Jason Dolynny and Laura Meyer answer a dozen questions on working with a contract manufacturer to help readers choose the right partner and get the most out of their manufacturing relationship.  Bonus: a responsibilities checklist.

What questions should I ask when I’m seeking a manufacturer?

The best thing to do is to go through a checklist of scope.  It will document what you are prepared to do and what you are asking the contractor to do.  There will be some grey areas where you don’t know the answer. Those are good topics for conversation with your contract manufacturer when you first engage.  What capabilities do they have? What can they support? —Maybe more effectively than you can.  That’s a good first conversation: What can you do for me and what kind of value will I get out of it?

Do I need to be geographically close to my manufacturer? 

Not necessarily.  We live in a digital environment.  Lots of clients are remote.  They come in occasionally or they don’t.  They choose not to.  It’s not necessary to be close to your manufacturer as long as you are in communication with them.  That’s key.

What is the number one thing a client should be looking for if they have a low volume, high complex, stop-start electro mechanical medical device?

A combination of communication and a real understanding of what you as a client expect the contract manufacturer to do and whether those capabilities are in place.   Those conversations should be held very early and be very clear about the capabilities you are expecting.  Then, you need to choose a partner that’s a good match.

It’s important during those conversations that you get an initial understanding of what “done” means.  When a client asks: “I’d like this done”, what does that mean?  What’s the deliverable that says, “This is complete”?  It could be any task they desire whether it is on the manufacturing side or the design side.

Really get an understanding of what “complete” means.  It’s the first question I ask people:  “If we move forward and I am your contract manufacturer, what does that feel like?  What does it look like to you?”  That drives a lot of the high level conversations.  A lot of the time clients will want to be very involved in day to day operations, weekly calls, and monthly calls.  Other times they just want reporting at intervals.  Some clients are even more removed than that.  Knowing what type of management and relationship clients want with their contract manufacturer is important.  And that ties in with communication.

Having clear conversations and understanding allows us to be flexible and diverse in our manufacturing environment.

How important is supply chain to manufacturing?

StarFish Medical supply chain is tightly integrated with both product engineering and manufacturing.  We support all the product requirements both in alpha, beta, and into manufacturing. Supply Chain begins with our opening communication with the client and ends with shipping the product to them.  Manufacturing is the main piece—it’s right in the middle.  I’m the lead for our manufacturing clients.  I communicate with the clients quite frequently on the status of their project, status of shipments, any issues or concerns, any non-conformances. We talk with clients weekly and provide them reports.  We really are the interface to make them aware of what is going on with their product.

Top tip for working with a Contract Manufacturer?

Talk to them. Set expectations early.  Make sure your Contract manufacturer can meet those expectations.

Most medical device design and development companies do not have their own manufacturing infrastructure. Why does StarFish Medical?

One of the reasons StarFish has full manufacturing capabilities is to provide a start-to-finish offering to clients that want to develop medical devices.  Not only can we help them define the product and take it through alpha, beta and transfer to manufacturing, we can transfer it to our on-site manufacturing to provide an all in one solution.  As a manufacturing team we’re not just working on a product going out the door, we’re working with engineering and product development teams on the prototyping, alpha and beta stages of a project.  We’re involved the product from the beginning. We know the product intimately and we work with the engineers on any Design For Manufacturing (DFM) issues that come up.  When StarFish design engineers make the actual transfer to manufacturing, it’s more efficient.  A lot of the learning curve and training is already in place.   That makes for a more seamless entry to market.

What percent of clients go for the whole design to manufacture process with StarFish?

Probably 30% of our design and development clients go through StarFish manufacturing.  Conversely, over 50% of the products we manufacture are transferred in from other designers or manufacturers.

The services StarFish provides are very modular.  Depending on what you require, you can have just the product engineering or design or layer in Quality or manufacturer.  It’s an individual conversation because all devices are so different.

What are three things you’d like readers to know about StarFish Manufacturing?

We have an educated, diverse skill set in manufacturing.  We understand the lifecycle of a medical device.  That adds value to a launch.  We’re ISO 13485 certified and set up to handle all types of demand—stops, starts, low to mid volume with anywhere from highly complex runs of 5 units to hundreds or thousands of units.

What are some examples of scalability?

Novadaq immediately comes to mind. Their SPY Elite Imaging System provides clinically relevant information that empowers surgeons to make better informed critical decisions in the operating room.  Our project started with designing the large cart for use in the operating room.  We went from start of project to manufacturing a volume of 1-2 units in six months because we were able to work with engineers and develop rapid prototypes, alpha and beta units.  Production ramped to 10 a week at market launch, and when the rate was ramping to 300 units, we transferred the work to their in-house manufacturing as planned.

The RoboSep™ robotic cell separator by StemCell Technologies is the first instrument to offer true walk-away automation of immunomagnetic cell separation. We built the RoboSep for over six years.  It was a great project for us.  We helped StemCell set up their service and preventative maintenance program.  We performed the worldwide field service.  When the volume rose to 100 a year, we worked with the in-house StemCell development team working on their next generation of device and transferred the original model end of life manufacturing into their facilities.

What types of clients and devices are you set up to handle?

We’re pretty diverse.  Clients come to us at different stages of the development of their product.  Some come from the Product development side of StarFish.  Others come to us with established manufacturing programs in place they want us to take over.  Our devices range from quite small clean room devices, to benchtop systems and assemblies and large carts—and everything in between. We have quite a diverse customer base.

High to mid-complex electro mechanical devices is where we can really add value for clients.  The sweet spot for us in terms of quantity is in low to mid volume.

What types of value do you add?

Typically when StarFish manufacturing starts engaging with a client, they are trying to launch into the market or transferring a project from a design team to get them into the market.  With that comes challenges to work through as the first units are put in the field. We add a lot of value by working through those issues prior to the transfer phase whether working with our clients’ engineering or technical lead, or StarFish engineering if the product was designed and developed by StarFish. We’re closely matched with the team to make any needed changes in the next unit out the door.  Coupled with our high mix, low volume product profile that means the customer isn’t required to build hundreds of thousands of units to start with.  We’re able to make 5, 10 or 20 units for initial volume.

During the development/transfer stage for a new product introduction, we’re in tune with the stop and start process that will inevitably occur.  We can stop, make changes and implement them quickly.

What’s unique about the StarFish Medical manufacturing workforce?

We have a highly technical team in manufacturing.  We have a very diverse set of skills in manufacturing– electrical engineering, mechanical technicians, technologists that work on the programs.

Because we’re so connected with the engineering teams in the prototype and alpha-beta phases of the projects, we focus on maintaining a really high skill level in manufacturing.   We have trained ISO 13485 auditors, we have an in-house lead auditor training program.  We have multiple six sigma green belts and an industrial engineer on the team.

Our clean room capabilities currently serve consumable items, optics and surgical equipment that requires post packaging sterilization.