Applications of robotics in the medical devices industry

Knee replacement surgery is one of the most common types of joint replacement surgery carried out in the world, according to the US Department of Health and Human Services’ Agency for Healthcare Research and Quality. In India, this involves more than 150,000 surgeries per year.

Knee orthopaedic surgery is challenging in that every patient has a different bone anatomy, with a different degree of damage to the joint. To improve the accuracy of knee replacement surgeries, Indian healthcare provider Hunjan Hospital deployed a surgical robot from Stryker, the Mako Robotic ArmAssisted Surgery system.

The MAKO system helps surgeons to create a 3D model of the damaged joint using the patient’s computerised tomography (CT) scan, helping surgeons to understand the damage and work on a suitable course of action. It gives a personalised digital surgical plan to match each patient’s requirements.

Planning helps surgeons to choose the best course of action and decide the bone cuts and alignments of the implant. Once the plan is finalised, the system assists surgeons with performing the surgery with precision in the operation theatre. In the event something goes wrong during the surgery, the system gives out a modified plan.

The MAKO robotic arm cannot move outside its virtual boundary, enabling surgeons to stay within the boundary and perform surgeries that ensure accurate bone cuts, alignments of implants, and protection against any damage to soft tissues. The robotic-assisted surgery reduces post-operative pain and accelerates recovery according to Stryker. However, the challenge for Hunjan Hospital is the heavy price of the MAKO system. In 2020 the robot cost $1.25m, and once purchased there is an extra $100,000 in service fees per year. 

There is a huge unmet need for the treatment of certain central nervous system (CNS) disorders, particularly those in the brain, as it is very difficult to precisely direct drugs to a particular area. Bionaut Labs is combining robotics with pharmacology to develop new therapies able to overcome this barrier.

Its remote-controlled micro-robots, Bionauts, enable precise targeting to deliver therapeutics such as gene therapies and oncolytic viruses. The Bionauts are untethered and remotely controlled by a magnetic propulsion system. Designed to move through fluid-filled spaces, the Bionauts can be directed to move, pierce tissue, and unload the contained therapeutics, before being safely directed back out of the patient.

Before use, a magnetic resonance imaging (MRI) scan of the patient is taken to map out the intended path, and real-time X-rays mean that surgeons can ensure the Bionaut is in the correct position. Ranging in size from 100 microns to one millimetre, the Bionauts can have many different forms dependent on their intended function.

Bionaut Labs is beginning with two focal areas for micro-surgical application. The first indication is for malignant gliomas and has received orphan drug designation from the FDA for its BNL-101 Bionaut in June 2021. BNL-101 can travel through the brain to deliver doxorubicin, a chemotherapy drug, directly into brain stem tumours.

The minimally invasive procedure is combined with standard-of-care radiation therapy, and in vivo studies showed superior efficacy and survival. Gaining orphan drug designation approval for BNL-101 provides benefits such as assistance in the drug development process, tax credits, exemptions from certain fees, and seven years of marketing exclusivity.

Since receiving orphan drug designation for BNL-101, Bionaut Labs has partnered with Candel Therapeutics to deliver Candel’s oncolytic viruses to brain stem tumours with the Bionauts.

Bionaut Labs’s second focus area is Dandy-Walker syndrome (DWS), a congenital paediatric condition. Current treatment targets the fluid-filled cysts that develop in the brain of those affected and involves inserting a tube into the brain to reduce pressure.

However, the treatment comes with complications, especially for children as they grow. In September 2021, Bionaut Labs received humanitarian use device designation (HUD) from the FDA for a Bionaut designed to pierce the cysts in patients with DWS in a minimally invasive procedure.

The HUD approval will significantly accelerate the pathway for market approval. Having tested the micro-robot on large mammals, Bionaut Labs aims to begin human proof-of-concept studies in 2024.

To cover the costs of bringing a new device to market and accelerate the process, Bionaut Labs has strategically chosen to target rare diseases, enabling its products to go through accelerated regulatory pathways, including HUD and orphan drug designation.

DWS in particular is one such rare disease, affecting up to 1 in 25,000, that Bionaut Labs will be able to carry out an early feasibility study on up to five patients. Further safety data from Bionaut Labs’s clinical trials will serve to accelerate investment. 

The Global Burden of Disease Study, published in 2021, found that at least one billion people suffered from a vision impairment that could have been prevented or had yet to be addressed. Of that population, 94 million suffered from cataracts, with the prevalence much higher in low-to-middle-income countries. Cataract surgery can treat the condition by replacing the eye’s natural lens with an intraocular lens (IOL).

However, manufacturing IOLs requires extreme precision and accuracy, such as with material handling and the placement of components. Aravind Eye Care System provides cataract kits, including IOLs, for over 100 countries worldwide, particularly across Africa, Southeast Asia, Central America, and India. Its manufacturing division, Aurolab, chose to implement industrial co-bots for the manufacturing of its cataract kits, more specifically IOLs.

Aurolab chose the UR5 co-bot from Universal Robot, a subsidiary of Teradyne. Following a successful proof-of-concept study with one co-bot, a further seven were deployed. The UR5 is a flexible robotic arm able to carry loads of up to five kilograms, making it ideal for picking, placing, and testing.

Aurolab’s product output increased by 15%, with the UR5 robots able to create 10,000 lenses per day and over two million annually. The co-bots are affordable, have low power usage, and include safety controls for staff. Deploying the co-bots also meant that more staff were relieved from night shift duties.