The growth and advancement of medical technology has reached unprecedented levels in the past few decades, and has significantly impacted our world from both a commercial and personal perspective. Medical device companies and the devices that they produce have permanently changed our lives, our families, the manner in which we conduct business, and each of us in how we conduct our daily lives.
Various sources estimate that the global medical device market is expected to grow to $800 billion (USD) by 2025*, and will continue to grow at a rapid rate.
There are several factors that make the medical device manufacturing market a sector of marked and continuous growth, with some key factors to be explored in this article.
The Global Community - Specific Needs:
According to the World Health Organization (WHO), a growing demographic transition to older populations is expected, not only in the United States, but also globally. This therefore calls for a comprehensive response from the health system, with the need to keep pace with the sustained increase in life expectancy.
There are also legal and regulatory frameworks such as "The Political Declaration and the Madrid International Plan of Action on Aging”, as well as international human rights and other national standards such as the "Affordable Care Act 2010" that favor and encourage the implementation and development of a comprehensive health system that can respond to this need, in old age and in any age segment.
In the US, the consequent manifestation of chronic diseases provided by the increase in life expectancy, added to the increase in the number of people who can access the health system due to the "Act 2010", has generated a need for a priority solution.
Response from Global Regulatory Bodies:
In the past decades, agencies around the world have become increasingly regulated in response to the growing complexity of medical products and the potential risks to the health of patients and caregivers that this complexity creates. In addition, other organizations and third parties, often through cross functional working groups and other partnerships across the public sector, industry and healthcare professionals, have made great advancements in standardization and guidance to industry in support of device compliance.
Various government agencies have been at the forefront of this increasing regulation and have taken varying approaches with respect to compliance and enforcement. Some government agencies have become increasingly robust with their requirements, while others have taken a milder approach, and in some cases have added exemptions and/or greater flexibility for device manufacturers in recent years.
A sampling of some key markets and the approach and strategy taken by their associated regulatory agencies are included below:
Health Canada – All in with MDSAP:
The Canadian market (with Health Canada as its governing regulatory body) became the
first agency to require compliance to the Medical Device Single Audit Program (MDSAP) for market access. This requirement for market access has been a significant incentive for program adoption by device manufacturers and is often implemented as part of their overall ISO 13485 quality systems strategy. MDSAP compliance has become increasingly popular among these manufacturers for the benefits it offers. With MDSAP compliance, manufacturer use an MDSAP-accredited certification body to complete an assessment on behalf of the 5 MDSAP participating countries, consolidating the requirements of 5 different countries into a single review. This certification can offer significant savings of time and money by eliminating the need for routine agency inspections, shortens the review process and/or expedites approvals for easier, faster entry into markets, among other factors.
CE Marking and Clinical Evidence in the European Community:
There has been an ongoing joke (or light-hearted suggestion) among industry professionals that the acronym CE no longer stands for European conformity, but rather for clinical evaluation, due to the significant increase in clinical literature review, research and / or evaluation now required for CE marking and access into the European community for many categories of devices. The publication of the medical device regulation (MDR) in 2017 replaces and supersedes the former Medical Device Directive (MDD) from 1993, and has adopted greater overall controls with respect to device safety and effectiveness.
Australia and Others Follow the CE Lead:
The Therapeutic Goods Administration (TGA) in Australia acknowledges the CE mark, and device manufacturers often leverage this CE mark compliance to fast track market entry. In addition, various other markets globally also use unofficially the CE mark as a dependency with their review and approval process.
The United States – Taking a Complementary Approach:
In contrast to the increasing regulations and controls applied throughout the European community, the US Food and Drug Administration (FDA) has taken a quite different approach over the past several years, allowing greater flexibility for device manufacturers. Among these actions, the FDA has exempted certain product categories, especially that of lower risk class devices, to increase and improve the accessibility to the US market.
An example of these exemptions is from 2016, when the Food and Drug Administration (FDA) published a list of class II Product Codes it proposed to exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). The exemption applies to hundreds of different product codes and types of Medical Devices, including many electrically operated devices. Given the low-risk nature of the devices included in these Product Codes, the FDA believed that these exemptions would relieve manufacturers from the need to submit premarket notification submissions for these devices and would enable the FDA to redirect the resources to issues identified as higher priority. Since its publication, numerous device manufacturers have leveraged this exemption to gain Access to the US market with a comparatively lower investment in time and resources.
Key offices supporting the areas of device compliance and enforcement include the Center for Devices and Radiological Health (CDRH) and the Office of Regulatory Affairs (ORA).
US and EU – Two Key Markets to Global Access:
It is generally acknowledged throughout industry that both CE marking for the European community as well as US approval / clearance, working together, serve as launching pads to global market access. These two critical market areas are typically seen as staples and key dependencies for the global rollout of new device offerings, as various markets globally use these market approvals as either a basis for their own country submissions or otherwise fast track their own approval process.
Response from Global Industry:
Companies have responded to this need with pronounced, though not always solid growth, both in start ups and large established companies, and a wide network of collaborators worldwide, with objectives to provide increasingly cost-effective products, as well as permanent innovation. Large companies have adopted inorganic methods to grow substantially and embrace greater diversity, such as mergers and acquisitions of other smaller and more specialized companies. This competition among a few large companies is expected to be countered by the constant birth of new companies.
There are various challenges facing medical device manufacturers, including but not limited to the following:
· Speed of production and the resulting quantity
· Achieving cost-effectiveness
· Reducing product recalls
· Launching less and less invasive products (improvements in minimally invasive devices)
In addition to changing regulations by government agencies, other third party organizations throughout the medical device industry have responded to this growth through publication of global quality systems standards, performance standards, industry guidance for manufacturers, among various other activities and factors that impact device manufacturers globally.
A list of some key third party organizations which serve in the development and publication of guidance and standards for industry are included below for reference:
· International Organization for Standardization (ISO)
· MEDDEV (Guidance Documents developed on behalf of the European Commission
· International Electrotechnical Commission (IEC)
· ASTM International
The Market in Numbers:
Currently the global medical device market is worth US$ 442 billion, and the US has an approximate 40% segment with US$177 billion compound annual growth. Annual growth is forecast at 5% through 2028.*
Market Segments:
The medical device market is commonly categorized into various segments, often based on factors such as indications for use, intended use and risk, and include the following categories of devices:
· Diagnostic imaging
· Consumables
· Patient assistance
· Orthopedics
· Other
Diagnostic imaging leads the largest segment of the market and offers sustained growth. This is because it not only offers a wide range of options when it comes to diagnosing diseases, but also represents some of the most accurate and appropriate methods for the early detection of diseases. This generates one of the most favorable advantages in improving the quality of life of people, reducing morbidity and mortality and in turn triggers the relief of the health system at all levels, both in time and in other human and economic resources.
Conclusion - A Bright Future with Opportunities and Challenges
The medical device industry generates and will undoubtedly generate great opportunities for human improvement in the quality of life of patients, as well as an integral relief of the health system, and a positive collateral impact on the economy by generating thousands of jobs of different kinds around the world.
In addition to this great potential for advancement in human quality of life, there exists great opportunities as well as challenges for global device manufacturers. With the ever-changing dynamics with respect to global regulation and its resulting impact to global market Access, device businesses Will need to incorporate effective planning, assessment, and execution as part of their overall global strategy to ensure their long-term success.
* www.bccresearch.com; www.grandviewresearch.com; Nagarro: Analysis of the global medical device market, July 2021.
Resources:
EU Medical Device Regulation (MDR):
FDA Class I and Class II Device Exemptions:
Medical Device Single Audit Program (MDSAP) Overview (from the FDA):
MEDDEV:
ASTM International:
International Electrotechnical Commission:
댓글