Ingle Pediatric Device Consortium talk

Tactics, hindsight, and predictions in
medical device development
December 14, 2010
Frank Ingle, Ph.D., PE
Instruments for Science and Medicine, Inc. (ISM)
Love is not enough
To get funded you need:
Large potential market
Freedom to operate
To develop a successful product you need
The right target
Do the difficult part first
Rigorous design reviews
Shake and bake testing philosophy
Pilot runs until the documents can make it
Medical Devices remain a growth area
Trends in medical devices
•Combining instruments from different manufacturers into a
system with added capabilities.
Stimulate nerves and muscles
Vasculature goes everywhere:
use it for minimally invasive access.
Home medical care at lower cost.
• Computer controlled exercise for knee
joint replacement.
• Easier, pain free, more effective than PT.
Personalized Dx and Tx.
• Customize drug to
patient’s unique genetic
• Problem: how to afford
clinical trials for small
patient population?
Robotics for patient care
• With increasingly
aged population,
Japan and China
will need this before
we do, but our time
is coming soon
Robotic surgery
Quicker patient recovery time,
but will it become cost effective?
Vanity devices – patient pays cash.
Cellphone medical apps
But how will FDA regulate them?
Cellphone GUI with
external electronics for Dx and Tx.
The main reason why companies fail:
they aim at the wrong target and hit it squarely.
To succeed, everything has to be
Technically feasible.
Customer wants it.
Material and labor available.
Large enough market.
Adequate profit margin.
IP control or at least freedom to
No regulatory barrier.
Low barrier to entry.
It’s not that you do not know what to develop.
What you know is wrong.
Talk to the customer directly to learn what they need.
The problem:
Real life is not like a homework set.
• No one tells you the problem or
• The more technical risk, the more
difficult it is to get funded.
• Medical device regulation
requires “Design Control” which is
time consuming and expensive.
• A false start will waste precious
• So how do I start?
How products are born
• Usually an inventor has a
vision and recruits others
to join him.
• He might be right, but
usually it is only a
starting point.
• The idea might be right,
but poor business
strategy could kill it.
The occasional stroke of genius
The physics is with you,
but how do you get personal solutions
manufactured and distributed cheaply and accurately?
Another stroke of genius:
Early success, but will the FDA allow it to be a
510(K) product?
Obvious, but they got there first.
SoundID Bluetooth “hearing assist device”
NOT a “hearing aid”
A hammer looking for a nail:
MMR on-site liquid nitrogen source
We can design and build miniature extreme refrigerators,
but who needs them? Dermatologists everywhere.
How to identify the target
The user tells you what he THINKS
he wants.
However, there may be a solution
he would like even better.
How can you best meet his
“needs”, in contrast to his stated
Brainstorming, crude prototyping,
show and tell: iterate until you find
the right target.
the first step
must be right.
You have limited time
and money.
Wrong problem or wrong
solution: the longer you
are stuck, the more it will
cost to recover.
Hold frequent design
reviews to find your
errors, not to compliment
your brilliance.
Big companies vs. little ones
• Big companies
Huge sales force
Low cost manufacture
Proven Quality System, but legacy products cause continual headaches
Employees tend to be there for life, recycled despite mismatch
Threatened by small companies’ new products
More effective at acquisition than product development.
• Little companies
Blazingly fast
Highly innovative
Single product focus
Minimally compliant, do not meet big company’s quality standards
Very thinly financed
Overqualified employees bound by stock options
Hope to go public (unlikely) or be acquired
Get the help you need
• Evaluate your strengths and weaknesses.
• Do what you do best – use others to do what
they do best.
• Define the needs of the new project.
• Recruit helpers to fill the holes.
• Hire full time help only as you need it.
• Supplement with part time help or consultants.
• Define now how you will later reward them.
IP position:
Only monopolies are funded.
•Talk to “luminaries” about the potential
•Patent searches for potential patent
•Invent unique solutions if possible.
•Redesign the product if there is a
conflict, if possible.
•Brainstorm and form a “picket fence”
around your preferred method.
•File “provisional patents” ($100)
frequently, before you talk to any
outsiders, like ESPECIALLY VCs.
Move quickly
• Simulate where you can, but only
if it is faster than prototyping.
• Ask your friends for advice.
• Risk management is one of your
best engineering tools.
• Engineer if you can, from:
– past designs from competitive
– manufacturer’s data
– application notes
– Published designs
• But invent or control IP or you
won’t get funded.
Proof of concept – buy down the risk
Try to prove it does NOT work.
If you cannot, then physics may be with you.
Define the essential mechanism and challenge it.
Start with “Friday afternoon” POC tests.
Design as little as possible.
Build a crude model.
Use borrowed equipment and canned software if
• Review the experimental design with your cohorts.
• Write a summary lab report, with attachments.
Risk Management is your best engineering
tool. It might have prevented this:
1950: Scientific medicine is king.
Newborns routinely given oxygen.
All become blind.
And this:
No polio vaccine until 1962.
No medical device law until 1976.
No risk management on the “iron lung”
All these patients died the same day.
All products are systems
Use systems engineering “V” model
Design reviews
All errors must be found and fixed.
You want your friends to find your errors before
your enemies do.
Design and build sequential prototypes
Snapshot needed for each prototype.
Engineering docs on each prototype.
Test each prototype.
Review results and decide what changes
to make.
• Report with summary of what went wrong
and what you plan to do for the next one.
• Iterate until results meet requirements.
Shake and bake:
break it and then fix the weaknesses
Pilot run
Production environment and personnel
Verifies that the documents can build the product
Key R&D concepts to remember
• Fail fast and fail cheap – time for more tries.
• Do the impossible part first.
• If you can solve the difficult problems, the rest
will be more predictable. Nothing comes easily.
• Have a Plan A which will make you a hero,
and a secret Plan B to save your job if Plan A
Storms on the horizon for medical products:
• Uncertain regulatory requirements
and reimbursement.
• How to pay for clinical trials of personalized
treatments with small patient populations?
• How to balance patient needs with available
government resources?
• Increasingly long product cycle time: conflict
between development speed and compliance.
Potential Game Changer:
Medical Tourism
• A substantial fraction of US population has
minimal or no medical insurance
• OUS procedure cost 1/5 to 1/10 of US.
• Longer hospital recovery stay provided.
• Accreditation agencies reduce the risk of a
bad choice.
• And maybe you can get in some tourism
along the way.