What do you need to know to transfer your product to manufacturing? How can we improve the transfer process and make it easier for everyone involved? 

In this episode Julia and Britt interview Blur’s Director of Electrical Engineering, David Moody. He has 30 years of experience in the pharmaceutical and medical industry, and for the past 20 years he’s been directly involved in the transfer to manufacturing process for small and large companies. It’s safe to say he’s seen the good, the bad, and the ugly when it comes to the transfer process, and he has lots of advice for us on how to make the process workable for everyone involved. 

Julia

David, in your own words, can you describe what transfer to manufacturing is? 

David

Transfer to manufacturing is when you start getting all of the documentation in place such that somebody besides the engineers who designed it can put something together. And put it together over and over and over again in a consistent and reliable manner. So you’re not constantly changing stuff. 

You wanna have all of your bill of materials in place so people know what to purchase. You need to have assembly instructions so people know how to put this device together. Any other instructions that go with it, programming instructions, calibration instructions, those all need to be prepared. [These are prepared] a lot of times with the collaboration of the manufacturer, and that is some place where Blur does excel is in helping our customers create these documents. 

The transfer to manufacturing is literally transferring all of the knowledge that the customer has about this product to another set of people. 

Julia

It’s the process of making a device or a product repeatable and consistent by someone else. 

David

Correct.

Julia

So what would you say that most people miss in transferring to manufacturing?

David

Usually people are good during the design aspects,  thinking about how something is going to be built. They will maybe design it so you can get to all the fasteners or, you know, the cables are routed nicely so that you could put them in after things are built. Items that people don’t usually think about are the manufacturing specific, which would be any test fixtures. You might need something to hold parts together. You know, when it’s built by R&D engineers, they’re just going to put it on their desk and put it together. But when you have to build hundreds of these, you might need some fixtures to hold things in place. When there’s electronics with microprocessors on board, now you have to support the programming of the devices. So you may need a dedicated programming fixture that might power the circuit board and has a dedicated computer with all the programming software. 

The other thing people don’t realize is all of the incoming inspection that goes on with manufacturing. Whenever parts are ordered, they need to be inspected. They need to be input into a quality system, an inventory system. Those are the things that everybody forgets about. 

There’s a huge difference in building one in an R&D lab versus some large number per month for many months.

Britt

And there’s also just scaling that too. I mean, after you start manufacturing a product, you may go back and realize you need another fixture because of an end-of-line failure that you could have caught, you know, upstream. And so you and I have worked together on some things like that, where there was an LED indicator that was failing at the end and we were having to NCMR that to troubleshoot it. And you quickly came up with a fixture that allowed for us to test that real time to avoid that failure. 

David

Right, and we’ll come up with, “We think this is a list of all the test fixtures that we’re gonna need,” but really you don’t know until you’ve gone through the process once. Britt mentioned there’s always room for improvement in our process. So we try to make it as efficient as we can. If we can automate a process, it may sound like it’s expensive upfront, but if you’re eliminating a person doing a job repeatedly, your automation always pays for itself. 

Britt

How soon should you transfer to a manufacturer? Is there a too early and is there a too late? 

David

There is a too early. If you get manufacturing involved too early and you’re still making change after change after change, there’s a lot of wasted effort. People are looking at designs that may or may not be what you’re going to build. 

The too late would be when you have completed all of your project, you’ve done all of your verification tests, and now you just want to do a handover. A lot of times the manufacturing people are going to request some changes, either to make things easier to build, easier to assemble, easier to test. 

Usually once you get to a design freeze point where the customer has all of the key features, the key functionality of the device, that’s when you want to start engaging your manufacturing partner. At that point, they can go through, they can review the design, they can help you fill in gaps with documentation you may need like if your bill of materials isn’t correct. If you’re missing assembly instructions, they can help with assembly instructions. 

They can guide with suggestions on what kind of fixturing you might need. If you need test fixturing, you may need to change your design. That is especially true with circuit boards. If you have to measure voltages or signals or something on a circuit board as an in-process check, if those are not in place during the design of the board, then it’s very difficult to measure those after the fact. 

You really need to know the requirements of who you’re working with. Large manufacturers can have a lot more requirements than a small company does. You really need to get involved early to know who you’re working with so that in the end, it doesn’t delay your final product. 

Britt

Yeah, I agree. 

How would you say we’re unique at Blur and in our manufacturing transfer process? 

David

We’re all under one house, one roof. We have, I think, the luxury right now of being in two buildings right beside each other. If the manufacturing team has any questions, the engineering team just willingly jumps in and helps. 

Britt

You guys are pretty much on the line for our first builds every time. You’re very nearby. 

David

Yeah. There’s usually a key contact person engineer. It’s their responsibility to get to understand the project and get to understand how it’s built so when questions do arise, we have a resource available immediately. You know, usually within minutes of being contacted, someone is helping production with something. 

A lot of times we can address issues internally. By addressing things internally, it allows us to be much quicker, much more reactive to whenever a problem comes up. 

We all are really one big team, one family. The engineering and manufacturing, it’s not us versus them. The engineers work really well with the manufacturing team. 

Julia

I think that team mindset too is reflected even in the way that we talk about the two different buildings. The R&D space we call Upstairs, the manufacturing space we call Downstairs, which can be a little confusing to clients sometimes when we forget. “Oh, they’re downstairs, I mean manufacturing.”

David

Right. I think it’s the only place I’ve worked where there’s not a like, “Oh, you’re a totally different team,” mentality. We really are just one group here. 

Britt

Yeah, that’s what I’ve seen as well. It’s a great culture and we work well together and it makes things go smoother, I’d say, and makes an overall better product as well. 

Julia

Well, thank you, David, for being with us today on the podcast. You had some really awesome insight into the transfer to manufacturing process, specifically at Blur and what clients need to look out for in general when they’re going through that. 

David

It’s been my pleasure.