Frequently Asked Questions
Table of Contents
Use the following links to navigate the FAQ page.
General About DEM
What does full turnkey manufacturing mean?
Full turnkey manufacturing means your product moves from concept to production with company-employed engineers, technicians, and assembly personnel, without the delays and risks of outsourcing. A turnkey partner handles design, engineering, prototyping, tooling, production, and testing all in-house.
At DEM, that’s exactly how we operate. Our vertically integrated process gives you direct access to engineers and faster timelines, bringing your product from idea to production in as little as 10 weeks. You don’t have to manage multiple vendors or worry about third-party quality issues. We simplify the process, keep you in control, and take responsibility to deliver a product on time that performs to specification.
What services does DEM provide, and what are its capabilities?
DEM provides end-to-end product development and manufacturing services, all handled in-house:
Design
- Concept development and 3D CAD modeling
- Functional prototypes using additive manufacturing
Engineering
- Electrical and mechanical engineering
- Design for Manufacturing (DFM) optimization
- PCB layout and circuit design
- Functional circuit testing and validation
- Compliance planning (ITAR, FDA, etc.)
- Product requirements testing
- Testing protocol and instrumentation design and fabrication
Manufacturing
- Printed Circuit Board Assemblies (PCBAs)
- Electro mechanical product assemblies
- Custom cable assemblies and ruggedized connectors
- Injection molded components and tooling fabrication
- Analog and digital communication systems
- Medical device manufacturing
You can learn more about our solutions and capabilities on our website.
Is DEM a U.S.-based company?
Yes. DEM is 100% U.S.-based. All of our design, engineering, and manufacturing happens domestically in our Ohio facility. We don’t outsource because that’s how we maintain full control over quality, lead times, and compliance.
Our U.S.-based production is especially critical for clients in defense, medical, and other industries where security, traceability, and quality assurance matter.
H3: Does DEM provide any guarantees?
Yes. Every product we manufacture comes with a minimum one-year parts and labor guarantee. This reflects our confidence in the quality and reliability of our work and our commitment to getting it right.
We test every product we build to ensure it meets or exceeds the agreed performance requirements before it leaves our facility.
What is DEM Medical?
DEM Medical is a dedicated division of DEM Manufacturing focused on the development and production of medical devices. Following our acquisition of Virtec Medical, DEM Medical was formed to bring our engineering expertise, speed-to-market advantage, and regulatory compliance to Class I and II medical products.
Product Development & Time to Market
How do I bring a product to market faster?
The most important factors to accelerate product development are the following:
- Vertically integrated operations (everything in-house)
- Cross-functional teams that collaborate from day one
- Design for Manufacturing (DFM) practices are baked into early-stage development
- In-house prototyping and tooling capabilities to eliminate delays
These structures reduce handoffs, eliminate rework, and keep your timeline under control.
At DEM, we design, engineer, and manufacture entirely in-house, bringing products from concept to production in as little as 10 weeks.
What is the average timeline to develop a new product?
Product development timelines vary depending on the complexity, compliance needs, and available engineering resources. For example:
- A simple connector redesign might take 6–8 weeks.
- A ruggedized electronics assembly with custom tooling might take several months.
- A regulated medical device could take 6–12 months, depending on FDA classification.
That said, there are ways to dramatically improve your time to market:
- Work with a turnkey manufacturer who brings design, engineering, and production together.
- Involve production experts early in the design phase to avoid costly rework.
- Use rapid prototyping and parallel development workflows.
DEM applies all of the above. We help you cut through complexity and get your product to market faster—without compromising quality or compliance.
How long does it take to build a prototype?
Prototype timelines vary, but with modern tools and additive manufacturing, initial prototypes can often be produced in as little as a few hours.
When the right CAD models and materials are in place, DEM’s in-house prototyping capabilities—including SLA, FDM, and composite printing—allow us to quickly deliver functional samples for design validation, testing, or customer review.
This fast feedback loop is one of the biggest accelerators in early-stage product development.
Is there a faster alternative to traditional contract manufacturers?
Yes. Traditional contract manufacturers often rely on fragmented vendor networks and offshore production, leading to slow timelines that stretch beyond 12 months.
DEM is built to move faster with less risk. With a vertically integrated U.S.-based facility, we eliminate handoffs, delays, and outsourcing risks. We can take your product from concept to production in as little as 10 weeks, while ensuring compliance, quality, and performance at every step.
Design & Engineering
Can my manufacturing partner help me with the design and engineering of my product?
Not all manufacturing partners offer design and engineering support. Many traditional contract manufacturers require a finished design before they start production. This creates a disconnect between design intent and manufacturability, leading to costly delays, rework, or design revisions late in the process.
However, many companies need support with the design and engineering of a product prior to bringing the product to production. That’s where a full-service manufacturer brings the greatest value.
DEM is a full-service manufacturer, integrating design, engineering, and manufacturing all under one roof. Our clients work with our teams to refine their products' form, function, and performance prior to manufacturing, avoiding common manufacturing issues that cause production slowdowns.
How do you go about building a prototype?
There are many ways to go about building out a prototype. Our process at DEM is designed to help teams move faster and reduce risk. Here’s how it works:
- Concept & CAD Modeling - We start with 3D modeling and photo-realistic renderings to bring your concept to life digitally.
- Additive Manufacturing - Using a variety of 3D printing technologies, we produce functional prototypes for early testing and iteration.
- Assembly & Testing - Prototypes are built in-house by our engineering team to showcase product form and core functionality. We perform R&D and functional testing to validate key performance features.
This process allows for rapid iteration and helps ensure the final product is both production-ready and cost-effective.
What is Design for Manufacturing (DFM)?
Design for Manufacturing (DFM) is the process of designing a product specifically so it can be produced efficiently, reliably, and at scale.
It involves engineering decisions that:
- Minimize unnecessary complexity
- Align with available equipment and processes
- Reduce production time and cost
- Increase quality and consistency
When you’re building a product, DFM should be built into the design and engineering process from day one. At DEM, our engineers collaborate with manufacturing experts to catch potential issues early and ensure your product is ready for smooth, scalable production.
What tools or platforms are used in the design and engineering process?
DEM uses industry-leading design and engineering software to ensure precision, speed, and collaboration throughout the product development process:
- SolidWorks – For mechanical design and 3D modeling
- Altium Designer – For PCB layout, circuit design, and electrical schematics
- ERP Integration – For real-time version control and BOM management during prototype and production builds
These tools allow our team to move quickly, communicate clearly, and ensure every product is optimized for production from the start.
Manufacturing Capabilities
What are DEM’s manufacturing capabilities?
DEM offers a wide range of in-house manufacturing capabilities to support high-performance, custom electronic products:
- Printed Circuit Board Assemblies (PCBAs) – In-house PCB layout, assembly, and testing with fast-turn capabilities
- Custom Cable Assemblies & Connectors – Including ruggedized connectors and defense-grade communication interfaces
- Mechanical Assembly – Precision mechanical builds that integrate seamlessly with electrical and molded components
- Electromechanical Assembly – Complete system integration of mechanical and electronic subsystems, assembled under one roof
- Injection Molding – Including mold design, tooling fabrication, and production of rugged housings and components
- Skilled Soldering – IPC-certified technicians soldering to the highest standards for quality and consistency
- Additive Manufacturing – Fast, flexible prototyping and low-volume production using advanced 3D printing technologies and materials
- Laser cutting – High-precision laser cutting for rapid part fabrication, prototyping, and custom marking
- Machining – Precision CNC machining for custom components and tight-tolerance applications
- Tooling – In-house tooling design and fabrication to support faster, cost-effective production startup
- Pad Printing – Durable component labeling and branding with consistent, high-quality print application
- Quality and Performance Testing – Functional and environmental testing to ensure every product meets defined requirements before it ships
All manufacturing is completed in our U.S.-based facility, ensuring full control over quality, lead times, and security.
What are the benefits of partnering with DEM to manufacture your products?
When you manufacture with DEM, you get a true product development partner.
Because we handle design, engineering, and manufacturing under one roof, our team can:
- Catch design issues early—before they cause delays
- Modify and optimize products in real time
- Solve problems fast, without waiting on third parties
- Align every decision with production efficiency and performance goals
This makes the process faster, smarter, and far more responsive to your product’s real-world demands. If you want to see how this plays out in practice, check out our success story with Endolumik, a medical device company that partnered with DEM to bring a complex, regulated product to life.
How scalable is manufacturing with DEM?
DEM is built for scalable production. Whether you're launching a new product with limited volume or ramping up to meet growing demand, our flexible operations support both short runs and high-output builds without compromising on quality.
We tailor tooling, assembly, and testing processes based on your volume requirements and product complexity. That means you can start small and scale fast, knowing your product will be built with the same level of precision and compliance at every stage.
Medical Device Development & Manufacturing
What types of medical products can DEM help me bring to market?
DEM is FDA-certified to develop and manufacture Class I and Class II medical devices. We support a wide range of medical technologies, including:
- Wearable and handheld electronic devices
- Diagnostic and monitoring equipment
- Catheter systems and surgical components
- Respiratory and ventilatory device assemblies
- Homecare and hospital-use electromechanical systems
From early-stage prototyping to full-scale manufacturing, DEM handles everything in-house—including design, engineering, compliance planning, tooling, assembly, and testing.
Does DEM assist with FDA validation and documentation?
Yes. DEM supports clients through FDA validation and regulatory documentation, including assistance with 510(k) submissions for medical devices.
Our team helps ensure your product is developed in alignment with FDA QSR (Quality System Regulation) standards, and we provide:
- Traceable design history files (DHF)
- Risk management documentation
- Process validation reports
- Bill of materials and component traceability
- Supplier qualification and inspection records
We understand the complexity of medical compliance, and we’re equipped to guide you through it.
What’s the process to go from prototype to production for a medical device?
At DEM, we use a structured process designed for regulated industries like healthcare:
- Concept Development - We define functionality, compliance needs, and user requirements.
- Design & Engineering - Our in-house team handles prototyping and mechanical and electrical design, including PCB layout and product integration, ensuring your device is built for both performance and manufacturability.
- Regulatory Support - We align your product with FDA and ISO 13485 standards, and can support 510(k) submissions with full documentation and traceability.
- Pilot Builds & Validation - Pilot production runs help identify and fix issues early. Our integrated team manages root cause analysis and remediation in-house, saving you time and money.
- Full-Scale Manufacturing - Once validated, we move to production and fulfillment.
Want a real-world example? Check out our case study on how we helped a medical-device startup bring an FDA-cleared device to market fast.
What certifications does DEM have for medical device development?
DEM holds the following certifications and registrations for medical device manufacturing:
- ISO 13485:2016 – Quality management for medical devices
- FDA Registration (Class I & II Devices) – Registration Number: 3030708724
- IPC-A-610 and IPC/WHMA-A-620 – Electronics assembly and cable manufacturing standards
- UL Certification – Available for components requiring UL safety approval
- Intrinsically Safe Design – Support for designs requiring intrinsic safety in hazardous environments
- NIOSH Compliance – Experience supporting products aligned with NIOSH performance standards
- MIL-STD-810 – Capable of meeting military standards for environmental and durability testing
- Ingress Protection (IP) – Design and testing support for products requiring IP-rated enclosures
You can find our full list of certifications on our certifications page.
Defense & Tactical Electronics Manufacturing
What is ITAR compliance?
ITAR (International Traffic in Arms Regulations) is a set of U.S. government rules that control the manufacturing, export, and handling of defense-related products and technical data. Companies working on defense-related systems or components must ensure their entire process—people, documentation, and production—is secure and U.S.-controlled.
This is especially important when working with sensitive technologies or subcontracting for government or defense primes.
DEM is ITAR registered and fully compliant, ensuring your defense projects stay secure and meet all required federal regulations.
What is MIL-STD-810?
MIL-STD-810 is a U.S. military standard that outlines environmental testing methods to evaluate how equipment performs under harsh conditions such as vibration, shock, dust, extreme temperatures, water submersion, and more.
It’s used to ensure equipment is rugged and reliable enough for field use by the military in tactical environments.
DEM conducts MIL-STD-810 specification testing for many of the ruggedized electronic components we design and manufacture. We help ensure your product meets the operational demands of defense and first responder use.
What type of defense and tactical electronics manufacturing does DEM specialize in?
DEM specializes in ruggedized, small-form electronics designed for defense and tactical use. Our expertise includes:
- Custom connectors and cabling systems compatible with radios like the Harris PRC-163, Thales MBITR series, Sylvus, Revision Systems, and TrellisWare
- Waterproof, low-profile cable assemblies built to route through MOLLE gear
- PCB assemblies and signal management for communication devices
- Analog and digital communication interfaces used in field operations
- Subsystems built to meet MIL-STD and ITAR requirements
Compliance & Quality Assurance
What compliance requirements should I look for in a manufacturing partner?
The compliance standards you need will depend on your industry:
- General manufacturing: Look for ISO 9001 certification to ensure consistent quality and traceability.
- Medical devices: You’ll need a partner with ISO 13485 certification and FDA registration for Class I or II devices.
- Defense and tactical products: Make sure your partner is ITAR registered and familiar with MIL-STD-810 requirements.
Choosing a manufacturer with the right certifications ensures your product can be brought to market legally, safely, and efficiently, especially in regulated industries.
What certifications does DEM have?
DEM maintains a robust set of industry certifications to meet the needs of high-performance, regulated applications:
- ISO 9001:2015 – General quality management systems
- ISO 13485:2016 – Medical device development and manufacturing
- FDA-Registered Medical Device Manufacturer – Class I and II (Registration #3030708724)
- ITAR Registered – Registration code M47849
- IPC/WHMA-A-620 & IPC-A-610 Certified – Electronics assembly and cable quality standards
- RoHS & REACH Compliant – Available as needed for environmental standards
- Cybersecurity Maturity Model Certification (CMMC)
See a full list of certifications on our certifications page.
What’s the difference between MIL-STD-810 and IP ratings?
MIL-STD-810 and IP (Ingress Protection) ratings both evaluate durability, but they serve different purposes:
- MIL-STD-810 – A military standard that tests how well equipment withstands extreme environmental stress—shock, vibration, altitude, humidity, etc.
- IP Ratings – A global standard that rates how well a product is sealed against solids (like dust) and liquids (like water).
Think of MIL-STD-810 as a broader, more intense test suite often used for tactical and field equipment. IP ratings are more focused on waterproofing and dust resistance.
DEM supports both MIL-STD-810 and IP testing depending on your product’s use case.
How does DEM test its products?
Every product manufactured by DEM goes through multiple rounds of inspection and performance testing—starting with first article builds and continuing through final production.
We conduct:
- Functional testing for every electronic assembly
- Environmental testing including IP submersion and ingress tests
- In-line quality checks during key production phases
- Final inspection protocols before shipment
All testing is done in-house by trained technicians using calibrated equipment. And every product we ship is backed by a minimum one-year parts and labor guarantee, so you can trust it’s built to last in the field.