Medical optics devices: A SWOT analysis for academia and industry
Medical devices used in patient care have many forms, ranging from multimillion-dollar imaging systems that guide interventional procedures, to pocket-sized diagnostic systems that cost a few hundred dollars. The major tools developed for imaging or intervention fall into two broad categories—radiologic systems or optical systems. Radiological systems are well defined (every hospital has a radiology department) and organized around a small set of medical specialties. Optical systems, on the other hand, are widely distributed and not clearly appreciated as a singular technology, even though optical devices are used in nearly all medical specialties and comprise an even more diverse set of tools than radiological systems.
The field of medical optical devices is both heterogenous and dispersed, which makes any analysis a challenge. This article attempts to use the ubiquitous SWOT (strengths, weaknesses, opportunities, and threats) analysis to summarize the status of the medical optical imaging technology sector and to help point towards areas ripe for development or improvement.
Strengths
The technological strength of optical imaging tracks the enormous advances in CMOS camera sensors in the past 25 years. These devices now widely outnumber humans on the planet, are ubiquitous in cellphones and computers, and are responsible for nearly every digital image posted on Instagram. Very high-end sensors can be manufactured for just a few dollars, which has spurred the $2.5 trillion optical device industry that comprises 3 percent of the global economy. Biomedical optics is actually a fairly small sector, estimated at $128 billion in 2023. But this means that biomedical optics, at 0.15 percent of the entire global optics industry, leverages an economy of scale 700 times its size. Within medicine, however, optics forms the largest technology market in medical imaging.
Perhaps the most obvious medical strength of optical systems is their use for point-of-care vision, with the physician and patient in the same room. Doctors want to see inside the body—through the ear, eye, nose, throat, rectum, colon, vagina, urethra, or skin—during a clinical exam. Optical cameras augment clinicians’ vision with tools that fit into various body cavities, delivering high-fidelity images.
Weaknesses
The weaknesses of optical imaging limit what is possible today and in the future. Most obvious is that light is highly scattered in tissue, relegating imaging mostly to surfaces of the skin, ears, eyes, or mucosal cavities. Deep tissue imaging of more than a millimeter or two has never been commercially successful due to limited spatial resolution. While significant advances have occurred in deep tissue sensing and imaging research, with approaches like diffuse optical tomography and photoacoustic imaging, these have not yet translated into routine clinical practice. There are many good applications for sensing through tissue, such as pulse oximetry, but true imaging with spatial resolution has not yet been commercially adopted.
There is another weakness inherent in optical systems for direct point of care: Each new application has a specialized system, and there can be very little commonality between systems in different medical specialties.
Opportunities
Key technological opportunities for optical medical imaging lie in simply harvesting from the ongoing explosion of consumer technologies that keeps producing more features and capabilities, including embedded processing and expanded spatial resolution, wavelength range, dynamic range, low noise, and expanded size scales. Continuous development of new tools at low-cost production will allow major advances in areas such as surgical, laparoscopic, and endoscopic technologies. Additionally, incredible opportunities lie in combining microscopic with macroscopic imaging in the same instrument, allowing point-of-care or interventionalists to utilize both size scales. Optics has always been good at both magnification scales separately, but rarely in blending the two.
Opportunities remain undeveloped for molecular sensing in medicine. Though widely utilized in vitro through millions of microscopy, molecular pathology, flow cytometry, gene profiling, and clinical chemistry techniques, many molecular sensing tools are not used in vivo. Advancement of surgical or diagnostic trials with well-tolerated molecular contrast agents is an area ripe for advancement. An additional feature of optical sensing through tissue is that, while multiple scattering reduces the ability to image with high resolution, it also increases the path length in tissue by five to six times, thereby enhancing sensitivity to cells and capillaries. So, non-image-based sensing of molecular and capillary features can be significantly improved with highly scattered light. This is a factor exploited in pulse oximetry sensing, for example, but not yet for other applications.
Future opportunities lie in the ongoing shifts in healthcare towards wellness and health monitoring, instead of acute delivery of treatment once problems emerge. Commercial monitoring tools developed for home sensing and daily monitoring come from the consumer electronics industry where optical sensing is a core technology. These screening and monitoring technologies each requires a low-cost, low-risk system, and optical technologies are likely going to be a key part of this pipeline.
Threats
One of the largest threats to the advancement of optical technologies in medicine is that academia and industry are not aligned in terms of research goals, nor in communications with each other. Academic research is mostly funded by government agencies, such as NIH, which openly advance scientifically intriguing technology, but do not require a commercial product as an end-goal. The optical device industry, however, tends to be insular, with each company inventing their own technologies to advance new products. Unlike the radiological field, where industry experts, academics, and physicians often attend the same conferences (i.e., RSNA or ASTRO), and work on the same devices, the optical device sector and stakeholders are highly diversified into physician specialty areas. There is little communication about devices across medical specialties like dermatology, surgery, cardiology, family medicine, oncology, and so on.
A medical threat can be seen also in a comparison between biomedical optics and radiology. Most radiology and radiation oncology departments have entire subspecialties of medical physicists who provide them with technical expertise, repair, installation, and commissioning of new devices. Optical devices, however, are rarely deployed with technical guidance beyond a company sales or installation specialist. Training is either remote or nonexistent. Thus, as optical technologies become more advanced, the potential for misuse or for early adopters to fail in the accurate or informed use of the technology also increases. Finally, there is some risk that high-end technology will limit its advance in routine medicine because of growing patient loads, documentation requirements, and billing. Physician burnout may inevitably reduce use of technology, limiting future innovation adoption.
Conclusion
Optical systems are highly divergent, stratified along medical specialties, with comparatively little crosstalk in the user base. This contrasts with radiology, which is homogeneously represented within a single department, fostering collaboration and accelerating development of the field.
The takeaway from this SWOT analysis is that the optical medical device industry has the force of significant technological and market strengths behind it, but is hindered by its distributed nature, which makes it a challenge to fully realize the opportunities and overcome the threats. Such extreme heterogeneity diffuses the broader view of what optical imaging technology is within medicine or medical imaging. Solving problems of communication between academia and industry would have positive potential for technological advancement across medicine and may help better align funding deficiencies in certain areas of research. These are problems that professional societies like SPIE might work on to better represent the field of biomedical optics in academia and industry.
Brian Pogue is chair of the Department of Medical Physics at University of Wisconsin-Madison, and editor-in-chief of the Journal of Biomedical Optics. This article is an excerpt from a longer perspective published in JBO and available free online doi.org/10.1117/1.JBO.28.12.121208
