1/8/20 – MDG-Boston – Software as a Medical Device (SaMD)

Bayard Design is a proud sponsor of Medical Development Group Boston (MDG-Boston). We’ll be at the next event on Jan 8 – Wednesday from 5:30 – 8:30 PM at Fine Arts Center – Regis College 235 Wellesley Street – Weston, MA.

You can register for the event here. This month’s event is on:

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 ReynoldsMark 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.

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


  • 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

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