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
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. 


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
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.