All articles by Ky Nikitha
Ky Nikitha
Fit to print
Manufacturing has traditionally been a long process from initial design to finished part, and in light of the highly regulated environment, the medical device sector is conservative in its approach. But the industry’s use of stock component offerings and the rise of industrial-grade 3D printing could drive a shift towards an on-demand approach. Emma Green speaks to Brennan Miles, senior consultant at Team Consulting, about the present and future application of this method.
Myopic medicine
In order to achieve sustainability in manufacturing operations, it needs to be incorporated in all stages of the supply chain. One key aspect is obtaining sustainable components from eligible suppliers. Recently, this topic has gained greater attention from industry and academia. Ben Wicks from Team Consulting speaks to Emma Green about the status of sustainability within medical device manufacturing.
Next evolutionary step
Thanks to bioelectronics, devices are starting to replace drugs for a wide range of conditions. Bioelectronic medicine explores how targeted electrical signals can harness the body’s natural mechanisms to diagnose and treat a range of diseases, helping the body heal itself. Emma Green speaks to Lan Yue, assistant professor of research at USC, about the potential of this technology for medical device manufacturers.
Your own devices
The US FDA plans to develop a new regulatory framework for reviewing ‘software as a medical device’ and has also issued guidance regarding the FDA’s regulatory process for digital tools. Aiming for a more ‘streamlined’ review, the FDA has updated the software pre-certification pilot programme and a working model of this will soon be released. Stephanie Webster speaks to Sundeep Karnik and Matt Singer from ZS about the implications of this new regulation for the industry.
Global regulatory trends: how do they impact quality management systems?
Kim Trautman, executive vice-president, NSF International, explores the convergence of worldwide regulatory trends impacting quality management systems, to include risk management, clinical evaluations and post-market surveillance.
Fit to print
Manufacturing has traditionally been a long process from initial design to finished part, and in light of the highly regulated environment, the medical device sector is conservative in its approach. But the industry’s use of stock component offerings and the rise of industrial-grade 3D printing could drive a shift towards an on-demand approach. Emma Green speaks to Brennan Miles, senior consultant at Team Consulting, about the present and future application of this method.
A light touch
Biophotonics is the science of producing and using photons or light to image, identify and engineer biological materials. The potential of the technology in optimising diagnosis and treatment is huge. Elena Beletkaia, project leader at the European Photonics Industry Consortium, discusses its significance for the industry.
Tech helping tech
Additive manufacturing is attracting increased attention in the medical device sector, but analysts say more must be done to improve digital security. Patrick Kingsland asks Deloitte researchers how blockchain technology could help protect the 3D devices of tomorrow.
Your heart on your sleeve
Advances in wireless technologies, low-power electronics and the internet of things are driving innovations in wearables at a tremendous pace. Emma Green speaks to Yasser Khan, a doctoral researcher in the Department of Chemical Engineering at Stanford University, about the key considerations when selecting materials for these devices.
Lean, mean micromachine
Micromachining represents an exciting field in medical device development with the potential to minimise patient trauma and spark new forms of surgery and drug delivery. Will Moffitt speaks to Antoine Barbot, research associate at the EPSRC Micro-Machining Facility at Imperial College London, about the trials and tribulations of manufacturing medical devices in the submillimetre realm.