With the multiple phases and capabilities required in the process of designing and manufacturing a medical device, this particular definition of teamwork is especially astute. Even if a company knows
exactly how it wants its product to look, or what the desired performance is, the route to accomplish it isn’t always clear, or agreed upon. As a result, missteps can occur, maybe some obstacles and even a few dead-ends.
But, if the design team is workingclosely with the prototype and manufacturing team at the outset of the project, it’s like having an experienced scout guide your steps through the manufacturing process. Most of those blind spots are avoided, the project is kept on track and goals are reached more quickly.
To help realign engineering, prototyping and manufacturing departments,consider these practical perspectives for following a less arduous, more efficient path from product development to full-scale production.
1. Ask for Input
At their core, most engineers are creative people who like to tackle problems and figure out solutions. However, in some medical technology companies, thosetalents are restricted when the engineering
department is disconnected from othersolution-oriented departments such as prototyping and manufacturing.
For example, a design engineer might create a detailed CAD drawing of a surgical handpiece that looks exactly like what the customer requested. But when it’s passed on to the manufacturing department, the design may include features or materials that make it costly and time-consuming to produce.
As a result, the engineer has to go back to the drawing board, make revisions and the whole process starts all over again. This “siloed” approach tends to delay the project and add unnecessary steps and cost.
Alternatively, if the engineer had asked the prototype department early in thedesign phase—even before a prototype is made—about the manufacturability of their design, it’s likely that the design could have been modified to alleviate issues that may hold up production.
2. Build Bridges Between Engineering and Manufacturing
Having a prototype made of an engineer’s design is a critical aspect of product development. But it’s one thing to get a prototype made (using a 3-D printer, for example) just to have something to see and feel. It’sanother to have a prototype made with respect to design for manufacturing (DFM).
If a medical device manufacturer has the advantage of having an in-houseprototype department, it has the ability todesign and develop products moreefficiently, in accelerated timeframes, with fewer iterations and less cost.
There are many reasons for this. Animportant one to note is that the prototype machinist has extensive knowledge about the machines on the manufacturing floor, as well as the ability to offer invaluable
insight to the design engineer about themachines’ capabilities.
For example, when a design engineer is in the early stages of creating a CAD drawing, the focus mainly is on incorporating the functionality, materials, torque requirements and other product specifications provided by the customer. By showing the design to the prototype machinist—even before a physical prototype is made—the machinist has the insight to know if the in-house machines will have the capability to efficiently produce the parts or whether a certainfeature will make it difficult, costly orimpossible to run through full production. If the current design does not meet the available requirements, the prototype team can convey that insight promptly to theengineer so that revisions can be made early.
Additionally, the Prototype department’s familiarity with in-house tooling and machines makes the group a valuableresource for suggestions on how to modify the design to meet in-house manufacturing capabilities while still maintaining thecustomer’s requirements.
Without a knowledgeable prototype team serving as a bridge between Engineering and Manufacturing, the engineer is likely to be unaware of inefficiencies in the design before releasing the design to Manufacturing. When machining issues emerge, the whole process has to be halted. The part either has to be sent out and machined by a third-party vendor, adding cost and time to the project, or the design needs be modified late in the process, making it near impossible to meet the customer’s deadline.
3. Look Down the Path
Another reason that in-house prototyping gives medical device manufacturers aproductivity edge is consideration of theassembly process.
Besides to building the prototype and providing input on ways to make the design compatible with in-house machining capabilities, the prototype department also builds the assembly and testing fixtures. This gives them a unique foresight into the types of fixtures needed for easier handling during the assembly process.
Early in the design process, an engineer mainly is focused on designing a device that functions and incorporates customer specifications. For example, it is unlikely that, at this initial stage, an engineer would think about adding flats to the design to accommodate a torque requirement in the assembly process.
Consequently, once it gets to theassembly stage and it’s discovered that additional features are needed, the whole process gets interrupted. The engineer has to go back, revise the drawing, make deviations, and redlines, update routers and bill of materials and take extra steps that extend time to market.
By coordinating closely with theprototype department—even when the prototype is only a computer-generated model—and getting the group’s valuable perspective, the engineer can design the device so that it is easier to manufacture and more efficient to assemble.
4. Follow More Direct Routes
One of the most direct paths to producing a high-quality medical device in an accelerated timeframe is through a contract manufacturer with in-house design, prototyping, manufacturing and assembly capabilities. Having these different, symbiotic departments under one roof makes it easier for collaborative communication and dynamic problem-solving to transpire.
While there are highly capable facilities that just focus on design, or prototyping or manufacturing, if all those different facilities are not communicating with one another, the route to project completion is likely to be indirect, tedious and prolonged.
Take, for example, a medical technology company that designs a surgical device in-house, but sends the design out to a prototype house. The prototype house will make a physical model based on the design they were given and a few weeks later, they’ll deliver the prototype to their customer. However, it is unlikely that the prototype house will provide feedback about whether or not the device will be cost-effective to produce or whether or not it will be efficient to manufacture in higher production quantities.
Not having that feedback is like lacking the “print preview” option in your word processing software. The process is more laborious and time-consuming because you have to wait until after it is printed to see what sections look odd, where the page breaks are needed, or where the mistakes are. At that point you must go backto the original document, make more changes, print it again and start the process all over.
On the other hand, having an in-house prototype department—or working with a contract manufacturer that has design, prototyping and manufacturing capabilities in-house—can be compared to the “print preview” feature. Important adjustments can be made to the design before it gets to full production.
When it comes to developing a medical device, this advantage helps an OEMensure that their product will look, feel and function exactly how they want it to and will be designed in a way that is compatible with their manufacturing and assembly capabilities.
If in-house prototyping is not anoption, and the design is sent to anoutside prototype house, it’s essential for the design engineer to solicit feedback from the prototype machinists beforemoving on to the next design phase.
Asking the prototype machinist for his or her observations and inquiring about any manufacturing difficulties he or she may have encountered directly related to the design supports a more straightforward DFM process. Without that feedback, the benefits of outside prototyping fall short because nothing is being learned about how to improve the design so that it’s more efficient and cost-effective to manufacture.
5. Take Dry Runs
Once one or two prototypes have been made, fit-checks and reliability tests have been conducted and feedback has been received from other cross-functional team members involved in the project, the
approved device can move forward to the next stage of the manufacturing process.
For some organizations, the next phase is full production. However, an often overlooked step is pre-production. In pre-production the exact same machines, systems, programs, routers, fixtures, inspection gages, materials, and tools are used as they are in full production—but only a small batch of ten to twenty units is run through the process. Pre-production bridges the gap between prototyping and manufacturing and offers substantial DFM benefits.
For example, if there’s a feature thatrequires a unique drill size to create adistinct hole-size, a pre-production run can reveal that a slight update to thedesign will allow a standard drill to be used instead, saving time and resources. That crucial observation is conveyed back to the prototype machinist who can then work with engineering on making adjustments.
Rather than having to buy custom tools or fixtures to solve the issue, slight modifications can be made during the final design stage that ultimately will streamline full production. Furthermore, the feedback acquired from the pre-production process strengthens overall communication and collaboration between manufacturing and engineering.
Keep Focused on the Destination
The less-arduous, more efficient path to producing the best product at the best cost, in a compressed timeframe, starts with aligning the unique qualities, capabilities and talents within your organization.
Teamwork among engineering, prototyping and manufacturing means that open dialogue is occurring between the departments and that important questions are being asked related to the product and design for manufacturing.
Collaborative product development also enables the design and manufacturing team to bring necessary changes to their customer’s attention at the outset of the project. This is key particularly if
significant refinements need to be made that affect the customer’s budget and timeline. Making the customer aware of issues at the very beginning—instead of uncovering them toward the end of the process—demonstrates your company’s initiative, transparency, innovative thinking, and most importantly, respect for your customers.
Daniel Santos is the engineering manager and Fernando Jaramillo is the senior toolmaker/machinist at Pro-Dex, Inc., an Irvine, Calif.-based company that designs, develops and manufactures surgical devices, motors, metal components, and sub-assemblies for world-class medical device OEMs.