Events
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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
(For More Information, Please Click on the Event Title Above.)
- 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
(For More Information, Please Click on the Event Title Above.)
- 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
(For More Information, Please Click on the Event Title Above.)
- 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
(For More Information, Please Click on the Event Title Above.)
- 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
(For More Information, Please Click on the Event Title Above.)
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Archives
2010
- 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
(For More Information, Please Click on the Event Title Above.)
- 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
(For More Information, Please Click on the Event Title Above.)
- 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
(For More Information, Please Click on the Event Title Above.)
2009
- 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.)
Conference Highlights:
- Regional Perspectives on MedTech Entrepreneurialism Panel Discussion
- Presentations from 25 early stage MedTech companies
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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.
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- 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.
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- 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.
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