With the rapid advancement in medtech, medical devices have been made increasingly based on additive manufacturing techniques. According to GlobalData, a leading data and analytics company, 3D printing in medical devices is forecast to become a $4 billion industry by 20261. The use of additive manufacturing techniques in medtech is particularly advantageous as it can accelerate the design process of new medical devices and can allow the medical devices be made with customized, intricate structures that are otherwise not possible using traditional manufacturing techniques.
As an example of advancement in 3D printed medical device, a research team at the Washington State University has recently developed a 3D printed skin-wearable sweat biosensor2. The sweat biosensor includes a microfluidic structure with self-supporting microfluidic channels and nanomaterials based colorimetric bioassays connected with the microfluidic structure, which are operable for measuring sweat rate as well as concentration of metabolites (glucose, lactate, and uric acid) in sweat. The microfluidic structure is made based on direct ink writing, a specific 3D printing technique, and is arranged between a skin adhesive layer and a polymeric cover film. The sweat biosensor can potentially be commercialised as a health monitor for use during sports or exercise.
As the use of 3D printing is becoming more prevalent in medtech, opening the door to non-traditional competitors, the importance of properly and timely protecting the intellectual property (IP) associated with these medical devices cannot be understated.
Problematically, however, some of the unique challenges associated with the protection of a 3D printed medical device are that the device can be easily manufactured and distributed in a decentralised way across different territories and, in some cases, only part of the device is 3D printed. These unique challenges may render traditional IP protection strategy for medical devices, which focuses on protecting the entire physical device in specific territories, less useful.
Indeed, the IP of 3D printed medical devices relates not only the 3D printing process and the 3D printed device or device part, but also the digital data, such as computer-aided design (CAD) file, that enables the distribution of design and the 3D printing of the device or device part. To accommodate this, the IP protection strategy for 3D printed medical devices should be more diversified to cover these physical and digital aspects, and with a broader territorial protection consideration.
As this field of technology continues to grow and evolve, more innovative and exciting medical devices and applications will become available. Properly protecting the IP of these 3D printed medical devices will allow innovators and companies to reap reward of their innovation and stay ahead of the competition.
Footnotes
2. https://pubs.acs.org/doi/pdf/10.1021/acssensors.4c00528
} Given its advantages, the medical 3D printing market is forecast to grow from just over $2 billion in sales in 2022 to $4 billion in 2026 at a 21% compound annual growth rate www.globaldata.com/...
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