Medical Device Emerging Markets - Market Access & Obstacles

Speaker

Instructor: James W Monroe
Product ID: 706493
Training Level: Intermediate

Location
  • Duration: 60 Min
This webinar will focus on "non-traditional" medical device markets, challenges to market access including competitors and government regulation or lack thereof. Outside of the most developed countries, there are many areas in the world, not as developed, where registration and marketing of medical devices is extremely lucrative. These include: Latin America (LATAM), Asia Pacific (APAC), and The Middle East (EMEA).
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Why Should You Attend:

  • Does your company operate internationally?
  • Awareness of Emerging Markets establishing FDA/EU Like Regulations
  • Are there untapped markets where your company can enter and provide medical device rapidly that are cost effective?
  • Understanding how to leverage legacy devices in markets where there is a lower barrier to market access.
  • What does the competition look like in these markets?

The obstacles include:

  • Limited financial resources and a frugal attitude toward spending on healthcare
  • Multiple customer segments and efficiency issues
  • Underdeveloped medical infrastructure and workforce
  • Adoption of new technology
  • Inconsistent regulatory and reimbursement guidelines
  • Competition from regional start-ups

In this webinar, we will examine how to overcome these barriers.

Areas Covered in the Webinar:

  • Market Access
  • Market drivers and restraints
  • Local governments: obstacles & hurdles
  • Political Environment
  • Infrastructure Requirements
  • Regulatory structure and government support
  • Cost of product development
    • Pricing and Reimbursement
    • Profitability
  • Competitors

Who Will Benefit:

  • Consultants
  • Marketing Executives
  • Medical Device Manufacturers
  • Regulatory Specialist
  • Investors
Instructor Profile:
James W Monroe

James W Monroe
President and CEO, Global RQC Med Device Solutions

Over the past 20 years James has been exclusively involved in the medical device field focusing on Regulatory Affairs and Quality Assurance. Within this arena he has focused on getting medical devices registered globally. His background and track record demonstrates his leadership, from product concept through obsolescence, by (1.) ensuring regulatory compliance, (2.) providing strategic, tactical and operational direction and support for working within the regulations to expedite the development of safe and effective products, (3.) preparing/submitting submissions and managing communications with the Regulatory Bodies, and (4.) keeping up-to-date with changes to the regulatory environment, science and technology, the medical device industry and the healthcare sector through regulatory intelligence.

His regulatory focus is to develop and execute regulatory strategies for client domestically and internationally. He has successful gain multiple 510(k) clearances in the US, and approvals in the EU, Canada, South Korea, and Japan. He is at the forefront of regulatory intelligence staying abreast of the ever-changing medical device requirements globally. His device specialties include but are not limited to: Electro-mechanical and software driven devices, in-vitro diagnostics, digital health (Software as Medical Device, Artificial Intelligence, Machine Learning, Cybersecurity), and Risk Management.

He also holds both a Bachelors and Masters of Electrical Engineering. His Post-Graduate studies were conducted in the Department of Radiology at The Ohio State University where he developed hardware and software applications for the MRI systems and accessories. He has published multiple peer reviewed papers on image processing of medical images for image improvement.

He has held several leadership positions within regulatory and quality including: Director of Regulatory and Clinical at Pharmatech Associates-Medical Devices, Director Regulatory, Pentax Medical, Director of Regulatory & Quality at Immacor Inc., Interim Director at Convatec Inc., Manager of Regulatory at B. Braun Medical. In his role as a consultant he has worked globally with clients as the key regulatory expert responsible for developing regulatory strategies and gaining approval/clearance in multiple countries. He has also served as a 3rd party reviewer for the FDA’s 510(k) program at Intertek.

He has received clearance of over 35 510(k)”s, o f which 90%, involved software. More recently he has focused his regulatory experience in the area of digital health that includes: Software as Medical Device, Artificial Intelligence, Machine Learning, Cybersecurity, and Risk Management. He has also served as a 3rd party reviewer for the FDA’s 510(k) program.

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