Medical Device Prototyping

Medical Prototyping Seisa Medical

Launching & manufacturing a new medical product in the market entails multiple stakes. Medical Device Prototyping is accomplished to specify opportunities and challenges in the initial phases of medical device design development.

Working with Seisa Medical as an experienced medical prototype manufacturer means you can get more than just a sample presentation of your medical product or component. In Seisa, we offer prototyping value at every step, sharing our knowledge and expertise to allow for ultimate flexibility and innovation in medical prototype design, material selection, budget, and the overall product’s design, use, and function. Injection molding medical devices is a highly complicated, specialized process, and our medical prototype development must be up to the task.

With quick turnabout processes for rapid prototyping, including 3-D printers, fast mold generation, and in-house tooling abilities, Seisa can produce prototypes and medical device and component samples quickly and efficiently from various materials for rigid and reliable in-house testing.

Best Practices Supported By Medical Device Prototyping And Manufacturing Process

The design and development of new medical devices can be costly and time-consuming. However, famous developers redefine best practices from idea to commercialization, and your new medical device can be carried to market with absolute efficiency and economy.

Rapid prototyping manufacturers like Seisa medical can quickly, consistently, and cost-effectively deliver prototypes with essential functions and production portions in low-volume manufacturing for the idea and market testing of medical devices and health products. This allows you to explore concepts, generate early customer feedback, and develop fit-for-purpose solutions to put them into lab or clinical tests and ultimately get them to market faster.

seisa best practices

Proof of Concept

Create product ideas for medical devices into a manageable scope while working on setting the necessary details and fully understanding the design plan through proof-of-concept prototypes.

Visual Presentation

Visual presentation models assign designers to share the impression and aesthetics of their designs with colleagues, customers, and stakeholders to facilitate clear and actionable feedback.

Functional Prototyping

The medical device functional prototype product (also referred to as Beta prototype) can be used to test the form, fit, and process of parts to refine design iterations and product performance, let any issues be discovered and fixed well before getting to a final product and reduce the business threat.

Engineering Validation

Making engineering prototypes of medical devices that fit the final product makes it easier to confirm the design, engineering, and manufacturability before financing inexpensive tools and putting them into production.

Pilot Production

Rapid manufacturing of medical devices and custom low-volume production will be capable of bridging the gap between prototype and production and making your product go to market quicker with high standards.

The Medical Prototyping Process

The medical device prototyping process consists of four key phases: forming alpha, beta, and pilot prototypes and drafting a final (or mature) product.

Alpha prototypes

Alpha prototypes are usually non-functioning, reducing the cost and time required for production. Manufacturers use these 3D-printed prototypes to test product dimensions.

Beta prototypes

They are functional but may not resemble the aesthetic design of the final product. Manufacturers use them to test for available design flaws and seek out investor funding.

Pilot prototypes

Pilot prototypes are similar to beta prototypes but resemble the final product more closely. Manufacturers construct these prototypes to exact design and material specifications and use them from soft launches or clinical trials.

Final product

The final matured product employs the finalized design that incorporates any desired modifications made to the previous prototypes.

Medical Device Design Control Process

In addition to design and practical prototyping for medical devices and products, prototyping can also be brought out for manufacturer capability and compliance with medical regulations. Manufacturability stays a top concern in medical manufacturing and prototyping for several causes:

Advanced Mechanical Engineering Capabilities

There is no guesswork at Seisa Medical. When we start a project, our skilled mechanical engineers thoroughly explore the eventual user’s needs to ensure the effectiveness of the final product.

Benefit from our broad range of mechanical engineering services, which include:

  • Modeling solids and surfaces with CAD applications
  • Computational fluid dynamics such as mold flow analisys. (CFD)
  • Design reference for plastic, metal, and rubber injection molding.
  • And more

Our engineers use complex data to merge customer insights and regulatory demands into precise mechanical requirements. This ample process ensures your product is the best it can be.

Time-Tested Medical Device Prototyping Methods

When you work with SEISA, we’ll walk you through the prototyping process to ready your device for production:
  • Proof-of-Concept (POC) Prototype – Used to diagnose if the product is practical and suitable for production and to identify risks.
  • Concept Prototyping – See and judge how the device will look and behave for the best user experience.
  • Form, Fit, and Function Prototype – A fully functional medical device to test for manufacturability and electromagnetic compatibility (EMC). This prototype can also be utilized in clinical trials.
  • Pre-Production Prototype – The final product arrangement for verification and validation before the production run.

Feasibility Support

Not all product designs are possible. Understanding how to make a practical concept prototype can take time and effort, particularly for smaller firms still in the early stages of growth and development.

With over 35+ years of experience, the experts at SEISA will guide you through the development process to ensure your idea is feasible for production.

We will perform a thorough assessment of all parts of the design process, including:

  • Regulatory restrictions
  • Budgeting
  • Marketing approval
  • Manufacturing difficulties
  • And more

When you work with SEISA, you can rest assured that your prototypes are feasible and ready for an entire, issue-free production run.

Manufacturing Medical Device Prototypes

SEISA adopts a rapid prototyping model manufacture using:

  • High-speed CNC machining
  • Prototype mold tool design, aluminum or steel.
  • Where required is a single or multi-cavity mold tool design, including hot runner systems and robotics.
  • Design assessment of current tools, with suggestions to enhance or extend tool longevity

Seisa Medical Device Prototyping Products Applications

Our broad range of medical device prototype offerings includes:

  • Catheters – from single-use urology catheters, diagnostic, guiding sheaths, and crossing catheters to stent delivery systems, SEISA has you covered.
  • Stents – rapid prototyping at our New Jersey facility.
  • Medical prototype molded parts.
  • Quick turnabout aluminum mold for rapid prototyping – up to 1000 parts.
  • Quick turnaround soft steel molds for medium quantities (perfect for validated cardiovascular devices) up to 15,000 parts.
  • Hard Steel tool – perfect for high volumes, > 50,000.

Reduce Manufacturing Costs

Our capabilities cover a broad range of medical device products. Our team members have extensive experience in the design, development, and manufacturing of medical devices, giving us a first-hand experience with the industry’s product development needs. We’re well-versed in the latest technology, including usability, software, and equipment.

With deep experience in both the front-end design and back-end manufacturing phases, SEISA’S team can design high-performing medical devices that can also be efficiently and cost-effectively manufactured. Our design for manufacturability expertise can reduce the complexity, reducing both cost and quality issues while assuring long-term, efficient manufacturing operations.

As an extension of your business’s R&D department, we rapidly develop a detailed plan that minimizes steps but optimizes material yield.


Medical Device Prototyping FAQ

Q. What is medical device prototyping?

A. Medical device prototyping is an early sample, model, or release of a medical device built that shows the basics of what a product will look like, what the outcome will do, and how the product operates. In other words, medical device prototyping tests a design concept. Medical device prototyping incorporates design, engineering, and human factors intended to identify opportunities and challenges in the initial stages of medical device design development.

Q. What are the different types of prototypes?

A. The medical device prototypes are divided into physical and analytical prototypes. The physical prototypes are a tangible approximation of the product, while the analytical prototypes are mathematical models of the development or 3D CAD models. The focused prototypes implement one or a few attributes of the product, while the complete prototypes implement many characteristics.

Q. What should you look for in a medical prototype manufacturing company?

A. It would be best if you looked for a medical prototype manufacturing company capable of producing rapid prototyping through 3D printing/additive manufacturing, CNC Machining, and Rapid Mold Tooling, as well as the capacity to offer immediate manufacturing solutions to suit the needs of the medical device industry. Seisa Medical is a trusted medical prototype manufacturing company.

Seisa’s assistance and prototyping service will be your perfect ally if you want to turn life-saving ideas into reality.

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