Women in MedTech Series
- Our Virtual Women in MedTech Networking and Leadership Forum is a four-part series designed to inspire and help our community stay productive during the Covid-19 quarantine. Featuring thought leaders, mental health experts, political leaders and entrepreneurs, this series will inspire and enlighten you.
Episode One: Take Your Shot
- Don't miss this Founders Story and Q&A with Maureen Boyce and Amy Salzhauer, co-founders of Good Growth Capital. Good Growth Capital (GGC) is a majority women and minority-owned early stage venture capital firm known for its exceptional expertise in finding, cultivating and assessing complex science and technology start-ups.
Episode Two: Mental Health Matters
- This virtual event focused on giving ourselves a moment to "not be okay" and getting back to our personal best. Dr. Daphne Holt, Associate Professor of Psychiatry at Massachusetts General Hospital and Harvard Medical School, shared on understanding self-care, developing resilience and tips/strategies to support your overall well being.
Episode Three: Make the Most of the Moment
- The third event in this series centered around how we can utilize our time and reach the next level of our professional development. Rep. Joseph P. Kennedy III and Holly Scott, Vice President & Senior Partner at The Mullings Group led a conversation on how to be your own career advocate and put yourself in a position to advance.
Episode Four: Inspire and be Inspired
- The final event in our Women in MedTech Networking & Leadership Forum Virtual series focused on women sharing stories of inspiration. Guest speakers included Massachusetts Attorney General Maura Healey and Easton Town Clerk Danielle Sicard.
- This video contains sensitive information regarding assault and domestic violence. There is a trigger warning in the video prior to this content. Should you find this content triggering, when you see the warning you may skip to timestamp 26:30 to hear the remainder of the talk while avoiding the potentially triggering content.
Designing Under Pressure Series
- Our Virtual Designing Under Pressure series is a two part series designed to educate and help our community face the unexpected during the Covid-19 quarantine. Featuring design leaders and entrepreneurs, this series will inspire and enlighten you. You will find that design is inherently optimistic and learn how this optimism may help us during tribulations.
Episode One: Designing for the Unprecedented
- MassMEDIC's Rachel Robinson hosted a "screenside" chat with Loft's Jeanette Numbers about designing in "unprecedented" times. Loft recently designed mobile COVID-19 testing sites that have been deployed across Rhode Island. Jeannette shared lessons learned from this project and keys to quick turnaround and successful design with the end user in mind.
Episode Two: Designing the Future We Want
- During periods of great uncertainty, people tend to rely on mindsets and assumptions that have served them well in the past. However, past experience may not be as helpful as we seek to manage the now of this crisis and plan to emerge in a different world in its aftermath. Design is inherently optimistic and design thinking is a process to help people solve “wicked problems”. We can draw on these skills and processes to help guide us into the future. We can stop wondering what the future will bring, and start discussing the future we want to design. Watch this session for a presentation on how to lead in times of uncertainty.
MedTech at Home Series
- Our Virtual MedTech at Home series is a two part series designed to inform and help our community better understand strategies of reimbursement and regulation, and the effects of the current Covid-19 crisis to medical technologies. Featuring thought leaders, reimbursement experts, regulatory specialists and entrepreneurs, this series will inspire and enlighten you.
Episode One: Key Regulatory and Reimbursement Strategies
- Home use devices can provide significant benefits to patients and families, including quality of life improvements and cost savings. However, there are special challenges involved in developing devices designed for home use including regulatory and reimbursement issues that need to be considered. Increasing use of devices to monitor and screen patients' health conditions, and even provide self administered therapy, isa trend we’ve seen over the last few years. This trend is accelerating rapidly with Covid-19, presenting both opportunity and new challenges for device manufacturers. This webinar shared strategies in navigating regulatory pathways and reimbursement barriers.
Episode Two: Key Considerations and Solutions for Medical Devices
- Home use medical devices provide significant benefits to patients and families, including quality of life improvements and cost savings. Designing a product that balances the needs of patients, clinicians and medical device companies is challenging, but critical for successful product adoption. This webinar shared the issues that block adoption of home use medical devices and the strategies you can use to overcome them with a successful design.
Episode One: RTSM & Remote Monitoring: Realizing Quality while Mitigating Risk in Clinical Trials
- As COVID-19 continues to spread, the impact on clinical trials is unmistakable. On this program, Medidata experts discussed the challenges in device supply management and remote monitoring to realize quality while mitigating study and site risk during these challenging times.
Episode Two: Reconsidering Trial Design To Ensure Data Capture in the COVID-19 ERA
- COVID-19 has forced a reckoning in how we conduct all aspects of our lives, and clinical trials are no exception. Patient safety is the foundational principle of any trial, and suddenly we have a situation where having patients come into clinical sites for their scheduled visits poses a significant risk to their health and well-being. In this session Medidata shared its perspective on how clinical trials will be affected in the short term, as the industry rapidly attempts to manage the crisis caused by Covid-19, but also the long term view of how the landscape will be changed by the increased use of technology in trials and the move to trial virtualization.
Episode Three: The New World: Connecting Patient Data and Devices with Deep Analytics
- Every day, hospitals, doctors, and life science companies collect infinite amounts of data on individual patients, diseases, and medical procedures. The rise of a new generation of robotic, precision, and surgical devices has created boundless stores of video, imaging, and other electronic surgical notes, while the proliferation of digital patient technologies—such as electronic medical records, telemetry, wearable sensors and mobile apps—are generating a menu of personalized data for each patient. This leaves us to ask: Beyond acquisition, how do we standardize and harmonize disparate data sources to gain insights and visibility into patient treatments and outcomes? In this webinar, we shared a use case on the process of building the standardized, multi-faceted data set to enable deep real-world data analysis for pre-surgical population management, surgical treatment patterns and post-operative outcomes assessment.
Medical Device Regulation and Manufacturing
Transitioning to European Medical Device Regulation
- Sweeping changes to the regulation of medical devices in Europe went into effect in May 2017, with a 3-year transition period from MDD to MDR. However, due to coronavirus, the transition has been extended until May 2021, giving companies more time to implement the new regulations. In this webinar, some key issues related to the new MDR will be addressed, including: Current status of notified body accreditation; Clinical evaluations, clinical data, equivalence; Changes in classification; and Non-clinical challenges – Authorized Representative (AR), Person Responsible for Regulatory Compliance (PRRC), Post Market Surveillance (PMS).
MassMEDIC's State of Manufacturing Summit
- This program, recorded on June 17, 2020, takes a deep dive on the state of the medtech supply chain, with a presentation on the state of the Massachusetts med tech contract manufacturing ecosystem from Alira Health, and a brand new panel The Insider Perspective: The state of supply chain.
- This panel features a discussion with outsourcing decision makers from Olympus, Medtronic, Boston Scientific, Zoll and Smith & Nephew on how suppliers can interact with vendor management teams. This critical discussion on one of our most critical aspects of medtech will also look at the current state of our supply chain, examine how current events may impact our future and how suppliers can make an impression that translates to a productive partnership at large and, often fragmented organizations
Checklist for Digital Health Collaborations
- Digital health technologies can empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. As digital health companies mature there is continued interest from corporate partners to both acquire and create alliances. Over one hundred digital health companies were acquired in 2019. That said, digital health collaborations pose some unique challenges. Join MassMEDIC and Covington for an in-depth discussion and key practical tips for approaching Digital Health transactions, including a checklist of topics to consider for your term sheets and agreements.
Engineering and Design
Getting to the Root Cause: A MassMEDIC Engineering Webinar
- In this MassMEDIC webinar, we're joined by MPR Associates for a discussion around what to when your engineering project goes wrong. In this program you'll learn:
- Root cause analysis methodology
- Data collection strategies
- Organizing and evaluating facts
- Analyzing potential causes
- Common pitfalls and potential biases
- Case studies
Human Factors Engineering: Practical Tips for User-Centered Design
- Human factors engineering is a critical – and in the medical device industry, mandated – part of the product development process. The data generated from human factors activities can help you create products that are useful and can stand up to its competition. In this MassMEDIC webinar, Goddard's principal mechanical engineer Orlando Soto and senior industrial designer Omar Bermudez will share practical tips to help you keep the core principles of human factors engineering in mind as you design and build.