As a member benefit, MassMEDIC holds an Annual Conference in May, an Annual MedTech Investors Conference in October and a series of informational programs throughout the year on a wide range of topics of interest to MassMEDIC members, including regulatory affairs, product development trends and reimbursement issues.
August 2 and 3rd – 8:00 am to 4:00 pm
Developing software in compliance with FDA, EU regulations and international standards is challenging. This two-day intensive course provides practical guidance and suggestions for developing software that complies with applicable FDA and EU regulations, guidance documents and international standards such as IEC 62304 and ISO 14971. The focus of this course is interpreting Design Controls for software. Each section of the Design Controls regulation (820.30) is discussed from the software perspective. Corresponding requirements from IEC 62304 are woven into the flow.
In-depth discussion of critical topics such as Requirements, Software Verification & Validation, Risk Management and Fault Tree Analysis are included. In addition, techniques for validating software development tools and software used in Manufacturing and Quality Systems are also discussed. Interactive group exercises are included to facilitate discussion and learning.
WHO SHOULD ATTEND
Software and firmware engineers, software managers, RA/QA staff, validation engineers, and project managers. Anyone interested in learning how to develop medical device software in compliance with regulations, standards and guidance documents.
Steven R. Rakitin has over 40 years experience as a software engineer and software quality manager. He helped write the first IEEE Software Engineering Standard (IEEE-STD-730 Standard for Software Quality Assurance Plans) as well as the current revision IEEE 730-2014. He is also a member of the working group writing IEEE Standard 1012 (System Verification & Validation). He has written several papers on medical software risk management as well as a book titled: Software Verification & Validation for Practitioners and Managers.
He received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a Life Senior member of IEEE and a member of MassMEDIC.
He is on the Editorial Review Board for the ASQ Journal Software Quality Professional.
As President of Software Quality Consulting Inc., he helps medical device companies comply with FDA regulations, guidance documents, and international standards in an efficient and cost-effective manner.
Registration: $599 – includes all meals and background materials.
3 Components of Strategic Innovation that can Streamline Product Development
In a technology based business it’s easy to perceive that technology drives innovation, when in fact, innovation drives technology. Thus, an effective innovation strategy can help generate the ideas and vision that create the technologies that supports a business’s goals. This webinar presents 3 fundamental components of a strategic approach to innovation and what it takes to execute them successfully.
The discussion will center around how management systems and structures can support a team’s ability to innovate efficiently and effectively. We will also explore how the right strategic approach can increase recognition of internal opportunities for innovation and improve understanding of external factors that affect innovation. The following are some of the concepts that we’ll review relative to their impact on innovation:
This webinar will provide a broad framework that you can use to assess your approach to innovation. It will also provide language and structure that allow you to begin to articulate how your approach to innovation is creating the right technology to drive your business’s success.
Presenter: Robert McDonald, Managing Director, ipCapital Group
Robert McDonald, Managing Director, leads the healthcare practice vertical at ipCapital Group. Robert has a long track record of success in providing advice to and helping solve complex problems for the healthcare industry.
Prior to joining ipCapital Group, Robert led the internal consulting practice for the hospital group at the MAYO Clinic. Robert helped to build a health consulting practice at the Deloitte Firm in Minneapolis. Robert was recruited to rebuild the health practice for Coopers and Lybrand with 130 consultants located in five different practice locations. Robert was also asked to serve as the healthcare industry chair for the entire Cooper’s Healthcare practice including audit, actuarial, tax and consulting services.
Robert has a lifelong interest in applying industrial engineering, process improvement and structured processes to accelerate innovation, resulting in reduced costs and improvements in clinical results. He has a demonstrated record as a highly effective business leader, teacher, coach and strategic thinker.
Robert holds a Bachelor of Science degree from the University of Vermont and a Master of Science in Health Administration from Trinity University. Robert has done post-master’s study at Harvard University, The University of Michigan and The University of California, Los Angeles.
After registering, you will receive a confirmation email containing information about joining the webinar.
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Remaining relevant in a competitive market requires life cycle management of existing products and developing new innovative products at any given time. Although the level of uncertainty and risks differ significantly, both types of projects compete for the same resource pool (budget and skills). How can you ensure your project portfolio prioritization attends to these diverse needs, maximizes resource utilization, and is aligned with the strategic goals of the organization? A change in the standard operating model to more effectively deal with the requirements of innovation and life cycle management projects may need to be considered.
Is your organization prepared to field high functioning teams that can deliver on your strategic initiative? Establishing a Project Portfolio Management (PPM) capability is a significant undertaking for any organization. Join us for a round table discussion with industry experts familiar with the benefits and challenges associated with building and sustaining strong Portfolio, Program and Project Management practices within their organizations.
Welcome and Introduction
Panel Discussion and Audience Q&A
Moderator: Andrew Dolvig
Director, Regional Operations
Integrated Project Management Company, Inc.
Andrew Dolvig is responsible for driving quality execution of projects across a variety of clients in the Life Science, Consumer and Healthcare Industries and developing the skills and careers of the project managers on his team. Additionally, Andrew leads the IPM Service Line to establish or enhance the Project Portfolio Management and PMO maturity of clients by implementing customized solutions that will have a sustained impact on their organization.
Andrew has over 15 years of experience leading a variety of projects spanning Fortune 100 companies, start-up ventures and the Federal Government. These projects have ranged from PMO establishment, Portfolio Management software and process, new product development, capital equipment installations, mergers and acquisitions, and software development.
Andrew graduated from the University of Illinois, Champaign-Urbana, with a degree in Material Science and Engineering. He currently lives in Elmhurst, IL with his wife, Nikki, and three wonderful children.
Vice President, Research & Development
Susan Moreira leads technology research, product development and ophthalmic clinical teams at Beaver-Visitec International, Inc. She also directs the Global IP Portfolio, facilitates the Portfolio Decision Team’s investment review process, and manages relationships with KOLs and Scientific Advisors. Previously, Ms. Moreira served as Director of Research & Development at Becton Dickinson’s BD Ophthalmic Systems business (part of the BD Medical worldwide business segment) where she worked for 14 years. Prior to her focus on product development and innovation, Ms. Moreira held positions in a number of BD business units where she addressed process development, automation and quality management challenges. She joined BD as part of a rotational Manufacturing Development Program. Ms. Moreira graduated Magna Cum Laude with an MBA from the F.W. Olin Graduate School of Business at Babson College and a Bachelor of Science degree in Mechanical Engineering from Worcester Polytechnic Institute.
Director, Global Project Management
Kristin Watson, PMP is currently Director of Global Project Management for Medtronic where she is focusing on strategic business alignment and special projects for a business based in Mansfield, MA. Her career spans over 25 years in medical device development, including R&D and PMO for new product development and new businesses. She enjoys pioneering creative ways to maximize alignment and leverage the team’s strengths.
Kristin earned a B.S. in Mechanical Engineering from University of Massachusetts in Lowell, MA and a B.S. in Mathematics from Gordon College in Wenham, MA. She and her family spent most of their lives living and working in Massachusetts until moving to Florida two years ago to help launch a new business for Medtronic.
Executive Vice President, Technology & Operations
As head of technology and operations, Michael leads Ximedica’s product development service and manufacturing operation and is responsible for ensuring the proper execution of the programs and guaranteeing that their overall goals, as well as their technical, financial, operational, quality, and compliance metrics are achieved by Ximedica’s management and teams. Michael emphasizes Ximedica’s philosophy of cross -functional collaboration with clients, continuous improvement processes and quality systems, and accountability towards delivering superior products.
Michael has over 20 years of product development and manufacturing experience and has been at Ximedica for 15 years. During his tenure at Ximedica, he has been involved in the development of hundreds of medical and consumer products in a variety of roles, including Lead Engineer, Program Manager, and Head of Program Management and Engineering.
In addition to his responsibilities within Ximedica, Michael presents at industry events and is a member of Medical Design Technology’s Editorial Advisory Board.
Michael holds a Bachelor of Science in Mechanical Engineering from Worcester Polytechnic Institute and a Masters of Science in Mechanical Engineering from Northeastern University.
MassMEDIC and Halloran Consulting Group invite you to attend this free webinar session on one of the most compelling trends in the medical device industry.
Mark Vermette and Peter Ohanian of Halloran Consulting Group discuss the fine line between mobile technology and medical devices, what to do when your tech crosses that line, and how to comply with FDA regulatory requirements in this rapidly evolving and competitive space.
Peter joined Halloran Consulting Group in 2015. He has more than 35 years of industry experience in medical device quality assurance and regulatory affairs. He has an extensive background establishing compliance programs and developing product clearance strategies.
Prior to joining Halloran, Peter was the Vice President of Quality and Regulatory Affairs for Philips Healthcare, providing leadership and strategic direction for their patient monitoring and clinical informatics business. Peter has also held similar roles with ZOLL Medical Corporation and Visualization Technology Corporation. He has proven expertise in solving compliance problems, implementing effective and efficient quality systems, and getting high quality products to market. Peter has also served on the Board of Directors for MassMedic.
Peter earned a Bachelor of Science in Biology from Boston College and a Master of Science in Engineering Management from Northeastern University. He is also Regulatory Affairs Certified by the Regulatory Affairs Professional Society.
Mark joined Halloran Consulting Group in 2015 with over 25 years of experience delivering technology, consulting services, and software in the life sciences industry. He has led system implementations for Clinical Trials Management Systems (CTMS), Electronic Data Capture systems (EDC), safety systems, data warehouses, content management systems, and analytics and reporting platforms.
Prior to joining Halloran, Mark was Vice President of Infosario Customer Engagement at Quintiles, Inc., where he founded and was responsible for the professional services organization leading technology integration and services delivery. He has held similar roles at CrossPhase Consulting, Galt Associates, and First Consulting Group. Mark also served as the product manager for CRIX International, a consortium of five pharmaceutical companies, the National Cancer Institute, and FDA with a mission to develop and service a shared platform for registration of physicians conducting clinical studies.
Mark holds a Bachelor of Science from Davis and Elkins College in Elkins, West Virginia.
After registering, you will receive a confirmation email containing information about joining the webinar.