


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


Closing Remarks

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