How can we best expect the unexpected? In medical device contract manufacturing, there will always be roadblocks to getting your product to market safely and successfully. One way to avoid downstream pitfalls is to build your process — and device — with manufacturing in mind.
In this article, we’ll take you through the ins and outs of HDA Technology’s design for manufacturability approach: a design philosophy that encourages the design, development, and manufacturing of products that have high producibility, low cost, and long endurance.
What is Design for Manufacturability?
Design for manufacturability (DFM) refers to a design methodology embedded throughout a company’s manufacturing system. Implementing DFM yields two-pronged results:
- Strategically anticipate manufacturing needs early in the design process.
- Proactively design your product to meet those needs.
Through this dual output, DFM ensures that your product achieves ideal cost, quality, reliability, regulatory compliance, time to market, and customer satisfaction.
A core tenet of DFM is the simplification of production. This does not mean sacrificing quality – quite the opposite! Under DFM principles, the more “producible” a product is, the more likely it is to be manufactured at a higher level of quality, consistency, and reliability.
To achieve greater producibility, the design process focuses on simplifying your product to its more necessary elements and analyzing each component against the question, “What is the ‘best’ way to manufacture this?”. Depending on the industry and process technologies involved, DFM analysis might focus on improving process yields, fabrication, assembly, product testing, or packaging.
A Whole-System Approach to Medical Device Manufacturing
In medical device development and manufacturing, the FDA defines 5 phases of development for a medical device: design inputs, design, verification, validation, and transfer to manufacturing.
Design inputs are when your team generates the definition of what the product is supposed to be. This includes deciding on specifications and requirements and refining your end vision for the product.
Design refers to the part of the project where you design the device, build prototypes, and ensure it all works before you commit to manufacturing.
Verification is the phase in which you verify or evaluate whether the outputs of your design phase meet the specifications of your vision.
Validation involves testing your device to ensure it meets industry safety and certification requirements and that it performs its intended function (determined at the design inputs phase) properly and efficaciously.
Finally, transfer to manufacturing is the phase in which you set up the manufacturing processes themselves and validate them. At this point, your product is ready to be manufactured.
The earlier and more systemically embedded your DFM principles are adopted, the more likely it is that your device will succeed. By success, we mean: made under/meeting budgeted manufacturing costs; high quality; reliable; assembled parsimoniously; and, finally, meet all regulatory and performance requirements.
DFM is not just relevant to the whole manufacturing system in a technical sense: it has a human dimension, too. Successfully implemented DFM demands contribution, collaboration, and an integrated, forward-looking mindset from people at all levels of the manufacturing process.
That’s not to say timing doesn’t matter at all for DFM. In the linear production timeline, DFM is most important to the design phase of medical device manufacturing.
While in name DFM is tied to the design phase, strategies for implementing DFM engage with all stages of the D & M process. This includes culture, suppliers, finances, and timelines. Integrating multiple parts of your development process into one coherent system of development, design, and manufacturing is both important for and an outcome of DFM.
From Design to Manufacturing
The design input and design phases are where your product vision is tailored to meet your customer’s requirements. It’s after these two phases that you verify and validate your product for real-world settings. Having completed an initial opportunity and risk analysis and created a proof of concept (concerned chiefly with feasibility) for your product idea, we use this time to test the product against your original vision and industry safety and certification requirements. This is when you and your contract manufacturer will think hardest about your product’s manufacturability.
DFM considerations need to be incorporated at around the middle or toward the end of the design phase when functionality has been realized and refinement of the design is in process. A design phase that centers around DFM ensures the design of a product that is safe, reliable, and high quality. This phase is thus especially important for medical devices, which are used in high-stakes situations and require a very high level of quality, reliability, and consistency of production.
How Do We Implement DFM?
Strategies for practically implementing DFM can be many. Some ways HDA adopts the DFM approach include:
- Defining the product as clearly and methodically as possible. We work closely with you to ensure we’ve taken your needs into account from the start.
- Ensuring the resources needed for your product are available early in the development process.
- Creating a realistic timeline. Because HDA is also a development company, we ensure adequate attention is given to the development and design phases of product development.
- Taking a collaborative and communicative approach, we bridge gaps between people and phases in the development and manufacturing process to account for needs and perspectives at all points in the process.
- Regularly evaluating our progress, reflecting, and learning from feedback and past experience. We apply tools like the PDSA cycle to evaluate our work as we go.
- Designing your product with existing manufacturing processes in mind. As a company using lean manufacturing principles, we avoid the superfluous need for new manufacturing processes that may reinvent the wheel.
- Sourcing our materials from proven, trustworthy sources and vendors with reliable delivery times.
The Five Dimensions of a DFM Approach
The implementation of a DFM approach can be summarized as 5 interrelated dimensions.
Design refers to the development of product features according to 1) principles of good manufacturing and 2) whatever need the product is fulfilling.
As a medical device developer and manufacturer, HDA designs everything we manufacture for our clients. As a result, we have a deep technical knowledge of the products that we build and can support the process of manufacturing them more effectively and efficiently than if we were not involved the whole way through.
Materials focus on the type, makeup, quality, suitability, cost, and source of materials used to manufacture your product.
Here at HDA, all of our product materials are sourced from suppliers who pass our vendor approval process – a process defined by our ISO 13485 Certified Quality Management System. While some product components are only available in Europe and Asia, we aim to source as much as we are able from domestic suppliers to ensure the quality and transparency of the material’s makeup.
Process refers to the method and/or steps we use to assemble your product.
HDA Technology employs a collaborative process for manufacturing that leverages the input and capacity of the whole system. For example, we seek input from our manufacturing group during the design process to ensure that products are efficient to build and maximally reliable. This ensures a direct line of communication between the need, the design, and the final product.
Performance takes into consideration whether the product will perform as desired in “real world” situations.
Prototyping and verification testing are an integral part of HDA’s development process. We build development platforms that contain the necessary and representative components of your designed product, and in so doing can thoroughly test and verify the product’s “real world” useability before launch.
Regulations refer to any industry standards with which the product must comply to be marketable.
HDA is both ISO 13485 certified and FDA and FDB registered. This ensures that industry standards are embedded into our design process. All design and manufacturing considerations or decisions are made through the analysis of these industry standards. Through this, we embody the future-facing attitude that DFM demands.
DFM and Medical Devices: Designing for Safety and Reliability
Here at HDA Technology, we understand that the need for high reliability and repeatability is crucial to medical device manufacturing. Field failures, or the release of a product that is not functioning to specification, is not acceptable.
By using a medical device product manufacturer that has implemented DFM into their process, you ensure that your medical devices will be easily manufactured within your manufacturing cost target while also being compliant with regulatory requirements and performance/quality standards.
The Rule of Parsimony: Simpler is Better
Medical devices can sometimes be intricate or complicated to make. A manufacturer that has implemented DFM can reduce complexity as much as possible and pare the product’s design down to its most essential needs.
DFM Now, Time and Money Saved Later
DFM saves time, reduces the number of steps in production, and ultimately reduces the risk of error, which is critical for medical device production.
DFM also reduces accumulated costs down the line. While durability is a DFM consideration that may be costly up-front, the future-minded manufacturer understands how product durability will save money in the long run.
Restrictions, Regulations, and Recalls
Because medical devices are so highly regulated, post or end-of-production recalls, changes, and revisions are expensive and disruptive. DFM reduces the likelihood of revision later in production.
Managing Mass Production
Some medical devices need to be made at very high volume. Using DFM puts in place safeguards against the lure of producing products at “sufficient” or baseline quality, as much of the quality assurance work is done early in the design process.
As production volume increases the impact of DFM on production capacity becomes more apparent: the more you factor production efficiency into the design, the more devices you can build in a given period and allocation of space.
In working with a medical device contract developer and manufacturer like HDA Technology, you are secure in the knowledge that every device you produce will benefit from our systemic DFM approach.
If you have additional questions about how HDA has implemented Design for Manufacturability or would like to request a consultation, you are invited to get in touch.
