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Full-Service Medical Product Design, Engineering, and Manufacturing.

Need Help Bringing Your Medical Device to Market?

We help doctors, dentists, and companies develop innovative medical devices

  • Johns Hopkins
  • Medtronic
  • SomnoMed
  • Stanley
  • Tevosol
  • Cloud9

Leverage Our Experience in Your Medical Device Category

Line drawing of surgical forceps shown from the side and from above

Surgical Instruments

Turn your ideas for better surgical tools and instruments into working prototypes, ready for manufacturing.

Hands holding a white pen injector beside a clear cylinder on a lab bench

Drug Delivery Devices

Realize your product visions for innovative drug delivery devices that empower medical professionals and patients.

Portable powered lifting seat cushion with a blue fabric cover

Assistive Devices

Modern technology is creating new opportunities and assistive device product ideas to help people with disabilities.

Hand holding a small wearable vital sign monitor with a green display and lanyard

Vital Sign Monitoring

Sensor technology is fueling the rise of innovative vital sign devices, making new products and ideas possible.

Endoscope with camera head and a tablet display showing a throat image

Endoscope 3D Imaging

Endoscope technology continues to get smaller and more powerful, aided by compact chipsets and cameras.

Four dental handpiece heads with burs shown side by side

Dental Equipment

Transform your dental device vision into a full-functional prototype for user testing, and full volume production.

Two render views of a clear cylindrical device with a black cap and tubing

Wearable Health Devices

Wearable devices have moved away from novelty to medical use. Start moving your wearable device idea to market.

Labu white cube lab device beside a view of its green-lit sample compartment

Biotech Lab Equipment and Instruments

Advances in BioTech lab equipment are bringing innovative product ideas to market faster than ever.

Black tabletop medical device with a touchscreen showing the time

AI/ML Clinical Intelligence Devices

The rise of generative AI and machine learning is helping medical devices become more effective and accurate.

27 Years Experience | 75+ Design Awards | 1,000+ Manufactured Products

Proven 4-Step Medical Device Product Development Process

pedz concept design sketches

Concept Design

Turn your medical device concept into a refined design, assess risk factors, and create architecture plans ready for engineering.

Cutaway CAD render of a yellow wearable sensor showing its circuit board and battery

Detailed Engineering

Iterate on design features and create full regulator documentation for a pre-production prototype, ready for clinical trials.

Pedz physical prototype assembly

Prototype and Test

Validate product requirements, confirm usability, secure suppliers, and create a fully functioning prototype for user feedback

Doctor listening to a young boy's chest with a stethoscope; the boy wears a blue Pedz Tag wristband

Manufacturing Setup and Regulatory Approval

Select the most reliable manufacturer, implement quality-control processes, apply for regulatory approval and oversee production — turning your medical device idea into reality.

Frequently Asked Questions

How Long Will My Project Take?

The answer depends on the nature of the work you hire us to do. The work may be support-related where we contribute design or engineering services to your product development team and process. The time required varies from a few weeks to much longer depending on the activities you require from us. If our team takes your product concept from the idea stage all the way to a working product, it may take from 3 to 12+ months to complete the 4-stage design-engineering-prototyping and transfer to manufacturing process. It depends on the complexity of the product being designed.

Once the design concept is captured, engineering decisions are finalized and the product is 3D prototyped and documented, making it possible for manufacturers to bid on making the product in volume. Your design is carefully created and focused on product cost that meets quality and business needs.

The Product File documentation is well-defined, and release control managed, with manufacturers that want to produce it.

Do You Offer Manufacturing Help?

Our manufacturing setup experts will help you identify and secure trusted part suppliers and a contract manufacturer (CM) onshore, or offshore, depending on your product and business objectives.

We facilitate the prototyping and product builds, from helping coordinate the CM and parts supplier relationships, to overseeing product batch builds.

When asked we also do injection tooling approvals, release controlled documentation, regulatory testing, Bill of Materials (BOM) updates, in-process test jig creation, qualifying custom parts, MOQ ordering and supply coordination.

Why Should I Choose Design 1st?

We are an excellent fit for business teams new to hardware product development who want an expert team to plug in and move their concept design to volume production. We are experts at network products, wireless apps, and cloud integrations. Our diverse team of planners, designers, engineers, electronics, software and supply strategy experts makes the transition from product concept to manufacturing a much more predictable process.

Do I Need to Sign an NDA First?

NDA’s ensure confidentiality for both parties during conversations. We provide a mutual NDA where the terms apply to both parties. Your organization may already have a mutual NDA that requires our signature. Instead, we handle signatures via email, online, or as circumstances require.

How Much Will My Project Cost?

Designing a new hardware product starts with defining one or two possible Concept Designs (CD), based on requirements and business targets. Our technical sales team create the first CD budget with the major activities. When the work starts, we capture key product requirements, research opportunities, and unknowns, then together with you, we determine the best solution to develop.

Our experienced development team will then facilitate and help you define the many product requirements, carry out the creative design and engineering process, examine manufacturing feasibility, and provide an ongoing estimate of the direct product cost as details are filled in and decisions on features, functions, parts, and quality are made. For a new product concept of moderate complexity, the CD design exploration and architecture definition stage takes 200+ hours. This timeline depends on many factors, including uncertainty about first users and buyers, the uniqueness of the design relative to products in the market, the number of custom components required for design and manufacturing, product safety requirements, manufacturing setup, and the amount of documentation required.

Professional, experienced Product Design and Engineering teams in North America charge $125 to $400 USD per hour. Our rates are competitive at the lower end of this scale. After a phone discussion on your needs, we will provide a detailed design budget for review and signature.

Call us: 1.877.235.1004 x229 or schedule a meeting with Ian Kayser, our VP of Sales, who will help answer questions.

Have a product that needs building?

Tell us about your project and we’ll put together a development plan and timeline. No commitment, no pitch deck. Just a straight conversation about what it takes.

What Happens Next

  1. We review your brief
  2. You receive an NDA + D1 overview
  3. 30-minute intro call
  4. Development plan with timeline and budget

Prefer to talk?

Tell Us About Your Project

We reply within 1 business day with an NDA and a next step.