When manufacturing products, it is absolutely vital that you plan for an effective design transfer process. In a nutshell, this is how a product’s design is successfully transferred into a viable manufactured good that can pass quality assurance tests and be sold.
As you can imagine, many headaches can arise during this part of a project, such as having to completely change course on product design or necessary components, and can even include having to go back and do significant rework. Typically, less planning equals more problems.
Secrets to Profitable Manufacturing Success
The secret to successfully managing the design transfer process is to start before you’ve officially reached the design phase and part design. If you wait until things are already under way, you’re much more likely to find yourself facing unanticipated surprises that will impact deadlines, project workflows, and your overall budget. Redoing major pieces of design-related projects can be a death knell for forward momentum.
Wasting time and money can derail your mission and vision. Difficulty in the design transfer process isn’t just annoying; it can result in the need for additional rounds of funding, delayed launches, and unfulfilled consumer and investor expectations.
Key Factors in Revision Control
Design transfer must be air tight and steadfastly monitored. Because this is a meticulous process, revision control documents are crucial to success. Without them, the project can get sticky really fast. For instance, changes could result in tacking on an additional risk analysis, an expensive task best avoided with proper planning and control measures.
If revision control processes aren't in place, a development team will inevitably make expensive mistakes. For example, we’ve seen people order massive quantities of the wrong parts, or the “right” parts with the wrong dimensions. This can be a significant investment and a significant loss.
As a matter of fact, there are companies who have gone out of business because of the magnitude of their revision control problems. This can be an extremely costly situation - so much so that you can put an entire organization at risk if you haven't planned for effective controls.
Something else that can leave you hanging during manufacturing is actual component availability. Often, when we’re knee deep in the vision and creation process, we assume that we’ll be able to order or access needed components when it’s time to put the pieces together; however, the situation is not always so simple.
Let's imagine being this position: You've worked hard. You've released your product, you've gotten the approvals you need, and you're ready to go to market. Major milestones! However, when you get ready to order what you need, you find out there's only enough supply of a particular, necessary component for three months worth of production.
Ouch. Guess what? You're going to have to start all over again, and go through the entire testing process (and recertification) in order to bring your product to market. The time, energy, and money you’ve already invested are, in large part, wasted. Now, you’ll have to go back to the starting line and run that whole race again -- just to get up to this same place.
Even a seemingly minor change in one aspect of your product can result in a major chain reaction of issues.
At Nectar, we utilize a software tool early in the design phase that’s been specifically designed to help eliminate issues with late phase manufacturing issues. It monitors the international market for the components you’ll need, ensuring that global supply chain issues will not derail bringing a product to market.
Verification and Validation
Other issues we see when bringing a product to manufacturing and distribution involve testing methods and product validation, or lack thereof.
We cannot overemphasize the importance of this: It is a mistake to avoid thinking about production validation until you’re there.
Although we often think about design transfer as a part of the manufacturing stage, it really needs to be considered far earlier in development. For example, when you’re initially looking at design outputs, you should already be thinking about design transfer. Validation ensures a device will work end-to-end as expected, and if approached successfully can preserve time and money close to the finish line. Although you can’t prevent every single mishap, pre-planning can ensure that you’re able to minimize costly surprises.
In the same way that we monitor the markets for months in advance to ensure component availability, we also have to verify that the product performs to specifications, and we have to validate that it performs as documented. The best way to do this is to work closely with your manufacturers as early as possible in the development process.
Early-stage and on-going sight on verification and validation will greatly impact your budget and timeline, ensuring you'll be able to get your device to market as quickly and efficiently as possible.
Less Reworking, Less Headaches
In a perfect world, you’re actively working through a collaborative process where everyone is on board from beginning to end.
- Manufacturing partners are lined up early.
- Design for manufacturing is built into the process rather than shoehorned in later; making the “DFM” an afterthought leads to frustration, wasted time, and money.
- Your product is designed with manufacturing in mind, which decreases your costs during assembly.
- When your project gets to manufacturing, it’s greeted by experienced manufacturers who are already familiar with its assembly because they were involved early on in the process.
Pre-planning has decreased your costs overall, including decreasing your assembly costs. As a result, you’ve been able to decrease your total device cost.
Sounds amazing? It is! And it’s not too good to be true, either. In reality, this is the result of collaborating with the manufacturing team early in the design phase of your project. You decrease cost, decrease stress, and decrease unwelcome surprises along the way. At the end of the day, you’re able to deliver your product to the market on time, on budget, and without delay. By ensuring you have a capable team of people monitoring your development trajectory (and the final outcome), you achieve a really seamless approach.
The keys: Incorporate part sourcing early, and identify a contract manufacturer (CM) to begin looking at manufacturing procedures in order to prepare for design transfer. This naturally creates a more seamless approach.
When you look at the outcome of a project this way, you experience what it is to have a larger, more integrated organization. Although working with an external team, the development feels it is in-house because of the collaborative process. Collaboration enables creative and innovative thinking that flows organically between your team, your design partner, and the selected manufacturers.
Ready to commit to the success of your next manufacturing project? Read on for our top five tips for effective design transfer planning.
Top Five Tips for Effective Design Transfer Planning
Here are five tips for how to effectively set your design transfer process in place so that you, too, can achieve manufacturing success.
1 - Find an Experienced Partner
When you look for a partner to design a product you’re planning to take to market, you’ll want to find a group that has done this before.
For starters, you’ll want to look at their portfolio. Ideally, you want to see what projects they’ve built in the past, and especially what projects they have actually designed and taken to market. Pay attention to whether or not they have any projects similar to yours.
As you do so, don't be afraid to inquire more about their actual involvement in a specific project. Some firms and designers will display products on their websites or within their portfolios despite limited involvement in the product’s development. Ask about their role and level of responsibility, and consider how that compares to what you’re looking for.
Choosing this important of a partner is a really big decision, and who you choose will have a massive impact on the outcome of your project. Definitely do your homework!
At Nectar, we feel transparency is key to a successful engagement. For that reason, we are upfront about the complexity of medical devices, as well as about our experience with designing them.
Choosing a quality contract manufacturer is another portion of the partnership equation. We can assist with identifying a CM early on in the process. By bringing in production expertise on the front end, you can avoid huge hassles later.
2 - Find a Partner With an ISO 13485 Certification
You’ll also want to look for a partner who has their ISO 13485 certification. Honestly, this qualification isn’t common and can be overlooked; however, it is essential in order to get a safe medical device to market efficiently.
Brace yourselves: I'm about to throw some more letters and numbers out here. Bare with me, and don’t worry: There won't be a quiz.
THE FDA governs the development of medical devices with 21 CFR Part 820.30, which calls for the use of design controls and demands the regulation of quality management systems.
An ISO 13485:2016 is a specialized offshoot of the more commonplace ISO 9001 certification. This has become the guidance for the FDA, EU, and the international medical device market. (Summary: It is super important.)
In order to get cleared to bring your medical device to market, you absolutely need a design partner and manufacturer with a well-maintained quality management system. It is not “optional” and you should definitely not let a potential partner minimize the importance of it, or treat it as a stand alone effort. Organizations that have this certification will have the know how to build and document a design properly in order to achieve FDA approval with a well put together design history file (DHF).
Beyond approval, these efforts ultimately lead to a safe medical device for consumers which is the utmost priority, always. Acronyms and numbers aside, this tedious quality management system is what empowers us to improve the health and well-being of end-users. Take it seriously, and find partners who will as well!
3 - Use Components and Parts That are Accessible
We always advise that you look for parts that are likely to be around for a while. If a particular component ends up being a flash in the pan, or being very unusual or rare, it can derail your entire product. This is especially an issue when it comes to electronics that have a shorter life cycle.
You have to keep in mind that sometimes it takes quite a bit longer to get made-to-order, custom, or rarely used components. For example, you might be ordering a sample of a component for your product and find that it will take 10 weeks to get it - just to see if it will even work! We've also seen companies that will require you to get certified in order to be able to work with their components. That takes additional time, energy, and, undoubtedly, money.
Finally, they send you the samples. You develop on the samples. When the time finally comes and you're ready to manufacture your product and you go back to make a full order, it’s not unusual for it to take between 10 and 40 weeks to be fulfilled if the part is uncommon or not readily accessible.
At Nectar PD we have software that allows us to check the global supply chain. That way, we know up front what we're getting into with particular components that we choose to use in the design and building of the products that we help our clients bring to market. If you’re going to manage this part on your own, it's extremely important to understand how the supply chain works. Be sure to look for parts that are likely to be easily accessible.
4 - Select Manufacturing Processes That Will Scale With You
Strive to select manufacturing processes that are going to best meet your ultimate goals both now and in the future. When’s the best time to choose them? Early in the design phase. We begin to set these forth early in the project using an MRD (Marketing Requirements Document).
You’ll want to look for manufacturing processes that are scalable, and that will be capable of giving you the expected production volume. In addition, considering the price of materials and lead times for these tools is critical to fully understanding the ultimate project cost.
We’ve found that entering later phases with an early plan for manufacturing helps mitigate some of the uncertainties that can plague a project in design transfer. We’ve also noted that, by using design reviews throughout the project, we can ensure that critical decisions are not overlooked. We also ensure that all stakeholders are at the table when weighing critical time and cost decisions
Ultimately this informed, early approach will help ease the transition into process engineering down the road,
5 - Plan for Fixture Development and Long Term Success
Finally, it’s important to plan for fixture development when entering a development project. All too often, tooling costs and times are overlooked from the outset. Later, this results in delays, workflow disruptions, and budgetary concerns.
This becomes even more complicated when a medical device has associated consumables- for instance, you would not just sell a box cutter, but the razor blades that will be used and repurchased. However, that razor itself has to be seamlessly integrated to the design of the box cutter. It must be considered on its own for manufacturability, including how the razors will ultimately be installed into its box cutter.
With complex devices and tools, precision manufacturing is required, and the entire team must understand the exact processes and requirements to physically create the final products.This isn’t just about getting something “done” -- it’s about being able to trace how a product is assembled, and what the tools are that allow for exact replication every time. Ensuring quality is central, but we also then must consider time. How will we create a manufacturing process that achieves a desired amount of units in the necessary time frame?
When planning for long term success, consider questions such as:
- What does our company growth look like today? In five years?
- What is our current projected number of units?
- What will that number be in X years time?
- How quickly will we need to get a unit through production?
- What people do we need?
- What are the long-term processes that we need to have in place to be able to make money consistently?
Working With Nectar Product Development
At Nectar Product Development, we want to be your partner early on in the process. We want to get your design off on the right foot so we can help you take it smoothly through the manufacturing phase, rather than picking up the pieces later (although we can do that too).
We guarantee that an effective design transfer process will develop from our collaboration with your team, and that early in the process we will find you the right type of manufacturer for your needs.
Our job is to arm you with a team that is already aware of what's coming down the line. We will make sure you have the knowledge and awareness you need early in the process so that you can make informed decisions with a measurable impact on your goals.