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Accelerating time from medical device design transfer to production

Nick Ciccarelli is the president of Neuma, LLC a medical device engineering company based in King of Prussia, Pennsylvania. With a primary focus on drug delivery devices, Neuma is dedicated to helping pharmaceutical and medical technology companies accelerate the transition from design to production. The company’s Design for Production (DFP) services allow clients to address costs and risks related to testability, manufacturability, and assembly early on a product’s lifecycle.

EDWIN WARFIELD: How did you get your start in the medical device engineering field?

NICK CICCARELLI: I’m an engineer by training. I was bioengineering undergrad. Medical devices is a pretty broad and far-reaching field. I didn’t know quite what I would be getting into out of college, but I had an opportunity in the Philadelphia area to come back close to where I grew up and work at a startup in the Conshohocken area for an interventional radiologist.

It was a field I knew very little of, but it was a great first job for me because it gave me a lot of exposure to all aspects of product development in the medical device field, as well as those particular devices for interventional radiology and minimally invasive surgery, which is the leading edge as far as surgical procedures go. These days, we’re moving away from more invasive types of surgery, and they’re elected for less and less. If you can reduce recovery time and reduce the amount of damages that you do to the individual while they are going through surgery then that’s obviously just a better prognosis. Minimally invasive surgery interested me once I got into it. For someone right out of college, I got a lot of exposure, right off the bat, to all sorts of different aspects of engineering—not just product design but testing, the regulatory side, and ultimately being able to see that product on the market. In a very short amount of time I got to see what people may spend 5, 10 years doing.

Q. Tell us about your company.

A. Neuma is a 12-person organization. There are three owners including myself, and then nine engineers. We are an engineering services company who provide product development support to our partners, which would be medical device companies or pharmaceutical companies. We try and implement a far-sighted approach to how we perform product development. It’s not just that frontend—let’s create IP, let’s generate designs or prototypes—but more so: “How are we going to test this thing? How are we going to submit for regulatory clearance. How are we going to manufacture this device and ultimately commercialize it?”

In any one of those steps, product can get bogged down. If you’re super hyper-focused, which many engineers are—and that includes me—you look at the immediate challenge: What is today’s problem? What you really have to do is to clear that first hurdle and you don’t want the next one to really be the end of the project. If you have more of a far-sighted approach to things you can try and implement some of those solutions to what future problems are much earlier on, and that’s what we try and help our customers do.

Q. What kinds of projects do you work on?

A. In pharmaceutical drug delivery, the role of combination products is probably one of the most complex and long-term type of projects in the medical device field. These are projects that mix the pharmaceutical agent with an actual medical device. The most basic would just be a syringe, but now with added complexity, we’re talking about the internet of things. Devices now can talk to apps or smartphones and register data through auto injectors and wearable injectors. We’ve had the opportunity to work on these types of projects. There are means by which you can monitor what you’re doing on a daily basis, but also your provider can also see what you’re doing and if you’re doing it correctly.

This is an exciting time to work in those types of devices because larger pharmaceutical companies are actually aware of the fact that people want that information and they want that ability to control their own regimens. They want to be able to administer medications when they want to and not necessarily go to a physician’s office. Patients are really demanding home health care now because they want control of their schedule and of their own health care. These are the types of devices that are kind of pushing now into the forefront of people’s minds. There are not too many of them out there right now, but as people become more aware of them, I think the market demand will grow stronger and greater, and it’ll be a real opportunity for the patient to take control of their own health care.

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ABOUT NEWMARK KNIGHT FRANK

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Edwin Warfield, CEO of citybizlist, conducts the CEO Interviews.

If you're interested in reaching CEOs, please contact edwin.warfield@citybuzz.co

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