2nd Annual Medical Devices Summit West

• Defining software is becoming a major conversation across the industry, and includes issues of data collection, intent and function
  
• Companies are coming under increased scrutiny because of the nature of their software, and some have already come under fire for misclassifying.
  
• The FDA released guidelines to address these issues in record time- make sure that you know the rules and regulations surround software by learning from this expert panel!

• Learn about effectively communicating healthcare information between devices and settings in this cross disciplinary panel
  
• Medical devices are subject to multiple standards that are not always in accordance with one another: learn from leaders about how to effectively navigate these criteria

• Security - it's more than about HIPPA
  
• Malware concern around connected devices
  
• Hardware features can be used to lower threat
  
• Software and Hardware combinations to lower threat

Few embedded devices have a more direct personal impact on users than medical devices. They control the heart rate of pacemaker users, manage the flow of life-saving medication in fragile patients, and provide continuous home monitoring for the chronically ill.

• Effectively develop and test sophisticated medical devices while remaining compliant with safety standards and certifications
  
• Increase the performance and reliability of your devices without increasing your project budget or missing your market window
  
• Address testing challenges and what you can do today to improve the quality of software in your medical devices

• Practical implications of the legislation: how will this impact business's day to day
  
• Post-Grant Review; absorbing the new work this brings

• To address growing patient needs, medical devices have been shrinking- which will allow many medical procedures and treatments to come out of the hospital and into the home: saving patients and hospitals millions
• Hear about the impact this is having on portability, and how this will change areas like emergency medicine forever

• Understanding the Fundamental Requirements of Design Control as Prescribed by FDA
  
• Identify Key Steps Associated with Design Control
  
• The Importance of the Design History File (DHF)
  
• The Importance of the Device Master Record (DMR)
  
• Design Validation versus Design Verification
  
• When to Hold Design Reviews
  
• Current FDA Enforcement Actions

• Choose 2 half hour long workshops to attend, and join other industry leaders as they host in-depth discussions on a variety of topics.
  
• After 30 minutes, attendees will be given the opportunity to switch rooms and hear from a different industry leader on a whole new topic

• Unpack some of the hot button issues brought up at the luncheon talk in this intimate, workshop setting!

Session A: Sorting out the deadlines for Medical Equipment tests to 60601- 3rd Ed.
Different countries and regions have different requirements and deadlines for bringing products into compliance with 60601-1 3rd Edition. This roundtable will lay out the deadlines and share details of the requirements in the USA, Canada, Europe, and other markets.

Session B - How to document Risk Management in order to meet 60601-1 3rd Ed.
Abstract - ISO14971:2007 is commonly used as the risk management standard for electrical medical equipment. This roundtable will examine the best ways to document your conformity to both ISO14971 and IEC 60601-1 3rd. Ed.

Speaker:
Dale Hallerberg, Technical Manager, Medical Product Testing, TUV Rheinland

Session A: A Comprehensive Defect Prevention Strategy for Medical Device Software
Session B: Policy Driven Software Development for Medical Device Software

Learn about Open Innovation and how it can deliver benefits in the mobile medical device space. Open innovation is a growing phenomenon across various markets, utilized by organizations as diverse as P&G, NASA, Dell, GSK and Life Technologies. It’s about bridging internal and external resources and acting on those opportunities to bring better innovation to market faster. In addition to "better innovation", benefits can include faster development cycles and lower costs. Let’s discuss how your company might benefit from open innovation with respect to development efforts for mobile medical devices.

• Crossing the Valley of Death- incubating technology and getting to the next stage of development
  
• More than ever it's important to "incorporate the endgame", and be up to date on reimbursement issues
  
• How companies are evaluating how meaningful a product is in the lives of future patients

• Cardiovascular disease is the leading cause of death in the U.S. Why and how has this spawned numerous medical device therapeutic strategies, companies and products?
• Understanding basic mechanisms of disease, therapeutics, and technology will ultimately reduce risk. 
• Understanding timing/costs of development, regulatory and reimbursement approval are key to a successful business strategy
• How important are regulatory and reimbursement strategies? When should these enter the equation
• How should you bring forward platform technology? Do you cross-over to non-medical applications? How does this alter business strategies?
• The role of the market and understanding of its complexities  - vital to an effective business strategy.  Should a "low-hanging fruit" market opportunity trump a higher return complex opportunity or vice versa?  Can one be too far ahead? What are the consequences?

• Understanding the medical device landscape: how do companies set themselves apart
• Raising capital- who, what, where, when and how
• Get a better understanding of the accelerator model: what’s viable and what isn't
• Facing the regulatory challenges ahead and building a supportive infrastructure

• Learn from a case study on how one company is putting medicine back into the patients hands, and using mobile health to engage them as an agent of their own care

• Sharing insight and information between design, engineering and partners is a vital step to take early on: gain skills for ensuring communication throughout your product's lifecycle
• Use these skills to promote innovation, accelerate time to market and reduce cost