Digital Health Archives - AdvaMed https://www.advamed.org/topics/digital-health/ Advanced Medical Technology Association Fri, 14 Feb 2025 15:52:27 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 https://www.advamed.org/wp-content/uploads/2021/05/cropped-AdvaMed_A_color-32x32.png Digital Health Archives - AdvaMed https://www.advamed.org/topics/digital-health/ 32 32 AdvaMed 2025 State Policy Briefing: Data Privacy https://www.advamed.org/member-center/resource-library/advamed-2025-state-policy-briefing-data-privacy/ Wed, 05 Feb 2025 16:35:49 +0000 https://www.advamed.org/?post_type=resource&p=13086 Hear from AdvaMed’s data privacy expert, Terry Chang, on the critical exemptions we seek in comprehensive data privacy laws across the country.

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Digital Health

Hear from AdvaMed’s data privacy expert, Terry Chang, on the critical exemptions we seek in comprehensive data privacy laws across the country.

For those who couldn’t attend live or wish to revisit key highlights, you can access the recording below.

Webinar Recording

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AdvaMed 2025 State Policy Briefing: AI in Healthcare https://www.advamed.org/member-center/resource-library/2025-state-briefing-ai-healthcare/ Mon, 27 Jan 2025 21:53:44 +0000 https://www.advamed.org/?post_type=resource&p=12966 AdvaMed’s digital health policy expert, Geeta Pamidimukkala, and payment and health care delivery policy expert, Kirsten Tullia, break down how artificial intelligence and machine learning (AI/ML) technologies are transforming patient care and the FDA’s crucial role in overseeing AI-powered medical devices.

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Digital Health

AdvaMed’s digital health policy expert, Geeta Pamidimukkala, and payment and health care delivery policy expert, Kirsten Tullia, break down how artificial intelligence and machine learning (AI/ML) technologies are transforming patient care and the FDA’s crucial role in overseeing AI-powered medical devices.

For those who couldn’t attend live or wish to revisit key highlights, you can access the recording below.

Webinar Recording

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The Art of the MedTech Real Estate Deal – Accelerating Innovation & Mitigating Risk Webinar https://www.advamed.org/events/the-art-of-the-medtech-real-estate-deal-accelerating-innovation-mitigating-risk-webinar/ Mon, 06 Jan 2025 15:50:11 +0000 https://www.advamed.org/?post_type=event&p=12725 Jones Lang Lasalle Inc. is the trusted real estate advisor to over 100 AdvaMed members across the globe and will be presenting the tools and strategies they have employed to achieve facility savings and mitigate risk within this very dynamic real estate market.

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Events

AdvaMed 2025 State Policy Briefing: Data Privacy

AdvaMed 2025 State Policy Briefing: Data Privacy

  1. Overview
  2. Speakers

AdvaMed 2025 State Policy Briefing: Data Privacy

Jones Lang Lasalle Inc. is the trusted real estate advisor to over 100 AdvaMed members across the globe. In this webinar, they will be presenting the tools and strategies they have employed to achieve aggressive facility savings and how to mitigate risk within this very dynamic real estate market. During this presentation, Jones Lang Lasalle Inc., will discuss topics such as Perfect Lease Index, M&A Due Diligence, Site Selection Check List, Labor Analytics, State Incentives and more.

Please join us on January 22nd, 2025 at 11am ET for this insightful webinar presentation.

Meet The Speakers

Matt Jackson – Executive Managing Director, JLL

Matt Jackson is an Executive Managing Director in JLL’s Business Consulting Group. He is based in Washington DC. Mr. Jackson is responsible for assisting companies with global strategy, location footprint configuration, location/site selection, portfolio and occupancy strategy, and global incentives negotiations. Matt has 22 years of experience assisting corporations with complex footprint configuration initiatives that achieve revenue, margin, integration and innovation objectives. He has conducted more than 400 related engagements for corporate clients and has recently negotiated investment agreements valued at more than US$6 billion. 

Having dedicated a career to global challenges, Matt brings a unique perspective to solving such issues. He has worked extensively in many of the world’s key investment markets.

Matt has been interviewed and written articles on global location footprint strategy, portfolio and occupancy related topics for Time International, Industry Week, LA Business Journal, USA today, Commercial Property News, Business Expansion Journal, CoreNet, Global Corporate Xpansion, Area Development, Supply Chain Management, Pharmaceutical Commerce and the Journal of Business Strategy. He is also a frequent presenter at industry conferences such as CoreNet, and IAMC. 

Joe Judge –  Executive Managing Director of MedTech & Life Sciences, JLL

Joe Judge is an Executive Managing Director of JLL’s MedTech & Life Sciences Practice.  Over the past 24 years Joe has developed relationships with and managed a wide variety of advisory and brokerage assignments ranging from global, national and regional headquarter relocations to consolidation studies for portfolio clients within the Medical Device and Life Science sectors throughout North America and across the globe. Joe is the active President of JLL’s Brokerage Leadership Board, which provides strategic insight to drive and enhance results at every level of JLL’s brokerage business. In 2020, Joe was presented with JLL’s highest honor, The Champion of Excellence, recognizing an employee that most exemplifies their values of teamwork, ethics and excellence. 

Anthony Fernando –  President & CEO, Asensus Surgical

As President and Chief Executive Officer, Mr. Fernando sets the company’s overall strategic vision and oversees its organic growth. Previously, he was the Chief Operating Officer and Chief Technology Officer at Asensus, where he led the company’s technology strategy and global business operations.

Prior to Asensus, Mr. Fernando was Vice President of Innovation and Technology within the International Group at Stryker Corporation, across Stryker’s medical device portfolio. Before joining Stryker, Mr. Fernando held positions at Becton Dickinson & Company as Director, R&D Devices & Global Health, Greater Asia; PerkinElmer Inc. as Director, R&D and CoE Leader in Asia; and Varian, Inc. as Director of Operations/General Manager of the Pharmaceutical Products business unit.

Mr. Fernando earned an MBA from the Kenan-Flagler Business School at the University of North Carolina, Chapel Hill, and MS and BS in Mechanical Engineering with concentrations in Robotics and Automation from the University of Nevada-Las Vegas.

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AdvaMed Commends House AI Taskforce’s Recommendation to Ensure Reimbursement, Expand Access to AI-Enabled Medical Devices https://www.advamed.org/industry-updates/news/advamed-commends-house-ai-taskforces-recommendation-to-ensure-reimbursement-expand-access-to-ai-enabled-medical-devices/ Tue, 17 Dec 2024 22:34:10 +0000 https://www.advamed.org/?post_type=news&p=12668 AdvaMed, the Medtech Association, commended the House of Representatives’ bipartisan Task Force on Artificial Intelligence for urging the Centers for Medicare & Medicaid Services (CMS) to develop a formalized payment pathway for AI-enabled medical devices. AI-enabled medical devices are FDA-cleared and produce clinical information to aid in patient diagnosis or treatment.

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Digital Health

Washington, D.C. – AdvaMed, the Medtech Association, commended the House of Representatives’ bipartisan Task Force on Artificial Intelligence for urging the Centers for Medicare & Medicaid Services (CMS) to develop a formalized payment pathway for AI-enabled medical devices. AI-enabled medical devices are FDA-cleared and produce clinical information to aid in patient diagnosis or treatment.

The Task Force highlights AI-enabled medical devices, stating, “Considering that AI tools streamline these practices and reduce time spent on services, current payment mechanisms cannot adequately reimburse these tools. Certainly, there will be no ‘one size fits all’ reimbursement policy for every AI technology, and developing appropriate payment mechanisms requires recognition of varying kinds of technology and clinical settings. For example, many AI technologies may fit into existing benefit categories or facility fees. Congress should continue to evaluate emerging technologies to ensure Medicare benefits adequately recognize appropriate AI-related medical technologies.”

The report went on to highlight the importance of data access, stating, “Policymakers could also develop or expand high-quality data access mechanisms that ensure the protection of patient data,” citing industry standards as a key path toward that goal. AdvaMed, which was recently accredited by the American National Standards Institute to develop industry standards for medical device innovation, looks forward to working alongside policymakers to enact policies that facilitate access to data and support standards development.

AdvaMed agrees with the Task Force suggestion that the Department of Commerce and other government agencies can learn more about AI risk mitigations through collaboration with the Food and Drug Administration (FDA) and the Department of Health & Human Services (HHS). AdvaMed stands ready to work with policymakers and the FDA to develop improved guidance for AI-enabled devices in the post-market space, as suggested in the report. 

Scott Whitaker, President and CEO of AdvaMed, said: “We thank these House lawmakers for their leadership and commitment to improving patient access to innovative medical devices. We look forward to continuing to work with CMS, patients, and policymakers to establish sensible, efficient Medicare coverage and reimbursement policies.”

Dr. Taha Kass-Hout, Global Chief Science and Technology Officer, GE HealthCare, and Chair of the AdvaMed Digital Health Tech Board of Directors, participated in an AI Task Force Panel examining Healthcare Applications. Each of the 15 AI Task Force Panels helped inform the report.

The Task Force’s report comes after continued advocacy in support of AI-enabled medical devices, including a bipartisan Senate letter and a patient sign-on letter sent to Congress earlier this year.

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Strategic Risk Assessment in Medical Device Compliance: Proactive Strategies for Effective Risk Management Webinar https://www.advamed.org/events/strategic-risk-assessment-in-medical-device-compliance-proactive-strategies-for-effective-risk-management-webinar/ Thu, 12 Dec 2024 16:08:41 +0000 https://www.advamed.org/?post_type=event&p=12569 Join Porzio in this session that will help med device compliance leaders with messaging, designing, and implementing risk assessments, a key component of an effective healthcare compliance program.

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Events

AdvaMed 2025 State Policy Briefing: Data Privacy

AdvaMed 2025 State Policy Briefing: Data Privacy

  1. Overview
  2. Speakers

AdvaMed 2025 State Policy Briefing: Data Privacy

Join Porzio, Bromberg, & Newman, P.C. in this webinar discussion: In the rapidly evolving landscape of medical device regulation, a thorough risk assessment is essential to identify, mitigate, and manage compliance risks. This interactive session provides in-house compliance teams with actionable insights into conducting comprehensive risk assessments tailored specifically to the medical device sector.

Attendees will gain practical knowledge on risk identification, prioritization, assessment methodologies, and compliance risk mitigation strategies that reduce regulatory exposure. Through real-world case studies and discussion of industry best practices, this session will help med device compliance leaders with messaging, designing, and implementing risk assessments, a key component of an effective healthcare compliance program.

Meet The Speakers

Jennifer A. Romanski, Principal, Life Sciences Legal, Regulatory, and Compliance – Porzio, Bromberg & Newman, P.C.

Ms. Romanski, chair of the firm’s Life Sciences Legal, Regulatory, and Compliance Practice Group, has broad experience counseling pharmaceutical, biotech and medical device companies in regulatory and compliance matters, including preparation of corporate compliance programs, advertising and promotion activities, medical publication planning, interactions with healthcare practitioners, grants and continuing medical education programs, FDA enforcement activity, and sample accountability and PDMA requirements. She worked for many years in Porzio’s Key Client program where she served as part of the in-house legal team for various pharmaceutical companies several days a week. She has also served as acting compliance director at a large pharmaceutical company, where she was involved in over twenty compliance reviews and investigations.

She has drafted contracts with co-promotion partners, direct mail companies, medical publication facilitators, and market research organizations. She has provided counsel on implementation of compliance measures for research and development companies, with emphasis on pre-market requirements, clinical trial registration and disclosure, and patient recruitment. In addition, she regularly counsels clients on compliance with state marketing disclosure reporting laws and the new requirements under the Patient Protection and Affordable Care Act, including compliance with healthcare practitioner transparency requirements.

Michelle D. Axelrod, Principal, Life Sciences Legal, Regulatory, and Compliance – Porzio, Bromberg & Newman, P.C.

Michelle Axelrod is a principal of Porzio, Bromberg & Newman P.C. in the Life Sciences Compliance and Regulatory Counseling team, a member of the firm’s Management Committee, and a Board Member of Porzio Compliance Services, a wholly-owned subsidiary of the firm. Michelle has over 25 years of experience addressing legal and compliance issues impacting companies in the life sciences industry; 15 years as in-house counsel.  Michelle advises pharmaceutical, biotech, and medical device clients on legal and compliance issues through all stages of development, from clinical stage through commercialization. She counsels on clinical trial related compliance matters, communications and recruitment matters, and on product commercialization and related sales, marketing and reimbursement activities, including fraud and abuse. She also advises on privacy matters and supports clients’ compliance initiatives, including conducting compliance assessments/audits, and developing and implementing compliance programs, policies/SOPs, training, and monitoring and auditing programs.  Michelle also negotiates, drafts and reviews various types of agreements common to the life sciences industry. 

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Life Sciences Strategy and Innovation https://www.advamed.org/member-center/resource-library/life-sciences-strategy-and-innovation/ Wed, 04 Dec 2024 19:25:00 +0000 https://www.advamed.org/?post_type=resource&p=12515 This white paper explores the evolution of current biopharmaceutical commercial models. By addressing key considerations essential for every healthcare leader, this shares the impact of integrating
digital assets clinician engagement
and enhancing health outcomes.

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Digital Health

In the past decade, advancements in scientific research and digital innovation have revolutionized healthcare, with patients, caregivers and clinicians alike reaping the benefits. At the same time, traditional clinical research has been augmented by new and expanded data sets that have accelerated the ability to identify diseases with precision, leading to targeted and effective treatments. Consider breast cancer:

The extraordinary clinical advancements seen in breast cancer are mirrored in other disease categories, most notably multiple myeloma (MM), where clinical improvements go beyond quality of life to possible cures. And while these advancements hint at a bright future for patient outcomes, a noticeable disparity remains.

So, what can be done to bridge the gap?

Using MM as an example, this white paper explores the evolution of current biopharmaceutical commercial models. By addressing key considerations essential for every healthcare leader, we illustrate the profound impact of integrating digital assets — from reshaping commercial frameworks and bolstering patient support to deepening clinician engagement and markedly enhancing health outcomes.

 Download the white paper now.

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Transforming Digital Innovation to Business Reality in Life Sciences https://www.advamed.org/member-center/resource-library/transforming-digital-innovation-to-business-reality-in-life-sciences/ Wed, 04 Dec 2024 19:17:23 +0000 https://www.advamed.org/?post_type=resource&p=12509 The industry is at the forefront of physical and digital technologies, with implications for research, development, manufacturing and patient care. Digital technologies and workflows can unlock discoveries, leading
to new markets, opportunities and better outcomes.

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Digital Health

The life sciences industry is at the forefront of physical and digital technologies, with implications for research, development, manufacturing and patient care. In historically physical-centric life sciences businesses, the move to digital solutions is an essential and increasingly complex transformation imperative. Digital technologies and workflows can unlock our physical discoveries and tools, leading to new markets, opportunities and better outcomes.

With a honed methodology for physical-digital product transformation, life sciences companies can help your teams and projects cross this divide. In this white paper, we break down a ‘system’ that we’ve used with our clients for change management and digital transformation.

Read our white paper to learn how you can merge the divide between digital and physical to foster innovation.

 Download the white paper now.

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Being a Trusted Advisor to Medical Device C-Suites During Government Investigations Webinar https://www.advamed.org/events/being-a-trusted-advisor-to-medical-device-c-suites-during-government-investigations-webinar/ Tue, 03 Dec 2024 14:58:13 +0000 https://www.advamed.org/?post_type=event&p=12342 Join King & Spalding for this engaging panel that will cover common experiences and practical considerations for advising medical device company executives during a government investigation.

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Events

AdvaMed 2025 State Policy Briefing: Data Privacy

AdvaMed 2025 State Policy Briefing: Data Privacy

  1. Overview
  2. Speakers

AdvaMed 2025 State Policy Briefing: Data Privacy

Join King & Spalding for this engaging panel that will cover common experiences and practical considerations for advising medical device company executives during a government investigation.  A range of topics will be discussed, including engaging with the board of directors, keeping executives apprised of developments in the investigation, making disclosures in SEC filings and communications with investors, common questions and complications around potential individual liability for executives, the importance of achieving business objectives with compliance considerations, and garnering support from executives for business process changes and compliance enhancements made during an investigation.  

Meet The Speakers

John C Richter – Partner, King & Spalding

John Richter is a trial and investigations partner in the special matters and government investigations practice group, often representing medical device and other types of companies in high-stakes enforcement investigations, cases, and trials in federal districts across the U.S. and with the litigating divisions at DOJ in Washington, D.C. John brings more than 30 years of legal experience in his defense of companies, boards of directors, board committees, and executives facing enforcement action, parallel civil actions, and administrative proceedings.  John previously served as the acting Assistant Attorney General in charge of the Criminal Division at DOJ, as the presidentially appointed and Senate-confirmed U.S. Attorney for the Western District of Oklahoma, as an Assistant U.S. Attorney in Georgia and Oklahoma, and as an Assistant District Attorney in Georgia.

Ethan P. Davis –  Partner, King & Spalding

Dustin is a health care and medical devices expert, specializing in leading integrated digital transformation programs across product, business, technology, and experience. With a strong focus on innovation, he guides teams in qualitative research to inform strategic roadmaps and drive new-to-market offerings. His multi-disciplinary background in brand strategy, marketing, and interaction design allows him to communicate vision and change management effectively to C-Suite leaders and teams, crafting human-centric solutions that resonate in the marketplace.

Brian A. Bohnenkamp –  Partner, King & Spalding

Brian Bohnenkamp is a partner in the FDA and life sciences practice. He has extensive experience counseling pharmaceutical and device manufacturers on fraud and abuse laws and industry codes of conduct, including the PhRMA and AdvaMed codes. Brian often serves as a thought partner and sounding board to senior compliance and legal professionals. He spends much of his day-to-day working with in-house colleagues on various compliance questions, proposals and arrangements proposed by their businesses.

Sophie Hafley –  Associate, King & Spalding

Sophie Hafley focuses her practice on the regulation of pharmaceuticals and medical devices, as well as healthcare providers and suppliers. Specifically, Sophie advises companies on healthcare fraud and abuse matters, including analyzing arrangements under the AKS and assisting with government and internal investigations. Sophie also provides counsel on a range of state law issues, including drug price transparency, licensing and the corporate practice of medicine.

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Preparing for the FDA’s Quality Management System Regulation (QMSR) Rollout in 2026 – Understanding the changes and aligning with ISO 13485 Webinar https://www.advamed.org/events/preparing-for-the-fdas-quality-management-system-regulation-qmsr-rollout-in-2026-understanding-the-changes-and-aligning-with-iso-13485-webinar/ Tue, 03 Dec 2024 14:57:34 +0000 https://www.advamed.org/?post_type=event&p=12480 Join Lachman Consultants for a webinar that will equip medical device companies with the knowledge to navigate the upcoming FDA QMSR changes set for 2026.

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Events

AdvaMed 2025 State Policy Briefing: Data Privacy

AdvaMed 2025 State Policy Briefing: Data Privacy

  1. Overview
  2. Speakers

AdvaMed 2025 State Policy Briefing: Data Privacy

Join Lachman Consultants for a webinar that will equip medical device companies with the knowledge to navigate the upcoming FDA QMSR changes set for 2026. Key topics include a thorough understanding of the new regulations, how they integrate with ISO 13485, and what companies need to do to maintain compliance. Attendees will gain insights into the practical steps required to update quality systems, prepare for FDA inspections, and avoid compliance pitfalls during the transition. This is a must-attend for quality and regulatory professionals in the medical device industry.

Meet The Speakers

David Day, Director of Compliance, Lachman Consultants

David Day, M.Sc. is a Director at Lachman Consultants with 20+ years of experience in the medical device industry. Career highlights include attainment of MDR 2017/745 certification for Class III medical device, multiple successful FDA inspections, Notified Body and ANVISA audits. He has worked on a wide variety of products from conventional vascular devices to combination products.

He is a quality and regulatory professional who brings strong technical skills across a range of areas – Quality Systems, Operations, Change Management and Design Assurance. He is experienced in Quality Management Systems compliant to 21 CFR 820, 21 CFR Part 4 and ISO 13485. He is proficient in EU MDR 2017/745, MDD 93/42 and UK MDR 2002. He has been responsible for technical file development, Post Market Surveillance programs, Internal Audit programs and continuous improvement projects. He has extensive Project Management experience in complex regulatory and product changes. David is also proficient in external audit preparation and management with Notified Bodies (BSI, TUV, Dekra), FDA and ANVISA.




Deanna Anderson, Sr. Director of Medical Compliance, Lachman Consultants

Deanna Anderson is a Senior Director at Lachman Consultants who has more than 25 years of pharmaceutical, medical device and combination products experience in Quality Assurance, Compliance, Manufacturing and Laboratories. A practiced audit and compliance management professional with experience working collaboratively with top leaders and staff to optimize adherence to policies, procedures, standards, and regulations. Career highlights include experienced in comprehensive analysis of operations, recommending process improvements, introducing best practices, and supporting development of talented teams. Experienced leader of site remediations to address regulatory agency enforcement actions.

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The AI-Enabled Supply Chain: End-to-End Visibility and Enhanced Decision-Making Webinar https://www.advamed.org/events/the-ai-enabled-supply-chain-end-to-end-visibility-and-enhanced-decision-making-webinar/ Tue, 03 Dec 2024 14:54:56 +0000 https://www.advamed.org/?post_type=event&p=12484 Join EPAM for an engaging webinar that explores how AI is reshaping the supply chain into a data-rich environment.

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Events

AdvaMed 2025 State Policy Briefing: Data Privacy

AdvaMed 2025 State Policy Briefing: Data Privacy

  1. Overview
  2. Speakers

AdvaMed 2025 State Policy Briefing: Data Privacy

Join EPAM for an engaging webinar that explores how AI is reshaping the supply chain into a data-rich environment. Our expert speakers will delve into how emerging technologies are transforming supply chain management, from demand planning to direct-to-consumer delivery. Discover how continuous data availability and advancements in AI and data analytics are setting a new standard for supply chain management. This session will outline the foundational elements required for advanced analytics and how control towers, digital twins, and intelligent agents are reshaping the future of supply chain management.

Don’t miss this opportunity to learn how your organization can harness these changes for a more connected and effective healthcare ecosystem.

Meet The Speakers

Joe Vernon, Principal of Supply Chain Consulting, EPAM

Joe Vernon is Principal Business Consultant at EPAM Systems focused on supply chain emerging technologies and the application of AI. His 25 years of experience combines knowledge of best-in-class technologies with process redesign, creative solutioning, optimization strategy, and manufacturing and distribution operations. His customer portfolio spans across multiple industries, including retail, CPG, healthcare and telecommunications. Prior to joining EPAM, Mr. Vernon led multiple supply chain transformation road-map assessments and AI and analytics POC engagements for Fortune 100 companies. 

  • 25+ years of supply chain and manufacturing operations consulting and industry experience
  • End to End supply chain process engineering and technology enablement
  • Transformation and Next-Gen technology roadmap creation and thought leadership in digital twin, computer vision and AI-enabled capabilities

Aaron Attermann, Sr. Manager of Supply Chain Consulting, EPAM

Aaron Attermann is a Senior Manager in EPAM’s Supply Chain Business Consulting Practice.  He focuses on supporting Life Science and Medical Device companies to deliver on their Digital Supply Chain journeys.  Aaron has over 5 years tenure at EPAM.  Before EPAM, Aaron worked in consulting at Cognizant and in industry at FMC Corporation, in addition to serving 6 years in the United States Army.  He holds an MBA from the Tepper School of Business at Carnegie Mellon University, and a Bachelor degree in Chemistry/Life Sciences from the United States Military Academy.  Outside work, Aaron volunteers with the Civil Air Patrol, works during the winter as a Ski Patroller, and enjoys spending time with his family.

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