Neo-Bionica specialises in developing, manufacturing and testing bioelectric and neurotechnology devices for use in targeted therapies and diagnostics. Neo-Bionica CEO, Mr Ludovic Labat (PhD) spoke to new AMT Editor, Paul Hellard.

AMT: Can you please describe what is involved in bioelectric and neurotechnology device development?

Ludovic Labat: Simply put, we develop neurotechnologies and bio-electronics medical devices for our clients. There are devices that are used in patients to either stimulate a nerve or to read activity on a nerve as a way of treating a variety of diseases and conditions. Historically, the most commonly known device is a pacemaker where the devices apply an electrical signal on the heart to help with coronary issues. The cochlear implant is another very common application for the technology. There are now many more other applications in the field of epilepsy and Parkinson research and treatment and many other medical arenas.

AMT:  With the development of neurotechnology devices, talk about Neo-Bionica’s part in that area of manufacturing.

LL:  Our clients are all developing technologies for new treatments. We are in the innovation field of neuro-technology and we initially help our clients from the ideation, the concept point of view. We then develop prototypes to work out the feasibility issues the technology may be facing. And then we converge toward defining the product, and executing the detailed design of the product. These prototypes are tested intensely in verification testing before moving into clinical trials.

There are many iterations of prototypes, and the first models are always benchtop models where you don’t have any physiology attached. That’s a good way of progressing fast and verifying that the device is safe. Safety of the product is the first aspect that must be verified. The efficacy of the expected clinical intent from the devices is then proven.

This is the space where Neo-Bionica has succeeded in the field of neurotechnology, even before there was a facility or teams in Australia capable of designing neurotechnology devices to the level of what we’re doing. Being able to produce prototypes for first in-human testing in Australia and the facility that we’ve built fills that gap in the supply chain for the market.

AMT:  Tell us about a couple of your recent successes.

LL:  We currently have a dozen clients and the business is only just nine months old. And from those clients, there are two pretty significant projects. One for a big multinational corporation in the US and one for a mid-size company. And the feedback from these clients is tremendously encouraging. Everybody’s extremely pleased with what we bring and the pace at which we move and the co-location in between the Neo-Bionica facility and St. Vincent’s Hospital in Melbourne. The fact that our engineers are working with clinicians on a very regular basis is very well received. This is proof that the vision of the founders of Neo-Bionica is now proven. There was a gap in the market. And our client’s people are really interested in us delivering on these needs.

One of the key attributes of our business is discretion. And we really wanted to differentiate ourselves from research organisations. Our clients come to us with their IP. If they are young start-ups, they may be raising money and they may want the publicity. We are working with a company named Nirtek, in Melbourne. They are very pleased to share that we work with them, but many clients ask us to be extremely discreet as the work we are doing for them is highly novel.

And part of the offering is to respect that, but the type of product we are developing at the moment for our clients are really places where new technologies are going to the next step. There are some pretty significant clinical challenges that the clients are trying to solve, and we help them solve these clinical challenges through engineering solutions. This is the type of neurotechnology that we will begin to see on the market in seven to ten years.

AMT:  What’s your view on where Medtech industry is right now?

LL:  I’ve been very fortunate to work in many industries. I did my PhD in the Aerospace Industry and then worked in the Automotive Industry for a few years. And I’ve been a general manager at Tektronix, working in test-and-measurement solutions and so I’ve seen quite a bit of industry, and here in the medical devices industry, it’s still young but it’s extremely regulated. And there’s significant maturity coming naturally from the fact that we are so highly regulated. I would say it is a young and fast-growing industry, but very mature.

AMT:  What would you say to engineers and manufacturers wanting to be part of the creation of these medical devices?

LL:  There’s no typical product, but there is a typical process. We are extremely strong on having a defined process. Some of our team members come from the MedTech industry, some of our team members come from an engineering background, and some have clinical expertise. And so those who are coming from the industry bring that very defined and repetitive process. We always start from the unmet clinical need. Product definition must start there. And we spend time with our clients, understanding what they are trying to achieve from the patient’s point of view.

And that’s where the co-location with the clinical world in the St.Vincent hospital is a massive, unique advantage for our clients. We listen to these needs and translate these very quickly into a set of requirements. And then the team is working on ideations. Working, creating concepts in a very fast-moving cycle of designing, testing, and learning. There is a point where we stop these loops and we move into the detailed design, which will be far more linear. And going into the verification testing which is far more structured especially when we are in the Class Two and Class Three medical devices.

What we do at the core is produce electrodes and electronic systems for implanted devices and so a key focus is the safety and longevity of devices. We put a lot of effort into manufacturing and fabrication techniques, and consideration into material choices. Choosing the right material is critical to ensuring the safety and long-term reliability of the unit. And so that, that’s a big, big part.

Also, understanding all the aspects of biocompatibility requires specialised knowledge. There’s a limited subset of materials that you can use as implants, for example, silicones, and certain polymers. These materials will have their own mechanical properties, their own electrical properties. Depending on where the implant is set and its purpose, there are challenges in selecting the right materials – and so having the right people on your team with expertise in this area is critical.

AMT:  Where do you see the Medtech industry going, what is in Neo-Bionica’s future?

LL:  Unfortunately, we can’t talk specifically about our client projects, but they are really exciting, innovative technologies across a wide range of applications.

And as our team has experience in taking medical device prototypes through to pre-clinical and clinical testing, often these clients come to us as they know we have the expertise to make sure the device systems and hardware work together seamlessly and that materials used in the device subcomponents – such as stimulators, electrode arrays, and leads – are biocompatible and safe.

AMT:  What makes you most excited to be working in the medtech field?

LL:  You know, the day I decided to sign for this job, I watched a YouTube video where a baby was receiving their first cochlear implant and hearing the voice of their mother for the first time. And firstly, it’s difficult not to cry because it’s extremely moving, but as an engineer, you have an opportunity to have a massive impact on the life of real people. We know that engineers can make people travel far or communicate faster like we are doing right now. But when it’s about the life of a patient and we can see that impact, it’s very special.