The Internationalization Challenge of Biomedical Innovations

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The umbrella term ‘life sciences’ is often used to refer specifically to medical technology, biotechnology and pharmaceuticals.

Life Sciences Among High-Technology Industries

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.

Early internationalization is facilitated by simultaneous forces both empowering and constraining operations: To recover their investments and to increase turnover, life science companies and medical technology companies, especially, are facing a strong push towards an international outlook with a high technology that has a competitive advantage at an early stage but is not culture-specific.

However, the first challenges that especially early stage life science and technology companies face is the lack of understanding how the healthcare ecosystem works on a global scale, how to meet safety desing features of the diverse target markets and finding appropriate partners as a key-challenge in the internationalization of life sciences and medical technology is often dependent of the right network.

Forces enabling and constraining internationalization

Bringing largely unchanged medical technology to international markets is typically due to the demand to meet local regulations of the manufacturer, but also because the manufacturers assume that users will adapt to new technology through training. However, training is often ineffective when faced with ingrained customs and user expectations in individual countries, which can be seen during the transition phase in the increased use error rate when operating new technology.

Hence, device features should be designed keeping in mind the cross-cultural and cross-national requirements, especially as failure to meet these requirements could easily violate the international risk management (ISO 14971) and usability (IEC 62366) standard compliance.

As mentioned, the life science industry is highly regulated, which means that companies need to comply with local demands in their international business activities. Logically, adhering to compliance with a single country’s requirements can result in a design that is likely to induce use errors in another country with different user needs and expectations or use-shaping factors.

Reimbursement strategy is another factor that most companies do not plan early enough when planning internationalization; “who pays for your product?” is a very relevant question as it dictates who will be financing the life science industry across nations. For example, in the Nordics healthcare is mostly funded through social security system (or taxes from the U.S point of view), whereas in the U.S and Germany – example-wise – health insurance is the most preferred financial model.

Nonetheless, there is a strong push to expand from smaller home markets across borders that comes from the need to amortize high research and development (R&D) costs. Even when most companies have limited financial and managerial resources and the key-challenge identified by many life science companies operating in an international healthcare market is to find appropriate partners for ventures. Apart from complying regulatory demands and financing R&D process, organizing clinical trials, including difficulties in getting access to hospitals and doctors, as well as scaling up marketing and sales are among challenges making an international product launch a complex endeavour.

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

It is a known fact that most internationalization attempts fail due to lack of thorough preparation and adhering to the chosen strategy.

When it comes to life sciences – healthcare technology, biomedical technology and pharmaceuticals – that is 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 quality for patients and to lower healthcare costs. At the same time developers have to keep in mind the ease of use of the devices and gaining regulatory approval for them in the highly internationalized market.

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.

Apply for HealthTech Online Pitching

On 22nd May an online pitching for HealthTech Startups is organized by inXso together with Slush China to Venture Capital investors of which there is a significant participation from the Chinese Venture Capital investment companies focused on HealthTech, BioPharma and BioMedTech.

What are the Key Points of Chinese Health Tech Initiatives – Join Discussion on May 29th

What are we discussing? In our series focusing on Health Tech in Chinese market inXso is organizing an interactive webinar “Health Tech China Focus” together with Tampere HealthHUB that will briefly discuss some of the key points and rather unique aspects of Chinese...