Below, we would like to introduce our third podcast session about 3D Printing at the Point-of-Care, in which we are talking about the industry with the experts in the branch. In the following episode, our guest was Beatriz Dominguez Gonzalez, a Global Market Hospital Manager at the industry-leading company, Materialise, whom we spoke about “Materialise and Global Point-of-Care Additive Manufacturing Market“. Generally, we were talking about Beatriz’s personal experience and career development in the medical 3D Printing industry, the history and the current state of one of the most well-known in the medical 3D Printing field, Materialise company and also the implementation of in-house, Point-of-Care 3D Printing of medical devices, implants, guides and anatomical models. We have also covered a lot about the regulation challenges or 3D printing technologies such as softwares, extended or virtual reality and their constant innovation. Generally, the podcast was focused on the implementation and development of 3D Printing of medical applications at the Point-of-Care on the global hospital market, in which our guest is an expert in for many years.
The following episode of our podcast sessions about 3D Printing at the Point-of-Care was specifically focused on the additive manufacturing processes directly at the Point-of-Care in the hospitals. As our guest, Beatriz Dominguez Gonzalez is a real expert in the industry, she was able to provide us the most in-detailed and accurate information about the global hospital market, regulations, technologies and challenges regarding bringing the 3D Printing facility into the hospitals and medical clinic infrastructure. While she has an impressive background and experience regarding the innovative health care system and patient care, she was able to give the most insightful data about allocating the 3D Printing at the Point-of-Care.
We have begun our session with the introduction of our program as well as our guest and then, we moved forward to the most industry-specific questions. As speaking about the Materialise company, we got to know a little bit more about the history and the challenge of 3D printing in the early nineties. As our guest, Beatriz Dominguez Gonzalez from Materialise confirmed, with the development of innovative technologies and softwares such as Mimics or Magics, the process became much more efficient and time-saving. Actually, Mimics was the world’s first software to turn CT image data into anatomical models and thanks to that, the company was able to print out their first anatomical models and then proceeded with surgical guides. At the present moment, Materialise is actually having more than 6 million patients scans analyzed with our medical software, 50,000 patients that are helping every year and there are more than 400,000 patients and the numbers are still rising. However, as Beatriz outlined, the limitation is still being seen in regulations. As U.S (FDA) and European Union ones differ a lot, there is always a challenge in making it more clear and easy to understand. The aim is to make the 3D Printing technology at the point of care more accessible. Taking that into consideration, we can see that it is actually possible to make it more approachable. While Materialise is helping to bring 3D printing technology in-house and assist the hospitals in developing and implementing the 3D printing strategy, the Point-of-Care is actually gaining more awareness.
As Beatriz Dominguez Gonzalez mentions, a good example of that can be the relationship of the Materialise company with one of the most well-known, Mayo Clinic, which right now, thanks to the collaboration with Materialise since 2006, is one of the pioneers in the 3D Printing Point-of-Care industry. However, when asked about the biggest challenge ahead 3D Printing, Beatriz says it’s still about the regulations and the reimbursement. ‘’As soon as I hospitals will be reimbursed, I believe that we will have a bigger, much larger implementation of the technology’’ Beatriz comments. “Regulations are making the life of the hospitals a little bit more complicated because they need to work in a compliant way”. As we can deduce from the following statements, the solution for that would be to make the regulations as clear as possible and raise the hospital’s awareness about the worth of the investment in 3D Printing Point-of-Care facility, which will result in a reduction of turnaround time, costs or resources in the long run and provide the best possible, personalized patient care.
Above, we shortly summarized our podcast session with Beatriz Dominquez Gonzales, a Global Market Hospital Manager at Materialise, however for more in-detail information listen to the whole episode about the “Materialise and Global Point-of-Care Additive Manufacturing Market” or read the transcript below!
Weronika Zapędowska (3dpoc.com): Hi! Welcome to our third podcast session. My name is Weronika, the host of this program, in which we are talking about the 3D printing industry at the point of care with our guests who are the real experts in the branch. In the meantime, you can check also our website 3D pointofcare.com where we post the latest news and advancements in the 3D printing and point of care industry. Now, let’s move on to our first episode.Today, our guest is Beatriz Dominguez Gonzalez, who is currently working as a Global Hospital Market Manager at Materialise, a leading additive manufacturing company with 25 years of experience in the 3D printing for medical applications. Hi Beatriz! It’s an honor to have you with us today. Once again, thank you for participating in our podcast program. We know that you have impressive experience, especially in 3D printing and the point of care industry and we would like to know more about you. However, can you tell us first about yourself and your career in the industry?
Beatriz Dominguez Gonzalez: (Materialise): Hi Weronika. First, thank you for having me speaking today here. I’m very delighted by it. About myself. I studied Pharmacy in Madrid. I am Spanish by origin and then I came to Belgium to do a PhD in biomedical Sciences at KU Leuven. That time I was working in basic science, which of course is crucial, is essential, but I was missing a bit more of something that can be really applied immediately to improve the life of people. I’ve always been passionate about the Innovation. About how that can make the life of people better and especially health care. And that’s when I decided to then go to Materialise. It was more interested in 3D Technologies already. And of course, it was a great opportunity in which I started as an Academic Market Manager. And so, that time gave me a great visibility of most Innovative applications of 3D Technologies. And now, as you said, I am the Market Manager for Hospitals and I work bringing the latest 3D Technologies to hospitals to ultimately improve patient care.
Weronika Zapędowska (3dpoc.com). I understand great. Thank you so much. Like it was a great introduction and it was great to know you better. So, now, let’s move on to our main questions. So let’s start with can you explain shortly the history of Materialise and the current state of the company? We know that you divide it between Materialise software, Materialise Medical and Materialise Manufacturing. Can you tell us more about it?
Beatriz Dominguez Gonzalez (Materialise): Yeah. Sure. So, to go first into the first question, Materialise was founded in 1990, but by Wilfried Vancraen, who is said to be the CEO and it only started as a personal bet in a way so Wilfried was In his job. He got to visit the lab and in that lab, they called a 3D printer and he immediately saw the potential of that technology. So he came back to his work and try to convince his work of investing in a 3D printer and he was unsuccessful, but that actually is why we are here, he basically called, involved friends, family and a loan from the bank to get the 3D, the first 3D printer and as soon as he started to work with it, he realized the Gap there were a big gap in the software’s used to create these parts for for 3D printer. So, just as an anecdote, backpack then, in those times in early 90s, it took two to three months to make a print of a hip model by our current CTO, Bart Van der Schuerenbut. Two to three months of manual work he had to do. So there was obviously a gap in there and a way of making 3D printing more accessible for the clinical practice and in general for other Industries. We needed to work on the software and that’s how two years later Materialise choose 2 software programs, which are still today shaping the industry standard and Industrial medical 3D printing. So that’s in one side Mimics, which was the world’s first software to turn CT image data into anatomical models and also Magics that is for industrial purposes. After that, we have done the first anatomical models as I would say is in the early 90s, but in 1996, we already progressed to 3D printed guides. We also the same year launched virtual planning software in 2011. We also brought hip implants into our portfolio and many others implants to come. In 2018 we had the first software in the world to receive FDA clearance for 3D printing anatomical models for diagnostic use. And just to make this story come to an end to the current status, today there is more than six million patients scans analyzed with our medical software. There is more than 50,000 patients that are help every year and there is more than 400,000 patients specific model guides and implants created today, which I think is it was the numbers of how many patients had we helped thanks to this technology. It’s beautiful to see the progress, right?
Weronika Zapędowska (3dpoc.com): Yes, it is. Do you want to continue with that question?
Beatriz Dominguez Gonzalez (Materialise): Yeah, I was going to answer your second part of it.
Weronika Zapędowska (3dpoc.com): Okay, perfect.
Beatriz Dominguez Gonzalez (Materialise): So as you were mentioning, we have three branches so Medical Software. Medical Materials or Medical and Manufacturing. As I was saying, in medical we pioneered many medical applications in 3D printing and I already gave an
about it. In software, what we do is to provide companies with the platform of software tools to manage and control 3D printing processes and with manufacturing what we do is to make 3D printing available for everyone. So we bring 3D printing products to customers.
Weronika Zapędowska (3dpoc.com): I see now, thank you. So, we also know that you’re operating in different countries and locations. And how challenging is that specifically, how material has approached the regulatory challenges?
Beatriz Dominguez Gonzalez(Materialise): Well, that’s a good question. That’s very challenging. So, in this question, there is, for us for example in the terms of the medical device operation, so that the parts that we print. Much of the regulations we follow are based on International standards, so in nicer regulation. And then, that being International is easier to follow. When it comes to be more challenging is in terms of software regulation, which is very fragmented. Each country has their own way of regulating these. We have a very good view on point of care regulation on in the US and the European Union. Mostly, in the industrialized countries in Australia and so on. But as you are saying, it’s extremely challenging because of the differences per region. Now, Materialise also by the history and being the Pioneer in the field has a grown also with the regulations in a way and also participate in many initiatives to try to make regulations clearer and easier. And for example, we are participating right now in the medical device single audit program that will serve with one audit in five countries US, Canada Brazil, Japan and Australia. And this is just one example of efforts to make this relation more more clear and easier. So more people and more patients and for 3D printing to be more accessible to everyone.
Weronika Zapędowska (3dpoc.com): Yes, definitely. Thank you. So, we are also focused on like 3D printing at the point of care and you are also like a Global Hospital Market Manager. So, our question is could you tell us more about the relationship of Materialise and the hospitals? To what extent do you work or collaborate with them?
Beatriz Dominguez Gonzalez(Materialise): Yeah, so Materilaise has a long historical relationship with hospitals. We were pioneers in bringing 3D printing applications to the clinical practice and being the first in that gave us the opportunity to grow as a company and to grow our products with the needs of the Clinics. So, our products and our company and our services has always been adapted to the demands of the hospitals. Now, as 3D printing has become more accessible with this year software to use more reliable printers, we see hospitals bringing the technology in-house, which enables them to support more cases using 3D printing, because they have more rapid turnaround times and also they have greater awareness of the technology within the clinical, the different clinical specialties. We basically assist hospitals in developing and implementing the strategy for 3D printing based on their vision and the certifications. So we’ve basically helped them with our knowledge and expertise in any stage of the 3D printing journey that they are. So, we can advise them implementing a start-up lab from scratch and raising what they already have, the hardware and software structure to a scale a multidisciplinary work flow and anywhere in between. A good example of that is it’s our relationship with Mayo Clinic. So Mayo Clinic had their first 3D model printed in 2006 to help the team a very large team to do a very complex surgery to separate conjoined twins. And today they are producing more than 6,000 models and models for them in many cases is just standard care. So, we have in all the way with them and we don’t see as ourselves as I’m near provider of a software is that we really collaborate together to improve patient care and make the most out of three technologies within the unique characteristic of each hospital.
Weronika Zapędowska (3dpoc.com):I know some. Thank you so much. Like it was a very interesting answer for this question, especially with my Mayo Clinic. So, also talking about point of care, we can also see that there is a dedicated session on Materialise about it. Can you elaborate more on that? Like what kind of products and services do you specifically provide for 3D printing at the point of care?
Beatriz Dominguez Gonzalez (Materialise): Yeah, so Materialise seems to make the world a better and healthier place and that’s why we have a dedicated. We are very motivated for 3D printing at the point of care and it is really ingrained in the Materialise strategy, because we really aim to bring 3D printing to a routine clinical practice. In terms of how, what kind of products while we have a broad portfolio of software products and one of our software was we are one of the only providers of FDA-cleared software for 3D printed models for diagnostic use. We offer different softwares to bring images to 3D models, design and print, surgical guides, surgical planning, perform, of course, research in engineering. We also have softwares for communication of digital 3D models. We do it between the clinical team and with patients. Of course, we also have the patient specific implants, but aside from the products itself what I think is more important that we provide for 3D printing at the point-of-care is our expertise. After all, Materialise has decades of experience and understanding of the 3D printing process. And that also comes with a large network of users and of Industry partners. So, I think that part is really crucial and the support we offer of course, because we have a dedicated team of application Engineers that are there just a phone call away if any doubts arise to our customers.
Weronika Zapędowska (3dpoc.com): I see thank you. I understand. Also, like as an expert in the industry, what do you consider to be the biggest challenges or challenge ahead of 3D Printing medical devices at the point of care and what could be the solution for that?
Beatriz Dominguez Gonzalez: (Materialise): This is also an Interesting question. In my opinion, the biggest challenge is a regulation reimbursement mostly as the biggest challenge I would base. And that is because in order for 3D printing to be more current, more implemented in the clinical practice of every hospital. We spoke about Mayo Clinic, but not every hospital has the resources of Mayo Clinic and still they have patients that should be treated with the best care, with the best health care available, right? And in order for that to happen, there is a big barrier, which is a reimbursement. As soon as I hospitals will be reimbursed,I believe that we will have a bigger, much larger implementation of the technology. A solution for that, well, of course, I don’t have the magic answer for that as well. For sure, a starting point is to gather data to support the future reimbursement and guide the standards and develop guide standards. So, to put an example there, because this is already happening In the U.S. So, in the U.S right now, there are rather logical Society of North America and the American College of Radiology. They are currently busy with the 3D printing clinical trial and clinical data registry in which they are collecting data to understand the clinical benefits and the appropriate use of 3D printing. And this is absolutely necessary to start having the conversation of why this should be reimbursed. So, we have also evidence of time saving in the OR, because of using anatomical models and an economical value of savings of 3D printing, because of less time in the OR. But, we also need this clinical evidence that actually is that we have a general acceptance of it being better, but we need these peer reviewed literature to demonstrate the value and registry that they want offers an A and ACR and they will supply this data to kind of benchmark the value of 3D printing in each application.
Weronika Zapędowska (3dpoc.com): Yes. That’s true.
Beatriz Dominguez Gonzalez (Materialise): Of course, there is the starting point when we want to talk to governments and so on of why this should be reimbursed. They measure, their major concern is always the patient care of course.
Weronika Zapędowska (3dpoc.com): Mhm. Yes, that’s for sure. Thank you. We know that Materialise is also one of the biggest companies always providing the great statistics and valuable information about the industry. So, what do you think is the current market trend for 3D Printing at the point of care? Is it growing and if yes, how fast is the market developing, can you answer that?
Beatriz Dominguez Gonzalez (Materialise): Yeah, sure. I can give you my point of view in it. For sure. Yeah, we for sure see a greater adoption of 3D printing in hospitals and clinics. It i is since it’s still growing at a rapid pace. The technology is more accessible. The benefits is far more appreciated, both like physicians and patients. And therefore more hospitals choose to invest in 3D printing infrastructure to have a personalized healthcare. One piece of data that supports these higher implementation is for example, the articles that we can find in PubMed that reference 3D printing. In 2009, we only have 200 articles. In 2019 there were more than 3,000. So it is clear that the implementation is continuing . In terms of the trends, your first question that you asked, I think we can, of course. The big one of 2020 is Covid19. Yeah, it’s impossible to escape that one. Yes. And yeah what we have seen during these very dramatic crisis is that there has been a shortage of critical safety and life supporting equipment and hospitals that had already implemented 3D labs, they have created very, they have very creative minds coming with solutions to repurpose their 3D printing labs to help in the crisis. And so in that way, we have seen I think the awareness and the value of 3D printing had has a life and an increase of awareness and not also, not only in between the medical community, but suddenly, it was very common to see 3D printing parts in media and seeing how general public is also more aware of it, which again is fascinating to see and it’s also fascinating to see how 3D printing than can help to in dramatic situations like this crisis. In terms of other trends that we are seeing in the 3D printing at the point of care right now there is for example, there is more integration of the 3D printing in the clinical workflow. And again, that will enable more hospitals to implement 3D printing and the ones that already have it to do more cases, because there is a widespread adoption of the new daikon encapsulated STL standard, which will enable 3D printing ties to be archived in the hospital packs. I’m associated with the patient’s medical records that makes us everything way easier for the hospital and this for example, this new dicom standard is available in our latest version of Mimics. I’m going to comment on two more trends that I think are relevant right now. One of them is the growth of the use of extended reality. So we are seeing more and more in the clinic segmented in our virtual reality technologies. And initially, it has been more established validation and training help, but we are starting to see also applications of support of procedural planning and even intraoperative titans. So, I think we will see more and more virtual reality and augmented reality in the clinic, which sounds to me. Also, it is a very interesting time to be in this industry. And the last thing I wanted to mention that for the Europeans that are hearing us is probably a must, is the new European medical device regulation that was postponed until 2021, but is still out there. And that in a way more regulations is making the life of the hospitals a little bit more complicated, because they need to work in a compliant way. And I think this is also where working with a partner with a lot of experience in the field takes a lot of value, because we can help them. We have many many hospitals. We have hundreds of hospitals that we have implemented 3D printing. So we have the experience to make this also in a compliant way and we can help this. As in the U.S., yeah the FDA continues to support dialogue with stakeholders to modify and make appropriate guidance for safety nets and effectiveness of the 3D printing at the point of care.
Weronika Zapędowska (3dpoc.com): Yes. Let’s see. Thank you. That was like a long answer for this question. So thank you so much. And we also heard that your company turned 30 this year. Yes, that’s a big thing. Can you shortly sum up the accomplishments you made?
Beatriz Dominguez Gonzalez (Materialise): Yes, yes. Well, actually I did many of them already during the one of the questions, right? I mean, I think yeah, I can come back with it. But basically getting things I get in the first of our FDA approved in the market also having our implants and so on but just not to repeat too much, I think what is more important is the amount of patients that we are helping. These six million scans and more than 50,000 patients helped every year. That means a lot really a lot to us. In terms of other industries, we also have Magics, which is, it enabled an entire industry to in productive in the same way that Mimics lead in the
in the medical industry. So, our manufacturing unit also brought a lot of new customers to 3D printing, because it allowed the technology to help a new people by transforming parts of the industry. We had examples as Yuniku, which is using a lot of Materialise knowledge on personalization of eyewear industry, but we can name those sense of industries benefit by it. It is a keyboard, personalized ski boots and then also less sexy things like optimizing supply chains are making new parts of production production lines that are also important. In the term of medical area, it’s clear that from the very first hip model that we printed that was acquainted manually in a minute took over two months to get finished to right now the bioresorbable track Alisprice? that they are doing that. That is allowing surgeries that otherwise would be very complex, it would be in a lot of much more complications. Yeah, I think that the way seeing the history, the 30-year celebration is a very important one to us.
Weronika Zapędowska (3dpoc.com): Yes it is. Thank you. Thanks a lot Beatriz. So that was my last question. And I think it’s the end of our session. It was great to know you better and once again, thank you for being our guest today.
Beatriz Dominguez Gonzalez (Materialise):Thank you so much Weronika.
Weronika Zapędowska (3dpoc.com): Yes. Thank you. Like, it was a great opportunity that you can join us and we hope that again you can also join in the other program and episodes we will make in the future. And we also want to wish you a lot of good luck in your future career and developments
Beatriz Dominguez Gonzalez (Materialise): Thank you so very much and Weronika.