Fusetec
Advanced Manufacturing a Medical Marvel

A mazingly, to this day, surgeons still train with 17th-century practices on either living patients or cadavers. In the surgical domain, this age old philosophy known as ‘See one, do one, teach one,’ is still prevalent. As a result, this translates to a resident observing surgical procedures in an apprenticeship like model, followed by conducting surgery under the guidance of an experienced surgeon until they reach competency, where the necessary skills are acquired to perform surgery unassisted, ultimately becoming the teacher of the next generation of residents.

Though this idea resonates across the medical realm, training surgical candidates effectively with this approach remains an arduous and costly task, with its many limitations. To overcome such confinements, the following questions, among others, must be asked:

• How can a young resident improve their skill set beyond that of the overseeing surgeon?

• What if, during the residency period, complex surgical procedures do not present themselves?

• How does the resident develop the skills necessary to become a true master?

The traditional answer lies with cadavers. Residents can practice their knowledge of anatomy, develop dexterity handling instruments, learn haptic feedback, and rehearse without risk to a living patient. Unknowingly, the residents’ health could be jeopardized. The risk of exposure to a variety of harmful microbes has come at the forefront of today’s climate, reminding us how vulnerable our surgeons are to health risks. Research shows that after the death of an individual, bacteria, and viruses could still be prevalent in the human body and in fresh frozen cadavers, which could host harmful disease causing pathogens like HIV and SARS-CoV-2. Furthermore, the scarce availability of cadavers, risks associated with storage and contamination, and corresponding regulatory requirements amplify the need to rethink, redesign, and restructure surgical training techniques to prepare surgeons better. These setbacks may deprive residents of the necessary surgical training hours, creating a training deficiency among surgical trainees.

According to Brian George MD, an Assistant Professor of Surgery at the University of Michigan, one requires at least 20,000 hours during surgical residency to train a surgeon to competency. However, completing this medical prerequisite of 20,000 hours in surgical procedures is still a challenge for medical professionals, mainly owing to non-standardized training procedures that create skill gaps. Dr. George serves as the Director of Educational Research at the Center for Health Outcomes and Policy at the University of Michigan, as well as the Director of the Center for Surgical Training and Research, also at the University of Michigan.

The answer to this conundrum lies with Fusetec, an industry 4.0 manufacturing company focused on revolutionizing medical training. The company solves such real-world problems through its advanced manufacturing expertise. “Fusetec enables medical students, surgical residents, and even fully skilled surgeons to continue with their training practices by utilizing cutting edge technologies to reproduce anatomically accurate medical training devices with pathologies,” says Mark Roe, Managing Director at Fusetec.

Fusetec manufactures fully operable, anatomically accurate human body parts by segmenting CT and MRI scans of actual patients to recreate anatomies and pathological conditions of a subject through 3D printing, thereby enabling medical professionals to understand the practical complexities associated with the patient under study. This allows surgeons and residents to rehearse new or complex procedures by practicing on models.

“Fusetec enables medical students, surgical residents, and even fully skilled surgeons to keep up with their training practices by utilizing 3D printing technologies to reproduce anatomically accurate medical training devices with pathologies “

Additionally, actual footage obtained from a real-world operation can be viewed, providing surgeons a comparative assessment of both scenarios. A benefit derived from this training methodology is the elimination of cadavers and the dangers associated with such practices, along with the laborious legalities. Further, training on such models enables Fusetec to create varying levels of difficulty and complexity by collaborating with surgical experts, transcending the barriers of traditional surgical training.

“Practice and rehearsal will save lives, and that’s what we are striving for,” states Roe.

Catalyzing Surgical Procedures through advanced manufacturing

In a world where 4.4 percent of all surgical cases end up in fatality within 30 days, Fusetec’s approach figuratively reinvents the wheel with surgical practices. Several universities around the world are researching the significance of Fusetec surgical training models, which arm medical professionals with the necessary tools for surgical excellence, eventuating in saving lives.

Fusetec has upheld this philosophy of changing lives through technology since its establishment. In fact, before its inception, Roe stumbled upon the merits of additive manufacturing techniques, which inspired him to study the subject extensively. “I wanted to bring some of the most promising additive manufacturing technologies to Australia; but, buying commercial technology and offering a bureau service is a recipe for disaster,” explains the managing director. “If you are buying off-the-shelf technology, there is nothing stopping competitors from doing the same. In my pursuit of a more beneficial business model, I discovered a hidden problem in the medical sector - how do surgeons train while avoiding the complexities associated with cadavers?”

The difficulty of the problem at hand invigorated Roe to take up the challenge head-on, bringing together a team of the most skilled professionals in the additive manufacturing, engineering, anatomy, and IT to reproduce human anatomy with accurate anatomies and haptic feedback for surgical training. The company has also built a library of actual footage obtained from surgical procedures that provide medical professionals with a comparison of their advanced manufactured anatomies with the genuine body part.

While promoting its products, Fusetec refrains from revealing to the surgeons that the body parts shown in the video are advanced manufactured anatomies until the end of the video.

Surgeons are generally flabbergasted, when it is revealed they have been viewing a manufactured, life-like model, designed with intricate pathologies and not the dissection of living tissue.

Transcending the Barriers of Surgical Residency

In the journey of achieving these levels of precision and anatomical accuracy through additive manufacturing techniques, Roe noticed that these technologies not only offer an important avenue to replace traditional yesteryear methodologies but also eliminate the dependency on cadavers. These medical specimens are often plagued with regulatory and health-related constraints such as procurement, logistics, bacterial contamination, and disposal. “Cultural, religious, and regional issues across many countries plague the logistics, preservation, and disposal of cadavers, wherein medical professionals spend exuberant amounts of money for training and end up missing out on an opportunity due to the stigma associated with such medical practices,” adds Roe.

Fusetec eradicates such problems through a synthetic replacement for cadavers, which improves the quality of surgical training while stepping away from the medical constraints associated with such practices. Furthermore, the company allows medical professionals to order specific pathologies on demand, which would then be shipped to the client—anywhere in the world—upon order. This merit alone proves to be a significant differentiator for Fusetec’s models over the use of cadavers.

Fusetec demonstrated this methodology of replacing cadavers with advanced manufactured pathologies through collaboration with world-renowned ENT surgeon Professor Peter-John Wormald, at the University of Adelaide’s Medical School. Historically, the professor would order 20 cadavers to train 40 international surgeons, and each trainee would effectively be the recipient of half a nose to perform surgical dissections. In this setup, surgical trainees could not obtain enough hands-on experience or training time with problematic cadavers, and have zero ability to train on specific pathologies, as cadavers containing pathologies cannot be ordered.

In November 2019, Professor Wormald (‘PJ’ as he is known to his friends) decided to opt for Fusetec’s advanced manufactured sinus trainers; each surgeon received four different sinus training specimens to dissect. “You can effectively conduct 12 different operations on one sinus trainer, so each surgeon has the opportunity to conduct 48 different operations and variations. That is 48 different operations for the price of one cadaver,” explains a passionate Roe. Fusetec has designed a range of models by collaborating with PJ, thereby controlling the learning FESS Course Adelaide University, exclusively used of Fusetec sinus trainers, no Cadavers. RAH Neurosurgeon removing a brain tumour on a curve. Surgeons are now encouraged to make mistakes, take risks, and learn. “They can always purchase a new model to complete their rehearsal at their convenience,” smiles Roe.

PJ has heaped praises for the technological revolution brought forth by the advanced manufacturing experts. “Fusetec is changing how we train our surgeons. The pathology on cadavers can’t be ordered or predicted; hence, surgical training is a limited and uncontrolled experience. Yet, with Fusetec appearing on the scene, surgeons can now order pathologies in large quantities. Not only can surgeons and students get more practice, but they could also choose different levels of complexity and difficulty, which means that they can tackle challenging conditions step by step. Furthermore, as all students get the same models, it is much easier for the teacher to monitor their progress,” says PJ.

Such merits and advantages over the conventional cadaver-based surgical practices give Fusetec a head start in completely revolutionizing the medical training industry. Fusetec is already partnering with some of the leading medical professionals in the industry, making the technology readily available to surgeons across the world while also promoting risk-free, hygienic, and regulation-friendly surgical practices.

BC and AC - Before COVID and After COVID

With Fusetec’s Sinus Trainer product launch at McGill University, Montreal in Sept 2019, followed in quick succession in New Orleans, then Australia and the Middle East, momentum was gaining rapidly.

With the onset of the global pandemic, however, sales came to a grinding halt like so many other businesses. “Who is undertaking surgical training during the COVID-19 period?” frowns Roe.

Once again, Fusetec put on their thinking cap and repurposed their first sinus surgical training products into a COVID-19 swab training model. Partnering with the head of ENT, Associate Professor Alkis Psaltis at the Queen Elizabeth Hospital, Fusetec filmed a swab training video and Personal Protection Equipment (PPE) training video circulated around the globe.

Fusetec also responded to a call from the South Australian government, seeking local companies to manufacture PPE. Fusetec is now a proud manufacturer of Face Shields. As Roe states, “It’s kept the lights on while aiding our frontline workers. I am proud of the Fusetec team’s creativity, constantly accepting new challenges, and helping others in the process.”

When asked, “What does the future look like for Fusetec post COVID-19?” Roe did not hesitate to respond, as if the answer had already been considered.

“COVID-19 has caused global turmoil, with potentially catastrophic financial disruption to all market sectors. Particularly, Fusetec, who manufactures human body parts for surgical training, is currently canceled, globally. Albeit, the medical sector which equated to 10% of global GDP has greatly increased since the outbreak of COVID-19.

In response to our new reality, Fusetec will support specialist surgeons teaching dissections via webinars. This has never been done before, but Fusetec has the technology and capability to manufacture human body parts without the risk of harmful bacteria. Fusetec can airfreight human body parts globally, and surgeons can now rehearse, anywhere, including their kitchen table, via a webinar training session. This ability also reduces the risk to surgeons for traveling especially to countries where cadavers have less rigorous standards. Other options include surgical training tourism in Australia, and we have a few more strategies up our sleeve.

I am confident that whatever obstacles are thrown at Fusetec; we will find a solution.”