Medical innovation does not always begin with a new technology. Often, it starts with a clinical problem that has not yet been translated into engineering terms. Researchers in Brazil are using biodesign to bridge this gap, developing neonatal lung simulators, new cancer therapies, personalized light-based treatments and digital tools by bringing physicians and engineers together.
During the COVID-19 pandemic, Brazil’s Ministry of Health asked researchers to validate and calibrate ventilators intended for hospitals in the country’s Unified Health System, or SUS.
The researchers discovered that existing testing equipment did not adequately simulate the respiratory mechanics of critically ill premature infants. Commercially available simulators were largely designed for adults and older children and did not meet the compliance requirements needed for neonatal ventilation.
Biomedical engineer Sara Gomes Mello Santiago and colleagues subsequently developed six low-cost neonatal simulator designs using commercially available silicone bellows, acrylic plates and steel springs.
One configuration achieved a static compliance of 0.52 mL/hPa, close to the regulatory target of 0.5 mL/hPa, and was approved in Brazilian laboratory accreditation audits.
According to Santiago, one of the central roles of biomedical engineering is translation.
Clinicians and physical therapists often recognise a practical problem because they experience it directly in patient care. However, they may not know how to translate that problem into technical specifications.
Biomedical engineers can convert these clinical needs into measurable parameters, interpret regulatory requirements and develop solutions that can be reproduced in everyday healthcare practice.
This principle is at the heart of biodesign, an innovation methodology in which physicians, engineers and managers work across disciplinary boundaries.
The Stanford Mussallem Center for Biodesign challenged the traditional idea that innovation depends primarily on individual talent.
Instead, it developed a structured process based on three stages: Identify, Invent and Implement.
The approach encourages healthcare professionals to spend more time understanding the underlying clinical problem before attempting to create a product.
This also requires a change in mindset for physicians. Whereas medical training often emphasises certainty and avoiding mistakes, innovation requires professionals to test hypotheses, discard unsuccessful approaches and rebuild solutions based on what they learn.
At Hospital Israelita Albert Einstein in São Paulo, an eight-month biodesign fellowship requires participants to work around 20 hours per week.
Teams typically include a physician, an engineer and a management or business professional.
Each brings a different perspective: the physician understands the clinical problem, the engineer can design and prototype a solution, and the business expert evaluates how the technology can be financed and introduced into the market.
Biodesign is not limited to creating startups or patents. The same approach can also be used to continuously improve everyday patient care.
Around three quarters of medical technology startups do not generate a return on investment, according to the article.
The main reason is often not engineering failure. Technologies can fail because developers did not adequately consider questions such as reimbursement, regulatory approval, nursing acceptance or whether the technology fits into hospital workflows.
As Conrado Tramontini of Hospital Sírio-Libanês put it, successful innovation begins with “a real problem seeking a solution” rather than a technology searching for a problem.
The article also describes an experimental approach to treating glioblastoma.
The blood-brain barrier prevents more than 98% of therapeutic agents administered orally or intravenously from reaching brain tumors. Temozolomide, the standard chemotherapy used for glioblastoma, also has a blood half-life of only around two hours.
Researchers therefore developed polymeric nanoparticles containing temozolomide and coated them with fragments of tumor cell membranes.
The coating allows the particles to preferentially adhere to tumor cells. Administered through the nose, the nanoparticles can reach the brain via the olfactory and trigeminal nerves, bypassing the blood-brain barrier.
In laboratory and animal models, the nanoparticles reached the brain within 30 minutes, reduced cancer cell viability and inhibited blood vessels supplying the tumor.
Further in vivo preclinical studies and work on large-scale production are now required.
Another example involves high-risk non-muscle-invasive bladder cancer.
The standard treatment following surgical resection is intravesical Bacillus Calmette-Guérin therapy, but BCG fails in approximately half of patients. Radical cystectomy may then be recommended, although it is associated with substantial complication rates.
Researchers developed OncoTherad, a synthetic nanocomplex designed to stimulate the immune system to attack tumor cells.
In a phase 1/2, open-label, single-arm clinical trial involving 44 patients who had an indication for radical cystectomy, 72.7% achieved complete tumor elimination. No patient required removal of the bladder and no deaths occurred during two years of follow-up.
Adverse effects were described as mild and included dysuria, cystitis, joint pain and low-grade fever.
Researchers also identified overexpression of monoamine oxidase A, or MAO-A, as a potential mechanism of resistance in patients who did not respond. This finding contributed to the development of a second-generation platform called ImmunoClor.
Photodynamic and photobiomodulation therapies use light to inactivate bacteria and influence inflammatory processes in the lungs.
Because light applied to the chest must pass through skin, fat, muscle and bone, the amount that reaches diseased lung tissue can vary considerably between patients.
Researchers used CT scans to create detailed three-dimensional chest models and simulated the paths of millions of photons through the rib cage.
Their study showed that pneumonia-affected areas absorbed around 3.0% to 4.5% of the light energy and proportionally more energy than healthy lung tissue because diseased regions were denser.
This modelling approach could allow clinicians to plan the optimal light configuration for individual patients before treatment.
An in vivo study in sheep is planned as preparation for future human trials.
The same innovation principle is being applied to clinical data.
At Hospital Sírio-Libanês, BRONCOAlert continuously analyses electronic health record data to identify hospitalised patients who may be at risk of bronchoaspiration before an adverse event occurs.
Thoracic surgeons at the same hospital are also using mixed-reality glasses to visualise tumors in three dimensions during surgery.
In both examples, the innovation did not necessarily involve creating new information. Instead, researchers asked new questions about how existing information could be used.
Moving a technology successfully from the laboratory into routine healthcare remains difficult.
Brazil faces challenges including regulatory frameworks that may not yet cover emerging technologies, separate reimbursement systems for public and private healthcare, and dependence on imported pharmaceutical products.
For example, Brazilian regulations currently lack specific good manufacturing practice rules for nanomedicines, creating difficulties for scaling up production.
Researchers have responded by establishing regional innovation hubs in which universities provide technology and municipalities provide hospitals for treatment within the public health system.
The article ultimately presents medical technology as a tool for supporting healthcare professionals rather than replacing them.
New technologies may help reduce administrative burdens and allow physicians to recover something increasingly limited in modern healthcare: time for their patients.
As the article concludes, the central skill is translation, turning a clinical need into a technical parameter and ultimately into a practical solution for patients. Better communication between physicians, engineers, scientists and other professionals may help overcome biological, physical and systemic barriers to innovation.
Read the full article here.