Croom Precision Medical turns to Renishaw for AM and metrology
June 10, 2020
Renishaw, Wotton-under-Edge, Gloucestershire, UK, was recently selected as Additive Manufacturing and metrology partner by Croom Precision Medical (CPM), Croom, County Limerick, Ireland, a manufacturer of medical devices for the orthopaedic market. Under the partnership, Renishaw’s technology was used for the production and validation of CPM’s ISO13485 certified medical devices.
Using Renishaw’s metal Additive Manufacturing technology, CPM was able to incorporate complex features into its implant design at a commercially viable cost. In addition, Renishaw’s built-in AM software, used in combination with its metrology solutions, are said to have allowed CPM to maintain traceability throughout its manufacturing process, essential in a heavily-regulated environment.
Founded in 1984, CPM has been supplying Class I, II and III medical devices to the orthopaedic market for over thirty-five years. The company states that, as these devices will ultimately impact patients’ lives, it is essential that rigorous quality procedures are applied to help achieve safety and effectiveness both during and following implantation.
“We want to achieve consistency and reliability in the products that we make,” stated Patrick Byrnes, Research and Development Manager at CPM. “CPM has a vision of becoming a centre of excellence for Additive Manufacturing in Ireland.”
CPM operates an Integrated Management System (IMS) which encompasses ISO 9001, ISO 13485 and ISO 14001 accreditation. In order to demonstrate compliance with the standards, CPM must maintain transparency and traceability at each stage of the manufacturing process.
The challenge: Complex, quality-assured metal implants
Medical implant designs are advancing rapidly and manufacturers are increasingly incorporating novel and complex structures into implant designs, with the aim of improving implant performance and longevity. Making such structures with traditional manufacturing techniques can be challenging and is not always economically feasible, explains Renishaw.
In order to assess the quality of parts, CPM carries out a series of offline tests to check the chemical, mechanical and morphological properties of the implant. Whilst these tests are essential to measure the mechanical and chemical consistency of the implants, they can be time consuming and add to the overall cost per part. CPM’s aim was to transform its production so that more of the monitoring would take place during the manufacturing process.
“We’re looking for a red light or a green light, whether the part is good or bad,” explained Byrnes. “At the moment there’s a lot of offline testing that we do, and we want to get away from that in order to reduce our cost of goods. We’ve done a lot of work on that over the last couple of years, there’s still a bit to go, but we feel that we’re ahead of some of our competitors in the area of in-process monitoring.”
The solution: Renishaw AM with inline process monitoring
CPM has invested in a RenAM 500M Additive Manufacturing machine, which it uses to additively manufacture titanium medical devices with geometries that would not be possible using conventional manufacturing techniques. For example, it has begun assessing the use of gyroid lattices on acetabular cups; the resulting implants have reportedly stood up to rigorous quality testing, and CPM reports notably good density and Young’s modulus values.
Byrnes added that it is the inline process monitoring offered by Renishaw’s machine that gives CPM a competitive edge. He commented, “The Renishaw software provides us with all the necessary information to stand over the quality of our parts, from build reports to post-processing, so we can have traceability of our parts from start to finish.”
To promote quality and consistency in its parts, CPM has also chosen Renishaw as its partner in precision metrology equipment, employing Renishaw’s technology at various stages in its testing and part validation workflow. Byrnes further added, “When you go around to the multinational companies, and you see all the Renishaw products on the shop floor, they have a name for being repeatable and reliable and well able to operate in harsh environments consistently.”
The outcome
Since investing in Renishaw’s AM and metrology equipment, CPM reports an increased market share, which it directly attributes to the investment. “We’ve managed to gain a new market share in international markets, in East Asia and North America, that were not feasible for us before,” Byrnes continued. “It’s only the last two years that these markets have opened.”
According to CPM, the company sees Renishaw as a strategic partner in driving the advances in AM technology. “Approaching AM for us has been a journey, it’s a completely different way of thinking. It’s much more of a laboratory environment, more of a cognitive way of approaching a process, rather than conventional engineering,” Byrnes concluded.
