Consumer Peripherals

Microengineering in medical devices

12 August 2023

The significance of biomedical microtechnologies in the academic field cannot be underestimated, having brought about innovative treatment and diagnostic methods. However, a gap exists between the conception of a medical device and its implementation in healthcare, largely due to a disproportionate focus on the medical implications of technological advancements and a lack of emphasis on the critical engineering steps involved in bringing these ideas to fruition. As we venture further into the intersection of micro- and nanotechnologies with medicine, addressing this imbalance becomes of increasing importance.

Propulsion of the biomedical field and an impact paradox

This uneven emphasis often leads to a phenomenon known as an impact paradox. This is where researchers prioritize novelty over the robustness and reliability of their technological innovations, resulting in a plethora of studies that tout clinical applicability without sufficient validation of reliability. However, many microengineering developments have made a lasting impression on the medical industry.

Figure 1: Medical equipment in surgery room. Source: Public domainFigure 1: Medical equipment in surgery room. Source: Public domain

For example, several micro- and nano-fabrication techniques, including photolithography, thin film deposition and etching, have proven crucial in propelling the biomedical field forward. Photolithography, a process that uses light to transfer geometric patterns onto a substrate, is particularly significant. This method, borrowed from the semiconductor industry, has been instrumental in the creation of micro- and nano-scale devices, enabling the miniaturization necessary for advancements in implantable and wearable devices.

Similarly, thin film deposition techniques have been pivotal in biomedical advancements. This process involves depositing a thin layer of material, usually a few nanometers or micrometers thick, onto a substrate. The precise control of these layers' thickness and uniformity has facilitated the production of biosensors, microelectrodes and various micro-electromechanical systems (MEMS), all of which are key to modern medicine.

Etching techniques also play a vital role in the biomedical field. These methods, whether chemical or physical, are used to remove layers from the surface of a substrate, helping shape and structure devices at the micro- and nanoscale. In the context of biomedical microdevices, etching allows for the creation of intricate features, which are often essential for device functionality.

Figure 2: Photolithography lab. Source: University College London Faculty of Mathematical & Physical Sciences/CC BY 2.0Figure 2: Photolithography lab. Source: University College London Faculty of Mathematical & Physical Sciences/CC BY 2.0

The combination of these fabrication techniques with the advent of polymers and soft elastomers has broadened the horizons for wearable and implantable devices. Nevertheless, the bias toward groundbreaking results over iterative improvements creates a distorted perception of progress. This issue has led to a disconnect between patient expectations and real-world healthcare applications and has obstructed the translation of academic research into practical healthcare solutions. To mitigate this, there's a growing need for the biomedical community to reconsider how research impact is measured, fostering comprehensive reliability testing and effective communication of research outcomes.

In microengineering, additive manufacturing or 3D printing has proven to be a revolutionary tool. For instance, microneedles (MNs), minimally invasive devices used in drug delivery, disease diagnosis, and even cosmetics, have benefited immensely from this technology. Traditional manufacturing techniques like molding often fall short when rapid design modifications are needed. In contrast, 3D printing allows for the swift, precise and customizable creation of complex MN prototypes.

The utility of 3D printing extends far beyond MNs. It enables the layer-by-layer assembly of intricate structures, which is crucial in the production of bespoke medical devices and personalized medicines. It has even found applications in tissue and organ regeneration. In 2015, the U.S. Food and Drug Administration approved Spritam, the first 3D-printed medicine, which marked a significant milestone in healthcare. This technology's potential was further demonstrated during the 2020 pandemic when it facilitated the mass production of face masks and shields, showcasing its versatility and adaptability.

Challenges of translational research

However, the path from the laboratory to the clinic is not without challenges. Translational research, which seeks to apply basic scientific findings to clinical settings, often stumbles due to misperceptions and methodological flaws. For instance, the notion that findings from animal model studies readily translate to human clinical trials is a widespread misconception. To counter these hurdles, an integrated approach involving both academia and industry that emphasizes the necessity of reliability tests in academic research may become necessary. Establishing community-agreed standards for testing medical devices could enhance cross-study comparisons and benchmarking, thereby contributing to a more accurate and realistic perspective on biomedical technology.

Funding medical innovation: Novel approaches

Traditional academic research funding often leads to a “valley of death” for medical device technologies, where projects reaching “academic maturity” are left unsupported due to their perceived lack of novelty. This pattern risks undermining the overall return on investment of research funding. Increasingly, researchers incorporate preliminary clinical usability data early in their work, but this often requires external private funding. An alternative funding model focusing on translational research could help bridge the gap between published research and actual healthcare delivery. This shift, together with the recognition of the impact of medical technology research beyond scholarly citations, could prompt academic institutions to adapt their scoring criteria.

Bridging the gap

The challenge is to ensure that the engineering discoveries which form the foundation for clinical outcomes receive adequate support and recognition. While early-stage in vivo trials are enticing, investing in making technologies reliable and usable is paramount to minimize project failures. The academic environment's self-regulated mechanisms can play a key role in establishing quality standards, provided that researchers comply with and contribute to their improvement. A "build-upon" strategy, creating funding bridges, could be the key to achieving a higher return on investment in biomedical technology research.

About the author

Jody Dascalu is a freelance writer in the technology and engineering niche. She studied in Canada and earned a Bachelor of Engineering. As an avid reader, she enjoys researching upcoming technologies and is an expert on a variety of topics.

To contact the author of this article, email GlobalSpecEditors@globalspec.com


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