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.
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.
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.
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.
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.