Specialises in titanium limb salvage implants.
Keen competition in a growing market segment and maintaining necessary standards of quality make the medical implant industry a challenging business. Manufacturing of prosthetic devices and implants is one important segment of this burgeoning industry. However, medical implant work is not just small in terms of workpiece sizes and batch sizes – lead times can also be small and one size does not fit all. To compete for implant work it is not only the expertise in design that counts. You also have to have the manufacturing tools at your disposal.
LRS Implants, headed up by Neil Campbell, is one of South Africa’s leading companies providing a full suite of solutions for both upper and lower limb salvage scenarios. Neil is passionate about finding solutions for any orthopaedic case or problem. He holds an Honours degree in Mechanical Engineering and a Masters degree in Biomedical Engineering, both from the University of Cape Town. He has spent over 10 years in the industry, working closely with leading international orthopaedic surgeons, both in the field of limb salvage and general orthopaedics.
An LRS Implants modular scapular – proximal humerus reconstruction system
“Today medical machining can refer to a host of CNC machining related operations producing a variety of components and products from surgical implants to orthopaedic devices to medical instruments. Various medical parts involve a range of challenges, but certain machining challenges in particular are common among medical parts. They include small-scale machining or micromachining, because implanted devices often consist of very tiny components; Machining titanium, a material often used in medical devices because of its non-reactivity with the body and machining plastics, because certain plastics also have this advantage and custom machining, because some medical components can only be machined to specifications tailored to a particular patient’s body,” said Campbell.
“Efficient small-batch machining is essential because new medical devices are developed quickly and refined through many iterations, making it necessary for machine shops to responsively provide prototype parts. Outsourcing of medical machining is becoming more and more common in the industry. This means that one additional challenge for shops that wish to participate in this market is to build, advance and maintain relationships with medical-industry customers in need of machining work.”
“In recent years, titanium has become dramatically more significant as a workpiece material in machine shops. Two industries are driving this. One is aerospace. The latest aircraft designs use dramatically more titanium than planes of the past. The other is the medical industry. Titanium is a common material used for implants and devices used within the body. Titanium’s low thermal conductivity and tendency to work harden make it more challenging to machine than other metals that most machine shops are more accustomed to facing.”
Custom 3D printed Ti6Al4V hemi-pelvis on pelvis model
“Technology advanced to allow the use of titanium alloy powders and through the use of an electron beam melting or selective laser sintering process components were manufactured. Titanium alloy powder has a high level of sphericity, low oxygen content, high density (bulk and tapped) as well as controlled grain size. These properties are necessary to make it compatible with even the most demanding industrial applications. The use of these processes, which is a form of additive manufacturing (3D Printing), facilitated rapid, cost-effective manufacture of customised components that would not have been possible using conventional machining techniques.”
“Today however, with the development of processes and equipment, 3D printing of medical components has become a reality. When 3D printing first appeared, production applications were not on the cards. The technology was thought of as a tool for rapid prototyping, one that could not be trusted to make end-use parts, and one that could not compete at scale.”
“As the technology has evolved, however, these assumptions have had to change. 3D printing has progressed beyond prototyping into the making of functional tooling and on to the additive manufacturing of end-use parts in increasingly larger quantities. Today, 3D printing can be a more cost-effective way of producing parts that would otherwise require prohibitively expensive or time-consuming tooling, setups or assembly.”
“Two-dimensional imaging often falls short in conveying enough information about the complex three-dimensional (3D) anatomy of the body. The 3D capabilities of computed tomography (CT) and magnetic resonance imaging (MRI) can expand these capabilities significantly. However, in the past, proprietary hardware, software and services were known to be extremely costly when customised reconstructions were required. This gap has begun to shrink as has the technology.”
“The use of 3D printing and rapid prototyping can now provide affordable and personalised templates and implants, which are useful in planning and performing technically difficult surgeries.”
“CT DICOM (Digital imaging and communications in medicine) data is converted into stereolithography (.stl) file format and imported into 3D Computer Aided Design (CAD) software, in my case Solidworks. The models are then used to design a suitable prosthesis, as well as the templates and jigs required for the insertion of the implant.”
“The primary goals of both the designer and the surgeon are to reconstruct and recreate the integrity and symmetry of the limb so as to provide the patient with a long-term, functioning and pain-free limb.”
Local manufacture with Executive Engineering
“Revision surgery and limb-reconstruction surgery are technically demanding and require careful pre-operative planning in order to achieve accurate bony cuts and correct implant positioning and fixation. With the use of our proprietary CAD software and embracing the 3D printing technology, we as a company have advanced consequently.”
“However, up until now we have been hampered by the fact that we could not get our 3D printed implants manufactured locally. We would have to send our files to a 3D printing bureau in Europe and then wait for the component to be returned. This led to longer lead times and less control of the manufacturing environment.”
LRS Implants modular limb salvage reconstruction systems
“We have now partnered with Executive Engineering who have invested in a new EOS M 290 metal sintering machine, supplied by Rapid 3D. The EOS M 290 is based on the DMLS (Direct Metal Laser Sintering) 3D printing technology developed by EOS. This 3D printing technique uses a fiber laser to melt and fuse fine metal powder. Layer after layer the 3D object is built. This 3D printing method allows us to create 3D printed products with complex geometries including elements such as freeform surfaces, deep slots. More importantly, it allows us to create “mesh” like surfaces that mimic the structure and porosity of bone. This encourages bone in-growth into the implant and greatly increases implant fixation.”
“We now outsource all our manufacturing to Executive Engineering. Partnering with Executive Engineering has freed us up to concentrate on our core competencies of implant design in conjunction with surgeons. The team at Executive Engineering has delivered exemplary quality products, often under tight deadlines. This is born out by their having been awarded the ISO 13485 accreditation for medical manufacture and having a full service machining setup. Machining still needs to take place once the 3D object is built. Logistically it was becoming a nightmare for us and we now have a local partner that can provide us with a full service.”
“We appreciate the fact that they have a can do attitude and have exacting quality standards, and we are exceptionally happy to partner with them going forward to grow our business.”
“The addition of the titanium 3D printer by Executive Engineering opens up huge new possibilities for us going forward, especially in the patient-specific custom implant market. The most fulfilling part of my job is seeing a design move from computer, to machine, to patient, knowing that we have made a difference in that patient’s life.”
For further details contact LRS Implants on TEL: 021 510 3106 or visit www.lrsimplants.com