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Embracing Regulatory Change to Improve Market Access
Mike King, Senior Director, Product & Strategy, IQVIA
Mar 06, 2024
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  • Embracing Regulatory Change to Improve Market Access

How can MedTech organizations ensure their products reach global markets?

The MedTech industry is an innovative and rapidly changing healthcare sector, with regulatory bodies working hard to keep up with technological advances, especially with the increased focus on artificial intelligence (AI). Whilst regulations used to be seen as a barrier to business, the activities of quality and regulatory professionals are increasingly recognized as integral to business and key to market access.

There are an estimated two million different types of medical devices on the world market, with global revenue projected to reach US$511.20bn by the end of this year.1,2 In the US alone, revenue in the medical devices market is projected to reach US$182bn.2 The medical device industry is ‘poised for steady growth’, with global annual sales forecast to reach nearly US$800 billion by 2030.3

Manufacturers of medical devices, like all life sciences organizations, must meet regulatory requirements and global standards to develop and market their products, so patients have access to high quality, safe and effective medical devices. ‘When appropriately implemented, regulation ensures public health benefit and the safety of patients, health care workers and the community.’4

‘Gone are the days where regulation was seen as an obstacle to selling products, now it’s becoming something that’s to be embraced.’ Gabriel Adusei, Founder of Triune Technologies Limited

The public rightly demand high quality products and quality and regulatory professionals, along with the regulators themselves, are there to ensure products that go to market are safe for use. When product quality fails, or when unapproved products reach the market, the results can negatively affect patient health.

Regulation of medical devices used to be heavily based on global standards; now there’s a more stringent, and more risk-averse approach with MedTech organizations having a legal imperative to be compliant with advancing regulations and standards in many regions. This approach has led to increased complexity within the industry as regulators work to keep up with evolving technology – including the integration of AI into medical devices and quality management systems – and manufacturers work to keep up with evolving regulations.

‘From innovation through to procurement QARA professionals are getting more involved in how products are getting developed and their route to the patient.’ Phil Brown, Director, Regulatory and Compliance, ABHI

Manufacturers must consider not just changing regulations but regulations that are specific to the market they want to access. For example, regulatory requirements set out by the Food and Drug Administration (FDA) to access the US market may differ from the European Union Medical Device Regulation (EU MDR) requirements for European market access and the regulations set out by the Medicines and Healthcare products Regulatory Agency (MHRA) for devices to be placed in the UK market. This has cost implications for manufacturers and can prevent innovations that are deemed safe in one country from being used in another, denying patients access to products which could improve their health outcomes.

In 2011 the International Medical Device Regulators Forum (IMDRF) was established to ‘accelerate international medical device harmonization and convergence’.5 While it may be inevitable that political and economic factors prevent complete global harmonization, at least for the foreseeable future, there remains a real need for it in order to minimize regulatory barriers, facilitate trade between different countries and reduce the cost burden of implementing regulations for governments, and for the medical device industry.3

A company’s quality management system (QMS) must talk to their regulatory strategy and integrate regulatory requirements in order to achieve compliance. In advanced, end-to-end, systems AI and machine learning (ML) can be used to help quality and regulatory professionals understand the regulatory requirements of different countries and regions and what is needed to be captured early in the design phase in order for their product to comply with these requirements.

‘A lot of SMEs cut corners and hope the law doesn’t apply to them. It does. Find out what regulations are required and how to comply with them. Outsource. Do not build your own regulatory system from scratch, get expert advice.’  Alex Denoon, Partner and Head of Life Sciences and Regulatory Team, Bristows LLP

To learn more about evolving regulations, how public awareness can be a driver of regulatory change and what experts really think about global harmonization of medical device regulations, watch The Future of Quality, Regulatory and Safety in the MedTech Industry.

 

References:

  1. https://www.who.int/health-topics/medical-devices#tab=tab_1
  2. https://www.statista.com/outlook/hmo/medical-technology/medical-devices/worldwide#:~:text=Revenue%20in%20the%20Medical%20Devices,US%24511.20bn%20in%202024
  3. https://www.sciencedirect.com/topics/engineering/medical-device-industry
  4. https://www.who.int/europe/activities/regulating-medical-products#:~:text=Medical%20devices&text=When%20appropriately%20implemented%2C%20regulation%20ensures,care%20workers%20and%20the%20community
  5. https://www.imdrf.org/about

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