Monthly Listing of Events
12/14/11 (W) 12:00 - 1:30 pm
Rochester BioVenture Center, 77 Ridgeland Road, Rochester, NY
Regulatory requirements appear to many to be an endless labyrinth of bureaucracy and can pose significant barriers to market entry for new medical devices. However, companies with an understanding of the FDA and effective approaches to filings and reviews can build strategies for successfully bringing new products to market. Strong regulatory strategies translate to lower product review costs and more predictable commercialization schedules.
In this session you will learn about regulatory strategies, specific steps for filings - both PMA and 510(k), and the impact that regulatory factors can have on product development, clinical trials, marketing, and sales planning for a new medical device.
Presenters:
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Zvi Ladin, Ph.D., Principal, Boston MedTech Advisors
Dr. Ladin’s experiences include establishing reimbursement and regulatory strategies for therapeutic and diagnostic medical device companies as well as submission of regulatory applications, including 510(k) and PMAs for products in Class I-III and drug-device combination products. Dr. Ladin has represented companies in negotiations with the FDA, European and Asian regulatory agencies, and served for five years as a scientific advisor to the Food and Drug Administration.
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Monica Bhatt, Associate, Hodgson Russ Attorneys
Ms. Bhatt’s practice is focused on regulatory compliance with the FDA and she advises clients on regulatory issues at different stages of product development including: product classification, regulatory approval pathway, import detentions by the FDA, confidentiality issues with pre-market submissions, product recalls, and client preparation for meetings with the FDA as well as filing premarket submissions.
Early-stage companies, diagnostics and medical device inventors, and medical researchers that are interested in developing new medical or life science products are encouraged to participate.
FREE EVENT—REGISTRATION REQUIRED
SPACE IS LIMITED--PLEASE REGISTER EARLY!
A light lunch will be available
Please register using the link below, by December 12
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12/07/11 (W) 4:30 - 9:00 pm
Buffalo, NY
Part of a series of events connecting MedTech members with the clinical community. These informal conversations will cover areas of shared interest, clinical problems that are unmet or under-met, and potential joint research and development projects. Participation is limited to MedTech members. Contact Heather Erickson for more information.
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11/16/11 (W) 12:00-1:30 pm
Rochester BioVenture Center, 77 Ridgeland Road, Rochester, NY
Designing new medical devices requires integration of technology for specific diagnostic and therapeutic applications with usability, manufacturability, sterility (in some cases), and sustainability. Companies that successfully produce sophisticated medical products bring together a number of collaborative, expert resources to ensure development of a market-ready device.
The presenters for this session include medical device designers at both large and early-stage companies who will speak to the approaches that they take and the issues they navigate in designing leading diagnostic products for front-line and laboratory settings.
Presenters:
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Robert Juncosa, Chief Technical Officer, Thermal Gradient
Thermal Gradient is developing miniaturized DNA amplification devices to achieve “PCR as fast as nature allows.” Reaching this goal involves advances in applied microfluidics along with design decisions for product usability, performance, and what is expected to be high-volume manufacture of single-use cartridges.
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Henk Keesom, Systems Development Director, Ortho Clinical Diagnostics
Ortho Clinical Diagnostics serves the transfusion medicine community and laboratories around the world as the leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases. With global R&D operations based in Rochester, OCD integrates numerous fluid assays with complex robotics into complete systems for hospitals, laboratories and blood centers worldwide.
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Tom Meyers, User Experience Design Engineer, Welch Allyn
Welch Allyn is renowned for their high-quality products used in virtually every doctor’s office and emergency room. “By deeply understanding customer needs we more effectively provide solutions to help them be successful” - a statement that encapsulates the company's focus on incorporating the user experience into every element of new product development.
Early-stage companies, diagnostics and medical device inventors, and medical researchers that are interested in developing new medical or life science products are encouraged to participate.
FREE EVENT—REGISTRATION REQUIRED
SPACE IS LIMITED--PLEASE REGISTER EARLY!
A light lunch will be available
Registration for this program is now closed
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11/01/11 (T) 9:00 am–3:30 pm
Bausch + Lomb Global Eye Health Center, 1400 N. Goodman Street, Area 67 A&B Training Room, Rochester, NY
Application of risk management to medical products.
Program Overview
Part 1: EU Notified Body
Presented by: TÜV SÜD America
In order to place a medical device or diagnostic product on the European market, manufacturers must meet all applicable directives. If you are looking to enter the European market and you manufacture a Class I (Sterile or Measuring), Class IIa, IIb or III device, you will need the services of a Notified Body, sometimes also called a Registrar. This portion of the program will cover updates on recent directives, expectations and anticipated changes.
Part 2: Important Pre-Launch Considerations
Presented by: Alquest
Standards and expectations vary between European regulations and U.S. regulations. This portion of the program will focus on applying risk management practices in the product development stage and requirements under the EU and U.S. systems, providing practical pre-launch details.
Part 3: The Legal Perspective
Presented by: Hodgson Russ and Harris Beach
FDA has dramatically increased its scrutiny of product risk management practices. Risk management programs should be implemented across the product life cycle and across functional teams, including communication of risk, to help with regulatory compliance and minimize product liability risk.. This portion of the program will focus on both pre- and post-launch considerations from a lawyer's perspective. Learn from recent warning letters and real life enforcement actions.
Part 4: Industry Panel
Industry insights from leading device and diagnostics manufacturers.
> Paul Buckley, President, Applied Sciences Group
> Jennifer Murray, Manager, Global Regulatory Affiars, Bausch + Lomb
> Nelson Schwenk, Quality Engineer, Bausch + Lomb
> Christine Ehmann, Regulatory Affairs Director, Carestream Health
> George Aldrich, Sr. Manager, Quality Systems, Conmed
> Eric Schaeffer, Staff Engineer, Ortho Clinical Diagnostics (a J&J Company)
> Brian Ray, Sr. Manager, Risk Management, Welch Allyn
Participants attending the full workshop will receive a certificate of completion from MedTech.
Who Should Attend
Medical device and diagnostics manufacturers, regulatory affairs, product safety, quality systems, risk management professionals, manufacturing management, clinical representatives
Sponsored by:
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10/31/11-11/4/11
Radisson Utica
This intensive one-week course provides the basic knowledge and skills needed to develop and maintain a quality system program that conforms to the FDA's Quality System regulation.
The course is designed for professionals directly involved in meeting FDA's Quality System requirements or those who are ultimately responsible for compliance; a basic understanding of the FDA quality system requirements, including direct work experience, is strongly recommended. Course content is the culmination of almost two years of consensus development on the part of a respected group of more than thirty quality system experts from the Medical Device Industry. Instruction will be provided by experts in the field who were instrumental in developing the program.
An optional 2.5 hour exam will be administered on Friday to test mastery of the materials and ability to interpret the regulation correctly. Those who pass the exam will receive a certificate of achievement directly from AAMI. The registration rate includes all course materials, meals during the day, and exam/certification expenses.
COURSE Instructors:
Annette M. Hillring, RAC
Annette Hillring has been an independent regulatory affairs consultant since 1998. Prior to consulting, she worked in the medical device industry with ophthalmic, cardiovascular and general hospital devices. She has over 25 years experience in regulatory affairs, compliance and clinical affairs. Her worldwide regulatory affairs responsibilities have included FDA and worldwide device submissions, GMP/QSR compliance, interpretation of all FDA regulations and policies, regulatory representation on new product development teams, due diligence assessments and product liability. She has also served as an expert witness for FDA and has extensive experience in software related FDA/industry guidance and standards-setting activities.
Ms. Hillring is Regulatory Affairs Certified and holds BA degrees in biology, microbiology and secondary science education.
Christine Nelson
After 15 years with FDA and a total of 34 years with the Federal Government, Chris Nelson retired in January 2006. Chris currently provides training on FDA’s quality system requirements for medical device manufacturers. While working for FDA Chris provided advice, guidance and training on the Quality System regulation and other device regulations to FDA headquarters and field staff, the medical device industry and foreign government officials. Chris joined the Office of Compliance in FDA/CDRH in 1990, and evaluated medical device manufacturers for compliance with first, the GMP regulation and, more recently, the Quality System regulation. From 1995 to 2005, Chris was FDA’s representative on the Global Harmonization Task Force’s Study Group that is working to achieve international harmonization of regulatory auditing of device manufacturers. In 2000 Chris transferred to CDRH’s Division of Small Manufacturers, International and Consumer Assistance where she coordinated CDRH’s international activities until she retired. Ms. Nelson received a BS degree from Northern Illinois University and a MS degree from the University of Illinois.
More course details from AAMI >>
REGISTRATION IS NOW CLOSED
Examination is included in registration fee. Registration fee also includes course textbook, The Quality System Compendium; notebook of course materials and case studies; continental breakfast, lunch, and refreshments for four days.
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10/19/11 (W) 12:00–1:30 PM
Rochester BioVenture Center, 77 Ridgeland Road, Rochester, NY
Get current on recent developments that affect life science businesses and organizations throughout the Upstate region at this session that features the latest designs for a future biotech and medical device business incubation facility, news about grant opportunities, and specific actions that you might need to take to benefit from the recent patent reform act.
Developing the community resources needed to grow new life science businesses is at the core of this discussion—you need to be at this session to participate and to learn about the critical patent law changes that are now signed into U.S. law.
Presenters:
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James Senall, President High Tech Rochester
Jim serves on the New York State Regional Council, Entrepreneurship & Innovation workgroup - 1 of 11 workgroups in our region. He has had a lot of insights from other groups, and the council as a whole. Jim will describe the initiative and provide a high-level overview of the process, dates, and next steps--including the workgroup's proposal for a future incubation center.
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Mike Riedlinger, HTR Manager at the Rochester BioVenture Center
Planning for a future incubation facility to nurture early-stage life science and medical device companies is at a point where we have a few conceptual drawings and some site surveys have been completed. We will present and discuss these as well as the next steps toward bringing a new facility into operation as a creative hub for innovation in our community.
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Robert Gunderman and John Hammond, Patent Agents
Bob and John have nearly two decades of combined experience assisting corporations and their inventors. They have studied the new patent reform act and will present a brief synopsis of the key elements of the patent laws changes. Specific actions that inventors need to be taking now to protect their intellectual property and benefit from this sweeping reform will be discussed.
Entrepreneurs of early-stage companies, diagnostics and medical device inventors, and medical researchers that are interested in creating a new company or are considering developing new medical devices, pharmaceuticals, or biologics are encouraged to participate.
FREE EVENT—REGISTRATION REQUIRED
SPACE IS LIMITED--PLEASE REGISTER EARLY!
A light lunch will be available
The Rochester BioVenture Center (RBC) is a technology incubator with wet-lab facilities that serves as a link in the chain of resources to promote and foster the growth of early stage life science companies in the Upstate New York region. The facility is located at 77 Ridgeland Road off of Jefferson Road east of the intersection of Interstate 390.
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10/04/11 (F) 12:00-1:30pm
The VPA Warehouse, Downtown, Syracuse, NY
Join us for a unique opportunity to hear Todd Park, Chief Technology Officer for the U.S. Department of Health and Human Services, give a presentation on new policies from the White House and Department of Health and Human Services aimed at:
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Stimulating Innovation
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Liberating Data for Entrepreneurs
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Opportunities in Health IT
Mr. Park will speak for 45 minutes, followed by a 30-minute open Q&A with the audience.
This event is free and open to the public, healthcare and education community
Download PDF Flyer
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9/30/11 (F) 8:00-9:00 AM
Buffalo, NY
MedTech’s Executive Connections bring together key influencers from pharma, biotech and medical technology organizations to identify areas of common interest, to take coordinated action, and to invest in collaborative endeavors. The next series of forums will focus on soliciting input from Bio/Med industry leadership to the Governor's Regional Economic Development Council (REDC) planning process.
Participationis limited; by invitation only to MedTech members and guests.
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9/29/11 (TH) 5:00-600 PM
Rochester, NY
MedTech’s Executive Connections bring together key influencers from pharma, biotech and medical technology organizations to identify areas of common interest, to take coordinated action, and to invest in collaborative endeavors. The next series of forums will focus on soliciting input from Bio/Med industry leadership to the Governor's Regional Economic Development Council (REDC) planning process.
Participationis limited; by invitation only to MedTech members and guests.
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9/29/11 (TH) 8:00-9:00 AM
Liverpool, NY
MedTech’s Executive Connections bring together key influencers from pharma, biotech and medical technology organizations to identify areas of common interest, to take coordinated action, and to invest in collaborative endeavors. The next series of forums will focus on soliciting input from Bio/Med industry leadership to the Governor's Regional Economic Development Council (REDC) planning process.
Participationis limited; by invitation only to MedTech members and guests.
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