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Software as a Medical Device (SaMD)
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Join Us for a Discussion on of current trends in Software as a Medical Device (SaMD) including technological advances, regulatory challenges, and intellectual property strategies.

 Export to Your Calendar 1/8/2020
When: Jan 8, 2020
5:30-8:30
Where: Regis College
Fine Art Center
235 Wellesley Street
Weston, Massachusetts  02110
United States
Contact: Bill Munger
617-620-4161


Online registration is available until: 1/8/2020
« Go to Upcoming Event List  

Software as a Medical Device (SaMD)
Jan 8, 2020 - Wednesday - Regis College Fine Arts Center
This Week's Featured Panelist
Mark Solomon
Principal, Hamilton Brook Smith Reynolds
Mark Solomon has dedicated his 20-year legal career to guiding engineering companies and university engineering centers through the development, management, protection, and enforcement of intellectual property rights. He provides high-value intellectual property services for clients who value intellectual property by drafting and prosecuting patent applications from strategic business or licensing perspectives, as applicable.

Mark also assists clients with intellectual property matters relating to patent litigation, written and oral opinions, trademark prosecution and oppositions, copyright law, trade secret law, licensing, domain name disputes, sale and licensing of intellectual property assets, and associated counseling strategies.

Adaptive software-based technologies, such as Artificial Intelligence (AI) and Machine Learning (ML), have the potential to adapt and enhance medical device performance in real-time by deriving insights from the vast data collected to continuously improve healthcare delivery for patients.
 
Among the high-value applications identified by the FDA for such technologies are earlier disease detection, more accurate diagnosis, and development of personalized diagnostics and therapeutics.

Event Sponsor

Jan 8 - Wednesday
 5:30 - 8:30 PM

Fine Arts Center - Regis College
235 Wellesley Street - Weston, MA
Join Us for a Discussion on current trends in Software as a Medical Device (SaMD) including technological advances, regulatory challenges, and intellectual property strategies.
 
TOPICS
  • What is Software as a Medical Device?
  • What are the opportunities and advances in SaMD?
  • What are the unique developmental challenges?
  • What is the FDA pre-certification program for SaMD? How does it work?
  • What is the best strategy for protection including coverage, timing, and budgets?
  • Are medical software innovations more or less patentable given current United States Patent and Trademark Office guidelines

 Earlybird Fees by Jan 2
 Member/Alliance Partner - $35         
   Non-member - $45  
Regis Alumni - $25   
   Student (member) - $10
   Student (non-member) - $15
Gold Member - No Charge
     
Event Sponsorship - $750
(contact sponsorship@mdgboston.org)

Who Should Attend:
  • Entrepreneurs and Investors - Find out about innovative business opportunities and IP strategies
  • Physicians and Engineers - Hear about technological advances and development pathways
  • Medical Professionals, Scientists and Clinicians-Gain insights on regulatory approval
  • Regulatory and Clinical Development - Learn about testing, validation, and monitoring of software products
Bios of Our Distinguished Panel 
 
Mark Solomon
Principal, Hamilton Brook Smith Reynolds
Mark Solomon has dedicated his 20-year legal career to guiding engineering companies and university engineering centers through the development, management, protection, and enforcement of intellectual property rights. He provides high-value intellectual property services for clients who value intellectual property by drafting and prosecuting patent applications from strategic business or licensing perspectives, as applicable.

Mark also assists clients with intellectual property matters relating to patent litigation, written and oral opinions, trademark prosecution and oppositions, copyright law, trade secret law, licensing, domain name disputes, sale and licensing of intellectual property assets, and associated counseling strategies.

Scott Blood
Principal Quality and Regulatory Consultant MEDIcept
Scott Blood brings more than 25 years of professional experience and leadership in quality, regulatory, operations, and product design for life sciences companies. Scott has held leadership positions in Quality, Regulatory, and Operations at Solace Therapeutics, NinePoint Medical, Candela Corporation, InfraReDx, Inc., Fossa Medical, and PercuSurge, Inc as well as providing consulting services to several other life sciences companiesScott is the Past Chair of the Biomedical Division of the American Society of Quality (ASQ), a former member of the Board of Directors of the Massachusetts Medical Device Industry Council (MassMEDIC), and a member of the Regulatory Affairs Professionals Society, as well as a frequent lecturer on quality, clinical and regulatory topics relevant to the medical device industry. Scott holds a BS degree from Wentworth Institute of Technology, as well as CQE and CQA certification through ASQ and RAC-US through RAPS.

Navin Dewagan
President, Digital Health Solutions
Navin is an experienced Digital Health executive with over 20 years of experience in leading software focused product development for large and small healthcare companies. He has been with Medical Device startups and has also held leadership roles in large companies like Medtronic and Fresenius. He is currently the President of Digital Health Solutions that provides software development and validation services for Healthcare organization, with teams based in Boston and India.


Alexander Adam, PhD - Co-Champion
Principal, Hamilton Brook Smith Reynolds
Alexander is an IP attorney who advises clients on U.S. and international patent strategy. He specializes in drafting and prosecuting patent applications in the fields of medical devices, biotechnology, and life sciences, computer systems, electronics, imaging software, control systems, mechanical devices, robotics, mobile telecommunications, and clean energy.
Fees -  (Light dinner included)
Fee Category Early Registration
(By Jan 2)
Week Prior
(Jan 2 - Jan 8)

At the Door
(Jan 8
 
Member/Alliance Partner: $35 $35 $45
Non-Member: $45 $55 $65
Regis Alumni $25 $25 $25
Student Member $10 $12 $15    
Student Non-member w/ a valid ID $15 $18 $20 
Gold Member No Charge No Charge  No Charge
Event Sponsor - $750 - Contact sponsorship@mdgboston.org
MDG Boston
Connecting Professionals - Advancing Healthcare  
MDG Mission - enable diverse professionals to grow through  
expert forums, collaboration, and knowledge sharing.

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