Orchid Technologies Engineering & Consulting president and CTO Paul Nickelsberg is an electronics industry veteran, with experience ranging from high-end computing design to networking and telecommunications under his belt.
But it was his “try anything once” attitude that helped him break into the medical devices market.MassDevice caught up with Nickelsberg recently to get his ideas on coming challenges for the medical device market and his strategy for keeping clients happy during uncertain economic times.
MassDevice: How did your company get into medical devices?
Paul Nickelsberg: I’ve been in electronic product development for more than 20 years. I developed Orchid about 15 years ago to create custom electronic product designs.
Basically, a company comes to us with an idea and we help them get started on creating the product with the electronic design that goes behind it. That’s about half of our customers. The other half of our business comes from customers who have something that was started and needs to be improved, or they have a product that needs to be fixed.
For our first medical device, a private company asked us to help them develop an ECG machine. We said, “Sure, we’ll try that.”
Since then, we’ve designed heart pump monitors, battery-powered portable defibrillators, an EEG monitor that supervises operating room anesthesia and other monitoring functions for the operating room.
Now, about 25 percent of our business comes from the medical devices area.
MassDevice: What’s your value proposition and how do you differentiate Orchid from your competitors?
PN: We have a very direct attitude toward our clients’ particular needs. We approach a design with a very practical and “can-do” attitude. In customer electronics, we stand out above the rest because electronics is our specialty. We don’t try to do anything else.
The special sauce in medical device design is safety and our clients depend on us to provide this through our designs. We’re well-versed in the different safety standards that are required.
MassDevice: What’s the biggest leadership lesson you’ve learned over the years?
PN: The most effective strategy is to do the most effective job for your customers. Provide honest value at the end of the day and treat them like kings.
MassDevice: What’s the biggest challenge confronting the medical devices industry and how should it respond?
PN: It’s a pretty big industry, so there are a lot of issues, but safety and regulatory concerns are probably the biggest challenges.
{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Nickelsberg_Paul_100x100.jpg}The FDA in the U.S. has a sizeable regulatory structure, which translates into a lot of paperwork. But the paperwork itself doesn’t mean the product is safe.
When you look at the FDA regulatory process from a legal point of view, the whole purpose for the paperwork is to force the process of correctly thinking about a design and analyzing it from every point of view so something bad doesn’t happen.
This can cause friction between designers and the FDA. In the clamor of completing all the paperwork, real safety can get lost.
Safety can get lost on management too. Even though they should foster care and safety, management is asking, “When is it going to get done? We need it tomorrow.”
But these concerns don’t go together with the amount of paperwork required. Engineers get frustrated with the process. This could cause them to do a slipshod job, or the good engineers have left the process because the paperwork is more than creative minds can stand.
Safety is today’s conundrum, but it’s essential. The reality is that there is an incredible amount of paperwork required and this can result in competing interests between engineers and managers. Real safety comes from good work, with people doing all that paperwork notwithstanding.
MassDevice: What strategies have you adopted to deal with the economic downturn and what’s your forecast for short- and long-term prospects?
PN: Business has been very good for us in this field. Still, during this downturn, visibility is important. Some of our success has to do with us being involved in a medical development group and participating in panel discussions. This type of networking has worked out well for our business.
We’ve been fortunate, because our clients are loyal and we have a good depth of clients. Since we work in an electronics playground, we’ll focus on our other industries if medical devices slows down.
MassDevice: What changes have you seen in the industry over the years?
PN: The biggest thing is the sheer speed of getting things done. In the old days, there was no email and it was easier to use mail and FedEx to send something like a data file.
The speed of communications has really put a lot of pressure on people, because you’re always on, always available. So people are expecting decisions and answers quicker than before. It’s a challenge.
MassDevice: Where do see the next innovation coming from in medical device electronics?
Miniaturization continues to develop, and nanotechnology will advance too, as devices become smaller and more portable. I’m sure in the next 10 years we’ll see unbelievable breakthroughs in devices connected to neuroscience. We’ll see some sort of man-machine interface.