Global Health

The MedTech Conference provides the ideal environment for medtech professionals to learn about and discuss favorable market access and reimbursement in foreign markets.

Below are just a few of the Global Health sessions that were offered at The MedTech Conference in 2019. The 2020 conference program will be available June 2020.

View the 2019 full conference program

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MDR/IVDR – What NOW?

Implementation of the MDR/IVDR remains problematic. Relevant and necessary implementing acts remain in limbo, notified body capacity does not appear sufficient to be able to do the necessary reviews in advance of the deadlines and many additional technical questions remain unresolved. This panel addressed the fundamental issues in implementing the regulations, as well as offered perspective on potential mechanisms that could be utilized to reduce the review backlog and ensure products can remain on the market in the EU. The panel had wide representation from industry, regulators, consultants, and notified bodies. The session provided a comprehensive update of the scenarios that are likely to unfold in the coming months and offered insight into how these may be addressed.

Revolutionizing the Silver Economy

Aging has taken on a persona of its own. It is not just about people getting older, it represents a fundamental paradigm shift about how we live, work and achieve fulfilling lives. It also entails dramatic decreases in the size of the productive workforce, the number of qualified physicians and the availability of care givers across society. Whether it is called the “Silver Tsunami,” the “Longevity Economy” or the “Silver Economy,” the realities, opportunities and risks are ever more present. Longevity is an all-encompassing megatrend with social, political, economic and security implications that will impact governments, nations, companies and health care.

The percentage of the world’s population over 60 years of age will jump from 12% to 22% between 2000 and 2050, and for those over 80 it will quadruple. In the U.S. alone, 15.6% of the population is now over 65 and by 2030 this will increase to 20.6%. Japan, with nearly 100,000 citizens who have reached the age of 100 or older, and Finland are two of the fastest “graying” and “super graying” populations, with Europe not too far behind.

Health care systems are watching, acting and learning. With aging comes geriatric diseases, comorbidities and loneliness. The need to diagnose these disease states faster and more accurately is critical. Digital technologies have proven to be valuable assets, though more computational horsepower is needed to optimize them and address anticipated future needs. Physicians are also relying on AI-based automation fueled by automatic tracking of biometric information for certain tasks. AI is also helping patients and their families understand diseases and treatment options. But is the key AI or IA, intelligence augmentation, where machines extend human capabilities instead of replacing them? Human versus machine is a tricky subject. People need to feel comfortable for the technology to work and deliver impact. Referred to as the “uncanny valley,” the balance between man and robot interaction still needs work.

A recent Smithsonian article states “The tension between what technology can now do and how much older people actually use it is at the heart of what’s become known as ‘connected aging.’” Experts in aging, health care, policy and technology from Japan, Finland, Australia, the U.K. and U.S. discussed this exciting opportunity and how their countries are leveraging digital platforms, AI and other cutting-edge technologies for elderly care and economic benefit.

SME MedTech Innovations that are Transforming Health Care in the US and Abroad

Given the complexities of payment, policy and care delivery ecosystems in low and middle Income countries it should come as no surprise that change agents in these regions are developing innovations with the potential to transform health systems not only in their own communities but in countries of all sizes around the world. Fostering breakthroughs in health care delivery models, affordable technologies, and more, these organizations are creating new pathways to improving health care quality and access while challenging the paradigm of modern day patient care.

International Digital Testbeds: Perspectives on Partnerships and Organic Investment Models

As monetization of big data and the trend away from the traditional unit sales model takes the medical device industry by storm, questions around digital strategy move from “if” to “how.” In an outcomes-based market where data has quickly become a product’s value driver, manufacturers inevitably come to a fork in the road: invest in-house or partner? The panel offered perspectives on both routes, from efficiencies realized through partnered drug/device adherence programs to in-house digital R&D programs supporting enhanced patient experience, testing scalable models in international markets.

China Market Access Updates – Regulatory, Clinical, Reimbursement & IP

China is the 2nd largest medtech market with 20% annual growth rate. The session will cover key China market access updates: NMPA (CFDA) Major regulatory and clinical affairs updates, IP reform, Reimbursement and their implications on overseas manufacturers.

China NMPA (CFDA):

Recent Developments in China Medical and IVD Devices: MAH/Legal Agents and the Implications in local manufacturing and product registration. China Post Market Compliance and the mandatory reporting. Innovation, companion diagnostic/biomarker(CDx), combination device classification, Registration Guidelines Revision Plan.

UDI has implications on everyone. What is its status and implementation?
China is reforming its IP law. What is the status with IP protection for both domestic and overseas companies?

China NMPA (CFDA) Clinical Affairs Key Updates:

Clinical updates to support regulatory registration and compliance: as the chairing country for the IMDRF clinical evaluation committee, what are the latest updates in the real world evidence, clinical trial/evaluation, international clinical data acceptance guideline? How do you know which path to take or combine to mitigate the clinical trial requirements?

Has the acceptance of overseas clinical data been successful in avoiding clinical trial or reducing clinical trial sample size? How to provide Chinese ethnic justification?

China Reimbursement Reform:

China reimbursement framework and concepts: high level key differences between China and US reimbursement systems, China provincial vs national reimbursement vs private payment systems.

US based executive practical perspectives on prioritizing China provincial reimbursements efforts, obtaining patient charge codes and reimbursements for new product and existing product codes and reimbursements. What are the lessons learned?