Listen to the full interview!

Browse our ASSEMBLY Audible podcasts

Editor’s note: On Oct. 8, shortly after this podcast was recorded, Intricon merged with another medical device manufacturer, Minnetronix Medical, to form a new company, Forj Medical. 

Q: Tell our listeners about Intricon.

Tavakolian: Intricon is a global contract development and manufacturing organization. We've been in business for over 40 years. We have a full suite of capabilities and technologies, including precision micro-molding and overmolding needle assemblies for custom sensors, device assembly, printed circuit boards, and electronics, all the way through final kit packaging.

We are 100 percent medical. But we partner with the top 30 medical device manufacturers that people would be more familiar with to make devices.

Q: How do you define advanced micro assembly? And what are some of the features or characteristics of working at that scale?

Tavakolian: I think that's a great question because nowadays, miniature or micro assembly gets thrown around quite a bit. Miniature and micro assemblies push the limits of what humans, automation, and equipment are capable of, and we are continually pushing that line to make things smaller.

[Making such small devices] really requires insight and expertise to develop tooling and processes to handle that type of wire or those component sizes. We use 3D printing for rapid prototyping, but then we lock our process down to standardize.

We like to partner with our customers up front if they have a design, and we try to continually shrink it down. There's always that push to make things smaller, especially with medical devices.

We also like to partner with equipment OEMs for, say, our pick-and-place systems. We partner with them on their newest designs and prototypes to use them, tell them what's working and what's not, and then push the limits of what we're capable of doing.

Q: How do you determine the optimal mix of automation, 3D techniques, and precision manufacturing required to produce these components?

Tavakolian: It really combines a lot of different fields of expertise in mechanical design, 3D printing, and toolmaking. 3D printing enables rapid prototyping that might have taken weeks or months with conventional methods. Now we can turn to polymer 3D printing to get results within hours. Our automation team uses that technology to design robotic tooling to pick and place certain components in a specific orientation. When you pair that with fixed ring and molding to back the micro assembly, we can achieve tolerances in the fractions of a thousandths of an inch.

Q: What are some of the projects or products that you're currently working on?  

Tavakolian: One of our main runners is a continuous glucose monitor, which is worn on the arm or abdomen.  

We have our eon sensors, with micro coils that go at the tip of either catheters or needle assemblies that are used for internal tracking and biopsies to know exactly where the tip of that catheter is located. Some of the newer products that are coming out integrate micro needles and needle technology. We are also working on sensor technology aimed at trying to detect cancer, whether that's through your skin or even through your breath.

Q: What are some of the challenges that you're facing and solutions that you're coming up with to address some of those challenges?

Tavakolian: Anything that can go wrong in manufacturing, will go wrong. That's not an excuse, but it's something to keep in mind. So, implementing design for manufacturability and design for quality up front is key, because it can limit mistakes.

If you're doing manual or automated assembly, controlling the parts you use, limiting complexity, and allowing flexible orientation for specific parts really help reduce challenges or issues on the floor.  

I mentioned the component sizes that we're placing. Some of the sensor technology we have uses wafers or chips that you can't touch the top of. You can only grab the sides. How can you pick up a wafer and place it onto an assembly without touching the top of it?

Those are just some of the things that you have to work through witheither tool design or automation.

In terms of scaling, sometimes when you're going through prototyping and building a few of something, you're most trained operators are doing it to get through validation. However, you have to make sure things are in order as you transition into training others and start building fast. You can move too quickly, which can lead to mistakes if you don't have a robust training system.

So, knowing that balance, taking a steady approach, making sure you have the checks in place, are some things that come to mind. When you look at challenges on a floor, you want to error-proof production as much as possible. Set up processes so that someone new or anyone can't do it wrong; make a part that can only go in one way, or it doesn't work.

If you have a tester, lock down certain areas so settings cannot be changed, and make them password protected. Set up vision systems whenever possible. Robots and automation aren't as susceptible to human error. Limit manual entry of numbers. If people are typing numbers, something's probably going to go wrong at some point. So, just trying to control the variables as much as possible.

Q: So, what does the assembly process look like?  

Tavakolian: We like to set up our lines for specific products in a cell so that this cell does one specific product or capability. The cells are typically U-shaped, with production going from left to right in a continuous flow. That enables people to do multiple operations rather than in a linear line. Somebody could bounce back and forth, doing multiple things.  

You don't want one line that can do multiple things. That could also lead to issues in line clearance. When a cell is making one specific product, it only has the materials and tools needed for that specific product. Put everything else away. We can’t risk mixing parts or anything like that.

Q: What are some of the most cutting-edge assembly processes used in advanced micro assembly?

Tavakolian: We have this metal 3D printing capability. We use that for our injection molding tooling. If you tried to outsource that tooling, it would take months. With metal 3D printing, it takes just weeks.

Shortening that lead time from months to weeks is huge. Something that doesn't really get talked about a lot is time to market. Any delay with medical devices and regulatory submissions can cause you to lose market share.  

Q: How is automation making things more reliable?  

Tavakolian: If you can automate, you can remove the human element. One thing I think is really undervalued in manufacturing, particularly medical device manufacturing, is final kit packaging and labeling.  

That's something that we offer for some of our products. And when we took it on, the company we were working with said the packaging and labeling are the most significant source of field recalls for them, which seems surprising.  

If you have the same product, packaging can be split into, say, 100 SKUs based on the region it's going to. So, every region has its own language and might use different regulatory icons. It needs different boxes and literature, and making sure everything's printed perfectly.  

We've tried to automate our process as much as possible—no manual entry of anything. Every box will go through the packaging line. We have vision systems checking for presence and absence. We make sure everything that's supposed to be in there is there. It's reading the serial number and entering it into our ERP system so we can track it. It's reading the different part numbers in the literature to determine what should be in that kit. This has eliminated those types of packaging issues.