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Corporate Social Responsibility

CSR 101: Integrating corporate social responsibility (CSR) into your Medtech company

 

  • Integrating sustainability and corporate social responsibility (CSR) into your Medtech company can be overwhelming with all of the existing challenges of business today. CSR’s presence within our organizations doesn’t only make sense from an environmental and social standpoint, but it also makes business sense and generates shared value. Join MassMEDIC, Boston Scientific and Capaccio Environmental Engineering for a discussion on the basics of corporate social responsibility and sustainability.

 

 

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Diversity & Inclusion in MedTech: A Conversation with Camille Chang Gilmore

 

  • MassMedic, Boston Scientific and Capaccio Environmental Engineering host an informative discussion the Medical Device Industry and Corporate Social Responsibility (CSR). This session includes: A high level overview of Corporate Social Responsibility and what that mean for the Medtech community; and A deep dive into one of the core pillars of any CSR program, Diversity and Inclusion, with Camille Chang Gilmore, Vice President, Human Resources and Global Chief Diversity Officer at Boston Scientific.

 

 

 

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Ignite Cohort Program

  • MassMEDIC IGNITE is a training, mentorship and networking program designed to attract and nurture the next generation of Boston-area MedTech founders and entrepreneurs.

 

IGNITE 2020 Final Live Pitch, February 24, 2021

Join us as our IGNITE 2020 Cohort finalists compete one last time to win up to $15,000.

Six founders will compete for cash prizes to culminate this year’s IGNITE program!

The Finalists Include:

  1. Cellens
  2. Biomembretics
  3. Beacon Biomimetics
  4. Walkky
  5. Nesa Medtech
  6. People's Choice Winner: LivOnyx

 

Confirmed Judges

  • Zachary Leach, Associate, Catalyst Health Ventures
  • Peter K. Stebbins, VP, Business Development, Medical Devices, Johnson & Johnson Innovation Center Boston
  • Jennifer Griffin, VP Industry Strategy and Investments, Mass Life Sciences Center
  • Ashley Wittorf, Resident Operating Partner, Revival Healthcare Capital
  • Jeff Champagne, General Manager-Emerging Categories, Kohler Co.
  • Christos Monovoukas Vice President, Global M&A Leader / Business Development, Olympus

 

 

 

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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.

VIDEO PLAYLIST

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.

 

 

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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.

 

 

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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.

 

 

 

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Episode Four: Inspire and be Inspired

 

  • This episode focuses 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.

 

 

 

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Episode Five: Women who Inspire

 

  • In this episode, we hear from Nancy Wogrin Confrey, former CEO of Health Beacons, and Dr. Angelique Johnson CEO/founder of MEMStim LLC, who will share their experiences navigating the world of medical technology.

 

 

 

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Episode Six: Women Who Venture

 

  • Featuring Michal Geva, the first woman to found and manage a VC fund in Israel,
  • Maria Berkman, a key driver in MA.

 

 

 

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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.

VIDEO PLAYLIST

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.

 

 

 

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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.

 

 

 

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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.

VIDEO PLAYLIST

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.

 

 

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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.

 

 

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The Future of Clinical trials Series

  • Experts from MediData join MassMEDIC for a three part discussion on how the COVID-19 pandemic has accelerated the future of clinical trials.

VIDEO PLAYLIST

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.

 

 

 

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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.

 

 

 

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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.

 

 

 

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Medical Device Regulation and Manufacturing

Legal Toolkit for Early Stage MedTech Companies: Part One

 

  • Building a medtech company is like building a house. You need a solid foundation, sturdy beams, thick insulation, and a strong roof. Understanding the legal issues and risks faced by startups is critical to success and growth. Join attorneys from international law firm Greenberg Traurig for this two-part series providing a 360-degree view of best practices and missteps to avoid for companies at any stage of growth. The first session will cover Corporate & IP Issues including: entity formation, founder agreements, funding, and patents and trademark protection

 

 

 

 

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How Material Choices Can Impact a Medical Device Recall

 

  • Medical devices failures occur more often than we would like. Many times these failures stem from material issues, like embrittlement, creep, or chemical compatibility. During this discussion, polymer fundamentals will be presented by using medical device failures as examples. This knowledge will allow device design teams to ask the right questions and perform representative validation tests to produce more robust products. MassMEDIC and EWI host a discussion on how material selection can impact medical device failures and regulatory compliance.

 

 

 

 

 

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Computational Models used for Evaluating Medical Devices in Regulatory Submissions

 

  • Computational models are increasingly utilized in medical device regulatory submissions thanks to specific efforts by the FDA over the last decade to clarify expectations and benefits of the use of this tool. This included the 2019 official recognition of the consensus standard, ASME V&V40-2018 Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices. This document provides guidance for assessing the relevance and adequacy of verification and validation (V&V) activities for establishing model credibility, and its implementation within industry is expanding rapidly. In order to effectively use evidence from computational models in regulatory submissions, understanding and applying these methods for evaluating computational models is critical. This presentation will include a discussion of the document’s structure and content and provide attendees with useful insight into how the described methods can be used by their organization.

 

 

 

 

 

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FDA Medical Device Enforcement: Current Trends and Emerging Issues

 

  • The current FDA medical device enforcement climate is complex and unpredictable. Over the last several years, there has been a significant overall downward trend in the issuance of device-related Warning Letters. However, FDA has increasingly relied on the use of “non-traditional” enforcement tools. The pandemic has altered FDA’s enforcement priorities, and the reorganization and realignment of CDRH and ORA have triggered new enforcement patterns. Join MassMEDIC and Covington for an in-depth discussion of FDA enforcement trends in the medical device industry. We will explore FDA's current philosophy on enforcement actions, and discuss how the pandemic has impacted the agency’s enforcement posture. Covington's presenters are Pamela Forrest, Co-Chair of Covington's Medical Device Practice, with over 25 years of experience on a broad range of FDA regulatory issues, and Mutahar Shamsi, a non-lawyer who served 30 years at FDA in various compliance positions, including five years as FDA’s New England District Director

 

 

 

 

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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).

 

 

 

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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.

 

 

 

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Digital Health

Understanding Healthcare Users in a Distanced World

 

  • In the medical device industry, stopping a product's development due to a pandemic is not a productive option. As a result of COVID-19, medical device designers and manufacturers were forced to switch gears and develop practical ways to understand healthcare users in a remote world. But what comes next?
  • We've made it through some of the most critical and immediate impacts of the shutdown, but as we step back to think about the bigger picture, what is the impact to the development of medical devices in a distanced world? In what ways should we continue to adapt and evolve our processes and where do we draw the line to ensure user safety. Join MassMEDIC and PDD on November 19th for a robust discussion as we tackle the long-term impact of designing in a remote world.
  • About Our Speaker Chris Vincent, Principal, Sector Lead Healthcare PDD.
  • Chris leads the Healthcare Sector practice at PDD, the global design and innovation consultancy. Over the last 10 years, he has led a wide range of formative and summative usability studies across a range of medical devices, from consumables through to complex dialysis equipment in the UK, US and China.
  • With a background in healthcare, defence and aerospace. Chris has deep experience of regulatory aspects and risk management processes including test, evaluation and trials. He has directed strategy reviews and road-mapping processes across a variety of physical and digital systems and has reviewed for the NSF.
  • Before joining PDD, Chris spent five years working on the EPSRC-funded CHI+MED research project, investigating ways to make medical products safer. During this time, he explored the relationship between human factors, human error and interactive device design. He has published research relating to design for safety and usability, representation of complex systems (e.g. distributed cognition) and definition of human capabilities relating to visual perception and cognitive psychology. Chris is a guest lecturer at University College London as is regularly invited to speak about safety, usability and the design of digital services in healthcare settings.

 

 

 

 

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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.

 

 

 

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Engineering and Design

Using Real World Data in Medical Device Development

 

  • MassMEDIC, David Williams of Milliman, Inc, and Jeff Jung, formerly of Brain Sentinel, discuss the effective use of real world data in the development of medical devices. Topics include using data to support: -FDA approval; -Medical device pricing; -Medical device marketing strategies; and -Medical device sales.

 

 

 

 

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Speed to Clinical Data – CoolStat Targeted Temperature Management

 

  • Who doesn’t want faster MedTech product development times to get clinical data that proves efficacy? Tune in to this webinar to learn 6 Tips to Accelerate MedTech Time To Clinical Data in a presentation led by Andy Rogers from Key Tech. Key Tech saved CoolTech, a startup MedTech company, six months in development time to get to clinical data, and greater than $1 million in development costs. In this presentation, we will discuss driving speed to clinical data and reducing development costs substantially. About Our Speaker Andy Rogers, VP Business Development , Key Tech. Building on a decade of engineering experience, Andy looks for multidisciplinary challenges at global and startup clients like BD, Abiomed & Roche where there is no clear solution. He takes pleasure in asking the tough questions up front and starting to solve the problem on the spot because he can’t resist.

 

 

 

 

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Bluetooth LE in Medical Device Development

 

  • MassMEDIC and Sunrise Labs host a discussion on the 3 ‘gotchas’ that can derail your program. Bluetooth is widely used in consumer goods and increasingly in medical devices, driven in part by connected medical devices made for in-home use. A common misconception is that you can buy a Bluetooth wireless module, drop it into your design, and it will ‘just work’. In this technically focused webinar, Sunrise Labs’ Director of Electrical Engineering, Nick Lesniewski-Laas will address several of the most common risk areas, and what actions you can take to avoid derailment of your program.
  • Key Topics:
    • Workflow Design: managing the intersection of usability and detailed design.
    • Protocol Design: avoiding the extra work caused by undermining Bluetooth LE’s expressive feature set.
    • Designing for Vulnerability: understanding the most common security gaps and how to fill them.

 

 

 

 

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Systems Perspective Engineering : A webinar on Medical Device product development

 

  • Usability engineering can be viewed as a product lifecycle process and can be effectively integrated with an overall systems engineering approach.
  • When viewed with this systems perspective, we see users and their needs, environments, constraints, and risks as part of the product or device under development.
  • In this session, participants will explore this systems perspective on usability engineering and how it can be integrated in an overall development process.
  • About our Speaker:
    • Katie McHugh, Lead Systems Engineer, MPR Associates, Inc. Kathleen McHugh is a project manager and lead systems engineer with over 15 years of experience designing a wide variety of medical device systems. Her experience ranges from low-cost single use devices to complex, electromechanical systems for both hospital and home use. As the leader of MPR's systems engineering center of excellence, Kathleen has a particular focus on project management, systems engineering, usability and risk management processes.

 

 

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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

 

 

 

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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.

 

 

 

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Reimbursement

Getting a medtech investment: The do's and don'ts of raising money

 

  • These three CEOs just raised big money in 2020. How did they do it? What can you learn from their experiences? We dive deep into how they did it.
  • Confirmed Speakers:
    • Dave Sheppard, CEO, MedWorld Advisors
    • Jon Bloom, CEO, Podimetrics
    • Rahul Dhanda, Co-Founder & CEO, Sherlock Biosciences
    • Andy Levine, CEO, Conformal Medical

 

 

 

 

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Alternate Pricing Methods for High Value Medical Devices

 

  • This webinar provides an actuarial perspective on alternative pricing strategies for medical devices. This session will include:
    • Reasons for considering different reimbursement methods and value-based principles; -
    • Illustrative case studies;
    • An exploration of the potential risks and rewards;
    • An overview of considerations in key international markets.
  •  About Our Speakers:
    • David Williams, Healthcare Consultant, Milliman. David is a senior healthcare consultant in the Hartford office of Milliman. He joined the firm in 1999. David has more than 35 years of experience in healthcare economics and finance. His clients include medical device manufacturers, employers, insurers, physicians and hospitals. He uses big data and data science to help his clients. David started his career as the Director of Medical Economics with Kaiser Permanente and MedSpan.
    • Joanne Buckle, Lead Healthcare Consultant, Milliman. Joanne is the lead consultant in the Milliman London Healthcare practice. She has been at Milliman since 2001, including 18 months in the New York City office and has nearly 25 years of experience in health insurance markets.

 

 

 

 

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