We invite leaders and influencers from the healthcare 3D printing ecosystem to write short educational articles.
The congressional testimony by Mark Zuckerberg, CEO/founder of Facebook this week has left many in deep reflection. The data leak and the implicated political influence by a foreign country on the US politics woke many Americans (and perhaps the world) up. Fifteen years ago, when everyone in college just signed up for Facebook and excited about the phrase “social media”, few could imagine these dark days like this week. Few they were, but not none. The growth of the internet and mega-startups like Google, Twitter, and Facebook outpaced our ability to forecast, reflect, and protect against potential downside of technical revolutions. Therefore, as the city of San Francisco is getting ready for one of the largest cybersecurity conference RSA 2018 next week, it is a good opportunity to remind everyone again that in the realm of healthcare 3D printing, cybersecurity vulnerabilities are innumerable and need to be addressed now, or it will be an expensive lesson for all.
On the evening of January 22nd, 2018, 3DHEALS hosted the first pilot executive working conference at the Washington DC office of ReedSmith, a law firm with special interests in liability issues related to 3D printed medical device. The goal of this conference aims to bring executives from different healthcare organizations, additive manufacturing industry, bioprinting and pharma companies, academia, and the government policy experts together to tackle some of the tougher problems facing the healthcare 3D printing and bioprinting industry. In theory, the small group format will allow decision makers in each organization to have a multi-disciplinary conversation, outside of the silo they often found themselves in.
There was no sales pitch in this conference. The goal was one and only: Finding out what are the top challenges facing the industry, and have a conversation to initiate solutions. We named this 3-hour event, “3DHEALS: Taming the Wild West of 3D Printing”, and focused on policy related issues for the attendees. While due to inopportune government shut-down no government entity was present (i.e. FDA, DOD, NIH, etc), the conversations were filled with enthusiasms and inspiration. Below is our meeting minute and we think sharing the notes will be beneficial to everyone in the ecosystem.
The objectives of this white paper are to provide clarification and in-depth discussion of the topics below, which are critical elements to the additive manufacturing industry in healthcare:
Definition of biocompatibility.
Discussion on how biocompatibility is assessed within the current regulations of materials and medical devices by major regulatory agencies.
Summary of how different regulatory agencies are managing the introduction of 3D printing into the healthcare space to date.
List of major available biocompatibility materials and those in development.
As a closet introvert, I surprised myself with attending and organizing a dozen conferences and events in 2017. The goal of my journey was not only to continue to build 3DHEALS community but also to figure out how 3D printing startups can take off in healthcare. WSGR’s 2017 Medical Device Conference on June 21st, 2017 was memorable. An array of VCs, investment banks, and entrepreneurs with different strategies and styles participated in discussions that most medical device startups and investors should care about. At the end of the day, it seems to be an artful balance of risk assessment, mining opportunities, and occasional contrarian behaviors.
While much has been written on new developments in metal 3D printing, there have been several types of metal 3D printing systems producing otherwise impossible parts for many years. In order to fully understand where the industry is going, it’s important to first understand where it’s been, and the problems with the status quo.
Below, I’ve provided a brief overview of established and developing printing techniques. In a follow-up post, I’ll explain how developments in metal 3D printing can impact the medical industry.
(THIS IS A RE-POST OF DR. OTERO'S LINKEDIN POST.) Dear colleagues and friends, I have spent almost a year doing a clinical fellowship with Prof. Maurice Mommaerts at the European Face Centre in Brussels, a referral for hemifacial microsomia and surgery. I have noticed...
Dear colleagues and friends, Additive manufacturing (AM) has become a common technology in many departments, although regulations for its use in healthcare facilities may sometimes not be as clear as we would like. Last year, upon my arrival at the European Face...
Finalized, the FDA guidance document “Technical Considerations for Additive Manufactured Medical Devices”
The US Food and Drug Administration (FDA) published their guidance document on the use of additive manufactured medical devices on December 5th 2017. This is the finalized version of the draft document issued in May of 2016. The recommendations and considerations...
This piece may seem offbeat to my normal discussion on the field of healthcare 3D printing, but if I don’t share this, then I am not living what I preach. Recounting a casual conversation recently (last night) with a friend who is also the senior engineer at Twitter...
Marta Kazmierowska graduated from Hunter College, the City University of New York, with a Bachelor’s degree in chemistry. After returning to Poland she pursued a Master's degree in green chemistry at Gdansk University of Technology. During her second degree studies,...