An Interview With Medical Device Innovator Arieh Halpern - Part 1

Paul: So, Arieh, did a career in MedTech find you, or did you find it?

Well, I grew up in a family of physicians. Both my parents were doctors, my grandfather and great grandfather.

What kind of medicine?

My mother was a pediatrician. My father was an OB in internal medicine. And my dad was the epitome of Dr. House. He loved diagnosing problems. He always told me, "Let’s get to the root cause of the problem because that's what you want to treat."

And early on, when I was young, I think in fourth grade, he taught me Morse code and later I got my amateur radio license. I mean, who knew that my dad was a spy for the Jewish underground in Palestine during World War II?!

Really?

Yeah.They come from generations of Austrian doctors on my father's side of the family going back to WWI. And now, my brother is a physician, my cousins…it's mainly doctors.

So, I always had his inquisitive mind for conceiving of ideas. So I went and studied biomedical engineering. My brother went and studied pre-Med.

My first job was at Spacelabs Medical, which used to be part of NASA. And my boss came from Hughes Aerospace, I believe. And he says, "You know, you're our first biomedical engineer. Everybody else here are all aerospace engineers.”

And Spacelabs was located in "Aerospace Row". Most of the aerospace companies that were involved in the shuttle program were literally down the street.

So he says, “You have a natural gift. You can sit down with doctors, have a high level understanding of what their issues or problems are and, however your mind works, you're able to apply technology at a high level and see a big picture. I’ve got a dime a dozen great design engineers. You have an ability to identify their needs and issues and conceive of a solution. And for the "how", I've got the engineers that can do that.”

So we pioneered a lot of advances from the first modular touch screen patient monitor, to arrhythmia monitoring system to cardiac output. Spacelabs was an R&D driven company.

And from there I went on to Medtronic where I worked on laser angioplasty, then Bear Medical where we developed many novel life-saving mechanical ventilators for neonates that increased survivability of extremely low birth-weight infants which became standard of care, and then I got involved in a startup company, 20-25 years ago, that spun off some technology from DARPA, the Defense Advanced Research Project Group, for conductive fibers wearable sensors and monitoring.

I’m going to come back to those stories, but based on all that entrepreneurship, what can you say about managing risk when innovating?

Well, especially in small and mid-sized medical device companies, risk…having a product recall, depending upon what that product is and cause of the recall, could be a death sentence for the company, because of the associated cost implications. Not to mention that hopefully you don't have any serious, adverse events which induced patient harm.

Having a recall, even if it didn't induce an adverse event to a patient, can have a major impact (on your company.) It's expensive to implement, halts your revenue stream, and hurts your brand. And are you able to replace the product? Is there an alternative way that they can use it in another use mode? Because, if not it has to be taken out of operation.

But reducing risk starts with the voice of the customer, translating those needs into your product requirements, while complying with all of the industry standard requirements for that specific type of product. For example, if it's a hemodialysis machine or a pacemaker or a ventilator, there are specific standards and regulations for compliance that are part of the overall product requirements.

Then, once you've gathered all of your requirements, you perform your risk analysis, and then identify and track what is the mitigation to address each risk?

And if you can't mitigate the risk, you have to get rid of that function in some cases. If there is a way to mitigate the risk, then what is it? What's the change impact?

All of this needs to be clearly and concisely documented and it needs to be traceable, from one version to the next version.

From there, you continue through the various design and development phases.

You need to do your verification & validation tests, with complete requirements traceability, closed-loop, ensuring each of these associated requirements has a test case to it. And then you link up your test results to the test case back to the requirement.

Validation also includes all of the testing to adhere to industry standards such as electromagnetic compatibility testing, drop impact testing, and flow testing. Human factors testing is a huge part of it, depending on what the device is.

And you want your CAD drawings, electrical drawings, PCB layout, software and all your design outputs linked back to these requirements.

So during each stage of your development cycle, you have complete traceability.

ARIEH HALPERN

Arieh is a senior executive, thought leader, and strategic advisor with a passion for innovating digital health technology. With more than 25 years’ industry experience spanning VOC, business development, regulatory pathway, R&D, clinical trial, product/program management, and downstream marketing commercialization contributions at Medtronic, GE Medical, Cardiac Science, Bear Medical Systems, and Spacelabs as well as startup-to-exit strategy within entrepreneurial settings.

PAUL CASSIDY

Paul is Director Sales for PLM Solutions with CENIT North America. Paul has more than 20 years’ experience working with companies to achieve product development excellence through implementation of PLM, with a special focus on companies from the regulated industries of Medical Device, A&D and T&M.