Modern medicine is in a state of change. We see many catalysts for change: Personalized medicines, medical benefits, extended life expectancy, artificial intelligence, implants, and a dark horse in this race—bioelectronics.

While the United States continues to address many health issues as a total population, there is a rabid enthusiasm for technology, and specifically, how we use it to extend a high quality of life. This is of course intermingled with issues around health literacy, access to healthcare insurance, and intellectual property ownership for a whole new category of technology-driven health solutions.

First, bioelectronics are an ambitious, but actively developed area of medicine that allows for small, wireless electronics to counter or interact with already existing electronic transmissions produced by our bodies resulting from illness, pain, or acute reaction.

To date, the focus of the bioelectronic category is to counteract or potentially remove the physiological state associated with diabetes, pulmonary diseases, asthma, inflammatory bowel disease, Parkinson’s disease, arthritis, and hypertension. The role electronics will play as part of our biosphere will experience a cataclysmic change over the next 10 years. Bio-implants will provide security to limit fraud, ensure access to medicines, and help track our organic metrics. Dermal electronics will help provide measurements of patients during their hospital stays and outpatient procedures and will help increase the quality and effectiveness of therapies post discharge.

Pharma Manufacturer’s Changing Role in a Bioelectronics Market

For pharma, the emergence of bioelectronics as a therapy completely changes the approach to the existing patent-driven drug license model. By programming physical responses through bioelectronics, the body becomes a platform for software-driven solutions that allow a more nuanced model of delivery. Pharmaceuticals now play a different role as a potential vessel for electronics to transmit or to address side effects.

The yet-to-be-seen model of support in healthcare can result in a new kind of healthcare tiering model. As bioelectronics become increasingly more common in the near future, the specialists who manage them and how they are paid for will create a divide for consumers and payers in many markets.

Many of the major manufacturers and medical device companies are beginning their journey into bioelectronics solutions. Few are as mature as Medtronic, who for many years has been addressing Parkinson’s disease, pain, and other categories with electronic signals. GSK notably funded a $1 million prize for innovative bioelectronics research. They continue to realize the benefits of this research and identify the potential in and outside of augmenting their pharmaceutical portfolio.

Bioelectronics mark a significant change in effectiveness in many categories of disease. Specifically, it allows for a less invasive mechanism to address conditions and allows for more minute adjustment in response to patients’ individual needs, tolerances, and comorbidities. This kind of flexibility and scalability are driving research and investment at every level in healthcare today.

New Opportunities for Manufacturers and Traditional Medicine

For the major pharmaceutical manufacturers, bioelectronics provides a key area for investment that is directly in line with a patent-based molecule model, but does not necessarily have the same limitations of patent as pharmaceutical products. While the current model in the U.S. for patent expiration creates a business model that is fraught with public and investor criticism, bioelectronics provides manufacturers a new opportunity in delivering therapies as a process as well as a method of delivery.

The healthcare industry has been aggressive in making up the digital divide in the last few years, creating patient-focused programs around compliance and quantified personal health, and creating ecosystems around products. Many of these programs are competing for relevance among lesser regulated categories and startups practicing in the “wellness” space. A tough market.

Simultaneously, healthcare professionals have been a keen target to create favor with. For many looking to capture the attention of busy and increasingly less accessible healthcare professionals, being able to present new clinical data and therapies that are reliable and without significant side effects is the holy grail in patient care and will not only win preference, but also eclipse other therapies for physician and payers alike.

For startups practicing on the periphery of the pharma industry, this is a unique chance to compete with the industry giants. Moving fast and borrowing from a DNA rich in technology, the healthcare startup space has already iterated into the second and third generations of bioelectronic solutions. SetPoint, already working in several therapeutic areas including Crohn’s disease and multiple sclerosis, applies electrical impulses to the nervous and muscular systems to activate already existing, but little activated signals. Their research may provide a potential replacement for a disease traditionally treated with drugs.

Significant Changes in The Modern Treatment Journey

The regulated model is only the beginning of the new business model for bioelectronics. As with any electronic-based solution—healthcare-related or otherwise—there is a deep well of data that can be captured around a patient, their disease, response to therapy, environmental stimuli, and near unlimited responses to bioelectronic therapies. This allows for several significant changes in the modern treatment journey for both patient and physician:

  • Bioelectronic therapies can be completely customized based on patient and disease response. Personalized medicine is now completely quantified and can respond to biological response, side effects, adverse events, rejection, and patient input, among others. Based on how the therapy is administered, physicians can adjust and fine-tune therapies in real time or capture the data for broad categorical adjustments across patient type in their practice, or across practice or national guidelines. This constant opportunity for capture and optimization can make for an adaptive and more extensible kind of therapy.
  • The mechanism of administration provides many detectable signals that the therapy is being administered and is consistent in delivery. Although this does not account for the physiological response, it does provide assurances of activation once introduced to the patient’s body.
  • Unlike many other therapies, bioelectronic input can be removed from a patient’s system as a stimulus almost immediately. In the event that adverse events become an immediate challenge, patients and physicians have a fast pathway to remediation and application of an alternate therapy.

The bioelectronics market is not without its risks for both healthcare companies and patients: First, the technology driving this category is in its earliest days. Although the category was christened in 19901, the speed of innovation for this category of medicine is changing daily. For patients receiving a treatment, their mechanism of administration, reliability, or even the physical form of a device could evolve during their treatment cycle. As digital innovation in healthcare matures, this will be not only less volatile, but also more widely accepted by patients and physicians.

The Potential Downsides

An additional barrier is security. Although many of the technologies currently being developed are limited in their administration, having an implanted, ingested, or otherwise active electronic device supporting medical treatment presents not only safety and security risks, but also privacy risks.

For the early adopters, bioelectronics provide a unique solution and convenience. One of the bigger risks in creating these types of therapeutic solutions is ensuring that they are not affected by regular electronic signals, from airport scanners to WiFi routers, or by imaging equipment such as X-rays and MRIs. This category of medicine will not be commonplace for some time, and the healthcare system will need to provide an infrastructure to identify and work with implanted and applied bioelectronic therapies.

Security and privacy will also be a hurdle for this technology. As we become more aware in the U.S. (it is already a significant issue abroad), the protection and ownership of data is critical—more so when we are discussing medical data. What are the ramifications of tracking program metrics, device performance, comorbidities, and healthcare across multiple healthcare professionals and healthcare networks? The healthcare policies are under equal pressure to adapt to a changing marketplace.

Adding to potential risk is how bad actors can identify and hack such a device. The protection and fortification of these devices is going to play a key role in their adoption, coverage, and widespread public perception. The first publicly captured “hacking” of a bioelectronic device will result in a techno-panic.2 Although this should not factor into wide adoption, such reactions have long stood in the way of both innovation and industries not having widespread favor with the broader population.

Opportunities in Bioelectronics

Both as a technologist and as someone who has spent a career looking at what the near-term future of healthcare will be, I see bioelectronics as representing the next generation of healthcare. As a patient, I see this as a huge opportunity for a new category of medicine—one that is extensible and, although fraught with challenges, well worth what society has to gain from its wide adoption.

For the healthcare industry and pharmaceutical manufacturers, bioelectronics provide a new paradigm in quantified therapies, new business models, and a complete change to the practice of medicine. Medicine will see its integration with technology—and potentially the addition of a software engineer in scrubs. As these therapies become more widespread, analysts, experts in heuristics, and coders will augment nurses and anesthesiologists.

The thrilling frontier of this medicine will be how industries and experts converge to help lessen patient suffering, help alleviate the burden of chronic illnesses and common maladies, and remove pain without fear of side effects or lessening efficacy.

References:

  1. http://publications.drdo.gov.in/ojs/index.php/djlit/article/download/143/58
  2. https://www.forbes.com/sites/adamthierer/2012/03/04/the-six-things-that-drive-technopanics/#4654287a70b0.

 

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