Materialise: Innovative X-Ray Knee Guide System Rejected By FDA

Materialise_logo_withBaseline_ColorWhen following new innovations in the medical and healthcare industries, it often may not be apparent immediately, but if you dig deeply enough you will find involvement from Materialise in the majority of 3D printed devices, models, and implants being made for the healthcare system. The Belgium-based company is also often first on the list to be called when serious circumstances are at hand as well. This has been demonstrated repeatedly, most especially in cases like those of 3D printed models helping for the diagnosis and treatment of tumors, or 3D printed guides assisting in hip replacement surgeries.

download (2)From supplying Airbus with 3D printed parts for their planes to offering supportive 3D printing Magics20 software for architects, one could easily surmise that there’s rarely a quiet day at the office for the Materialise team. With one valuable innovation after another, they are certainly on top of their game as a leader in addivitive manufacturing developments. As they state, “We are Materialise and we are all around you, making the world a better and healthier place to live in.”

But you simply can’t win them all, and it looks as if the Materialise team may be going back to the drawing board regarding their latest design for a knee replacement guide. They have just announced receipt of a ‘not substantially equivalent’ letter from the FDA. This comes on the heels of their submission for an innovative X-ray knee guide system, which now seems to have a questionable future, as it stands. Materialise states that this 3D guide is meant for use as a surgical instrument which would help surgeons in the operating room while putting knee replacement components into place. This particular X-ray device allows for the positioning without an MRI or CT.

“We are disappointed that the FDA concluded that, based on the information submitted, our X-ray knee guide system cannot be considered as substantially equivalent to our solutions based on CT or MRI images,” said Wilfried Vancraen, Founder and CEO of Materialise. “While this decision will impact the timing of the marketing of our innovative solution in the United States, we will continue to pursue the regulatory clearance process, taking into account the feedback from the FDA.”

homepage-background-pic-2-e1435620001415Taking the try and try again approach, obviously Materialise is not giving up on the knee replacement guide. With the FDA issue being just a bump in the road, it’s to be expected that the company will have whatever issues are present with the design fixed expediently.

With its main branch in Leuven, Belgium, Materialise is a worldwide presence regarding complex 3D printing innovations and services. They are the very definition of versatile, offering products for a wide and varying range of industries, from healthcare to automotive. Creating products through 3D printing since 1990, Materialise continues to be the leader in numerous solutions–especially that of biomedical and clinical devices.

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Exclusive Interview: Wim Michiels, CEO of Materialise Malaysia, Discusses the 3D Printing Market …

i3dpconf mumbaiThere is no denying the global nature of the third industrial revolution, as additive manufacturing is sweeping the globe. As we gear up for India’s very first Inside 3D Printing Conference & Expo, presented in Mumbai by MecklerMedia, it’s hard to believe it’s already this week! Running December 3rd and 4th, Inside 3D Printing Mumbai is sure to showcase some incredible uses of this technology that has us all–the world over–in a tizzy. With a full agenda encompassing speakers, a 3D Design Challenge, and even a concert featuring 3D printed musical instruments, the event is sure to shine the spotlight on the incredible goings-on in the Asia/Pacific region.

Materialise_logo_withBaseline_ColorMaterialise, itself a global company, is among those entities we cover frequently here at 3DPrint.com. Offering an incredible array of products, services, and software, Materialise’s reach extends across the world. I recently had the opportunity to interview Wim Michiels, CEO of Materialise Malaysia Sdn Bhd and Vice President Asia Pacific, Materialise NV, who will be delivering the very first keynote at Inside 3D Printing Mumbai on Thursday, December 3rd.

Below is our interview in full, examining Materialise’s participation in Malaysia and India, as well as Michiels’ hopes for Inside 3D Printing Mumbai.

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Wim Michiels

How does Materialise approach the Indian market?

The Indian market is an interesting one, with its own dynamic and expectations. Materialise employs a team at our Malaysian office that is dedicated to the Indian market, understanding its specific needs, business culture, and speaks the same language – literally and figuratively. With such a dedicated team, we are able to work more closely with our valued customers and support them with our own experts. We also work very closely with other players in the 3D printing ecosystem, such as machine manufacturers and their partners, to jointly offer complete solutions to the market.

What impact has Materialise had in India? (We recently covered the story of Materialise’s 3D printed heart models saving the lives of two teenagers, for example–are these uses expected to expand?)

Materialise is offering a variety of 3D printing software and services in India. The focus is mainly on the various software solutions for industrial 3D Printing (with Magics, 3-matic, and Streamics), as well as for biomedical engineering (the Mimics Innovation Suite). In recent months, there has also been a growing interest in our medical services.

We have been able to offer a backbone to most leading companies and institutes in the 3D printing industry, thereby facilitating a strong start and presence in their respective markets and activities. Most leading universities are already using our software for research and education, service bureaus use our software to streamline their operations, and medical device companies continue to innovate with our biomedical engineering software. The recent cases of the heart models are indeed also an interesting indication of the interest to actually use 3D Printing in hospitals, assisting patients with difficult surgeries. We certainly hope that this use will expand, as we hope to see our innovative technology help as many patients as possible for a better and healthier life.

What makes the Indian market (or any Asian market) stand apart from Western markets– both for Materialise specifically and in general for the technology?

In terms of 3D Printing applications, Asian markets are on the whole still behind Western markets, with little development into advanced applications. The transition from prototyping to manufacturing is still rarely made in Asia, and India is no exception to that. Another notable trend is the enormous increase in machine manufacturers in Asia, with India also seeing some development in that respect. Since our software platforms are our main activity in Asia, used to power our customers’ business, our own activities are affected by those trends.

Although multiple countries in Asia have come up with ambitious plans to stimulate the growth of 3D Printing in the past few years, it is not yet clear what the impact of an initiative like ‘Make in India’ for instance will have on 3D Printing in India.

materialise malaysiaWhat will you be discussing at Inside 3D Printing Mumbai?

Successful 3D Printing is about getting the entire system and process right. 3D Printing applications are almost by definition complicated – due to customization, repeatability, decentralization, and so on – and therefore, these applications need thorough development.

I plan to use a recent case as an inspiring example of the various factors that were involved in making the project successful, drawing attention to the important lessons we can learn from that.

What do you hope attendees will gain from their presence at Inside 3D Printing Mumbai?

I hope visitors will get a taste of all that is currently happening in the world of 3D Printing, and how the industry can be a source of opportunity for India. I also hope attendees and the Indian 3D Printing community will get a sense of how 3D Printing can further improve our lives through improvements in processes, business, technology and creating opportunities for new products, collaborations, investments as well as synergies for collaboration, networking, education – and the list goes on. I believe visitors will see that there is already more going on in the Indian 3D Printing scene than expected, while there are many opportunities for the future.

What are you most looking forward to at Inside 3D Printing Mumbai?

I anticipate this will be one of the biggest 3D Printing events in India ever, where a lot of our friends, customers and partners will be present. It will be a great forum to meet these people again, hear their stories, discuss their latest projects and general progress, get a feel for how 3D Printing is evolving in India, and catch up on everything and anything.

Besides that, we know that quite a few companies are getting into 3D printer development and manufacturing in India, and I am curious to learn what is happening exactly in that field, and how Materialise can increase the success of these initiatives.

newmumbair180Inside 3D Printing Mumbai will take place December 3-4, and we’ll be following the goings-on closely!

If you’re interested in attending, remember that 3DPrint.com readers save 10% on registration using code 3DPRINT. Keep tabs on the latest using #I3DPConf on social media.