Medical device innovation – a combination of imagination and safety

The medical device field provides a fruitful ground for imaginative solutions that positively impact our health. However, producing an innovation is a complex journey, and when innovating medical devices, a variety of field specific characteristics and considerations are added to that journey. This blog discusses three points in terms of medical device innovation.

1. Aim for value creation by combining needs and supply

Medical device innovations can originate from clinical needs and ideas, scientific research, and utilization of improved technology. Optimally, the need and supply should meet to create a device which adds value to all its stakeholders – a common starting point for an innovation is to imagine what could be improved by implementing something new.

The potential for and amount of innovation in the medical device field is vast: according to MedTech Europe (2021) there are over 500 000 medical technologies (medical devices, in vitro diagnostic medical devices) available, and over 14 200 medical technology patent applications were filed with the European Patent Office in 2020.

A common starting point for innovation is to imagine what could be improved by implementing something new.

In the medical device field, the value of an innovation can be related for example to improving health condition and quality of life of a patient, enhancing clinical process and quality of care, reducing patient risks and costs, and increasing technical performance and efficiency. In early stages, it should be defined what kind of value the medical device innovation targets.

For example, the story of Heart2Save began once founder Helena Jäntti got an idea related to detecting heart arrhytmias, based on her work experiences as an emergency doctor. Nowadays, the idea has been developed into a medical device solution that can easily be used anywhere to detect heart arrhythmias and follow heart rhythm – creating value for consumers and health care providers and systems.

2. Don’t forget people and business model

Medical device innovation can be perceived mainly as product innovation, which is closely connected to various processes and clinical workflows. Although advanced technology would be the basis for improvement, success requires more – how can the value be delivered and to whom? Thus, considerations related to business model and stakeholders emerge.

Business model can be considered as the “ultimate product”. Medical devices can employ imaginative ways of creating and delivering value through their business models. As in other industries, devices can be implemented to a service or leased. In the era of data analytics, remote solutions, and rapid tech development, opportunities increase and imaginativeness creates competitive advantage.

Business model can be considered as the “ultimate product”.

For example, approaches kidney and antenatal testing from digital and home testing perspective: they have harnessed smartphone cameras, devices that many of us already possess, into a medical device solution. It’s not only about selling a test kit as a product for health care providers: the company takes care of the process from shipping the test kits and advising users in taking the test, to sharing test results with health care professionals, all powered by use of technology.

Medical device innovations are often placed in high-risk environments and are directed to various users from aged patients to busy health care professionals. It’s crucial to identify the users and engage them in the innovation process to ensure that their needs are met. This can also strengthen credibility and acceptance towards a new device solution.

Note that in health care users, buyers, and payers are often different actors and might have different interests. For example, user can be a patient, buyer a hospital, and payer an insurance company. Reimbursement for the device should be considered as it affects viability of the innovation. These perspectives are important aspects of business model planning and market exploration.

3. Plan a regulative strategy

Regulative strategy guides the journey of a medical device innovation to market and organizational development of its manufacturer. As regulation plays a comprehensive role, the innovation process should recognize medical device field as its target field as soon as possible. A deliberate decision to enter the field helps recognize possible constraints and characteristics early enough. This relates back to considering the intended purpose of a device concept: does it fall under the definition of a medical device? If yes, regulatory compliance must be guaranteed until the end of device life cycle to ensure safety.

Regulative strategy and quality management are assets for innovation.

In medical device field, business model and regulatory strategy are connected. The manufacturer must take responsibility of the device’s safety. Thus, organizational practices need to be thoroughly considered and a quality management system built. Stakeholders and partners are also covered: other economic operators, such as distributors, have their own regulatory requirements, and quality aspects need to be considered.

At crossroads of business and regulative strategy, manufacturers can consider if the first version of a product should be launched as a wellness product or with lower risk class to speed up placing on market. Consequences and liabilities for the end of life of the innovation should be noted already in concept phase. Thorough regulatory strategy and quality management are assets for innovation.

The effort will be appreciated

Medical device innovation combines imagination and safety, implementing new and taking existing aspects into account. The journey of an innovation can originate from needs and opportunities, and proceeds to considerations of business model and regulative strategy, essentially to create value for users, stakeholders, and systems. In addition to the “normal” uncertainty related to an innovation, medical device field specific characteristics require familiarization and attention to detail.

However, general vision of medical device innovations is fundamentally valuable for health and quality of life, so when succeeded, the outcome is worth it.


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Text: Kristiina Mäki

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