Design for Manufacturability (DFM) in medical device development is the practice of designing products so they can be manufactured easily and cost-effectively. When early design decisions can lock in roughly 80% of a product’s manufacturing costs, involving manufacturing considerations at the design stage is essential. By aligning design with manufacturing realities from day one, medical device teams can avoid expensive changes down the line, reduce quality risks, and accelerate time to market.  

TL;DR: Designing with manufacturability in mind from the outset reduces costs, speeds up time-to-market, ensures compliance, and improves quality, especially when working closely with a one-stop-shop medical device manufacturer like Micron Solutions.  

What is Design for Manufacturability (DFM)? 

Design for Manufacturability (DFM) is an engineering approach where you optimize a product’s design for the ease and efficiency of manufacturing. For example, engineers may eliminate or combine parts so that fewer components are needed, saving assembly time and reducing the risk of errors, such as by using two-shot injection molding, which enables two different materials or colors to be molded into a single component in one cycle.  

Why DFM Matters in Medical Device Development 

Medical devices need to perform a lifesaving or diagnostic function but also need to meet strict regulatory standards and quality requirements. Any hiccup in manufacturing can lead to costly fixes, project delays, or compliance issues. Integrating DFM early in development helps avoid these issues. 

Medical devices also have no margin for error when it comes to quality and safety. Engineers need to ensure chosen materials are not only biocompatible but also readily available and workable with the required manufacturing techniques (injection molding, CNC machining, etc.). They must plan for assembly in controlled environments like cleanrooms if required, and design components in a way that minimizes opportunities for human error during assembly.  

Milestones That Impact How DFM is Performed 

When it comes to medical device development, there are certain milestones that determine the type of DFM that can be performed. The most notable milestone is when the OEM enacts Design Controls. 

Early Concept Phase (Before Design Controls) 

During the early “sandbox” stage, teams can conceptualize all kinds of ideas, iterate quickly, and make adjustments without heavy documentation. This is the ideal time to incorporate DFM thinking because changes are fast, flexible, and cost-effective. 

Formal Design Phase (After Design Controls Are Enacted) 

Once an OEM activates Design Controls, all design decisions and modifications must be documented in the Design History File (DHF). At this stage, updates may also require additional testing, verification, or regulatory review. DFM still plays a critical role at this stage, but all recommendations must now operate within tighter boundaries, which makes these late changes more time-consuming and costly. 

Benefits of Early DFM 

Adopting DFM early in development yields several key benefits: 

• Reduced Cost & Time to Market: Some companies have seen manufacturing costs drop by over 20% after implementing DFM-driven design changes. A DFM-optimized device often has fewer parts and efficient processes, which lowers manufacturing costs and helps you launch faster. 
  

• Higher Quality & Consistency: Designs that follow DFM guidelines tend to have more consistent, defect-free outputs. Building within known process capabilities (proper tolerances, suitable materials, etc.) means fewer production issues and reliable quality from batch to batch. 
  

• Simplified Assembly / Part Consolidation: DFM can lead to combining parts to streamline assembly. For example, using two-shot injection molding, multiple components can be made as a single part. This reduces assembly labor and eliminates alignment errors, effectively “error-proofing” the product. 

Common DFM Challenges and How to Overcome Them 

Even with good intentions, teams may face some DFM challenges in practice. Here are a few and ways to address them: 

• Team Silos: If manufacturing experts are involved only after the design is done, key feedback arrives too late. A great solution is to involve production engineers early or work with a one-stop-shop contract manufacturer like Micron Solutions. 
   
• Regulatory & Quality Constraints: In MedTech, late design changes can trigger new rounds of testing or regulatory scrutiny. This can be addressed by integrating DFM into the design control process. By finalizing a compliant design before formal validation, you avoid last-minute surprises with regulators and quality checks. 

DFM Case Study 

Micron Solutions was selected to manufacture three critical components for a specialty wearable drug delivery device, a product that requires high precision and exceptional reliability. 

The challenge was significant: each component featured intricate geometry, multi-dimensional shapes, and tight integration requirements that stretched the limits of traditional molding methods. Rather than rely on multiple assembled pieces, the engineering team applied DFM thinking early and recommended leveraging advanced 2-shot injection molding to consolidate materials and reduce assembly complexity. 

The outcome was a set of fully integrated, high-precision components essential to the drug delivery device’s performance. By applying DFM early and choosing the right processes, planning for integration, and designing with manufacturability in mind, our team helped the customer bring a complex, life-changing device to market efficiently and confidently. 

Read the full case study: Case Study in Advanced 2-Shot Molding 

Final Thoughts 

An effective DFM medical devices strategy ensures even innovative products can be produced without compromising quality or compliance. For anyone involved in medical device development, adopting DFM early is key to avoiding pitfalls and smoothing the path to market. 

Ready to bring your idea to life? Reach out to our team at Micron Solutions to discuss your project. We’re here to help you design it right, build it right, and ultimately deliver a medical device that improves lives while meeting cost, quality, and speed goals. 

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FAQ 

When in the development process should we start thinking about DFM? 

As early as possible. The earlier you start, the easier it is to make tweaks that improve manufacturability (rather than overhaul designs later). 

How can working with a U.S.-based medical device manufacturer aid the DFM process? 

Partnering with a medical device manufacturer in the USA can greatly streamline DFM thanks to easier communication, geographic proximity, and often a strong understanding of FDA regulations. A domestic partner like Micron Solutions can collaborate in real-time with your team, provide immediate feedback or even rapid prototypes, and ensure the design aligns with proven manufacturing techniques.  

Will focusing on manufacturability limit creativity? 

By addressing manufacturability challenges early, you often discover creative solutions that enable your innovative concept to be produced reliably. Involving experienced engineers and manufacturers can actually spark innovation that makes the product even better.