J: Hi! Chris, thanks for taking some time with the 3DHEALS audience for this interview. Can you tell us a little about yourself?
C: I am a dentist by trade with a few qualifications including a bachelor of Dental Science with honours and a bachelor of science in biochemistry and physiology from the University of Queensland as well as an M.Phil. by research in Biomedical Science from Cambridge University. I have been in clinical practice since 1998 and since then built a national network of dental clinics within Australia which I sold to private equity investors in 2013. In clinical practice I developed a special interest in craniofacial pain, reconstructive dentistry and sleep dentistry. In terms of the latter I am a severe apneic myself also suffering from Nasal Obstruction. Within my patient population I recognized that approximately half of my patients also suffered from increased nasal congestion as evidenced by them being obligate mouth breathers or oro-nasal breathers. I recognized that airway issues were a major issue for patients developmentally in terms of development of malocclusion and also in adults in terms of obstructive sleep apnea. I also recognized that a failure to address these issues in the patient population meant that the long term oral health of my patients and the success rates of the dentistry I was performing was at risk.
J: Have you always been a very creative/innovative person?
C: I think whenever I didn’t have an answer I would go looking for one and if one was not available I would always try to solve the problem with lateral thinking. A lot of innovation is common sense that is not contained by conventional thinking or dogma.
J: Tell us about the story behind the inception of Oventus?
C: Out of my own personal desperation, having failed CPAP treatment and having difficulty using oral appliances due to my nasal obstruction, I fashioned an airway out of some flexible saliva ejector tubes in an attempt to get air to the back of my throat unimpeded. This worked for me and was in fact the first O2Vent device. I then started making a similar device out of plastic for my patients which was working for them but was very labour intensive and resulted in a very bulky device with limited space available for the airway so while it was working reasonably well for patients it was not commercially viable as a treatment. The incorporation of CAD design and 3D printing in titanium was a game changer and addressed these issues with an airway that was five times bigger (the same as a healthy human nose in fact) much lighter weight (30 grams) and much smaller in size (60% smaller).
J: What are some of the tipping points of the Oventus story?
C: The first major tipping point was when I met the current CEO Neil Anderson and he then introduced the concept to the CSIRO (Australia’s peak research body) and kicked off a project to start designing the devices with CAD software and then 3D printing them in titanium. From then we developed a device that was on the market in about a year. This was the product development tipping point.
Shortly after that we reached another tipping point where as a result of one press release we had several thousand patients register on line for the device in a matter of weeks. We could only make about 1000 devices so this was the business tipping point and the catalyst to take in some investor funds to scale up manufacturing further develop the product pipeline.
J: Are the regulatory entities in Australia/US challenging to understand and comply with? What are you experiences with these areas?
C: They are both different but there are clear guidelines as to what is required to comply. In many ways the US system is easier to comply with as there is more structure. In both cases it has been very important to engage advisors that understand the landscape and how to navigate through it. For our first device the O2Vent Mono there were predicate devices for a 510K FDA application and for our second Device, the O2Vent T, we are able to use our own device as the predicate. This process was relatively straight forward and there are also existing reimbursement codes for oral appliance therapy for the treatment of OSA. As our clinical evidence builds, our unique technologies and resulting products could in the future lead to their own reimbursement codes. These could be as a result of the airway being used in the treatment of nasal obstructers or connecting the airway to CPAP machines for lower and more comfortable positive air pressure.
J: What/who inspired you to use 3D printing technology to prototype, and then to manufacture Oventus device?
C: The bulk of the handmade device and the cost and time to make these devices by hand meant that it was not commercially viable. The devices are also custom made bespoke for each patient and contains within it a complex hollow three-dimensional structure that could not be milled, cast or moulded so 3D printing was the only viable manufacturing process. The ability to custom design a large number of devices with complex hollow three dimensional airways and print them simultaneously made the device manufacture scalable and commercially viable.
J: What are the most significant differences between making your device with 3D printing and traditional manufacture?
C: Time, cost, weight, size, effectiveness, scalability and commercial viability. The handmade device took about 18 hours to make one, it was more than twice the size, three times the weight and the airway was only one fifth the size.
J: Why is 3D printing necessary, in creating the bilateral airway to the back of throat ?
C: Any time a complex hollow custom three-dimensional structure is required it can only be made by additive manufacturing. Doing this by hand is not viable so 3D printing is the only viable option.
J: What do you think can be improved in terms of 3D printing technology that would enable Oventus to continue to improve?
C: At the moment 3D printed titanium products need to be polished. We are finalising a mechanical polishing solution at the moment which will be a huge benefit but a finer quality finish on the printed surface would be a break through particularly when considering finishing internal surfaces. In terms of 3D printing of plastics there is a need for commercial size open-source machines to allow the opening up of development of new materials. Large companies that limit the use of materials to the ones they supply are inhibiting the growth of the 3D printing field. Across all types of 3D printing we need more speed at lower cost. I think it is similar to the early days of computing.
J: What are your biggest challenges in using 3D printing technology? How did you overcome these?
C: We were really pioneers in this field so there were many challenges, for example there was no scalable software to design our devices, we needed to validate the accuracy of the build as well, we needed to develop finishing techniques, we needed to test for adherence to different polymers for the tooth engagement, we needed to find out what the tolerances were in terms of wall thickness and build quality and many more. Some of these issues we solved internally with good old fashioned lateral thinking and problem solving but many of these challenges were solved through collaboration with other groups that had specialised skills in each of these areas and then managing those collaborations to a commercial end point.
J: What are your biggest challenges in making Oventus successful? How did you overcome these?
C: Oventus is a paradigm shift in the treatment of OSA. Like many new technologies the initial response to a new concept from the incumbents can be scepticism and doubt. Often the response can also be particularly aggressive. I think the Oventus technology is quite elegant in its simplicity and so we have certainly been the recipient of some aggressive actions taken by incumbents that failed to develop something similar. We take this as a compliment. Flowing from this the two most common questions we encounter are “How can it work if it is so simple?” and “Why didn’t someone else think of it?” We could take that as an insult but what it really means is that we have to communicate more clearly as to how it works and why it was developed. So the answer is continuing to build clinical evidence and the communication of this. As Oventus builds its product pipeline on the patented 3D printed airway platform it will become more apparent that this is a unique solution for which there is a clear indication, a massive unmet clinical need, a growing body of evidence and over time this will convert to an acceptance that it is a new paradigm and a standard of care for the treatment of OSA either on its own or incorporated into complimentary technology.
J: What makes 3D printing technology particularly interesting to you?
C: 3D printing is the only way to manufacture the Oventus devices so that is of particular interest. Over and above that it opens up a whole host of different opportunities the scale of which we are not yet grasping. The applications in the dental field alone are extraordinary. If I could work on a dozen businesses at once I might develop some more applications myself but I think I will need to leave that to others. It has massive benefits in terms of the provision of health care but the wider applications are just as exciting.
J: What do you think are the biggest barrier(s) in scaling 3D printing in dentistry? And in healthcare at large?
C: I think the biggest barriers are the regulatory and reimbursement hurdles, the cost of the equipment, print speed and quality of the surface finish. The technology related issues are either in the process of being solved for, or are on the cusp of a solution. We are certainly focussing on some of these ourselves. In terms of regulatory and reimbursement we are lucky at Oventus in that we are a class II device so the regulatory hurdles are not so profound (compared to say a class III implantable) and there are existing reimbursement codes for some of our technology. The early adopters will no doubt pave the way for others in terms of these issues. The cost of the equipment will undoubtedly come down over time. The printers are in effect big computers. The rate limiting step will likely be validation of the cheaper emerging technologies but this will only hold the tide back for a short while.
J: What is your forecast of the 3D printing industry in dentistry? And in general in healthcare?
C: The big opportunity will be in the manufacture of complex hollow three dimensional structures and serial customization combined with the fact that additive manufacturing is low cost in terms of input costs and can be considered green manufacturing in many ways. I think the applications are huge and we really don’t know right now how far that will go. In combination with 3D imagining technology, CAD design and the development of different media (e.g. cell scaffolds and tissue cloning etc.) I think anything is possible.
J: What would you tell the next generation of entrepreneurs in dental and healthcare 3D printing about being innovative and building companies?
C: Three things:
- Think outside the box and back yourself.
- If someone tells you something cannot be done it is not that “it” cannot be done but just that the person telling you that can’t do it.
- Make sure you believe in what you are doing because when the going gets tough it is a lot easier to keep going if you believe in it.
J: What is your ultimate vision about Oventus? 3D printing in dentistry?
C: For Oventus I think we are just starting to scratch the surface of what 3D printing has allowed us to do. It has given us access to the oropharynx to allow unrestricted breathing, deliver oxygen and air pressure, to monitor efficacy and compliance and to gather information on what is happening in this part of the anatomy. The applications for this airway technology are not just in OSA but also in the fields of sports, orthodontics, anaesthetics, therapeutics and diagnostics. In terms of 3D printing in dentistry the applications certainly in terms of implant surgery and bone regeneration will be profound. There will also be a plethora of applications in prosthodontics, orthodontics and oral maxillofacial surgery to name a few.
As Clinical Director of Oventus, Dr Chris Hart is overseeing the launch of the O2Vent to patients and through clinicians. Prior to establishing Oventus, Chris owned and managed a multi-site national dental practice, training institute and management consultancy which he recently sold to private equity investors. He now works full time as the Oventus Clinical Director and sits on the Oventus Board as founder and major shareholder.
Chris also acts as an adviser to various bodies within the dental industry as well as the health care sector more broadly on the commercial aspects of health care delivery.