overcoming vision integration challenges in ......•limit yourself to one round of changes after...
TRANSCRIPT
OVERCOMING VISION INTEGRATION CHALLENGES IN THE LIFE SCIENCES INDUSTRY
Tom Brennan Artemis Vision
LIFE SCIENCES
• Imaging Products for Life Sciences • Camera + Optics + Lighting that improves diagnosis
CHALLENGES
• Very Different from Industrial Systems • Highly varied subjects • Difficult to Prototype • Deployment at Scale • Highly Regulated • Acceptance by many users
CHALLENGES
• Prototyping • Health Professional Acceptance
PROTOTYPING
• You have a great idea for imaging of: __________ • Find samples? • It’s difficult.
PROTOTYPING
• Samples can come from the grocery store • Veterinarians • Animal Processing Facilities • Vegetables are best
PROTOTYPING
• How to transition to human use: • Find a Doctor at a Research Hospital • Do mock Doctors visits. Without the Doctor. • The Doctor can’t put something in front of patients
that crashes or performs inconsistently.
PROTOTYPING
• Once the device is VERY reliable, leverage the Research Hospital doctor.
• Have the doctor do a mock visit with a nurse (or you)
• The device CANNOT be used to make a medical decision.
• However a doctor or nurse can use it, purely on an evaluative basis.
TEST AND DIAGNOSES
• Diagnosis MUST be backed by approved tests
SAVE ALL DATA
• Gather as many exposures and polarizations as possible.
• The most difficult part is getting valid samples.
• Data can be used later to tweak algorithms.
SAVE ALL DATA
• Compelling imagery across all use cases takes tweaking of algorithms.
SAVE ALL DATA
HIPAA
• Health Insurance Portability and Accountability Act • Simplified Administrative Version is 115 pages • Very strict on handling of patient information. • Images are patient information. • Anyone you take a picture of in a healthcare setting
= HIPAA release form. • Fines are $10,000+ (per violation = per image)
PROTOTYPING
• Device seems to work. Now what? • Clinical trial
• Long • Expensive • Many patients needed • Partner with research hospital so they bear most
of the costs.
ACCEPTANCE
• Industrial world: FAT (Factory Acceptance Test), SAT (Site Acceptance Test)
• Healthcare world: All Acceptance is Site Acceptance Testing by users.
• Difficult to change once approved for use.
APPROVAL VS FEATURES
• Good Product = Usage and Changes from Feedback
• Approval = Minimal Changes • The approval process and changes don’t go
together well. • Prioritize APPROVAL
SECRECY
• DON’T • Clinical Trials and Research require transparency • Doctors will require transparency • Use patents to protect IP if needed • Speed is much more valuable than secrecy and
secrecy will slow you down • Generate Buzz, Get Approved, Get Deployed
BEST PRACTICES
• Limit yourself to one round of changes after 1st clinical trial.
• The 1st clinical will be the smallest sample and results are not heavily weighed in the approval process.
• The 1st clinical trial is generally just to obtain a 2nd clinical.
• From there on out ONLY CHANGE IF REQUIRED TO GET APPROVAL.
BEST PRACTICES
• Generate excitement about the technology, research hospitals need to be excited.
• Use provisional patents and patents as needed. • Get approval and facts on the ground.
BEST PRACTICES
• Do NOT continue to make changes forever. More complexity and endless tweaks = longer approval.
