New Harbor SQA - Services: Events

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December 16, 2010, Software Development for Medical Devices: Managing Software Risk on the Road to FDA Compliance

As an accepted standard for the safe design and development of medical device software, IEC 62304 prescribes a set of processes, activities and information that, if followed, will support FDA compliance. To be compliant, manufacturers must make sure that their software lifecycle is supported by a solid quality and risk management strategy.

At this seminar, medical device software professionals will learn how to:
- Minimize the impact of IEC 62304 on the software development process.
- Use static analysis and unit testing to decrease risk and comply with the FDA.
- Lower costs, boost productivity and output top-notch software for medical devices.

Location: Forefront Center, 404 Wyman Street, Waltham MA 02451.

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December 3, 2010, North Shore Technology Council First Friday Bioscience Series Presents: Helicos BioSciences – From Research Tools to Diagnostics and Back

Join scientists and executives from local biomedical companies at the Office of McLane Law Firm, 128 TradeCenter in Woburn, MA for the North Shore Technology Council's First Friday Bioscience seminar series, sponsored by the Biomedical Technology Section. It's an informal gathering where you'll meet industry peers, learn the science behind local biomedical companies, and hear how they tackle business challenges.

Speaker Avak Kahvejian, Ph.D. (Vice President, Business Development, Helicos^® BioSciences Corporation) earned his PhD on messenger RNA translation mechanisms in the laboratory of Professor Nahum Sonenberg at McGill University. He joined Helicos Biosciences in 2004 as a Business Development Associate, working with the CEO and co-founder Stanley Lapidus to identify target customers and applications for the world's first single molecule sequencing system, the Helicos Genetic Analysis System. Avak's current focus is on fostering strategic partnerships in the areas of high-throughput sequencing and diagnostics.

Location: Offices of McLane Law Firm, 300 Route 128 Trade Center, Suite 600, Woburn, MA.

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December 1, 2010, MassMEDIC Annual End-of-Year Program on FDA Regulatory News and Policies

Join us for our annual end-of-the-year program on FDA regulatory news and policies. This year's keynote speaker will be Dr. Jeffrey Shuren, Director of the Center for Device and Radiological Health. Our day-long program will also feature presentations on:
- New England District Office News
- Changes at FDA & on Capitol Hill
- 510(k) Strategies
- EU Update
- What's new with 21 CFR Part 11
- Project Management Workshop
Location: Massachusetts Medical Society, 860 Winter Street, Waltham, MA.

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November 30, 2010, BEACON Alliance 10th Anniversary Celebration

Make plans to join us on Tuesday, November 30th for the BEACON 10th Anniversary Event! Soft music will set the mood as you enter the cash bar reception where you will meet old friends and make new ones. This "BEACON MEET & GREET" networking event, which is normally open to members only, is available to everyone attending the dinner. A family style dinner will be served after welcoming remarks by BEACON's Founder and President, Joseph Bronzino. After dinner our two keynote speakers will present during dessert featuring the BEACON Birthday Cake!

This year the BEACON Medical Technology Award will be given at the 10th Anniversary Celebration. The criterion for this annual award is: The BEACON Medical Technology Award is presented to an individual or organization/corporation in recognition of significant advancement in the development, commercialization and/or manufacturing of new medical technology. Past recipients have included Inframat Corporation; Genomas; Saint Francis Hospital & Medical Center; Soft Tissue Regeneration and Hospital of Central Connecticut. Candidates for this award are presently under review. This year's winner will be announced soon.

Location: Maneeley's Banquet Center, 65 Rye Street, South Windsor, CT 06074.

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November 10, 2010, MDG Medical Software SIG Presents – Embedded Design and Development for Medical Applications

As medical-device manufacturers concentrate their efforts on portability, wireless connectivity, home health, safety, data security, quality/reliability and low cost, they are moving rapidly toward embedded software implementations. At the same time, major suppliers in this area are offering more robust products, tools and services to support embedded development.

Although the lifecycle for embedded software development is very similar to that of conventional software, it differs in a few crucial aspects. Efficiency is much more of an issue, since the software is much "closer" to the hardware than conventional software operating on a general purpose computer. As well, real-time processing often imposes serious constraints.

Our speakers will discuss several key considerations for developers in embedded-software work, such as:
- Architecture alternatives for medical device development: features, benefits, and shortcomings
- Real-time operating systems and related products
- Hardware and software integration, along with development, emulation and testing tools
- Industry trends in both hardware and software
Bring plenty of business cards, your experience and interesting questions!

SIG Founders
Tony Raymond, New Harbor SQA – tonyraymond@newharborsqa.com
Brian Shoemaker, ShoeBar Associates – bshoemaker@shoebarassoc.com

Location: Padanarum Room, Reservoir Place, 1601 Trapelo Road, Waltham, MA 01451

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November 3, 2010, MDG November Forum – Clinical Trial Design and Management in an Evolving Regulatory Environment

Synopsis
This event addresses important recent changes in FDA expectations on clinical trial requirements towards regulatory approval. Presentations will cover the fundamentals, benefits, and challenges of Bayesian statistics; the clinical/regulatory landscape and challenges that face CAD device manufacturers; potential changes in the FDA 510(k) clearance process; and the impact of Comparative Effectiveness Research and Health Technology Assessments on reimbursement.

Moderator
Nandini Murthy, Principal, Regulatory Consultant, ENEM Consulting LLC

Cutoff for preregistration is 8 PM the evening before the event.

Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham MA 02451-1436

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October 28, 2010, Mass High Tech Presents it's All-Star Awards and Network Reception

Join Mass High Tech to honor our 2010 All-Stars, influential and dynamic leaders from across New England's innovation economy. This annual event is one of the best networking opportunities of the year, providing a unique venue where you can connect with the leaders of the region's most innovative companies.

For event questions please contact Amy Patten, at apatten@masshightech.com.

If you are a student and would like financial assistance to attend our events, please visit http://www.stayinma.com.

Advance registration and payment are required for all events. Please note that once you register, you have purchased a non-refundable ticket.

MDG Members receive a special discount on entering an MDG-only registration code. To obtain the code, click here and log in, then open this calendar item again.

Location: Intercontinental Hotel, 510 Atlantic Avenue, Boston, MA 02210

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October 18, 2010, 2010 Life Sciences Summit

Keynote Speaker
Professor Aaron Ciechanover, the 2004 Nobel Prize Laureate

Israel is a global leader in innovation and entrepreneurship, with numerous New England organizations already engaged in business relationships, scientific collaborations, and investments with their Israeli counterparts.

The 2010 Summit is the premier event in New England, offering a unique view of the quality, innovation and potential of the Israeli life science industry, as represented by a delegation of some of the most promising Israeli pharma, biotech and device companies, who are in advanced clinical stage or already selling their products, and are looking to expand collaborations with local organizations.

Location: International Business School, Brandeis University

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October 13, 2010, MDG Medical Software SIG Presents – Software Quality Assurance (SQA) Fundamentals

For some organizations, quality assurance seems like such an alien concept when applied to software, yet FDA requires evidence of following it: best practice and industry standards for software development and testing. (Note the FDA is not the only regulatory body to expect such proof!) Of course compliance is required, but we need to look beyond the agency's expectations to understand how quality can be a benefit to your business. Then, too, there's the issue of regulations and standards: FDA 21 CFR - GPSV – IEC 62304 – IEEE standards – IEC 600601-1-4 – ISO 14971 – and all the other bits in the alphabet soup.

Join Tony Raymond and Brian Shoemaker as they present a basic overview of software QA, put it in the framework of medical product development and testing, and bring in the important standards and regulations where they apply.

Make sure to bring plenty of your own examples and questions to share!

Moderators
Tony Raymond, New Harbor SQA – tonyraymond@newharborsqa.com
Brian Shoemaker, ShoeBar Associates – bshoemaker@shoebarassoc.com

Location: Reservoir Place, 1601 Trapelo Road, Waltham, MA

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October 12, 2010, Celebrating 20 Years of Success – Opportunities in Healthcare

The healthcare industry is undergoing a technology revolution as it struggles to process, manage and share information with patients, doctors and other healthcare providers, researchers, institutions, insurers, and government policy makers. Keynote speaker Robert Havasy will address today's opportunities and challenges facing entrepreneurs in healthcare IT.

Case Presentation
MedMinders Systems, Inc.

MedMinders Systems' flagship product, known as Maya, addresses the need for patient compliance in taking their prescribed medications by leasing a pill container consisting of 28 monitored wells. The case will be presented by Founder and CEO Eran Shavelsky, he has held leadership roles at Iscar, Sheer Networks and CentrePath, each of which were ultimately acquired.

Location: WPI Campus Center – Odeum, 3^rd Floor

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September 22, 2010, Massachusetts Medical Society Presents: Product Launch Strategies for MedTech Companies

In an increasingly competitive marketplace, medical device companies must execute all phases of a product launch flawlessly. In doing so, MedTech firms must navigate a maze of regulatory and payment obstacles from the "fuzzy front end" through market introduction.

This extended morning seminar examines all of the critical elements of a winning medical device launch, offers industry case studies and expert advice on winning strategies.

8:00 AM	Registration/Continental Breakfast/Networking
8:30 AM	Welcome and Introduction Tom Sommer, MassMEDIC President
8:45 AM	Taking Control of Your Fuzzy Front End Sanjeev Wadhwani, Project Management Consultant
9:45 AM	Break
10:00 AM	Putting Your Best Foot Forward for Launch Susan Posner, Vice President, Health Advances
11:00 AM	The Toddler's Guide to Marketing Molecular Diagnostics Deborah Lotterman, EVP Creative Director Jim Dowd, Senior Brand Planner
12:00 PM	Luncheon – Breakthrough Product Launches: The Formula for Success Guest Speaker: Joan Schneider, Author of The New Launch Plan – 152 Tips, Tactics, and Trends from the Most Memorable New Products

Location: Massachusetts Medical Society, 860 Winter Street, Waltham, MA

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September 21, 2010, Boston Business Alliance: "Asking for Success by Forming an Advisory Board" Why Now is the Right Time"

Many business owners can benefit from having a dedicated group of advisors that convenes regularly. For an advisory board to have maximum value, it must be comprised of the right people, structured to allow it to function most effectively to help meet their business challenges. In this interactive session, participants will learn what an advisory board is, and the steps to form their own advisory board when they are ready. Participants will evaluate the strengths and weaknesses of their organization and develop a draft of their business vision in preparation for attracting prospective advisors.

Speaker, Susan C. Hammond, Principal, scHammond Advisors (www.schammond.com), works with business owners and CEOs of small to mid-size companies and non-profit organizations on the formation and facilitation of advisory boards, ways to enhance CEO financial intelligence, and non-profit governance.

Location: Suffolk University, Sawyer Business School, Amenities Conference Room (1st Floor), 75 Tremont Street, Boston, MA

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September 14, 2010, WPI Venture Forum: Success Stories and Lessons Learned

Keynote speaker, Greg Bialecki, Massachusetts Secretary of Economic Development, will offer a current view of the growth prospects for the Massachusetts technology and biotech economy. He will offer his answer to the vital question: given its past history, how and when will the Massachusetts economy innovate and grow its way out of the current economic downturn?

Case Presentation: In an abbreviated case presentation format, several entrepreneurs who have presented in the past will share some of their experiences and the lessons learned.

Location: WPI Campus Center – Odeum, 100 Institute Road, Worcester, MA

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September 13, 2010, The FDA, the Internet & Social Media: Regulatory Issues and Evolving Policy

The social media phenomenon is changing the way people connect, but not just for social purposes. In addition to catching up with your high school chums, it is becoming a powerful tool for marketing, monitoring, and directing consumer behavior. The life sciences industries are no exception, and in many ways stand to benefit far more from this communication tool than companies like Starbucks that already have daily face-to-face contact with their customers.

As FDA scrambles to figure out how to regulate a low-level marketing associate at a drug, med device or other life sciences company who tweets about a product on his personal account, companies are faced with the even greater challenge of implementing policies and procedures company-wide that both protect the company and ensure the benefits of the new media.

Before making any decisions it is worth playing with this technology in a (semi) controlled environment – and this is the goal of this highly interactive session. It will be lead by David Crosbie, CTO at RedEngage - a company focused on social media solutions for companies in regulated industries.

There will be two intertwined overlapping sessions – one online and the other in the room. Please bring your laptop or smartphone – and make sure that you have signed up for a Twitter account!

Cutoff for preregistration is 8 PM the evening before the event.

Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, MA

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August 18, 2010, Getting Into the Medical Device Industry

The Medical Device Industry is alive, well, and growing in Massachusetts. Many people have identified the industry as a target for their own career progression. One of MDG objectives is to provide assistance to individuals that wish to pursue a career in the Medical Device Industry. At our next networking seminar, we will hear an industry overview from a leading venture capitalist who invests in medical device companies, an individual who has made a recent transition into the industry, and an industry veteran who will share some learnings from his vast experience starting out at a community hospital in Pennsylvania.

Geoff Pardo Partner,
Spray Ventures
President & CEO, Facet Solutions

Geoff Pardo brings years of medical device industry experience to Facet Solutions that encompasses work on the operating side of the business, as well as significant Venture Capital experience. While at Synthes, he championed the introduction of a novel bone graft substitute for cranio-maxillofacial applications. As a venture capital investor at Cardinal Partners and Spray Venture Partners, he has managed investments in areas of ophthalmology, urology, cardiovascular, and orthopedics. Additionally, Mr. Pardo has served on the board of numerous medical device companies, serving interim management roles at Highgate Orthopedics and Cascade Opthalmics. He has also co-founded start-ups including Interlace, TearScience, and Cascade Ophthalmics. Geoff has a B.A. with honors in History from Brown University and an M.B.A. from the Wharton School of Business.

Walter G. Christensen
Senior Vice President, Global Sales
Neurometrix, Inc.

Mr. Christensen brings over 30 years of experience in global, national, and regional sales leadership for small and large multi-national medical device companies. In addition, Mr. Christensen has been involved in creating, expanding, and reorganizing multi-national field sales network operations including direct and indirect sales staff. Prior to joining NeuroMetrix, Mr. Christensen was the Senior Vice President of Global Sales at Stereotaxis, Inc. At Stereotaxis he created sales and business network strategies that established market share in Asia, Europe, and the United States. Prior to Stereotaxis Mr. Christensen was Vice President, mid America zone at Philips Medical Systems. At Philips Medical Systems he created and expanded a successful U.S. sales operation that integrated the use of field sales personnel and a large dealer organization. Previously, Mr. Christensen served as General Manager at General Electric Medical Systems where he was responsible for the Nuclear/PET Division in North and South America. Mr. Christensen received his degree in business administration from Harrisburg Community College, Harrisburg, PA and his Radiology Technology Certification from Holy Spirit Hospital, Camp Hill, PA.

Location: Rebecca's Café, 275 Grove Street, Newton (Auburndale), MA – Adjacent to Riverside T Stop

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August 17, 2010, Plan Time To Plan

You've heard the adage, "If you fail to plan, you're planning to fail." In reality, 80% of all businesses never plan effectively. In this practical interactive session, participants will be challenged to plan ahead to avoid pitfalls and help ensure success.

In this presentation, you will learn:
- A simple, low-cost approach to strategic planning.
- When to do long-term strategic planning.
- Which two pieces of your plan must agree.
- The difference between a 3-year plan, 12-month goals, and 90-day action plans.
- What to look for in reviewing your financials.
- How to create your own 18-month implementation plan.

Speaker Kerri Salls of Breakthrough Enterprise LLC is a productivity and business process authority who helps high-achieving business owners establish a strong foundation of systems, processes, and productivity to focus on their most valuable activities.

Location: Courtyard Boston Woburn/North, 700 Unicorn Park Drive, Woburn, MA 01801

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August 10, 2010, How To Win SBIR Awards Presented by Worcester Polytechnic Collaborative for Entrepreneurship and Innovation

John Davis, General Manager of SBIR Resource Center, will discuss the phases for success in the federal SBIR & STTR programs with primary emphasis on learning to evoke positive responses in application reviewers to garner Phase I awards.
- Learn why SBIR is America's most important source of venture financing.
- Find out why some firms/projects should NOT pursue SBIR/STTR financing.
- Discover how SBIR & STTR proposals should be different and why.
- Be aware of varying agency approaches, proposal, and performance requirements.
- Employ strategies and techniques for developing compelling proposals.
- Understand how to handle cost estimates and develop budget proposals.

Registration is required. Class size limited. Attendee satisfaction is 100% guaranteed.

Location: Worcester Polytechnic Institute – Campus Center, Hagglund Room, 3^rd Floor

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June 30, 2010, New Group Forming for Healthcare Innovators

Special discussion led by: Dr. Allan Goroll. You are invited to join other entrepreneurs, healthcare experts, technology leaders, and healthcare innovators from around the region for this free event. At this unique evening event, Dr. Goroll will provide a briefing on key trends and resources related to healthcare reform and stimulus legislation, and the organizing team will introduce a new initiative: the Collaborative Care Technology Working Group, scheduled to commence activities in September 2010.

Location: IBM Innovation Center, 404 Wyman Street, Waltham, MA 02454

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June 29, 2010, Medical Compliance in a Box Seminar

Intertek's "Medical Compliance In A Box" seminars are informative two-day seminars that will help you navigate the market-entry requirements for your medical device in North America and the European Union.

Location: Intertek, 70 Codman Hill Road, Boxborough, MA

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June 28, 2010, Biomedical Engineering-Physician Collaboration: A Key Resource for Innovation

Innovation can take place in many scenarios, but in the greater Boston area, many early stage concepts are formed and evaluated at the interface between biomedical engineers and physician-scientists. The Biomedical Engineering Professional Chapter of Greater Boston will discuss this key resource for biomedical innovation during this Forum.

Location: Boston University Photonics Center, 8 St. Mary Street, The Colloquium Room, 9^th Floor

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May 26, 2010, MDG Medical Software SIG Presents: Risk Management in Software Development

Ever since the Therac-25 killed several cancer patients in the 1980's, FDA has been aware of the hazards present in software for medical applications. Our speaker will provide a high-level overview of risk management in the software lifecycle, with reference to the risk management standard (ISO 14971) and the AAMI Technical Information Report 32 Medical Device Software Risk Management

How does your team analyze and manage software-related risks? How do you ensure these risks are revisited in the course of a project? Do you use FTA, FMEA, FMECA, or other formal risk assessment techniques? What about off-the-shelf software and programmable chips?

Come prepared with examples of what has worked well, and questions for your colleagues.

Presenters:
Todd R. Konieczny, Staff Engineer, Safety, Intertek
Chas Burr, SM MBA, Graduate Program Director, Health Product Regulation, Regis College

SIG Co-Founders:
Tony Raymond, New Harbor SQA – tonyraymond@newharborsqa.com
Brian Shoemaker, ShoeBar Associates – bshoemaker@shoebarassoc.com

Location: Reservoir Place, 1601 Trapelo Road, Waltham, MA

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May 24 - 26, 2010, 13^th Software Design for Medical Devices

Help your development teams facilitate successful, strategic plans for developing effective software that will save you time and money by attending the 13^th Software Design for Medical Devices. Benefit from industry leaders presenting on successful FDA 510(k) submissions and resolutions to changes in the Medical Device Directive.

Location: The Westgate Hotel, San Diego, CA

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May 19, 2010, Product Liability for Device Manufacturers: Limiting Your Exposure

Medical device manufacturers need to understand the legal and financial risks posed by a complex and evolving product liability framework. Our speaker, Gwyn Williams, a leading medical product liability attorney, will provide an overview of the critical liability issues currently facing device companies in light of recent court decisions and Congressional initiatives.

Location: Rebecca's Café, 275 Grove Street, Newton (Auburndale), MA – adjacent to Riverside T Stop

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April 21-22, 2010, BIOMEDevice Forum

Join us for the third annual BIOMEDevice Executive Forum as we focus on convergence and cross-sector collaborations among biotechnology, medical device, IVD, and pharmaceutical companies. This two-day conference will provide you with the resources you need to strengthen connections between key stakeholders involved in investing, partnering, licensing, and developing business opportunities in the rapidly growing market for innovative healthcare products.

Topics addressed at this year's Forum will include:
- Regulatory & Reimbursement Issues
- Partnering & Collaborations
- Intellectual Property & Finance
- Technology & Innovation
Location: Boston Convention & Exhibition Center, Boston, MA

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April 20, 2010, Bio-IT World Conference & Expo ’10 – Enabling Technology. Leveraging Data.
Transforming Medicine

KEYNOTE PANEL:
The Future of Personal Genomics
A special plenary panel discussion featuring:
James Heywood, Co-founder and Chairman, PatientsLikeMe
Dan Vorhaus, J.D., M.A., Attorney, Robinson, Bradshaw & Hinson; Editor, Genomics Law Report
Dietrich Stephan, Ph.D., President & CEO, Ignite Institute
Kevin Davies, Ph.D., Editor-in-Chief, Bio-IT World

CONCURRENT TRACKS:
Track 1: IT Infrastructure – Hardware - NEW
Track 2: IT Infrastructure – Software - NEW
Track 3: Bioinformatics and Next-Gen Data
Track 4: Systems and Predictive Biology
Track 5: Cheminformatics and Computer-Aided Modeling
Track 6: eClinical Trials Technology
Track 7: eHealth Solutions

Location: World Trade Center, Boston, MA

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April 16, 2010, FDA/CDRH Legislative and Regulatory Update: Product Development in Changing Times with Frozen Budgets

Keynote Speaker:
Mark Leahey, President & CEO Medical Device Manufacturers Association (MDMA)
Mark Leahey is the President & CEO of the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that represents hundreds of innovative medical technology companies. Mr. Leahey's responsibilities include advocating on behalf of the membership before Congress, FDA, CMS and various federal and state agencies.

Location: Holiday Inn, 4 Highwood Drive, Tewksbury, MA 01876

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April 15, 2010, Babson Healthcare and Life Sciences Forum

The current healthcare debate and resulting legislation is a watershed moment for the delivery of care to patients. Old institutions and inefficiencies are being done away with in favor of technological advances that encourage high-touch care and patient empowerment. As occurs during industry turning points, opportunities for entrepreneurs are abundant. Identifying these opportunities and acting on them requires the ability to see and understand the interplay among many seemingly disparate groups.

The forum is set to represent a diverse set of sectors, from suppliers (pharmaceuticals, biotech, and medical devices) to healthcare delivery and services, as well as a broad range of functions, from marketing to business development to investors.

Location: Babson College, 231 Forest Street, Babson Park, MA 02457

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April 14, 2010, “TRI” Our New Technologies

Learn what exciting new medical advances are being developed in the tri-state area: Connecticut, New Hampshire, and Massachusetts.

Location: UMASS Medical Center, Amphitheatre 3, 55 Lake Ave North, Worcester, MA 01655

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March 11, 2010, New England Biomedical Discussion Group Presents, International Compliance: Supporting Global Medical Device Marketing Initiatives Beyond the U.S. Canada & Europe

Learn the necessary compliance requirements and good business practices required to gain approval of your medical device products globally!

Keynote Speaker:
Brad Hossack, Vice President International Regulatory Affairs, Boston Scientific Corporation

Mr Hossack has developed and implemented compliance systems encompassing all regions of the globe. He has successfully established credible relations with regulatory agencies and distributors and has set up direct sales centers in both traditional and emerging markets. Don't miss this opportunity to hear Mr. Hossack share his knowledge on creating a business focused regulatory compliance system that has given his employers a competitive advantage via timely approvals, increased speed to market and increased sales.

This seminar will explore and analyze the regulations, systems and processes necessary to bring products to countries in Latin America, South America, Asia Pacific, Eastern Europe and others. You will walk away with a better understanding of how to navigate these global waters and the questions you need to ask to better assure safe passage.

Location: Conference Center at Waltham Woods, 860 Winter Street, Waltham, MA 02451

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March 9, 2010, WPI Venture Forum, Sales and Selling are a Team Sport

Whether you're a one-person operation or part of a larger sales organization, you never sell alone, according to March WPI Venture Forum keynote speaker John Huck. The principal of WINNING Inc., he will discuss the sales process and specific steps to make that process more efficient and effective for companies of all sizes.

Huck has a strong track record of achievement and success within the technology and financial services industries, having rebuilt a struggling reseller channel for one company and exceeded sales records in another. A successful entrepreneur in his own right, Huck built a financial services firm from the ground up. He draws on more than 20 years of experience to help entrepreneurs and corporate executives break through barriers to sales success. A graduate of St. Lawrence University with a Bachelor of Arts in Economics, he earned membership into the International Economic Honorary.

Location: WPI – Worcester Campus, Campus Center – Odeum Room

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March 3, 2010, MDG March 2010 Forum, Neonates to Nonagenarians: Critical Unmet Needs of
Special Patients

Despite numerous initiatives such as Patient Centered Medical Home and Neonatal Intensive Care Unit of the Future plus media and government focus on problems and costs of healthcare delivery, infants and late-life adults remain under-served patients populations.

The two populations are excluded from clinical trials due to vulnerability and regulatory concern for the frailty, sensory neurological limitations, and susceptibility of the patients. It is also a reality, however, that there are not enough financial incentives for medical manufacturers to develop products to extend the indications specific to these patient populations.

Experts in the field and stakeholders in the business of geriatric medicine, and pediatric products will discuss the realities, important issues, value proposition, and challenges for treatment and prevention that encompass technology innovation, providers, patient quality of life, as well as regulatory and reimbursement.

Moderators:
Robert Burger, CTO and VP Product Development, Proxemics

Panelists:
Dr. Anne Fabiny, Chief of Geriatrics, Cambridge Health Alliance; Assistant Professor of Medicine, Harvard Medical School
Farzad Parsale, COO, Levitronix Saul Shapiro, VP Marketing and Product Development, VoiceFriend LLC
Yuval Malinsky, CEO, Vigorous Mind

Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, MA 02451

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March 1-4, 2010, HiMSS 2010 Health IT Conference

New Harbor SQA will be attending the HiMSS 2010 Health IT Conference in Atlanta on March 1-4, 2010 as the Validation partner to ValuTrack Corporation, along with TEKLYNX International, who will be showcasing the TEKLYNX Life Sciences label management and inventory control solution for FDA regulated industries. Recognized as one of the premier conferences in the healthcare industry, HiMSS expects to bring together 26,000 healthcare professionals across the globe for this annual gathering.

Location:Georgia World Congress Center, Atlanta, GA

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February 24, 2010, MDG Medical Software SIG Presents – Software Outsourcing and Supplier Management

Software development and testing often requires hiring other companies to provide the expertise that your company does not have. If our products are FDA-regulated, however, we’re responsible for ensuring that our vendors and partners follow documented practices as rigorously as we do. What processes do you use to manage these vendors? If you are one of these outsource suppliers, what processes do you use to manage your customers? What particular challenges do you face when managing a software project? What are your favorite tricks for successful team collaboration especially when distributed around the world?

SIG Co-Founders:
Tony Raymond, New Harbor SQA
Brian Shoemaker, ShoeBar Associates

Location: Reservoir Place, 1601 Trapelo Road, Padanarum Room, Waltham, MA

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February 3, 2010, The Interoperability Challenge – Getting Devices to Talk to Each Other

Your bank can text you if your account balance is too low, but a medication pump doesn’t have the feedback technology to prevent an overdose. Our program examines the challenges of making medical devices speak a common "language" so that say, results from a diagnostic device can be immediately transmitted to another vendor's treatment device. You’ll hear the latest in medical device open systems and an update from the Founding Director of the Program on Medical Device Interoperability at CIMIT regarding what’s currently in use clinically. Join us for an evening of “straight talk” about instrument collaboration.

Moderators:
Randy Chinnock, President, Optimum Technologies, Inc.
Rick Rollins, Nova Biomedical

Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, MA

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January 6, 2010, Women’s Health: New Markets, Expanding Opportunities

Join your colleagues to learn about the latest advances in detecting and treating common, and not so common, conditions that impact women’s health. From the latest methods of detecting and treating breast cancer to improving the lives of the 16% of women experiencing incontinence, our clinical specialists and industry leader will speak on ways new device technologies are meeting these ongoing medical challenges. Prepare to be dared to create new devices serving unmet clinical needs in mammography, MRI, and ultrasound.

Moderator:
Jerrold M. Shapiro, Ph.D., President and CEO, Fem-Medical LLC, a Women’s Health Company, Framingham, MA

Panelists:
Janet Baum, M.D., Director of Breast Imaging, Cambridge Breast Center, Cambridge Health Alliance
David Harding, Sr., VP and GM, Interventional Breast Solutions Group, Interventional Radiology, Hologic
Shimon Segal, M.D., F.A.C.O.G., Board-Certified Gynecologist

Event Champion:
Louise Bijk, VP Sale and Marketing, Advanced Media Productions, Natick, MA

Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, MA

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December 10, 2009, Our Current Environment – Emerging Threats and New Security Challenges

Security of biomedical research operations faces evolving challenges and requires adaptive strategies. There continues to be comprehensive physical security needs for plant and personnel. Intellectual property is almost wholly electronic, and protection against cyber-intrusion/cyber-theft is now essential, along with the protection of electronic records containing sensitive personnel, customer, and supplier data. Public companies also must decide how to handle shareholder motions brought by anti-research organizations that have purchased company stock. And hiring, particularly background checking, needs to be conducted in such a way that research staff is protected, as is the research facility itself, against infiltrator employees.

On December 10, 2009, these issues will be addressed at "Our Current Environment: Emerging Threats and New Security Challenges", a day-long professional development workshop offered by The Massachusetts Society for Medical Research. This event will be at the Colonnade Hotel in Boston and is designed for security and facilities professionals, HR and IR officers, and those who manage staffs engaged in sensitive research.

Location: Colonnade Hotel, Boston, MA

(For More Information, Please Click on the Event Title Above.)
December 2, 2009, MassMEDIC Presents: FDA Update

For further information and to register, please visit http://www.massmedic.com/meetings.htm

Location: Massachusetts Medical Society, 860 Winter Street, Waltham, MA 02451

(For More Information, Please Click on the Event Title Above.)
December 1, 2009, MDG Medical Software SIG Presents: Validation of Clinical Trial Software

Software used to collect, create, modify, maintain, archive, retrieve, or transmit clinical trial data and adverse event data falls in a category all its own – crucial for providing statistical input for determining whether a drug or device should be placed on the market. Our speaker will describe the key characteristics of this breed of software, along with trends occurring in standardization and electronic submission, and outline the challenges of validation.

Key background for this discussion will be the FDA guidance Computerized Systems in Clinical Investigations (click title to open the document)

Bring plenty of business cards, your experience and interesting questions!

SIG Founders (click web site links for biographical information):
Tony Raymond, New Harbor SQA, tonyraymond@newharborsqa.com
Brian Shoemaker, ShoeBar Associates, bshoemaker@shoebarassoc.com

Location: Padanarum Room, Reservoir Place, 1601 Trapelo Road, Waltham, MA 02451

(For More Information, Please Click on the Event Title Above.)
November 19, 2009, MIT Enterprise Forum Healthcare and Lifesciences SIG Presents: Drawn to the Dark Side: MDs and Scientists Who Became Entrepreneurs

Come join us for an evening with noted life sciences and healthcare professionals who shed their white coats to become successful entrepreneurs. Hear their stories of how they took their first steps and the lessons they have learned on the road to success, and get inspired to become an entrepreneur!

Location: Harvard Medical School, Medical Education Center, Room #209 (off the Atrium), 260 Longwood Avenue, Boston, MA

(For More Information, Please Click on the Event Title Above.)
October 27, 2009, Software SIG Meeting: Agile Methods

For our October meeting, Camille Bell, a leading Washington area Agile practitioner and coach, will speak on "What you must know about Agility now and why you must know it." Camille will bring her real world experience as a change agent and Agile mentor in government and industry. During her presentation, Camille will cover such topics as:

- Why industry and government is switching to Agile software development.
- General characteristics of Agile processes.
- An overview of leading agile processes: Lean, Scrum, eXtreme Programming.
- Target audience to whom each process sold.
- Why that Agile process appeals most to that audience.
- Some key principles and benefits of each Agile process.
- Some limitations of each Agile process.
- General challenges in adopting Agility.
- Business consequences of failing to adopt Agility.
- What you can do.

(For More Information, Please Click on the Event Title Above.)
October 27, 2009, Medical Product Outsourcing (MPO) Symposium 2009

Medical Product Outsourcing presents an opportunity for you to network, learn, and advance your skills. Medical device manufacturers and suppliers can take part in this interactive conference.

The practice of outsourcing continues to present challenges to medical devices manufacturers. This event is a high-level educational and networking program, designed to offer relevant information for solving business-critical issues in an environment that fosters interaction and industry development.

Click http://www.mposymposium.com/ to register.

Location: Conference Center at Waltham Woods, 860 Winter St, Waltham, MA 02451.

(For More Information, Please Click on the Event Title Above.)
October 26, 2009, New England – Israel Life Sciences Summit

More than 700 companies in Israel are engaged in research and development in the fields of biotechnology, pharmaceuticals, medical devices, and healthcare information technology with approximately 70 new companies formed every year. The New England-Israel Life Sciences Summit will feature a select number of these cutting edge Israeli life sciences companies. The program will include networking opportunities and company presentations, followed by one-on-one meetings with potential research and collaboration partners, and select prospective investors.

Location: Brandeis International Business School, 415 South Street, Waltham, MA 02451.

(For More Information, Please Click on the Event Title Above.)
October 21, 2009, MDG October 2009 Networking: Post-Approval Studies: Maximizing the Value of Clinical Experience

For many people in the medical device industry the term “clinical trials” is most often associated with the trials a company conducts during device development, validation, and as part of obtaining a regulatory clearance.

Additional trials may be conducted in parallel with the FDA review, after a regulatory clearance is issued, and after the device is launched commercially. Such trials may expand the clinical performance data as well as provide evidence on the organizational, financial, and other benefits of integrating a new device in a medical institution.

While these trial results can provide vital information, have a significant impact on the device acceptance by the medical community, and increase its adoption rate, it is crucial to strictly adhere to all the applicable rules and regulations.

This program will provide an overview of clinical trials at various stages following the submission of an application for a regulatory clearance including trial planning, control, identification of data that has to be reported to the FDA, and possible implications for the commercial use of the device.

Format: One 30 minute presentation followed by a moderated Q&A session.

Panelist/Speaker:
Mark Macedo, Director, Clinical Affairs, Levitronix LLC

Co-Champion:
Olga Cherniavsky, Chief Marketing Officer, Corum Medical, Inc.

Location: Rebecca’s Café, 275 Grove Street, Newton (Auburndale), MA – adjacent to Riverside T Stop

(For More Information, Please Click on the Event Title Above.)
October 15, 2009, ASQ NE Biomedical Discussion Group: Complaints and Beyond

Find out what others are doing. Listen to FDA views on the topic. Listen to the Authorized Representative view on complaints in the EU. Learn what experts consider acceptable and unacceptable complaint systems. Integrate complaints, CAPA, and Risk Management.

The ASQ Biomedical Division's New England Discussion Group proudly presents, “Complaints and Beyond” - Spend the day at our conference and hear:

- Karen Archdeacon, Consumer Safety Officer, FDA-ORA NE Field Office
- Dan O’Leary, President, Ombu Enterprises LLC
- Kathy Duke, Nova BioMedical
- Evangeline Loh, Vice President of Regulatory Affairs, Emergo Group
- Claire McKenna, Medical Devices Program Manager, NSAI, Inc
- Susan Reilly, Owner and Principal Consultant, Reilly and Associates
- Chas Burr, Graduate Program Director – Health Product Regulation, Regis College

Only $250, which includes Continental Breakfast, handouts, Lunch, and breaks. Seating is limited – register early and avoid the waiting list. Special discounts for 5 or more registering at one time

Location: Conference Center at Waltham Woods, 860 Winter St, Waltham, MA 02451.

(For More Information, Please Click on the Event Title Above.)
October 7, 2009, MDG October 2009 Forum: Merging Mindsets: Device-Biotech Combination Products

Some of the most medically important and commercially successful products consist of combinations of devices and pharmaceuticals (e.g., drug-eluting stents). Success in this medical development category requires bringing together diverse perspectives and expertise in engineering, materials, biology, chemistry, pharmacology, regulatory affairs, and manufacturing. New technologies are expected to provide more opportunities for such combinations. Three experienced professionals in this area with different perspectives will make presentations that include:

1) A survey of drug-device combinations now being marketed and in the pipeline.
2) Unmet medical needs that could potentially be treated with novel drug-device combinations.
3) The kinds of critical issues that drug-device development teams must understand and address.
4) Case history of successful drug-device product development.

Moderator:
Robert Ezzell, PhD, RAC, Regulatory Affairs Consultant, Medicept Inc, Ashland , MA

Panelists:
Sam Clark, PhD, Principal Scientist, Eisai Corporation, Lexington , MA
Jim Embree, Principal/President, JAGE Biotechnology, Wrentham , MA
William E. Munger, PhD, Biotechnology Consultant and Entrepreneur, Stow , MA (Formerly Executive Director, Technology and Program Management at Curis, Inc., Cambridge , MA )

Event Champion:
William E. Munger, PhD

Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, MA

(For More Information, Please Click on the Event Title Above.)
October 2, 2009, MassMEDIC’s 11th Annual MEDTECH INVESTORS CONFERENCE

Conference Highlights:

- Regional Perspectives on MedTech Entrepreneurialism Panel Discussion
- Presentations from 25 early stage MedTech companies
- Resources for Regional Entrepreneurs Panel Discussion
- Presentation of the 10K Innovative Design Winner
- Luncheon Speaker, Update on National Healthcare Reform PoliciesTony Raym

Conference Agenda

Register -- On-line Here

Location: Conference Center, University of Massachusetts, Boston, MA

(For More Information, Please Click on the Event Title Above.)

September 30, 2009, MDG Medical Software SIG September 2009 Development Lifecycle Roundtable

IEC 62304:2006 Medical device software – Software Life Cycle Processes has been recognized as a consensus standard by the FDA, and recently harmonized by the European Union. Where does your process stand? What kind of development lifecycle does your software group follow? What about it is working well – or what are the challenges you face? Do you struggle with moving customer requirements, priority conflicts, inadequate testing, traceability completion, or risk management? Have you conquered configuration control, product maintenance, defect management or CAPA in ways that you can be proud of?

SIG founders Tony Raymond and Brian Shoemaker will lead a discussion/networking session on these and other lifecycle topics of interest to the audience. Key subjects will be derived from IEC 62304, ISO 14971, and AAMI TIR 32. Come meet your colleagues in the medical software field, and be prepared to share your stories!

Moderators:
Tony Raymond, New Harbor SQA
Brian Shoemaker, ShoeBar Associates

Location: Padanarum Room, Reservoir Place, 1601 Trapelo Road, Waltham, MA

(For More Information, Please Click on the Event Title Above.)
September 24, 2009, WPI Venture Forum Networking Event (Co-promoted by MDG)

Please join WPI Venture Forum and MDG for a networking event at Bionostics Inc., ideally situated in the growing technology community of Devens, MA. Chat with colleagues, meet new people, and take a tour of their facility. Also, participate in a new award winning quality control product end user feedback group. Preregistration required: http://www.wpiventureforum.org/Programs/Events/Bionostics.html.

Location: Bionostics, Inc., 7 Jackson Rd., Devens, MA

(For More Information, Please Click on the Event Title Above.)
September 16, 2009, MDG September 2009 SuperNetworking: Start-up Funding in Hard Times

Synopsis:
Last year’s SuperNetworking event addressed how difficult medical device and diagnostics entrepreneurs had “… securing equity investments despite the fact that investors (VCs, private equity firms, etc.) have large amounts of uncommitted capital.”

What a difference a year makes! This year’s kickoff event addresses the challenges these same entrepreneurs now face, given today’s extremely difficult economic and financing environment. We are pleased to be able to offer attendees perspectives from both the private and public sectors, in what is sure to be an informative evening for medical device entrepreneurs of all stripes.

Moderator:
Christopher Palatucci, PhD, Partner, Palatucci Executive Search, Worcester , MA

Presenters: Chris Velis, Chairman and CEO, Medical Capital Advisors, Woburn , MA
Susan R. Windham-Bannister, PH.D. Massachusetts Life Sciences Center Board of Directors, Waltham, MA

Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, MA

(For More Information, Please Click on the Event Title Above.)
September 10 & 11, 2009, Inaugural Medical Device Connectivity Conference & Exhibition

ABOUT THE CONFERNECE:
"This is the first ever conference devoted to the topic of medical device connectivity, a surprising fact for a market that emerged in the 1980s with diagnostic and critical care applications. Continued pressure to improve patient safety and outcomes, and the adoption of EMRs, are the principal drivers for connectivity today. Connectivity recently became more closely tied to EMR adoption as a requirement of Meaningful Use. In addition to the general scope of connectivity, this conference zeros in on the point of care, whether in the hospital, the patient's home, or anywhere in between."
--Tim Gee, Principal, Medical Connectivity Consulting, Conference Chairperson & Keynote Speaker

Speakers:
Julian M. Goldman, MD, Medical Director of Biomedical Engineering, Partners HealthCare System, Director, CIMIT Program on Interoperability and Medical Device Plug-and-Play Interoperability Program, Massachusetts General Hospital
Stephen L. Grimes, FACCE, FHIMSS, FAIMBE, Vice President, Technology in Medicine, Inc. & Immediate Past President, American College of Clinical Engineering (ACCE)
Rick Hampton, Corporate Manager Wireless Communications, Partners HealthCare System
William A. Hyman, ScD, PE, Professor, Department of Biomedical Engineering, Texas A&M University & President, ACCE Healthcare Technology Foundation
Jason Joseph, Director Clinical Technology & Information Solutions, Spectrum Health
Bridget Moorman, CCE, President, BMoorman Consulting, LLC
Cynthia D. Nichols, PhD, FAASM, CBSM, Principal Investigator, Continuous Monitoring Project, Munson Medical Center Kristen O'Shea, Vice President of Patient Care Services, Gettysburg Hospital, WellSpan Health, Pennsylvania
Chuck Parker, Executive Director, Continua Health Alliance
Steven R. Rakitin, President, Software Quality Consulting & AAMI member

Location: Joseph B. Martin Conference Center, Harvard Medical School, Boston MA

(For More Information, Please Click on the Event Title Above.)
August 19, 2009, MDG August 2009 Networking: Transitioning to a Career in the Medical Devices Industry

Speaker:
Lisa Sasso, MDG Board Member
Past President, MDG

Networking Agenda:
5:30 Registration and informal networking
6:00 Introductions
6:15 Dinner
6:30 Upcoming events & job announcements
6:40 Presentation
7:10 Q&A and continued networking

Program Abstract:
MDG cares about helping people. This annual networking event drew more than 90 attendees last year and focused on recruiters' tips and advice. This year, we would like to have a panel with stories of how current MDG members transferred in. If you want to be involved or have your personal story considered please send an email and resume to lisasasso@comcast.net.Top of Form Come early - our networking meetings are increasingly popular! Registration is onsite only, and is on a first-come first-served basis.

Pricing: MDG Members: $10 Non-Members: $10 First Visit ($20 Subsequently). A meeting fee payable in cash or check (to "MedDev Group, Inc.") will be collected at the door

Location: Rebecca’s Café, 275 Grove Street, Newton (Auburndale) MA – adjacent to Riverside T Stop

(For More Information, Please Click on the Event Title Above.)
July 14, 2009, MDG/ENET Sunset Cruise of Boston Harbor and Networking Evening

Don't be left out!

This year MDG will be joining the Boston Entrepreneurs' Network at their annual summer cruise of Boston Harbor on Mass Baylines' Samuel Clemens, on Tuesday July 14th, 2009. We assemble at 6:45PM and leave at 7:15PM from Rowes Wharf behind Boston Harbor Hotel. We cruise the harbor until 9:30PM though networking sometimes continues dockside until 10:00PM.

We will be cruising on the Mass Bay Lines' M/V Samuel Clemens, a beautifully designed replica of the paddle wheel steamships that once plied the Mississippi in the time of Mark Twain. The main deck is climate controlled for year round comfort.

The cruise will again be catered by Off the Vine who received many compliments for the light dinner menu they served last summer. Don't miss out! MDG space allotment is limited to 40!

Pricing: MDG Members: $30 Non-Members: $45 NOTE: We cannot extend member pricing to Alliance Partners for this special event.

Location: Boston Harbor

(For More Information, Please Click on the Event Title Above.)
July 15, 2009, MDG July 2009 Networking: Risk-based Product Development - Using Design Thinking Processes to Best Manage Development Risks

Speaker:
Scott Stropkay. Partner, Essential, Inc.

Event Champion:
Robert Burger CTO and VP Product Development, Proxemics

Networking Agenda:
5:30 Registration and informal networking
6:00 Introductions
6:15 Dinner
6:30 Upcoming events & job announcements
6:40 Presentation
7:10 Q&A and continued networking

Program Abstract:
FDA and EMEA guidances specify that Design Control processes should incorporate Risk-based Assessment and metrics early and throughout the product development life cycle. Scott Stropkay of Essential-Design will discuss the use of design thinking processes to manage development risks in new product innovation opportunities thereby enabling the introduction of successful medical devices. The speaker’s presentation will draw from examples from Essential-Design’s extensive portfolio of successful medical product introductions.

Join MDG for a discussion of design thinking processes to successfully manage risk in innovation opportunities leading to new product introduction.

Come early - our networking meetings are increasingly popular! Registration is onsite only, and is on a first-come first-served basis.

Pricing: MDG Members: $10 Non-Members: $10 First Visit ($20 Subsequently). A meeting fee payable in cash or check (to "MedDev Group, Inc.") will be collected at the door.

Location: Pizzeria Uno, 287 Washington Street, Newton, MA 02458

(For More Information, Please Click on the Event Title Above.)
July 29, 2009, Wireless Interference in the Clinical Environment

MDG/AVNET Summer Educational Event
Wireless Interference in the Clinical Environment
Wireless Regulatory and Interoperability Update

Technology changes rapidly, but nowhere does it change as rapidly as in healthcare. The convergence of multiple wireless technologies with the need for "better, cheaper, faster" healthcare is driving the evolution of medical devices (along with healthcare in general) in directions and speeds never seen before.

The presentation will discuss the increasing use of wireless communications technologies in healthcare, the benefits, the problems, the obstacles, and the opportunities.

Speakers:
Rick Hampton, Wireless Manager, Partners Healthcare System, Boston, MA
Chuck Parker, Executive Director, Continua Alliance

Registration Fee:
Members - $20 (Prepaid), $30 at the door
NonMembers - $30 (Prepaid), $40 at the door

********************ROOM CAPACITY IS LIMITED********************

Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, MA 02451-1436

(For More Information, Please Click on the Event Title Above.)
June 3, 2009, Tony Raymond to Moderate the MDG June Forum: "Why devices fail... and what you
can do about it."

Panelists:

Paul Nickelsberg, President, Orchid Technologies, Maynard, MA
Chase Sebor, Founder & Partner, Venture Technologies, N. Billerica, MA
Brian Stonecipher, Principal, Human Factors, Continuum, Newton, MA

Moderator:

Tony Raymond, President and Consultant, New Harbor SQA

A successful medical device development process must meet many criteria – perhaps the most critical is reliability.
The varied engineering disciplines that enter into the device development process necessarily use different methodologies to attempt to ensure that their contribution to the process maximizes the reliability of that
component or subsystem. At the June 3rd Forum, attendees will hear from three experienced engineering professionals with three different perspectives on this problem. The panel and attendees will discuss
questions such as:
- When should failure analyses begin?
- How can information from past development processes be incorporated?
- How many different failure analysis methods should be used?
- How does one acquire probability data for failure analysis methods?
- How should failure analyses for different subsystems be combined?
Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, Massachusetts 02451-1436.

Registration Fee: Members $20 (prepaid) or $30 at the door; Nonmembers $30 (prepaid) or $40 at the door.

(Please click title for more Information.)
May 21, 2009, May Software SIG Meeting: "RoleBoldly Going Where Few Have Gone Before -- SCAMPI C Appraisal Using the CMMI Acquisition"

Speaker: Carol Klingler, MITRE.

Time: 6:30PM - Networking and Pizza(*); 7:00 - 8:00PM - Program.

Locations: The meeting will be held at MITRE, Room 1M306, 202 Burlington Road (Route 62), Bedford, MA 01730 using video teleconferencing (VTC). The presentation will originate from MITRE McLean, VA.

Registration: Begins after May 1st.

(*) - There is no cost to attend at McLean & Silver Spring.

(Please click title for more Information.)
May 21, 2009, M2D2 Presentations: "M2D2 Company Showcase and Open House"

UML M2D2 Business Presentations & Cocktail Reception

600 Suffolk Street
Lowell, MA 01854
3:30PM - 8:00PM

Please join us for the twelve new product ideas that will be presented. Posters illustrating two dozen potential new products will also be on display.

For Registration information, e-mail us at M2D2@uml.edu or call Ruth Dubey at 978-934-3499. Registration fee is $10 until Monday, May 18, 2009; after this date registration fee is $20 at the door. Networking (cash bar available) will take place from 6:00PM - 8:00PM.

For more information and agenda, please visit our Presentations page.

(Please click title for more Information.)
May 20, 2009, MDG May Networking: "Creating a Lifetime of Referrals"

Question: What stands between you and your next job or new business opportunity?

Answer: Usually, one or two people who know you and know of the opportunity but have not yet made the connection.

What can you do about it? On May 20th, please join Olga Taylor, Barbara Bix, and your fellow MDGers for "Creating a Lifetime of Referrals" - a highly interactive workshop on recognizing and training your best referral sources.

Location: Pizzeria Uno, 287 Washington Street, Newton, MA 02458.

Time: 5:30PM.

Fee: A meeting fee payable in cash or check ("MedDev Group, Inc.") will be collected at the door on a first come, first serve basis.

(Please click title for more Information.)
MDG May 13, 2009 Forum: "Business Matchmaking Event"

This event will align buyers and sellers with 10 minute, one-on-one meetings in an enjoyable and sociable forum. The 2009 Business Matchmaking event will add practical discussions about how to protect your company from making common IP mistakes in your outsource relationships! The Value Added expanded format will add case studies from industry, business, and legal professionals detailing common outsourcing Intellectual Property ("IP") landmines. Topics covered will include Trade Secret, Patent, Trademark/Branding, Copyright, and Contract issues.

Time: 2:30PM - 9:00PM.

Location: Newton Marriott.

(For more information, please contact Kevin Pelletier at (kpelletier@meddevgroup.org.)

(Please click title for more Information.)
MDG May 6, 2009 Forum: "Trends in Medical Devices M&A - Recent Experiences and Future Expectations."

Moderator: Carol Hempfling Pratt, Partner, Foley Hoag LLP. Panel: Don Haut, PhD, SVP Strategy & Business Development, Smith & Nephew Endoscopy and Daniel Lepanto, Managing Director, Mergers & Acquisitions, Leerink Swann.

Acquisition by a strategic partner has always been a primary exit strategy for entrepreneurs, particularly in the medical device industry, and that is even more true today with the IPO window firmly shut. Understanding the market, and the interests of and the needs of potential acquirers, can increase the odds of a successful acquisition.

Our panel will update you on the trends in the M&A market, provide an "inside view" of the M&A process from an acquirer's perspective, and discuss questions such as the following:
- What is going on in the medical device M&A market, and how has it been impacted by the current economic environment?
- What should you be doing to prepare your company for sale when the opportunity arises? Is there anything you should avoid doing?
- What is the best way - and the best time - to attract the attention of potential strategic partners?
- How do you know what the right price is for your company? How do acquirers determine what they are willing to pay?
- Once you have found a promising potential partner, why does it seem to take so long to complete the deal?

Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, Massachusetts 02451-1436.

Registration Fee: Members $20 (prepaid) or $30 at the door; Nonmembers $30 (prepaid) or $40 at the door.

(Please click title for more Information.)

April 28, 2009 - Tony Raymond to speak on “Software Change Management For Medical Devices” at "BOSCON 2009" to be held at The Conference Center at Waltham Woods, 860 Winter Street, Waltham, MA, on April 28, 2009. Change during the software lifecycle is inevitable. Even with great quality planning changes surface in the requirements, design, testing, and post release activities. Lack of change management in a software project can be frustrating, inefficient to unprofitable, and in medical devices harmful to users or patients. An appropriate software change management process drives communications, decision making, predictability, compliance, product quality, and above all ensures safety and efficacy.
(Click Title for More Information)
March 4, 2009 - MDG March 2009 Forum: "What VCs Want and How They Get It: Assessing, Reducing and Managing Investment Risk". Speaker: Robert Puopolo, Partner, Goodwin Procter, LLP. Despite the gloomy headlines and uncertain economic outlook, this may actually be a good time for entrepreneurs to start new companies and raise venture capital. Recent VC transaction statistics show that the financing market for early-stage start-ups remains surprisingly robust. VCs continue to seek out promising new technologies. which target large markets and address unmet clinical needs. The trick is knowing what matters most to your potential investors and addressing these issues early in the company formation process. Our experienced panel will offer their views on the current environment for venture capital financing and how best to address the needs of these investors. Location: Foley Hoag Emerging Enterprise Center, Bay Colony Corporate Center, 1000 Winter Street, Suite 4000, North Entrance, Waltham, MA 02458.
(Click Title for More Information)