How can digital health innovators navigate the complex market access landscape in different countries?

Digital health innovations have the potential to transform health care delivery, improve outcomes, and reduce costs. But to achieve these benefits, innovators need to overcome the challenges of market access in different countries. Market access refers to the process of ensuring that patients and health care providers can access, afford, and use digital health solutions that meet their needs and preferences. In this article, we will explore some of the key factors that influence market access for digital health innovations in different countries, and how innovators can navigate them successfully.

1 Regulatory frameworks

One of the first hurdles that digital health innovators face is complying with the regulatory frameworks of the countries where they want to operate. Regulatory frameworks vary widely across countries, and may include different definitions, classifications, requirements, and standards for digital health products and services. For example, some countries may require clinical evidence, quality assurance, data protection, and ethical approval for digital health solutions, while others may have more flexible or unclear regulations. Innovators need to understand the regulatory landscape of each country, and tailor their development, testing, and validation strategies accordingly. They also need to monitor the changes and updates in the regulations, and adapt to them quickly.

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Johan Trip

Grow Recurring Revenue | Subscriptions | Intrapreneur / ex-Philips, Alliander, WFP
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Regulatory frameworks per country, even in the European Union, and are not easily understood. In general, getting your product in the hands of users to get first feedback (validation), and then moving into small trails (clinical validation) before submitting your product for final review are the steps to take.

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THARIQ RAFEEQ

Strategic Marketing Specialist ⚡️ Cultivating Strategic Business Relationships
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Here are some tips for digital health innovators to navigate the complex market access landscape across different countries: - Conduct thorough market research to understand each country's regulatory environment, reimbursement landscape, and local partnerships needed. Identify key decision makers. - Be patient, persistent, and ready to educate. Market access takes time. Continued engagement with stakeholders builds trust and understanding. The key is determining your launch priorities and investing significant resource into understanding each market's unique dynamics and unmet needs. A flexible, localized strategy is key for global digital health growth.

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2 Health systems and stakeholders

Another factor that affects market access for digital health innovations is the structure and dynamics of the health systems and stakeholders in each country. Health systems vary in terms of their organization, financing, governance, delivery, and performance. They also involve multiple stakeholders, such as policymakers, payers, providers, patients, and civil society, who have different roles, interests, and influence in the health sector. Innovators need to map the health systems and stakeholders of each country, and identify their needs, expectations, and decision-making processes. They also need to engage with them effectively, and demonstrate the value proposition, feasibility, and impact of their digital health solutions.

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Johan Trip

Grow Recurring Revenue | Subscriptions | Intrapreneur / ex-Philips, Alliander, WFP
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Keep your stakeholder mapping and systemic approach clean for digital health. Focus on the 3P's. Patients, providers, and payers. This holy trinity provides enough dynamic to understand the market and its forces. Start adding other stakeholders only later in the process.

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3 Cultural and social factors

A third factor that influences market access for digital health innovations is the cultural and social context of each country. Cultural and social factors include the beliefs, norms, values, and behaviors of the people who use or interact with digital health solutions. They also include the level of awareness, acceptance, and adoption of digital health among the population and the health care professionals. Innovators need to conduct market research and user testing to understand the cultural and social factors of each country, and design their digital health solutions accordingly. They also need to communicate and educate their target audiences about the benefits, risks, and limitations of their digital health solutions.

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4 Technological and infrastructural factors

A fourth factor that affects market access for digital health innovations is the technological and infrastructural environment of each country. Technological and infrastructural factors include the availability, accessibility, affordability, and quality of the devices, platforms, networks, and services that enable or support digital health solutions. They also include the level of digital literacy, skills, and readiness among the users and providers of digital health solutions. Innovators need to assess the technological and infrastructural factors of each country, and select or develop their digital health solutions accordingly. They also need to address the potential barriers, gaps, and risks that may hinder the implementation and scalability of their digital health solutions.

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Johan Trip

Grow Recurring Revenue | Subscriptions | Intrapreneur / ex-Philips, Alliander, WFP
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Introducing new digital health innovations to a market is getting more and more streamlined due to the development of market platforms and marketplaces. Instead of approaching providers one by one, connect with the leading digital health platform in each market to gain market access and interoperability with each provider. As with payment-service-providers, health-service-providers are the tunnels that deliver health data to relevant providers.

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5 Competitive and collaborative landscape

A fifth factor that influences market access for digital health innovations is the competitive and collaborative landscape of each country. Competitive and collaborative landscape refers to the existing or emerging digital health solutions, players, and initiatives in the market or in the ecosystem. It also refers to the opportunities and challenges for cooperation or competition among them. Innovators need to analyze the competitive and collaborative landscape of each country, and position their digital health solutions accordingly. They also need to leverage the strengths and synergies of their partners, allies, and networks, and differentiate themselves from their rivals and competitors.

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Johan Trip

Grow Recurring Revenue | Subscriptions | Intrapreneur / ex-Philips, Alliander, WFP
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In health, the competitive landscape is still more collaborative than competitive. Find the sweet spot for your technology and partner up, reducing scope, instead of pushing out and increasing the scope of your value proposition.

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6 Policy and advocacy strategies

A sixth factor that affects market access for digital health innovations is the policy and advocacy strategies that innovators employ in each country. Policy and advocacy strategies refer to the actions and efforts that innovators take to influence the policies, regulations, standards, and practices that affect their digital health solutions. They also refer to the tools and channels that innovators use to communicate and persuade their key stakeholders and audiences. Innovators need to develop and execute effective policy and advocacy strategies in each country, and align them with their market access objectives and plans. They also need to monitor and evaluate the outcomes and impacts of their policy and advocacy strategies, and adjust them as needed.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Johan Trip

Grow Recurring Revenue | Subscriptions | Intrapreneur / ex-Philips, Alliander, WFP
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A thoughtful approach, validated by key-health experts is the starting point. During my time with Philips Personal Health, but also supporting health startups like Nooma Health, Hera Medical, and Oura I have seen a wide variety of go-to-market approaches.

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How can digital health innovators navigate the complex market access landscape in different countries?

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1 Regulatory frameworks

2 Health systems and stakeholders

3 Cultural and social factors

4 Technological and infrastructural factors

5 Competitive and collaborative landscape

6 Policy and advocacy strategies

7 Here’s what else to consider

Market Access

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