Mukesh Kumar, our Global Technology Director, discusses how our unique approach to using the latest technology benefits our customers.
2019, November 11
Today, orthopedic device companies looking to partner with contract manufacturers and service providers not only demand an efficient, reliable and cost-effective manufacturing service, but also the availability of technology that can offer novel solutions to unmet clinical needs, such as providing better load-bearing surfaces or anti-biofouling characteristics. Original equipment manufacturers (OEMs) are also looking for technology that will help them follow patients progress after implantation to meet with regulatory requirements and to demonstrate that their implants are not just safe and effective, but possibly better than existing devices, which will therefore help in demanding a better price for reimbursement.
As an integrated supply chain solution provider to orthopedic implant OEMs, our differentiated approach is to incorporate technology in our offerings. Within the Medical Division, we are evaluating technology from three different perspectives that OEMs can relate to and see to be of value:
- Manufacturing, validations, and quality control
- Device functionality (i.e. various kinds of coatings), and
- Device in vivo performance assessment.
To elaborate on the use of technology in manufacturing, validations, and quality control, let’s start to consider Additive manufacturing: this is an area of technology that we have mastered well, and this is evident from our output of over 100 thousand large joint implants just last year alone. Any company can go buy a 3D printing machine, that’s the easy part, but it takes a continued commitment to developing this technology so that it can be used to its best advantage for OEMs. Recently we opened a dedicated innovation and R&D center for additive manufacturing in Switzerland. The real hurdle to using this technology well lies in building the knowledge base and understanding the technology – to get the first useful validated part. It takes a lot of elbow grease and research to understand how to use the machines and how the additive manufacturing processes work best. Our ability to serially produce large orthopedic implants, with scrap rates of less than 1%, has been noticed by large fortune 500 companies in the non-medical space and with whom we are now engaging in technology transfer to help them with their serial production with additive manufacturing.
Manufacturing is nothing without ensuring the quality of what is being produced. Manufacturers of smart phones put out over 100 million phones a quarter, but these huge production volumes are not inspected with the traditional tools like calipers. To increase production and maintain quality we are evaluating and planning on implementing technologies that are touchless, very fast, and do not require human interaction. Such an approach will increase throughput and reduce batch co-mingling, errors in transcribing information, and the like. Of course, any introduction of new technology takes time due to validation requirements. Slowly but surely, these innovations will be deployed on the shop floor.
With regards to using technology for device functionality, we have developed coatings that are being evaluated for their wear properties. In terms of scale-up for serial production, our R&D is showing that our coatings not only meet or exceed current standards for wear characteristics, but also our coatings are very effective in reducing or even eliminating ion leaching. Another coating we are developing and evaluating is to address the reduction of biofouling without hindering osseointegration. We understand that applying new technology to coat materials takes a lot of time and resources, but we believe that the true potential of additive manufacturing technology will be realized when we can offer a solution that incorporates both – the material and the design, and we are investing to achieve this end.
We say to OEMs … think ahead, and we will get you there. We have the technology, the experience, and we are diligently working with the latest technologies that will help set your products apart from the rest.
Stay tuned! To be continued next time: we will consider one of our core services, thermal spray coatings.
In the meantime, for more details on our technologies, please Contact Us.