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Additive manufacturing for Medical Devices

EOS’ industrial 3D printing technology allows to produce specialized surgical instruments and medical devices quickly and cost-effectively

Every person is unique. Therefore, optimal patient care in dentistry, orthopedics and implantology requires medical products that provide a perfect fit. There is a high demand for one-off components and components produced in small production runs whose materials and manufacturing standards have to fulfil extremely stringent quality requirements. This also applies to specialized surgical instruments and medical devices. In addition, these products must be made available quickly and cost-effectively.

Additive Manufacturing is meeting these exact requirements – while paving the way for improved, patient-specific medical care. Additive Manufacturing enables producers to come up with faster, more flexible and more cost-effective development and production methods. Unlike conventional manufacturing methods, EOS Additive Manufacturing allows maximum design flexibility, enabling the implementation of innovative functions. Thus, test series, prototypes, patient-specific one-off parts and small production runs can be manufactured at a profit. To give an example, several hundred individual dental crowns can be produced in a single operation.

EOS provides far more than the necessary materials and systems for Additive Manufacturing: comprehensive market knowledge and a precise understanding of specific development processes in the field of medical technology enable EOS to collaborate closely with a strong network of partners. From Rapid Prototyping to series production – EOS provides comprehensive and competent advice and continuous support to customers during the entire development and production process.

EOS systems are able to manufacture medical devices. However, EOS cannot offer any guarantee that these devices meet all requirements.

White Paper: Bodycad Unicompartmental Knee System (BUKS)

Improving Precision and Accuracy with 3D Printing

When it comes to implanting a unicompartmental knee prosthesis (UKP), precision and accuracy are critical for the durability of the prosthesis, and ultimately for the quality of life for the patient. To deliver optimal results, Bodycad, a Quebec City-based developer and manufacturer of personalized orthopedic implants and instruments, has turned to additive manufacturing in development of their revolutionary Unicompartmental Knee System (BUKS). This whitepaper includes a background of the BUKS procedure, along with critical data and results of the new knee arthroplasty technique as it was put to the test and measured against other contemporary methods.

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3DLMS

Marco Ravanello, General Manager at 3DLMS talks about the usage of industrial 3D printing, addressed markets and the benefits of working with EOS.

EOS Additive Manufacturing technology – Medical best-practice examples

Medical: Alphaform – Production of hip implant by using Additive Manufacturing

15-Year-Old Cancer Patient Receives the Perfect Implant and Renewed Hope for the Future

For anyone affected by it, a cancer diagnosis always comes as a shock. In the case of a boy from Croatia this was particularly true

as an aggressive form of bone cancer had destroyed the teenager’s hip. The only option for the doctors treating him was a complete reconstruction of the hip bone. Once again, the 3D printing experts at Alphaform, a company with extensive experience in the medical sector, placed its trust in EOS’ technology to successfully produce the implant.

Challenge

A primary bone tumor (meaning one not formed by metastasis), is a cancer lying directly on the bone – a serious illness. The malignancies generally grow destructively, meaning that the original tissue must be removed. This was the case with a 15-year-old patient from Croatia. A complete arthroplasty of the hip was the fundamental prerequisite for ensuring the cancer cells did not continue to spread in the boy’s body. An intervention of this type limits the mobility of the joint, and thus the mobility of the patient. Particularly in young people it is important to find solutions that limit, or even prevent, any negative consequences further down the line.

With a precision implant, a patient’s motor skills can largely remain unaffected in the future. In the hip area, the precise shaping of the replacement bone is particularly important. The femoral neck functions as the central joint for the leg and is thereby fundamental to walking and running. It requires a perfect connection to the body in order to function correctly. What is important is not so much the fit of the hip bone in the joint. Rather, the complete artificial hip should correspond as precisely as possible to the original so that the entire positioning and all of the angles match one another again.

The manufacture of such an implant is of course no simple undertaking. However, the cancer in the body of the boy was a powerful adversary. In addition to its pure destructive force, the illness was also causing the doctors concern because of the speed with which it was spreading – time was of the essence. Furthermore, the new implant had to meet the doctors’ weight specifications. Lightweight, precision, fast – these were the three requirements with which the Croatian surgical team brought to Alphaform with their request for a corresponding metal bone part.

Solution

The German Additive Manufacturing expert has made a name for itself in the production of implants. It utilises a process whereby a powdered material is hardened with a laser, layer by layer, to create artificial bone parts. Having studied the available information it was quickly established that the boy could be helped. According to Christoph Erhardt, Director of Additive Manufacturing at Alphaform AG, “The design process was a real challenge. We received the complete 3D data including the cavities from Instrumentaria. Based on this we were able to start with the precise manufacture of the implant.”

This is where the advantages of EOS’ innovative production processes came into full effect. In order to keep the weight of the artificial hip to a minimum, Instrumentaria built in a large number of cavities. Such recesses in otherwise solid parts can only be achieved through Additive Manufacturing. Precision casting or conventional milling cannot achieve such a complex shape. The challenge with the integration of the empty spaces was to find the correct mix of stability and weight reduction because the implant also needed to withstand a high degree of physical stress.

Within one week the component was produced with the EOSINT M 280 using a stable yet light titanium alloy. The process, from the initial computer sketches to the final implant, took only six weeks. This period included the sophisticated finishing of the artificial bone. “We were making something that would be placed inside a human body. Even the slightest contamination, residues, or unevenness could have catastrophic consequences”, explains Erhardt. The high level of experience of the 3D service provider also had a positive effect here. The cleaned implant fulfilled the highest medical requirements and arrived in Croatia within an impressively short time.

Results

To the delight of everyone involved, the subsequent operation in May 2014 was a great success. First the team of doctors completely removed all of the parts affected by the cancer and then the new artificial hip was inserted, complete with the integrated joint. What’s more, a part of the young patient’s thigh was replaced so that both joint parts fit within one another perfectly. The precision, lightweight implant fulfilled all of the medical requirements and the foundation was laid for the patient’s successful recovery.

Besides the short duration of the planning and construction, the finishing process, which was developed by Alphaform and has subsequently proven its value on many occasions, was a further component of the overall success. Amongst other factors, the multi-step cleaning process facilitates the utilisation of the part for medical applications. It also guarantees over the long term, that the body and the implant harmonise with one another. In addition, depending on the growth rate of the young patient, it will also be possible to replace the hip with a larger one in a relatively simple procedure.

Atif Cakor is R&D Design Manager for Custom Implants at Instrumentaria and had a leading role in the joint project. He under

lines the importance of Additive Manufacturing in the medical sector: “The team that carried out the operation with Prof. Dr. Robert Kolundžić and Dr. Sc. Srećko Sabalić did a fantastic job. Together with the knowledge of the doctors it was the high quality of the implant that served as a guarantee for the enduring success of the procedure. The fact that these advantages do not come at an exorbitant cost is better still. The signs are that this technology will go on to help many more patients in the future.”

“We have not only contributed to saving the life of a 15-year-old boy, but also to making his life significantly more pleasant – what more could you hope to say about the advantages of an innovative solution? Both the Additive Manufacturing and the finishing have proven to be a great success. We are all very happy that the operation went well. It is a prime example of the way in which EOS technology can help people.”

Christoph Erhardt, Director, Additive Manufacturing at Alphaform AG

“In recent years we have been able to gain a great deal of knowledge and experience in the area of custom implants. Each new patient benefits from this expertise. The technical foundation is provided by Additive Manufacturing. It has been important that technology pioneers such as EOS were able to establish metal-based processes in this field. The result of their innovation is that we are able to offer people consistently better implants.”

 

Atif Cakor, R&D Design Manager for Custom Implants at Instrumentaria Co., J.S.C.

Medical: University of Michigan – Customizing a biocompatible material for additively manufactured medical implants

Materials that help save lives

An adolescent girl has now joined a group of three baby boys and one baby girl who have received novel 3D-printed tracheal splints to treat a congenital breathing condition called tracheobronchomalasia (TBM). It is estimated that one in every 2,000 children is affected by this life-threatening condition worldwide. All five patients continue to thrive thanks to the surgical procedures that have helped their collapsed airways function normally. The lifesaving procedures took place under FDA Emergency Clearance. EOS provided expert advice and Additive Manufacturing technology.

 

Challenge

Dr. Glenn Green, a pediatric otolaryngologist, and his surgical team from C.S. Mott Children’s Hospital, Ann Arbor, joined forces with Dr. Scott Hollister, professor of biomedical engineering at the University of Michigan, to pioneer the patient-specific designs. “It’s now pretty automatic to generate an individualized splint design and print it; the whole process only takes about two days now instead of three to five,” explains Dr. Hollister. However, there were some challenges to overcome in achieving this success.

How did the relatively small university team achieve this feat of creating surgery-ready implants on an academic research budget? Computer-aided design (CAD) sped up the engineering side and 3D printing provided cost-effective, patient-specific production. “Even if a market is relatively small, this doesn’t diminish the human need to be treated,” says Dr. Hollister, who first learned about Additive Manufacturing in the 1990s. “Later, when I started designing my own porous scaffolds for anatomic reconstruction, I realized that 3D printing would be useful for creating the complex geometries I had in mind.”

For a number of reasons, polycaprolactone (PCL) was found to be the perfect material for additively manufacturing a tracheal implant: Firstly, it has a long resorption time, which is very important in airway applications, because the implant needs to remain in place for at least two years before it is resorbed. Secondly, PCL is very ductile, so if it fails, it will not produce any particles that might puncture tissue. Thirdly, PCL can be readily processed for, and fabricated on, the EOS system.

Solution

Dr. Hollister and the University of Michigan had already purchased a FORMIGA P 100 in 2006 to aid research into scaffolds and biomaterials. “I chose EOS because we were looking for a system that was flexible and allowed us to change parameter settings like laser power, speed, powder-bed temperature, and so on, which we needed to do to customize our builds,” says Dr. Hollister. “Also, because biomaterials can be expensive and implants and scaffolds are typically not so big, we wanted a more limited build volume that didn’t use a lot of material. The FORMIGA P 100 fitted the bill for both of these requirements.”

Additive Manufacturing expertise was provided by EOS, who helped the team on site in their laboratory, advising them on how best to prepare the material for production. While the company offers a wide variety of proprietary plastic and metal materials, the use of PCL was a first in this case. “We make a point of being very open in terms of materials. We support universities in the development of their own parameters for novel materials on EOS systems, such as in this instance with the University of Michigan,” says Martin Bullemer, Business Development Manager Medical at EOS.

The University team uses patient data from MRI or CT scans to examine the defect to be repaired, then creates computer models of the anatomy. Engineers are then able to design splints with a highly compliant, porous structure of interconnected spaces, which will slowly expand along with the maturing airway over time. “EOS even gave us access to software patches, to enable us to change the range of parameters of the machine to best process the PCL material,” says Dr. Hollister.

Results

Finally, the splint was produced using the FORMIGA P 100 system. “Additive Manufacturing is one of the few methods I know that allows us to actually fabricate these complex designs,” says Dr. Hollister. After fabrication, the researchers measure the splint dimensions and then mechanically test them. The splint-supported trachea expands and is operational right away, so that when patients are weaned off oxygen, they are able to breathe normally. The first child is now nearly four years old and an active preschooler. And, as planned, the boy’s own tissues have successfully taken over the job of the implant, which has been almost completely reabsorbed into his body.

Dr. Hollister’s group is also developing craniofacial, spine, long bone, ear and nose scaffolds and implants—and producing them all using Additive Manufacturing technology from EOS, using a material with characteristics that promote reconstruction and regrowth following birth defects, illnesses or accidents. While 3D printing is being adapted to serve an ever-widening breadth of industrial applications, it is this kind of clinical translation of the technology to individual patient-specific solutions that is making life-altering history in the field of medicine.

Dr. Glenn Green saysthat his office is continually receiving phone calls and emails from parents and doctors enquiring about these implants. The future role of Additive Manufacturing in the medical field is clearly wide open, Dr. Hollister believes. “I see a time soon, probably within the next five years, when many hospitals and medical centers will print their own devices specifically for their own patients, and not need to get them off-the-shelf.”

“If we can expand the number of biomaterials used in Additive Manufacturing, we can tackle a tremendous number of problems in all fields of reconstructive surgery and make enormous strides for the benefit of patients.”

Dr. Scott Hollister, professor of biomedical engineering and lead researcher at the department of biomedical engineering at the University of Michigan

Short profile

The University of Michigan is one of the world’s most distinguished universities. Founded in 1817 in Detroit, it relocated to Ann Arbor in 1841. Its biomedical engineering department supports one of the largest healthcare complexes in the world.

 

Rapid Prototyping with additive manufacturing solutions by EOS

Additive manufacturing is ideally suited for Rapid Prototyping. Thanks to the highest possible degree of design freedom, even complex shapes such as bionic structures can be manufactured. It is possible to manufacture physical presentation and functional prototypes quickly and cost-efficiently without the need for manual processing – directly using three-dimensional CAD construction data. This makes the entire product development process considerably faster.

Flexible construction and material variants

EOS systems build up prototypes as well as end products layer-by-layer. Different metal and plastic powder materials are available. Products made of different materials belonging to one material family (metal or plastic) can be processed on one machine. This is especially interesting for prototype manufacturing.

Companies in many sectors of industry are now making successful use of laser sintering processes in their development and manufacturing processes.

EOS Quality: Result of extensive experience and the highest manufacturing standards

EOS continuously monitors the quality of all components at every process step in the value-added chain and holds the relevant product certifications and validations

The aim of EOS quality policy is to identify current customer needs and future market demands early on and meet these by means of the appropriate organisational, technological and economic resources. This is the only way to ensure the success and competitiveness of the company in the long term.

The cornerstones of our quality policy are:

EOS has defined quality principles which we implement throughout the entire company:

  • Our quality benchmark is the satisfaction of our customers
  • We strive to achieve an outstanding level of quality in all products and services
  • Secure organisational and technological processes allow us to maintain our high quality standards both reliably and economically
  • Every employee endeavours to produce work of impeccable quality and avoid errors
  • Every employee contributes to achieving our company goals and improving quality through responsible, quality-conscious action
  • We promote awareness of quality in every employee by providing training programs and information events

The key factor in implementing our quality policy is management acting as a role model of our principles. For this reason, the managing directors and every manager in the company are committed to align their day-to-day actions with the defined quality policy.

Quality Management

EOS quality management is focused on development and continuous improvement using the best methods available, both in terms of organisation as well as processes, systems and product. This is done in partnership with all colleagues and departments. In this way we are able to meet customer demands, our company goals and legal requirements in an efficient manner.

EOS documents its high standards by means of important certifications of its quality management system.

  • EOS GmbH: certified according to ISO 9001 since 1998 for development, manufacturing, sales and service of systems and solutions for Additive Manufacturing using laser sintering technology
  • EOS Finland Oy: Certified according to ISO 9001 for design, manufacture and sales of metal materials and processes for EOSINT M systems. Also certified according to ISO 13485 and Directive 93/42/EEC for medical applications with Cobalt Chrome SP2 registered as class II medical product in EU for dental applications.
  • KVS GmbH: certified according to ISO 9001 for the development, production, testing and sales of polyamide powders and mixtures

 

EOS updates the QM processes according to standards in the medical and aerospace industries and according to GMP. EOS continuously monitors the quality of all components at every process step in the value-added chain. EOS also holds the relevant product certifications and validations (IQ, OQ, PQ) for all components of the Additive Manufacturing process. This includes processes and finished parts on the customer side as well as regulatory certificates and registrations in global markets.

Quality Assurance for Direct Metal Laser Sintering (DMLS)

Quality assurance for system, material and process serves central customer requirements

Consistent and repeatable part quality is essential for series production applications.

Process, system and material –  the three technological elements of Additive Manufacturing have a direct influence on the quality of an additively manufactured component.

Thanks to the joint development and mutual adjustment of systems, materials and processes, EOS ultimately establishes the conditions for best possible part properties.

With quality control measures in all three areas this unique concept is a holistic approach to quality assurance in series production

Process: checked and validated parameters

  • all process parameters (laser power, layer thickness etc.) which are necessary for achieving certain component characteristics are based on more than 20 years of experience and comprehensive series of tests
  • required product characteristics can be achieved through the respectively optimum combination of individual parameters
  • material data sheets provide a detailed description of the material characteristics which can be achieved on this basis

System: reliably meeting manufacturing standards

  • certified to ISO 9001 for the development and manufacturing, sales and service of systems and solutions for Additive Manufacturing using the laser sintering technology since 1998
  • EOS machine acceptance tests include a comprehensive check of all system components as well as defined reference parts – test criteria: mechanical properties, tensile strength, elongation at break, surface quality, part density
  • DIN and ISO standards are applied for tests

Material: guaranteed consistent quality of every material batch

  • EOS Oy branch in Turku/Finland for development, qualification and quality assurance of metal materials: Certified to ISO 9001 and to the Medical Products Law ISO 13485
  • with multi-dimensional quality management EOS guarantees reliable consistent quality for every material batch
  • examination of every batch for its correct chemical characteristics
  • check for consistent grain size distribution
  • reference build job: density cubes and tensile bars are manufactured and analyzed according to fixed criteria under standardized conditions
  • mill test certificate is included with each delivery

Quality in industrial 3D printing: A holistic approach

Whitepaper: Hands-on quality

 

Setting standards for process and material development and qualification in AM

There are strict requirements when it comes to qualifying and certifying parts, materials and processes in the aerospace industry. However, the requirements have not yet been fully standardized for additive manufactuing. This article will focus on technological reliability, an aspect which is important for establishing trust in the technology. We will illustrate how material and process development is performed at EOS, setting standards for quality assurance in additive manufacturing.

Comprehensive quality management portfolio

EOS offers an expanding range of products in the field of quality management EOS-Services.

EOS also documents its own standards in the form of certifications of its quality management system and has numerous process and product certificates. Its product range also includes its material management system IPCM (Integrated Process Chain Management) for optimized material handling.