Case Study: Advancing artificial sight
Medical device companies face multiple challenges as they work to get safe and effective products to market. From contamination and stability issues to failure resolution and quality control. Our medical device testing experts help resolve these issues through scientific solutions based on more than 30 years of experience in materials science and mechanical and chemical testing.
Our commitment to Science-based Customer Excellence accelerates our customers’ product development and enables smoother regulatory submissions and approvals. We support customers through the entire product lifecycle – from clinical research, product development and regulatory submission, through to production. It’s an approach that’s tangibly making the world a better and a safer place.
Ensuring the safety of an innovative visual implant
The recent Visual Prosthesis initiative we supported in the US is the culmination of decades of research dedicated to providing artificial sight to blind people.
Our Medical Device team in Massachusetts was engaged to carry out the regulatory testing needed to demonstrate the device’s safety, so we conducted a design review of the implant and applicator and undertook EMC safety testing to the IEC 60601-1 standard. The prosthesis was approved by the U.S. Food and Drug Administration and surgically implanted in the first participant, as clinical trials commenced.
Following the trials, and after further evaluation and regulatory approval – which will also be supported by Intertek – our customer will design and test a new unit for use at home by trial subjects.
An engagement of this length and depth is a regular scenario for us, as many breakthrough medical products go through various stages of development before they get to market. In some cases, we work with clients for many years before final regulatory approval.
Our customer was extremely grateful for our support, acknowledging that we enabled them to get to an incredibly exciting and important point, not just for the field of biomedical engineering but also for people with blindness around the world.