strike the balance between innovation & regulation by driving … · 2017-05-09 · the medical...

1 www.SDMDConference.com • 1-800-882-8684 • [email protected] • 1-800-882-8684 • [email protected]

Gunther Lenz Director OCS Technology Office – Oncology Continuum Solutions (OCS) Varian Medical Systems

Don WoodlockSVP & GM, Cardiology IT GE Healthcare

Nias PuthenveettilChief Technology OfficerSiemens Healthcare

Chris Larkin CTO GE Healthcare

Jason FarnanSr. UX DesignerTandem Diabetes

Join Us in our Interactive Sessions on the Hottest Med Device Topics:

What else will we discuss? Mobile Medical, Quality Assurance, Regulatory Compliance... See our agenda and session topics on pages 3-5!

Sponsor: Media Partners:

presents:

May 11th & 12th, 2015 • San Francisco, CA

9

We’re back in California to offer you the actionable intelligence you need for TWO full days!

BENEFITS OF ATTENDING? Find out on page 2!

Distributed Rapid Learning

Agile Development

Data Analytics Next Generation Healthcare

Human Factors & Usability

For updates on twitter follow @MedTechUpdates Official Event Hashtag: #SDMDconf

Learn how using Distributed Rapid Learning enables clinical researchers around the world to define and validate models against large data sets.

Examine how Agile Approaches serve as Business Models that cut down the time-to-market when launching new, innovative products

Understand the best practices of Usability Engineering & lessons learned regarding Regulatory Compliance

Integrate Mobility, Big Data, Analytics & the Cloud to provide meaningful care and deliver proven outcomes!

Integrate Mobility, Big Data, Analytics & the Cloud to provide meaningful care and deliver proven outcomes!

Strike the Balance between Innovation & Regulation by Driving Down Costs & Time-to-Market

2 www.SDMDConference.com • 1-800-882-8684 • [email protected]

Network with Industry Colleagues & Expand your Knowledge by Registering for our Interactive Master Classes:

Why Sign-Up? Hear what your peers said about our workshops in Boston:

Don’t forget your business cards because you’ll be networking with:

Master Class A: Exploring Software Cyber Security within Medical Devices to Ensure the Privacy & Protection of Your Device Data

Master Class B: IEC 62304 Compliance: Ensuring Software Quality Requirements by Exploring Lightweight Documentation & Controls

“The workshops were very high quality.” – Associate Director Embedded IT (R&D) at

EMD Serono

“Workshops were great!” – Director at Rauland-Borg Corporation

Dear Industry Professionals,

After a great onsite experience and our most successful iteration to date, we’re thrilled to be back in San Francisco for IQPC’s 19th iteration of the Software Design for Medical Devices Summit Series convening this May 11th & 12th in San Francisco.

Based on your acclaim and recommendations, we’ve implemented the best elements from our October 2014 Boston Summit, and we’re striving to surpass expectations!

New for the West Coast 2015 Iteration?

· Incorporating Brand New Topics such as Cyber Security, Automated Testing, & Data Analytics · Offering more insight on Quality Assurance & Regulatory Compliance · Placing a heavier focus on audience interactions through our New Formats & Session Structures

that surpass the power point presentation and incorporate panel discussions as well as joint, team, and individual presentations

· We’ve expanded the Spring Summit to a Two-Day Event!

As you know – Front-End Designers and Back-End Development Teams are implementing new strategies & methodologies to meet the market’s needs. More so than ever, discussions within the medical device industry are all a buzz for: Mobile Medical, Human Factors, Cyber Security, Interoperability, Data Analytics, Agile Development, Quality Assurance, Regulatory Compliance and more.

However, IQPC understands that the rewards of innovation within a demanding marketplace are balanced by the risks and challenges of regulations, stringent quality requirements, and significant technical complexity. Therefore, we’re here to help balance the scale and focus on the big picture!

Top 5 Benefits of Attending?

· Understand the next steps in the usability for Mobile Medical to improve User Interfaces & the overall customer experience

· Improve Cyber Security & Risk Management Strategies to bolster patient privacy and protection · Benchmark Agile Development with competing strategies to advance software design & remain

“cutting edge” · Increase interoperability & connectivity between systems and across devices to maximize the use

of big data and analytics · Innovate your Quality Assurance & Regulatory Compliance procedures to increase product value

and decrease time-to-market

We’ve drawn from the best of the Design/ Development and Quality Assurance/ Regulatory Compliance worlds to generate insightful, interactive discussions that will leave you with actionable intelligence & pragmatic strategies to implement back home. However, don’t take my word for it! Having the Covidien team join us at our East Coast Summit, their Director of Quality Engineering will tell you himself, “I left with pragmatic ideas!”*

Don’t miss out on this exclusive opportunity to learn from and network with the best. Plus, I can’t wait to share another incredible onsite experience with you!

Best Wishes,

Alex Chard Divisional Director IQPC

*Source: Testimonial from Covidien

What your colleagues said about IQPC’s 18th Software Design for Medical Devices Summit in Boston last Fall:

“ Good range of topics, diverse solutions. Left with some pragmatic ideas to apply regarding agile methods.” –Director, Quality Engineering at Covidien

“The networking is great! Very engaging! Experienced discussions & audience interaction.” – Director, Software Engineering at Abiomed Inc.

“ Speakers provided interpretations of data, practices, and trends rather than merely reading facts.” –Software Engineer at CareStream Health

A

B

P.S. See our Agenda on Pages 3-5 to

Learn More about our Human Factors &

Regulatory Panels as well as our Quality

Assurance Master Class!

· CTOs · Technical Directors · Principal Engineers/ Architects · General & Project Managers · VPs, Directors, Manager of:

· Software Engineering · Software Validation · Software Development · Quality Assurance · Quality Engineering · Regulatory Affairs · Regulatory Compliance · Design Controls · Human Factors · Usability & User Experience · Human Factors · Risk Management


7:30am Registration for the Master Class A & Networking Breakfast

8:00am MASTER CLASS A: Exploring Software Cyber Security within Medical Devices

Although security-related processes have been improved, reducing cyber security risks is still a primary focus for medical device manufacturers in recent years since there is still much to be done before patients can have the level of confidence in the cybersecurity of healthcare organizations that they deserve. Although computer-related failures are known to play a significant role in deaths and injuries involving medical devices, security-related failures are still drenched in ambiguity. So how should we respond to cyber security risks?

This interactive pre-summit workshop will present recent case studies involving security breaches in healthcare in order to highlight the level of threat at hand leading into a discussion over what actions, strategies, and methodologies can be put in place when confronting security risks as a medical device manufacturer.

How You Will Benefit:

From identifying risks to running tests, the measures taken and needed with regards to patient privacy privacy are vast. This session will not only push the importance of software cybersecurity but also present pragmatic strategies when:

· Identifying risks and hazards associated with medical devices

· Implementing appropriate mitigations in place to assure proper device performance

· Approving operating system security patches through validation testing

Raymond P. Strucker Special Agent, Sr. Operations Manager, CDRH, CBER FDA - Office of Criminal Investigations Headquarters

9:30am End of Master Class A

9:15am Main Summit Registration & Networking Breakfast for Main Summit Attendees

10:00am Day One Opening Remarks & Chairman’s Welcome

10:15am The Future of Medical Design Through User Experience

By exploring the importance of Human Factors and User Experience when designing for today’s medical devices; you stand to provide not only a sea-change in perspective internally – but additional value in the long-run. This session will explore the meaning of both Human Factors and User Experience Design and what value they can provide, how the FDA is implicated and a case study on critical tasks and validating the design. Hear from Jason Farnan the Senior UX Designer for Tandem Diabetes to garner additional perspective on the issues highlighted above and much more!

· Intro on Tandem Diabetes Care, Software and UX

· What is Human Factors and User Experience Design?

· Why is the FDA concerned?

· The challenge of designing a user interface in the medical field

· Tandem’s Human Factors Process

· Making it look cool and not like a medical device

· Making it safe and FDA compliant

· Making it intuitive and easy to use

· Case study on critical tasks and validating the design

· Designing for the future

· Adaptive Design

· Form and Function Design

· Internal Visibility

· & More!

Jason Farnan Sr. UX Designer Tandem Diabetes

11:15am Morning Networking Break

11:45am Delivering on Next-Generation Healthcare Diving into examples from Cardiology as well as Radiology, High

Acuity, & Ambulatory Settings, this session will offer insight into GE Healthcare’s Next-Generation Solutions. Two of GE’s finest, Mr. Evren Eryurek & Mr. Don Woodlock, will cover the adoption of software & analytics into business segments, agile & lean methodologies, and enterprise-wide platform integration, offering the audience informative insight into future enterprise methodologies and the latest innovations in healthcare.

· Adopting software and analytics into business segments to drive customer productivity and improve diagnostic confidence with all products

· Exploring Agile and Lean Startup approaches that have been adopted to allow GE’s businesses to be more agile and launch new innovate products at a faster pace

· Addressing the Industrial Internet, GE’s belief that ‘Every industrial company will become a software company” and how GE is transforming itself to a software and analytics company

· Walking through GE Healthcare’s platform and technology strategy, Predix for Healthcare, and understanding how they are transforming their solutions from devices to software to better enable customer outcomes.

Don Woodlock SVP & GM, Cardiology IT GE Healthcare

Chris Larkin CTO GE Healthcare

1:00pm Networking Luncheon

Main Conference Day OneMonday, May 11th, 2015

A

OUR EXECUTIVE KEYNOTES ARE BACK to dig a little deeper into GE Next-Gen!

“Great talk on Agile from Don Woodlock at GE. Very informative,” - Software Engineer at CareStream Health


2:00pm Improving Verification & Validation through Automated Testing Processes

Exploring various aspects of testing and validation, this session will dive into how these processes can be improved throughout the development process and ensure optimal quality.

· Automation testing practices within the software design process

· Implementing Test Process Improvement (TPI) methodology to achieve a continuous improvement in software design, verification and validation processes

· Measurement techniques that can be used to show the level of software quality within the design process

· Implementing software verification and validation processes within an agile based development project

Vasudev Nambakam Principal Engineer/ Architect Stryker

2:45pm Afternoon Networking Break

3:45pm Taking a Closer Look at the Development Cycle through the Lens of Human Factors Techniques

The FDA’s draft guidance on Human Factors and IEC 62366 make it clear that the governing bodies around the world understand that working with and understanding your users is a process that has to happen throughout the development cycle. Yet many companies are still unsure how to incorporate these activities into their development process. This session will explain a few Human Factors tools and techniques and when to include them into the development cycle. It will go through some of the how to’s, best practices, and lessons learned based on recent FDA submissions where usability engineering was part of the process.

4:30pm End of Main Summit Day One

“Very dynamic speakers!” – Configuration Management

Architect at GE Healthcare

“Very insightful sessions” – Software Engineering Manager at

Daktari Diagnostics

“Excellent presentations, speakers, & workshops! Great size for meeting people & speakers.”

– President of Amaxo

Day One Continued

Did You Know?

500 million smartphone users, worldwide, will be using a health care application app by 2015

8% of medical device failures are due to

software flaws

7 out of 10 of the TOP Medical Device Companies are

U.S. based

Sources: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf, Drivers Behind the Biomed Software Industry


7:30am Registration for Master Class B & Networking Breakfast

8:00am MASTER CLASS B: IEC 62304 Compliance: Ensuring Software Quality Requirements through Lightweight Documentation & Controls

With consistent evolutions to quality standards and regulations, it is important to fully comprehend the criteria for compliance in order to ensure the functional safety of your medical devices. However, the obstacles faced when aligning safety with a robust software design can prove challenging. This interactive master class will lead the audience through discussions based around optimizing quality assurance and compliance.

What You Will Learn:

· Covering updates in safety standards, expectations, and requirements

· Ensuring operations requirements and weighing the benefits of internal tool kits wit assistance from third-party solution providers

· Reviewing all necessary documentation for the validation of embedded software components

· Assessing data management and qualification requirements

· Presenting test cases, procedures and results with supporting documentation

How You Will Benefit:

· Understanding overall risk management strategies that begin at the start of the design and development stages

· Assessing best practices and techniques in order to maintain regulatory standards while ensuring safety and efficiency

· Learning how to verify safety effectiveness and protocols

9:30am End of Master Class B

Interested in sponsoring this Master Class? Don’t let your competition get ahead of you – secure your sponsorship opportunity by contacting [email protected] at 212-885-2693.

9:15am Main Summit Registration & Networking Breakfast for Main Summit Attendees

10:00am Day Two Opening Remarks & Chairman’s Recap

10:15am Knowledge Based Decision Support: Distributed Rapid Learning & Clinical Decision Support for Oncology

In this session Gunther will show how using Distributed Rapid Learning enables clinical researchers around the world to define and validate models against large data sets with the goal to provide evidence based clinical decision support. Gunther will highlight the current problems in leveraging big data to run machine learning algorithms on clinical (oncology) data with the goal to establish, evidence based, clinical decision support and how to overcome those problems.

The talk is based on Varian’s experience of multiple projects which are deployed in 7 cancer center hospitals around the world and growing….

Gunther Lenz Director of OCS Technology Office Varian Medical Systems

11:15am Exploring Security Challenges for Medical Device and Diagnostics

Data security should be a priority for every business, to protect their trade secrets and employee and customer data. Often medical device and diagnostics companies have an additional layer of processing Protected Health Information (PHI) for their customers or clinical trial participants. A risk based approach to comprehensive data security preparedness will be discussed. HIPAA data security requirements for both small startups and large corporations will be reviewed. If you have ever wondered if you have done enough to protect the data that is vital to your business, this talk is for you.

· HIPAA privacy and security regulations – how to know if they apply to your business

· Data protection – what are the risks?

· Medical Identity Theft

· HIPAA Security Risk Assessment Tool

· Elements for comprehensive data security preparedness– physical, technical and administrative

12:00pm Networking Luncheon

1:00pm Reinventing Healthcare with Big Data, Analytics & the Cloud · What is Big Data in healthcare?

· Cloudy with a chance of High Availability

· Healthcare Analytics – Decision Support Systems and Population Care Management

· Accountable Care/ Meaningful Use regulations reshaping healthcare

· Bringing Mobility, Big Data, Analytics & Cloud together to provide meaningful care and deliver proven outcomes.

Nias Puthenveettil Chief Technology Officer Siemens Healthcare

Main Conference Day TwoTuesday, May 12th, 2015

B

OUR EXECUTIVE KEYNOTE IS BACK to shed light on pragmatic strategies & the benefits of data analytics within healthcare!


1:45pm Balancing Compliance within a Highly-Regulated Environment: Reviewing Electronic Document Management Systems

Speed & Agility, the original drivers of a innovative, successful company, are now are now perceived as the nemesis of regulatory and procedural compliance. As organizations ramp up to meet demand, or roll out new products to market, growing pains and compliance risks are magnified. Examine real world case studies from selection process, to implementation, and results in order to discuss:

· Applying agile methodologies to R&D to enable organizations to foster innovation while introducing new rigorous processes

· Reviewing the key criteria for Electronic Document

· Management Systems (EDMS) to leverage the technology needed to build-in and automatically demonstrate compliance

2:30pm Afternoon Networking Break

3:00pm Balancing Compliance within a Highly-Regulated Environment: Reviewing Electronic Document Management Systems

Speed & Agility, the original drivers of a innovative, successful company, are now are now perceived as the nemesis of regulatory and procedural compliance. As organizations ramp up to meet demand, or roll out new products to market, growing pains and compliance risks are magnified.

Examine real world case studies from selection process, to implementation, and results in order to discuss:

· Applying agile methodologies to R&D to enable organizations to foster innovation while introducing new rigorous processes

· Reviewing the key criteria for Electronic Document Management Systems (EDMS) to leverage the technology needed to build-in and automatically demonstrate compliance

· Comparing change management processes and how to determine the one that best aligns with your business needs

· Assessing best practices for organizing and migrating document storage from hard copies into an EDMS

Have an idea for a session? Have an incredible Case Study to share? Contact Sloan Mana for the opportunity to participate in the summit this May 2015 in San Francisco! [email protected]

3:45pm Improving Communication & Business Collaboration across Medical Device Departments

Explore case-by-case experiences on how the Medtronic team works together across departments, how they collaborate with each other throughout the design, development, and testing processes.

Eric Maass Engineering Director & Sr. Master Black Belt Medtronic

4:45pm End of Main Summit

Day Two Continued

“The way the conference engaged the sponsors & attendees was very well done.”

– EVP, Interoperability R&D at the Center for Medical Interoperability

“Great opportunity to learn from others and address various challenges by hearing how various companies implement & regulate software processes.”

– Sr. Manager, Regulatory Affairs at APTIV Solutions

Event sponsorship is an excellent opportunity for your company to showcase its products and services to senior level, targeted decision-makers attending IQPC’s 19th Software Design for Medical Devices Summit. IQPC and Pharma IQ help companies like yours achieve important sales, marketing and branding objectives by setting aside a limited number of event sponsorships – all of which are tailored to assist your organization in creating a platform to maximize its exposure at the event.

Don’t let your competition get ahead of you – secure your sponsorship opportunity by calling Eric Pompei at 212-885-2693 or email [email protected].

Sponsorship and Opportunities:

Hear from the Medtronic Team!

Payal Bhavsar Software Engineer Medtronic


Register Online, by Email, Phone, Fax or Mail

End User Pricing (Medical Device Manufacturers):

Web: www.SDMDConference.com

Email: [email protected]

Phone: 1.800.882.8684 or 1-646-378-6026

Fax: 646-378-6025, 24 hours a day

Mail: IQPC 535 5th Avenue, 8th Floor New York, NY 10017

Please note:• All ‘Early Bird’ discounts require payment at time of registration and before the cut-off date in order to receive any discount.• Any discounts offered (including team discounts) must also require payment at the time of registration.• All discount offers cannot be combined with any other offer.• Please view our registration policy for full information about payment, cancellation, postponement, substitution and discounts.• Please note multiple discounts cannot be combined.A $99 processing charge will be assessed to all registrations not accompanied by credit card payment at the time of registration.

MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC * CT residents or people employed in the state of CT must add 6.35% sales tax.

Team Discounts: For information on team discounts, please contact IQPC Customer Service at 1-800-882-8684. Only one discount may be applied per registrant.Special Discounts Available: A limited number of discounts are available for the non-profit sector, government organizations and academia. For more information, please contact customer service at 1-800-882-8684.

Details for making payment via EFT or wire transfer: Bank Name: JP Morgan Chase & Co. Name on Account: Penton Learning Systems LLC dba IQPC Account #: 937-332641 ABA/Routing #: 021000021Reference: IQPC: 10364.014

Payment Policy: Payment is due in full at the time of registration and includes lunches and refreshment. Your registration will not be confirmed until payment is received and may be subject to cancellation.For IQPC’s Cancellation, Postponement and Substitution Policy, please visit www.iqpc.com/cancellation

Special Dietary Needs: If you have a dietary restriction, please contact Customer Service at 1-800-882-8684 to discuss your specific needs.

©2014 IQPC. All Rights Reserved. The format, design, content and arrangement of this brochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable under the Lanham Act and common law principles

Location & Lodging Information

This event will be held in San Francisco, CA. As soon as a specific venue is confirmed we will post the information online. If you would like to be notified via email as soon as the information becomes availableplease email [email protected] with the following in the subject line: “Software Design for Medical Devices”

Package Register & Pay byApril 10th, 2015

Standard Price

Conference Only Save $200$1,799

$1,999

All-Access: Includes Main Conference & 2 Workshops Save $200$2,799

$2,999

Individual Master Classes $549 each

Package Register & Pay byApril 10th, 2015

Standard Price

Conference Only Save $400$2,599

$2,999

All-Access: Includes Main Conference & 2 Workshops Save $400$3,599

$3,999

Individual Master Classes $549 each

Branding Pass – Only 5 Passes Available Includes:

· 1x 3 Day All-Access Pass · Company Logo on event website · 50 word company or product description on event website

$4,499

Networking Pass – Only 5 Passes Available Includes: · 1x 3 Day All-Access Pass · Company Logo on event website · 50 word company or product description on event website · Small table to demonstrate product or service to all event attendees*

$5,499

Team Discounts*

* Discounts apply to registrations submitted together, at the same time. It is charged on the standard pricing and cannot be combined with any other discount.

Number of Attendees Savings

2 to 3 15%

5 or more 25%

Pricing & Registration

Vendor Pricing (Software Developers, Software Solutions, Consultants, Risk Management, Inventory & Supply Chain Management, PLM/ALM Companies):

to shed light on pragmatic strategies & the benefits of data analytics within healthcare!

Stay Up to Date!

Pharma IQ- Medical Devices & Diagnosis

Time: your time is your most valuable commodity, so we bring you only the most essential conferences, the most value-adding speakers and the most business-critical issues for discussion.

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strike the balance between innovation & regulation by driving … · 2017-05-09 · the medical...

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