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.

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

Happy Holidays from Bayard Design!

This year our annual holiday event was at Brooklyn Boulders in Union Square Somerville. A good time was had by all! Followed up by attending the very funny Open Mic Night at Sally O’Brien’s (because Aeronaut was closed – why Ben why?)

All Engineers CSWP!

All of the Mechanical Engineers are now Certified SolidWorks Professionals! According to Dassault System “each CSWP has proven their ability to design and analyze parametric parts and moveable assemblies using a variety of complex features in SOLIDWORKS software.” In other words no spaghetti models and rapid, accurate design changes from our team.

SolidWorks Certified Professional

12/4/19 – MDG-Boston – Cutting Edge Advances in Auditory Device Therapies

Another great topic by MDG. Bayard Design has executed on wearable miniature devices in the past using best practices in injection molding, flex circuits and other enabling technologies We’re excited to hear what the future holds! See you there..

Cutting Edge Advances
Auditory Device Therapies

Dec 4 at Foley Hoag, Boston Seaport

Note: Due to limited seating, registration will be closed when capacity is reached 

This Week’s Featured Panelist

Marcello Peppi, PhD
Senior Scientist II, Frequency Therapeutics
Dr. Peppi is an expert in inner ear drug delivery with experience in academia and industry. He received his PhD in physiology of sensory systems from the University of Cagliari, Italy. He joined Professor Bill Sewell and Sharon Kujawa ‘s laboratory, at the Mass Eye and Ear Institute, where he studied mechanisms of action of hearing protection and inner ear drug delivery.

Then, he joined Jeff Borenstein at Draper, in the Intracochlear drug delivery program, to apply cutting edge technology of intracochlear drug delivery for pre-clinical applications. Currently Marcello is Senior Scientist II at Frequency Therapeutics where he works in the in-vivo program focusing on compound screening and PK/PD assessment.

What are the opportunities and advances in device therapies for hearing loss and otitis?

What are the unique development challenges of auditory device therapies?

What is the patient perspective?How can translation be accelerated?Hearing loss presents a growing public health problem due to aging, disease, and noise, with the latter disproportionally affecting the young.

Overall, ~15% of the global population is affected across all age groups, leading to direct and indirect costs of untreated hearing loss totaling $750 billion. 

Ear related Treatments are Challenging
Ear related treatments are challenging owing to the complex etiology but also to complex anatomical and physiological barriers that limit device access to and drug and cell retention within the inner ear.As a result, even treatment of ear infections, the second most common reason childhood visits to the doctor are surprisingly challenging. 

Diverse Needs and Challenges
The diverse needs and challenges of the various auditory diseases have been benefiting from advances in implantable devices, drug development and delivery, and regenerative therapies. Each area has its unique opportunities and challenges and many of the exciting opportunities exist at the intersections of disciplines requiring a broad understanding of the field. 

Dec 4 – Wednesday 4:00 – 7:00 PM

FOLEY HOAG LLP Seaport West
155 Seaport Boulevard
Boston, Massachusetts
Map & Details

Join Us for this Vital Discussion Exploring
the New Opportunities to Help People
With This Underrated Disability

Boston has emerged as a hotbed for medical and medtech innovation and academic leadership in inner ear therapies with leadership in drug delivery, regenerative therapies, otitis treatment and cochlear implants.

The assembled a panel includes a mix of entrepreneurs, researche2s from academia and industry, and a practicing physician- scientist and his patients, to discuss the medical and patient needs related to hearing loss and otitis, the research and development challenges and the business opportunities in this fast evolving field.
Bios of Our Distinguished Panel  Daniel J. Lee, MD, FACS
Associate Professor, Department of Otology and Laryngology, Harvard Medical School
Daniel Lee is Director of Pediatric Otology and Neurotology and the Harvard Neurotology Fellowship at Mass. Eye and Ear. His primary clinical focus is cochlear implant (CI) surgery for infants, children, and adults with single-sided or bilateral hearing loss.

Dr. Lee is also the Director of the Wilson Auditory Brainstem Implant (ABI) Program, where he and his team work with patients who are deaf from absent or damaged cochlear nerves and cannot receive CIs. Dr. Lee’s laboratory seeks to answer fundamental questions about how the ABI provides hearing using animal models and to examine novel methods to correlate position of the array with ABI outcomes in the clinic.

Annahita Forghan
PharmD, Patient Advocate (patient of Dr. Daniel Lee)
Dr. Forghan is a graduate of UMass Amherst (BS) Lake Erie College of Osteopathic Medicine in Florida (PharmD). She will share the story of her benefits and challenges from her cochlear implantation as she progressed to profound deafness. Her daily obstacles throughout her changes in abilities have opened her eyes to the impact that hearing has on communicating in this society.

In 2013 and 2014 She received treatments in the hope of regaining some of her natural hearing in her left ear, and these medications created adverse effects, some of which became permanent. In 2015 she decided to undergo the cochlear implant surgery, with its additional permanent risks. Now, profoundly deaf in her right ear as well, she ironically refuses a second cochlear implant surgery even with her deep appreciation and continued use of the first one.

Cyrille SAGE, PhD
Senior Manager, R&D Project Manager, Senior Scientist, CILcare
Dr. Sage has nearly 20 years of experience in inner hair cell research, conducting research projects both in France and in the US. Prior to joining CILcare, he was a Research Associate in gene therapy in Harvard Medical School, where he studied the genomic regulation of hair cells. As Senior Scientist & Project Manager at CILcare, Dr. Sage brings extensive experience and know-how in inner ear biology including microsurgery (round window injection, intracochlear administration) cochleogram, and in vivo gene delivery. 

Ida Pavlichenko, PhD
Technology Development Fellow, Harvard Wyss Institute Co- founder, PionEar Technologies, Inc.
Dr. Ida Pavlichenko is a biomedical scientist and entrepreneur, and the winner of the MIT Technology Review’s 35 Innovators Under 35 Award in 2019. As a technology development fellow at the Harvard Wyss Institute for Biologically Inspired Engineering working in the group of Prof. Joanna Aizenberg, she focuses on bio-inspired design and engineering of tympanostomy implants. Together with researchers at the Massachusetts Eye and Ear Hospital, she developed a customizable anti-biofouling ear tube implant that can be tuned for specific medical indications and enable targeted therapeutic delivery to treat a broad spectrum of ear diseases.

Marcello Peppi, PhD 
Senior Scientist II, Frequency Therapeutics
Dr. Peppi is an expert in inner ear drug delivery with experience in academia and industry. He received his PhD in physiology of sensory systems from the University of Cagliari, Italy after which he joined Professor Bill Sewell and Sharon Kujawa ’s laboratory, at the Mass Eye and Ear Institute, where he studied mechanisms of action of hearing protection and inner ear drug delivery. Then, he joined Jeff Borenstein at Draper, in the Intracochlear drug delivery program, to apply cutting edge technology of intracochlear drug delivery for pre-clinical applications. Currently Marcello is Senior Scientist II at Frequency Therapeutics where he works in the in-vivo program focusing on compound screening and PK/PD assessment. 

Celia Belline – MODERATOR 
Co-founder & CEO, CILcare
Celia Belline has over 15 years’ experience in the pharmaceutical industry. She worked as the global head of clinical trial logistics and supply chains in Sanofi R&D, was a permanent member of clinical strategic committees, and the Director of projects dealing with major chronic diseases associated with aging, where she developed her interest and expertise in hearing disorders. In 2014, Celia along with Drs. Sylvie Pucheu & Marie-Pierre Pasdelou, founded CILcare, a premier CRO dedicated to the acceleration and development of novel therapies to prevent and treat ear disorders, with offices in Boston and France (Montpellier and Paris). 

Co-Champions   
David Parrillo, MBA Senior Account Executive CBSET

Rami Tzafriri, PhD Director of Research and Innovation CBSET