(originally published on “Two Cents“)
It is really a choice of perspectives.
Vinod Khosla once said, “not all difficult problems are valuable, but all valuable problems will be difficult.” The argument for “regulation” in healthcare is obvious: public safety. From an entrepreneur’s perspective, the high bar of regulation perhaps serves as a filter to difficult ideas not valuable enough and a litmus test of one’s vision for his/her startups.
Healthcare industry is no different from other highly regulated industries like the automobile, food, and aerospace industries. Human suffering is often at the end of a failed system. However, we have seen many unicorn-like startups in the past decades succeeded in many of these highly regulated industries.
Some examples include Uber/Lyft, Airbnb, Space X, Tesla.
When a new product becomes essential to a large number of consumers, cost-cutting, delivering equal or higher quality goods, improves accessibility, that is when the regulation will eventually back off and be changed based on newcomers, “updated”, “amended”, and etc.
It is very worthwhile to read about the strategies employed by these successful startups to innovate in a highly regulated field. The fights are fierce, from diplomacy to lawsuits. Links to a few are below:
Medical 3D Printing Companies Gain FDA Certification Under Materialise Program Materialise launches new FDA-approved certification program that allows 3D printer manufacturers to have their products tested and validated for use with Materialise’s Mimics inPrint software
Radiological Society of North America Post Guidelines for 3D Printed Anatomic Models Evidence-based 3D printing, the new guidelines are specialty-based, after reviewing over 500 published papers by SIG, a group formed by RSNA.
CELLINK and Prellis Biologics Inc. sign partnership to commercialize high-resolution holographic bioprinting technology for micro-printing An exciting partnership aiming at a hybrid extrusion and laster based bioprinting system at a resolution close to microvasculature.
MSF-run hospital offers 3D-printed prostheses to war wounded. A printer, a scanner, and a few compassionate dedicated individuals make all the difference in this devasting war-zone.
3DHEALS During 2019 JP Morgan Healthcare Conferences
Date: Tuesday, Jan 8th, 2019, | Event time: 6:30-8:30, San Francisco, CA, Register
3DHEALS Chicago: 3D Print Life
Date: Wednesday, March 6th, 2019 | Event time: 6:30 PM – 9:30 PM, Chicago, IL, Register
3DHEALS @ CMIT 2019: Entrepreneurship and Commercialization workshop during CMIT 2019
Date: Thursday, July 11, 2019 | Event time: 1:00 PM – 5:00 PM, Los Angeles, CA, More info in upcoming weeks