Member Exclusive Features Regulatory

Laure Le Calvé on the legal challenges in 3D printed medical devices

An interview with Laure Le Calvé (Law Compliance Health) on the legal challenges facing 3D printed medical devices, at the 3D Medical Expo in Maastricht (30–31 January, The Netherlands).

Go to the profile of 3DMedNet
Jul 31, 2018
1
3

Please sign in or register for FREE

Register to 3DMedNet

3DMedNet is a free content and networking hub aiming to encourage knowledge-sharing, interaction and discussion within the diverse 3D printing in medicine and healthcare community.

Register

3 Comments

Go to the profile of Banu Bilen
Banu Bilen 14 days ago

We don't fully know yet how the materials used in 3D printing will react in our body. Doctors in Finland released a new troubling study on the release of metal debris from knee replacement hardware. We need transparency about the potential risks. Innovation means new and new does not necessary mean better for patients. I highly recommend watch 'Bleeding Edge'- a documentary about medical devices. 

Go to the profile of Banu Bilen
Banu Bilen 13 days ago

Hi Georgi,

As to the medical device design and development, I also recommend  'Biodesign: The Process of Innovating Medical Technologies'. I certainly agree with you that Bioprinting/Tissue engineering might create a safe environment for medical devices to be tested fully before their launching. Companies like Cellink can be a pioneer to solve these issues about those 'approved' implants/devices.  

Thanks. Best Regards,

Banu

Go to the profile of Georgi Makin
Georgi Makin 14 days ago

Hi Banu,

Thank you for your comment! I certainly agree - 'The Bleeding Edge' opened my eyes to the holes in the current US medical device regulatory processes, but I am encouraged by conversations that have followed about how to improve medical device design, development and regulatory practices.

Who knows, maybe 3D printing could be the answer to some of the issues of current 'approved' implants and devices? It's definitely an exciting field to watch...

Best,
Georgi