Navigating the Future of Market Access: A Comprehensive Guide

1. Navigating the Future of Market Access

1.1 Introduction

The healthcare landscape is undergoing a seismic shift, accelerated by global challenges such as the COVID-19 pandemic. This transformation necessitates a reevaluation of traditional market access models. The new paradigm should be built around four key pillars to meet the evolving needs of global healthcare.

1.2 The Genesis and Evolution of Market Access

Market access originated in the early 2000s as a response to the growing influence of payers in healthcare systems. Initially, the focus was on securing reimbursement for new medicines at commercially viable prices. However, the healthcare landscape has evolved dramatically, necessitating a rethinking of market access as both a strategic objective and an operational activity.

1.3 The Four Pillars of Modern Market Access

1.3.1 Pillar 1: Driving Access and Value Across the Product Life Cycle

Market access should be a continuous process that spans the entire product life cycle. This involves not just securing reimbursement but also ensuring the product’s availability through formulary listings and pharmacy penetration.

1.3.2 Pillar 2: Shifting Emphasis from Product Access to Patient Access

The ultimate goal should be to improve patient access to essential therapies. This requires a more holistic approach that considers all barriers to access, including awareness and availability.

1.3.3 Pillar 3: Focus on the ‘Job to be Done’

An integrated approach to market access involves multiple stakeholders and functions within an organisation. Clear ownership of the overall access strategy and process is essential for effective coordination.

1.3.4 Pillar 4: Adding ‘Art’ to the Science

The advent of digital technologies and innovative business models calls for a more creative approach to market access. This includes leveraging data analytics and adopting outcomes-based payment models.

1.4 Regulatory Considerations

When formulating market access strategies, it’s crucial to consider various regulatory frameworks and international standards. Specifically, ISO 13485 for Quality Management Systems in Medical Devices and ISO 14971 for Risk Management in Medical Devices serve as key guidelines. These ISO standards ensure that market access activities meet stringent quality and risk management criteria, thereby aligning with international best practices.

In addition to ISO standards, it’s imperative to be aware of and comply with regional regulations that govern medical devices. These include:

1.5 How Deviceology Can Help

Deviceology, recognised as The Market Access People, specialises in establishing strategic partnerships with clients in the field of Medical Devices. Their expertise encompasses ISO 13485 for Quality Management Systems and ISO 14971 for Risk Management in Medical Devices. They also provide comprehensive guidance through intricate international and local standards, including Medical Devices Regulation in the UK and EU, ANVISA in Brazil, PMDA in Japan, FDA Regulations in the US, Health Canada’s Medical Device Regulations, and the Therapeutic Goods Administration (TGA) standards in Australia.

Deviceology’s services facilitate global market access by helping clients adhere to regulatory obligations, international standards, and local market requirements. They currently specialize in supporting access to the UK, EU, US, Brazil, Japan, Canada, and Australian markets. For more information, you can visit their official website or contact them at

1.6 The Impact of Artificial Intelligence on Regulatory Compliance

The integration of Artificial Intelligence (AI) into medical devices is revolutionising healthcare by enhancing diagnostic capabilities, personalising treatment plans, and improving operational efficiencies. However, the adoption of AI technologies also introduces an additional layer of complexity to regulatory compliance.

1.6.1 The EU Artificial Intelligence Act

The European Union has proposed the Artificial Intelligence Act, aiming to lay down harmonised rules on AI. This act focuses on human-centric AI and aims to ensure that AI technologies are safe and compliant with the law, including the respect of fundamental rights. Medical devices incorporating AI will need to align with these new regulations, adding another layer to the already complex compliance landscape.

1.6.2 Examples of Additional Compliance Burden

1. Risk Assessment: AI algorithms can change over time through machine learning, requiring continuous risk assessment in line with ISO 14971.

2. Data Protection: AI often involves the processing of sensitive health data, requiring stringent data protection measures in compliance with GDPR and other privacy laws.

3. Algorithm Transparency: Regulations may require companies to disclose how AI algorithms make decisions, impacting the design and development processes governed by ISO 13485.

1.6.3 Other Emerging Regulations

While the EU is at the forefront with the AI Act, other jurisdictions like the United States and Japan are also considering similar regulations. Companies must keep abreast of these developments to ensure global market access.

1.7 Conclusion

As the healthcare landscape continues to evolve, the strategic importance of market access is only growing. The new model should be built around the four key pillars discussed above, adapted to meet the evolving needs of global healthcare. Companies must rethink and re-strategise their approach to market access, keeping in line with international regulations and standards.

For those looking to navigate this complex landscape, partnering with experts like Deviceology can provide invaluable support, ensuring compliance with international standards and facilitating global market access.