October 20, 2020

How to build internationalization strategy for HealthTech

Essential factors to consider when drafting an internationalization strategy for healthtech.

Internationalization Starts with a Strategy

Internationalization attempts usually fail due to a lack of thorough preparation and adherence to the chosen strategy.

When it comes to the medical industry – such as life sciences, healthcare technology, biomedical technology, and pharmaceuticals – an industry operating in a heavily regulated environment, any attempt to seek market growth through internationalization faces a multitude of specific considerations.

The most crucial step is ensuring international standardization and regulatory requirements, which are at the core of innovation design when strategizing for global market access for the medical industry. When done right, aligning regulatory strategy for many target countries is advantageous, especially for nìche medical products, which should not be overlooked at the R&D phase.

However, when analyzing the potential market, one of the essential aspects is understanding the local healthcare ecosystem and its advantages and disadvantages compared to the domestic market, which is often used for innovation validation.

In an ideal case, internationalization has been integrated into the R&D process because the target market may encompass cross-cultural and cross-national aspects that need consideration in the design phase. Cross-cultural and cross-national elements are critical for the safe-by-design process, defined by international Human Factors and Usability Engineering and Risk Management standards. The safe-by-design process requires the earliest possible identification of target countries, enabling the implementation of regulatory requirements into the R&D process by aligning them where applicable.

In most cases, nevertheless, companies opt for a localization approach that seems a more robust solution but could cause some design alterations specific to the target market afterward.

Whether the strategy is to build a global design targeting many countries simultaneously or localization where domestic design is localized target country-specific, it is crucial to know, understand, and research the target market when expanding to another country.

Once it is clear that the device, application, or product fits into the target market, it is time to assess if there is a demand for it and how attractive the market is considering the competition.

Legislations do Differ

Every country has its laws and regulations that must be adhered to, and preparing for the regulatory requirements is a must and best made with someone who understands the local legislation and business environment. To highlight a few essential stumbling blocks in the regulatory framework most Startups in the medical industry face once seeking growth internationally.

For some companies, it may come as a surprise that standards for Quality Management Systems are not necessarily harmonized and national guidelines apply in significant healthcare markets. The classification of medical devices differs as well; a medical product that might be classified as an in vitro diagnostic device in the EU could be a class I medical device in a non-EU country, for example. The need for clinical trials is quite specific, depending on the local legislation and applicable regulatory pathway(s). For reimbursement strategy, it is essential to understand how the local healthcare system works: 

  • How much is healthcare spending, and what is the role of the government and insurance companies? 
  • How much is paid by the government, and how much is covered by the insurance? 
  • How much is the compulsory insurance, and how much is paid out-of-pocket by the patient? 
  • Who decides on the treatment? The physicians or the insurance company who pays the bill? 

The reimbursement landscape is usually deemed complicated due to the fragmented healthcare system and medical device distribution, including invoicing.

The one thing that most companies need to pay more attention to is the IP protection strategy, which requires thorough planning with the local legal system in mind.

Business Models and Partnerships

When considering appropriate market entry strategies, adapting the business model to the environment is an iterative process where market fit, distribution, and partnerships are some of the factors to consider. Also, what skills and resources are needed for successful business operations, and is there a need to relocate workers or hire locally in critical positions? Modifying the business model may take considerable time as it involves many managerial questions, including R&D and Know-How against IPR infringements.

“Appropriate partnerships are the key” to successful internationalization, and it will also influence the business model, so taking time to research the critical players thoroughly will pay back subsequently when creating a supply chain management system. One of the most essential aspects of partnerships concerns distributors, with whom discussions also need considerable attention regarding the trust of business operations. It is worth noting that all of this will influence the import and export operations regarding manufacturing and financial issues.

Although building an appropriate strategy for the internationalization of healthcare technology depends on the device, application, or product as well as the target market, this outlines those aspects essential for building an effective strategy. Even if not all of the above applies to a specific case, they should be considered when drafting plans.

FDA Regulatory Reform Outlook 2023

In recent years, the US Food and Drug Administration (FDA) has faced criticism regarding its review process, the need to keep up with the science today, and updating the regulatory framework accordingly. In response, the year 2023 has been the year that brings significant changes to the FDA regulatory framework, and several initiatives are waiting on the horizon.

Healing Childhood Abuse Wounds

Childhood abuse and assault can have a significant impact on a person’s mental wellbeing in adulthood. The trauma experienced in childhood can have lasting effects that can manifest in a variety of ways, including anxiety, depression, and post-traumatic stress disorder (PTSD).

Breaking the Taboo

A worrying trend observed across all regions and language groups is the global decline in the mental wellbeing of younger generations. The Mental Health Million data show that with each successively younger generation, there is a decline in mental wellbeing, as reflected in falling MHQ scores and a corresponding increase in the proportion of people who are distressed or struggling with significant mental health problems.

Innovation for Mental Wellness

Even today, mental health issues are branded with a high level of stigma although it has a profound impact on the individual and society as a whole. Negative perceptions that stigmatize mental health issues may discourage and prevent individuals to seek help. This combined with poor access to mental health care services leads to significant public health issues, not to forget the economic costs to society, including healthcare costs, lost productivity, and reduced economic growth. To begin with, mental health is a public health issue affecting a person’s overall well-being, quality of life, and productivity and is of vital importance to both individuals and societies.

The Entrepreneurial Boost Program

The Entrepreneurial Boost program – or Yrittäjyysbuusti in Finnish – is a program co-funded by the Pirkanmaa region Centre for Economic Development, Transport and the Environment, TE Services, and the Ministry of Economic Affairs and Employment of Finland. The program is a unique service model to support the entrepreneurial aspirations of early-stage entrepreneurs who are at the beginning of an entrepreneurial venture or business journey.

New Partnership Goals: inXso and BrainStormCorner

inXso is glad to share our new partnership goals with BrainStormCorner, founded as a business think tank with global roots, born right next to Tampere University campus. BrainStormCorner is a versatile toolbox of business services and research commercialization, based on long international and multidisciplinary experience.

Life Science & Medical Technology EXPO’s in Asia 2022 – Where you should start

Expos, trade fairs, and shows are a way to build business networks and search for partners that open new potential markets. It brings a lot of positive exposure for companies and their innovations, builds customer interest, and opens doors for collaborative projects along the life science and medical technology value chain.

Horizon Europe Cluster Health – Research and Innovation Funding

The EU Research and Innovation Programme 2021-2027 has gathered a lot of attention from the research communities around Europe this time around with their Cluster Health topics that are open for proposals. The published destinations aim to address acute and long-term problems in the healthcare ecosystem and the health and well-being of citizens from a societal point of view – without forgetting the lessons learned from the Covid-19 pandemic.

inXso 2021 MedTech Series R&D focal points

For 2021 inXso has created a webinar series outlining some specific features that are essential for global design of medical technology, and introduces some regulatory aspects in context of EU MDR and Swiss regulatory landscape, as well as some basic features from Chinese and Japanese regulations that everyone – or every company – considering these healthcare markets should now of.

How to build internationalization strategy for HealthTech

Internationalization attempts usually fail due to a lack of thorough preparation and adherence to the chosen strategy.
When it comes to the medical industry – such as life sciences, healthcare technology, biomedical technology, and pharmaceuticals – an industry operating in a heavily regulated environment, any attempt to seek market growth through internationalization faces a multitude of specific considerations.

User-Centered Design of Medical Devices

In recent years, medical technology has taken a trend towards creating personalized care while seeking ways to enhance the quality of healthcare for patients and lower healthcare costs. At the same time, developers must keep in mind the devices’ ease of use and gain regulatory approval in the highly internationalized market.
Capturing user profiles and use environments across nations and cultures needs more creative, wide-reaching, and complex problem-solving approaches than the conventional preference for scientific and technological advancement.

The Internationalization Challenge of Biomedical Innovations

The life science industry distinguishes itself from other high-technology industries with such fundamental dimensions as applying scientific knowledge to provide technological solutions aiming to improve health care and quality of life – in a highly regulated environment. At the same time, usually purchasing decisions are not made by end-consumers, but their physicians or such third party as an insurance company, for example.

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