5 min reading time

I’m really hoping this message gets out to anyone planning a clinical trial, so please forward it to your network.

This is an ambitious post, sharing two great 10x Conference presentations.

Doug Fankell, Ph.D. (on left) is an engineer with Structural Integrity Associates. He talked about predictive computational modelling.

Arlen Ward Ph.D. (on right) is co-founder and partner of System Insight Engineering. He answers the question, “What can we do besides standard-issue testing an animal labs to get answers in a more cost effective manner?”

I combined their talks in this one message for a reason (read on).

How to be Innovative (on a Budget) using Simulation

Arlen spoke first. It’s an extremely worthwhile video.

Top Takeaways from Arlen

Click here for Arlen’s slides.

• Simulations can save you big money and time. Testing at the production and trials stage can be 500-1000 times more expensive than tests at the concept stage.

• Pre-clinical data collection costs increase about 15% annually. That’s independent of any product launch schedule changes. It’s not just the test itself that gets more expensive. It’s also the regulatory questions that need to be investigated.

• Simulations complement tissue testing. Tissue testing is often a requirement to understand how your device works. But what if you can answer some questions that don’t involve the variability of tissue? If you can simulate, you’re doing it earlier in the process and circumventing some of the time-consuming, expensive, and difficult tissue testing.

Click through for:

• How regulators including FDA consider computer simulations, In Silico data.

• What cloud computing lets you do that you couldn’t before

• The SolidWorks limitation that persists

• … and more, too long to recap here.

A New Take on Prototyping that Could Save You Millions

Doug spoke the following day, thus the many Arlen references. I’m sure you see the common theme here: How you can use computing power to save time and money when designing and developing medical devices.

Top Takeaways from Doug

Click here for Doug’s slides.

• Developing something? It probably takes you 20 months from concept to proof of concept for a 510(k) product. Estimated cost of an eight-week delays for a 30-person company is about $1.8 million; 20 animal study, $5.5 million.

• Why predictive computational modeling? Because it can reduce your time to market, and speed up the design iteration process, so you can do more iterations. It not only models the device but also the physics within the tissue when it’s acted on by the device. He gave deformation and fluid flow through / within biological tissue examples.

Click through for:

• His Arterial Cutting and Fusion and Tubes case studies.

• How he was able to say, ““We’re going to predict the outcome of this surgery” and get it right 90 percent of the time.

• Expressions like “Isochoric Strain Energy,” “thermoporomechanics,” and other terms that went WAY over my head. 😊

Comparing how Arlen and Doug attack the problem

At 15:26 on the video, we began an illustrative 10-minute discussion with questions like,

• Are you two direct competitors?

• When should I call Arlen versus call Doug?

• When should I call neither of you?

I asked, “Is hiring your firms like an insurance policy against higher expenses and longer times?” They said yes, which made me think about the way I consider expensive earthquake insurance (I live near Seattle). Should I pay the certain insurance costs versus the uncertain catastrophic loss?

Did you even know you needed them?

After listening to both presentations, I thought, I didn’t know any of this stuff before. I just thought, “I’ll call Tor at HS Design (my fellow Medical Devices Advisory Group member) and he’ll “just do” the engineering work and come up with a testing plan.

I wonder how many “Tors” out there don’t know this stuff either. That neither of us knew to ask about computational modeling and simulations. Or worse, that I assumed “Tor would take care of everything” but my design firm lacked Doug and Arlen’s expertise – and didn’t know to ask for it!

So, that’s why I invested so much time in this post today.

If you got a modicum of value from it, please, click here and share it on LinkedIn. (Just click and, if you’re logged in to LinkedIn, it will pre-populate everything you need.)

Because the more people in our community, the more connections I can facilitate for you.

So, help me help you. From, like, now on. Okay?

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Whatcha doing tomorrow?

I’m starting my day by co-hosting a webinar with Walt Maclay from Voler Systems. He’ll discuss “What you need to know before manufacturing a wearable device.”

If that’s relevant for you, come! It’s free.

Click now to register.

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Some new jobs came in.

Click on the individual banners of interest, or here to see all opportunities.

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Questions and Answers?

• Who will win the Superbowl? 50% off any 10x Medical Device Conference registration to the poll winner!

• Anne-Marie needs your advice on marketing surveillance.
• Jana has a regulatory question about Conformity Assessment IIa MD.
• A group member needs a contract manufacturer.
• David needs sales education audio for his long commutes.

Can you help them?

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Thank you for being part of our Medical Devices Group community!

If you’re looking for work, we added new jobs this week here!

And please, click here to share this post with your LinkedIn network.

Make it a great week.

Joe Hage
Founding Principal,
Medical Devices Advisory Group

P.S. Pick up Walt’s webinar, Arlen’s slides, and Doug’s slides. All free.