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

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

10/30 – MDG-Boston – Combination Products for Drug Delivery

The MDG events continue. We’ll see you there!

Combination Products for Drug Delivery
Oct 30 – WednesdayWhat are the opportunities and advances in drug delivery?
What are the unique
developmental challenges?
What are the opportunities
for funding?
Success requires collaboration between drug developers and device engineers. This is a challenge as these groups are accustomed to functioning under different types of regulations, design criteria, and controls. This panel is a mix of entrepreneurs, big pharma, and biotech developers who will discuss the medical and business challenges where delivery innovations can provide a unique solution. Entrepreneurs will discuss strategies for funding and development issues specific to drug delivery products. Speakers from big pharma and biotech will discuss challenges across the value chain of manufacturing and selling combination products globally. Benefits of Drug/Device CombinationsFor many drugs, significant benefits could be obtained by combining the drug with a specialized delivery device, when compared to drugs which are primarily delivered by systemic means (e.g. orally, intravenously).   Advantages of Combination Products:Targeted delivery Reduced dosing of expensive compounds More control over the delivery profile Greater patient convenience/compliance
The ultimate goal is to improve patient outcomes. The success of many new therapies is contingent on the development of effective delivery systems as traditional delivery methods won’t work for some compounds and biologics.
 Opportunities exist for combination products  to extend the patent life of existing drugs on  the market.
A diverse set of scientific and engineering disciplines can converge to create elegant solutions to drug delivery problems. System level solutions may involve advanced materials, chemistry, sensors and software for monitoring and control. 
 
Oct 30 – Wednesday  5:30-8:30 PM
Regis College, Fine Arts Center
Join Us for a Discussion on
the
Growing Opportunities for
Development of
Combination Products

Bios of Our Distinguished Panel  

Michael J. Cima, PhD
Professor, Materials Science and Engineering, Massachusetts Institute of Technology
Dr. Cima is Associate Dean of Innovation at MIT, where he is Professor of Materials Science and Engineering and holds the David H. Koch Chair of Engineering. He is author of over 250 scientific publications, 50 patents, and is a recognized expert in the field of medical devices and materials processing.

Professor Cima also has extensive entrepreneurial experience. He is co-founder and director of MicroChips Biotech, a developer of microelectronic based drug delivery and diagnostic systems, and helped start Transform Pharmaceuticals Inc.(acquired by J&J). He is a co-founder and director at T2 Biosystems and Taris Biomedical. Professor Cima is an inventor of 3D printing. He is developing implantable MEMS devices for controlling drug delivery.

Dan Groszmann, PhD
Senior Manager, Device Technology Innovation Center, AmgenDan Groszmann has over 20 years of experience in medical devices, pharma, and engineering consulting. He is currently a Senior Manager in Amgen’s Device Technologies organization, leading an innovation team in drug delivery applications for combination products out of their Cambridge, MA facility. Prior to joining Amgen, Dan was the Advanced Technology Manager for GE Healthcare’s Surgical Navigation business.

During his tenure with GE, Dan led teams developing medical device technologies, managing external engagements, and launching commercial products. Dan holds a PhD and BS in Mechanical Engineering from Tufts University and an MS in Aerospace Engineering from Virginia Tech. He sits on the industrial advisory board for the UMass-Lowell Biomedical Engineering Department and has more than 25 issued and pending patents

Maria Palasis, PhDPresident and Chief Executive Officer, Lyra TherapeuticsMaria Palasis has extensive experience in combination products and drug-delivery innovation A repeat entrepreneur, her transformative leadership as CEO, and previously CTO, of 480 Biomedical and Arsenal Medical resulted in >$160 million of external and non-dilutive funding and the advancement of multiple programs into the clinic. Earlier in her career, she managed a portfolio of external biotech and medical device investments at Boston Scientific and led the development of several combination therapies. She is an inventor on more than 120 issued and pending patents. Maria received her BS and PhD in Chemical Engineering from the University of Cincinnati, and she held a postdoctoral fellowship in molecular biology at the University of Cincinnati School of Medicine. Rami Tzafriri, PhDDirector of Research and Innovation, CBSETCBSET is a not-for-profit pre-clinical research organization dedicated to research, education, and the advancement of early-stage biomedical technologies. He provides scientific direction to translational research and publications, leveraging institutional expertise in computational modeling, histopathology, animal models and interventions, imaging, and bioanalysis.

Rami received his PhD from the Hebrew University of Jerusalem for his research on biodegradable controlled release devices targeted toward the treatment of gingivitis and mammary tumors. He joined Professor Elazer Edelman’s laboratory at MIT where he developed quantitative models for growth factor biology and endovascular drug delivery and worked on the first FDA Workshops on Computer Methods for Cardiovascular Devices.

Maria Shepherd – MODERATOR President and CEO, Medi-VantageMaria launched Medi-Vantage in 2008 and has worked with over 250 medical device companies on strategy research for acquisitions, pricing, commercialization of new technologies and assisting product development teams. Previously, Maria was vice president of marketing for Oridion, a start-up company acquired by Covidien/ Medtronic. Maria served as director of marketing in the critical care patient monitoring division of Philips. 

Co-Champions   

Paul Hartung, MS Board Director MDG

Geoff Moodie, PhDSenior Principal Scientist The Getinge Group

10/2/19 – MDG-Boston Design-for-Usability

Bayard Design LLC is pleased to continue its support of MDG-Boston and contribute to this important topic. Usablity and Usercentric design is key to proper product execution. A product can’t be properly engineered if it can’t be used properly. We’ll see you there!

Medical Device Product Development
Design-for-Usability Oct 2 – Wednesday
 Design-for-Usability is a Critical Aspect of
Medical Device Product Development
More than a third of medical device incidents involve a use error and more than half of all device recalls for design problems involve the user interface.

Because of this, the FDA has made medical device usability a key topic of concern and has issued guidance.

User experience plays a vital role throughout the development process from early feasibility to validation to prevent these user errors from occurring.

Evan Gyllenhaal, Senior R&D Manager, Boston Scientific
will be the MODERATOR for this panel discussion about the importance of Usability in medical device design from software, hardware, human factors, clinical and regulatory perspectives.

Dorothy Shamonsky, Chief UX Strategy Officer, Boston UX
In February 2016, the FDA issued final guidance to help reduce the frequency of use errors and injuries associated with Medical Devices through the application of Usability Engineering. In, Applying Human Factors and Usability Engineering to Medical Devices, the FDA details its expectations to industry. Part of fulfilling those expectations is a long journey through the Human Factors design process. In this presentation Dorothy will discuss some of the essential processes inherent in good usability design.
Dr. Jason Gee, Urologist, Emerson HospitalAs a clinician, Dr. Gee will address the importance of medical device usability from the user perspective and the importance of collaboration in identifying the most relevant clinical problems to address. Dr. Gee will discuss practical aspects of device development and clinical trial design from a physician/medical perspective.
Bruce Johnston, Senior Software Engineering Specialist, MedAcuitySoftware engineering plays a critical role in medical device usability. When properly implemented and tightly-coupled with a proactive human factors analysis, a software development team can effectively mitigate the risk of usability issues downstream, resulting in optimal project outcomes.

Scott Blood, Principal Quality and Regulatory Consultant, MEDIceptFrom a regulatory perspective, FDA and other regulatory bodies include use-centered studies as part of the validation that your device is safe and effective. The prevalence of home-use devices is making that a priority. It’s important to know the WHY’s as much as the HOW’s when developing your usability plan and protocols. Speaking eloquently to FDA (and others) with this knowledge will ensure success in your device clearance or approval.

9/4/19 – MDG Boston – Point of Care Diagnostics

Bayard Design LLC is proud to announce our sponsorship of Medical Development Group Boston (MDG-Boston) for the 2019 and 2020 series of events.

Founder and Principal Matthew De Remer says “MDG is a great resource in the Boston area entrepreneur and medical device engineering communities. As far back as the Newton corner Bertucci’s days you could always find inspiration or advise at a meeting. We’re pleased to support its educational mission.”

The topic for the first meeting will be:

Sept 4 – Wednesday Current and Emerging Technologies
in Point-of-Care Diagnostics
Rapid Diagnosis at Bedside or Remotely
The Next Big Medical Game Changer
What This Means for Clinicians,Patients, and Competitiveness in the Medical Device Market
Mobile digital diagnostic technologies enable the advancement of digital biomarkers through continuous measurement of biological and pathogenic processes or pharmacological responses that translate to informative and actionable clinical insights.

Engineering advances lead to accelerated clinical adoption and winning business models

Daniel Sands, MD, MPH Beth Israel Deaconess Medical Center, Lahey Health Assistant Professor Harvard Medical School
Unmet Clinical Needs and Market Adoption: Opportunities and Challenges
Dr. Sands will address unmet clinical needs in care settings that require immediate data and situations where turnaround times for central laboratory results are insufficient to deliver quality care.

Anuj Dhingra, MBA
Vice President, Product Lifecycle Management and Global Marketing,
Siemens Healthineers POC Diagnostics
Clinical Solutions
Mr. Dhingra is responsible for effectively balancing the strategic, market, technical, and business aspects of all products within the Point of Care business unit.
Andrea Paraboschi, PhD Program Manager, EmpaticaEpisode Detection
and Caregiver Notification:
Innovation in Patient Wearables
Empatica has developed a medical-quality consumer wristband, called Embrace, that monitors stress signals to detect Generalized Tonic-Clonic (GTC) seizures, alert wearers and caregivers. Dr. Paraboschi oversees Empatica’s participation and the use of Empatica technology in support of large initiatives including clinical trials, global research projects, and federally funded research programs.

Qinxin (Chelsea) Pan, MS, PhD Director Health Advances, a Parexel Company
Leveraging Digital Health to
Transform Clinical Trials
Dr. Pan is a leading authority on digital health and serves as Health Advances’ most senior project manager addressing innovation in digital health, devices, and biopharmaceuticals in the U.S., EU, and APAC. As part of the HIT/Digital Health team, she has a particular focus in Digital Biomarkers spanning routine care and clinical trials.