Market research can drive product development and positioning for future success

In the life sciences arena, there is no shortage of astounding innovations that are enhancing the health and wellbeing of human beings, especially in the medical devices sector.

A key part of the new rise of smart medical devices and implants is the foundational element of artificial intelligence (AI) and machine learning (ML) – which has grown from autonomous vehicles and virtual assistants into healthcare.

In addition, ML takes things one-step further with algorithms that improve automatically through experience. It is also responsible for the vast majority of today’s AI advancements and applications. The most commonly known ML application is the recommendation engines behind popular services like Netflix, YouTube and Spotify.

For medical devices, AI and ML have unlimited potential for transforming care by providing access to actionable data, which enhances care decisions and could drive down overall costs.

Medical Device AI/ML in Action 

In December 2020, Bernhard Kappe, CEO of Orthagonal, a medical device software company, gave a presentation at Virtual Engineering Week, which clearly illustrated the power AI and ML for medical devices.

He discussed how his client, Quidel, a maker of point-of-care diagnostics, offers a small diagnostic device that can read a standard Sofia fluorescent immunoassay cartridge. Images of the cassette are then captured on the device and transmitted via Bluetooth to a mobile app – an AI software model then interprets the results.

Ultimately, this allows Quidel to take advantage of rapid and more cost-effective manufacturing, since these devices are easier to produce. The mobility and connectivity aspect enables rapid caregiver decision-making, and the AI algorithm continuously improves.

Role of the FDA and Other Regulatory Bodies

With these advancements moving very quickly, the U.S. Food & Drug Administration (FDA) and the European Medicine Agency (EMA) are heavily regulating the use of AI-based solutions.

In January, the FDA released its first AI/Machine Learning Action Plan, which lays out a multi-pronged approach to the agency’s oversight of this sector. Here are the key parts of this plan:

  • Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time).
  • Supporting the development of good machine learning practices to evaluate and improve machine-learning algorithms.
  • Fostering a patient-centered approach, including device transparency to users.
  • Developing methods to evaluate and improve machine learning algorithms.
  • Advancing real-world performance monitoring pilots.

Even in the face of regulations, it is not slowing down growth and expansion. AI in healthcare is expected to rise from its $1 billion valuation in 2016 to $28 billion in 2025.  With this in mind, expectations are high in the medical device industry, which points to the need for the right market research when launching new innovations.

Value of Market Research in AI/ML Development for Medical Devices

Just as knowledge is the power behind AI innovations, the same can be said about using market research to develop and introduce them to the marketplace.

In a highly competitive marketplace, it is ideal to have the right research partner who understands the medical device sector and can help drive insights for everything from positioning and branding to pricing and product/benefit optimization.

For medical device manufacturers looking to expand their AI and ML capabilities, MSI offers comprehensive market research solutions that can pave the way for future success in this arena. Please contact us here to learn more.