Medical Device Product Development Guide

medical device development process

The medical device development process can be long, complicated, and fraught with the potential for error. But many of these potential pitfalls can be avoided, mitigated, or outright eliminated with a validated and properly implemented medical device product development process.

The length and potential for error inherent in this process is a major reason why we’re seeing a substantial increase in companies outsourcing their medical design and development projects

See a proven medical product development lifecycle guide that includes seven key steps that ensure quality:

  1. Consult with experienced project management teams
  2. Develop a proof of concept prototype
  3. Build a comprehensive medical product design plan
  4. Design medical devices with the help of proven engineers
  5. Verify and validate your design
  6. Transfer your design to manufacturing
  7. Launch and sustain your design

1. Consult With an Experienced Project Management Team for Your Medical Product Development Needs

A trusted medical device design and manufacturing partner can work with you to ensure your device has the highest opportunity for success. 

McKinsey estimates that 12-18% of total revenue in the medical device industry goes into quality control, totaling up to $26 billion a year. And that makes sense, as medical device designs have to meet stringent regulatory compliance mandates (like ISO 13485, for instance). 

The purpose of the consultation is to mitigate that potential for error and failure, while offering recommendations and insights. 

These are vital points that the experienced project development teams will address during their consultation with you:

  • What is the intended use of the medical device?
  • What intellectual property and technology is available for this medical device innovation?
  • What do the market, user, and patient experience say about the problem you seek to solve with your medical device?
  • What are business and design risk factors?
  • What are the regulatory requirements?
  • Is there a similar device in the market that is already FDA approved? Will we seek CE mark certification?
  • What prototypes will be needed for marketing, clinical, engineering, certification and other purposes?
  • Are there any special supply/sourcing considerations?
  • What are the estimated volumes for manufacturing?
  • Most importantly, how will you define project success?

Without addressing these concerns and questions upfront, the entire development project risks stalling.

That potential consequence is why the project management team at RBC Medical Innovations, which is composed of experienced technical experts in the medical device industry, conducts intensive consultation with you to discuss the design process and other critical factors to maximize your product’s marketability.  

We have over 25 years of experience in managing projects for our clients of all types and sizes, ranging from start-ups to OEM companies. 

2. Develop a Proof Of Concept (POC) Medical Device Design Prototype

The next step of the medical device development process is prototyping; utilizing the information gathered in consultation with your partner’s team of project managers. 

Prototyping will:

  • Test feasibility and functionality of the product that involves human factors
  • Investigate scalability
  • Render images and mock-ups for investor presentations and marketing purposes

It is essential to engage with a reliable design and manufacture partner, who is equipped to guide costs appropriately from prototype to manufacturing level of production. 

Medical Product Development Needs

3. Ensure Error-Free Design of Medical Devices With a Comprehensive Plan

Transforming the prototype into a final product requires an investment of resources, time, and effort from you and your partner. 

Successful planning leads to an organized and documented framework, which ultimately leads to a successful medical instrument development and an expedited delivery to market. 

Your partner’s engineering team captures the system requirements from the inputs provided by the end-users, operators, buyers, regulatory agencies (UL, CSA, etc.), manufacturers, and others. 

Other important considerations include: 

  • Marketing strategies 
  • Intellectual property strategy 
  • Project timeline
  • Project cost
  • Risk analysis and mitigation
  • And more 

4. Design Medical Devices Right the First Time With Proven Experts

Your partner’s engineers receive the planning brief to continue improving your product’s form, fit, and function. 

Specifications and manufacturing procedures are iteratively generated based on feedback and made ready for the assembly line. 

Furthermore, every micro-step in this stage must also align with the input requirement gathered from the planning process. 

This is the stage where our engineers with medical device design experience start leveraging our proprietary Fast2MarketSM Development process to help our clients speed along the project timeline.

Many customers approached RBC expecting to launch a product in five years, then discovered we could get it off the ground within two using our unique platform technologies that simplify several lower-level design processes.

5. Verify and Validate Your Medical Device Design

This step is necessary before your medical device development company transfers the design of your product to manufacturing.

It tests the suitability of the device with respect to its intended users’ needs and makes sure the device will provide the desired results.

Additionally, it determines whether the requirements have been met.

Verification is an internal process, which determines whether a design outcome matches the specification or regulation defined in the design input. In contrast, validation is an external process and determines whether your product meets the needs of your clients.

6. Transfer the Design to Manufacturing as You Near Medical Product Development Completion

The objective of design transfer is to deliver the medical device design team’s vision to manufacturing.

RBC’s design team involves manufacturing during design and development to ensure the system is manufacturable. The manufacturing team involves the design team during the design transfer to ensure a smooth transition to production. 

With the knowledge of practical design transfer to production, RBC can accelerate the timeframe of your devices to market by up to 60%.

7. Launch and Sustain Your Medical Technologies

A well-rounded medical device design process and manufacturing partner also handles post-launch service and post-market evaluation. 

This is why it is essential to outsource the entire medical device product development process to a single vendor. One with the marketing or product innovation capability to gather market feedback, improve product features, and return the now effective medical devices to the market quickly to realize profitable results. 

Work With a Top Medical Device Design Partner

Ensure that all your medical device designs are managed by experts with requisite knowledge and expertise to ensure that your device reaches market faster without compromising on quality. 

Contact RBC today and partner with a proven, experienced team of professionals with a long track record of successful medical device design and development projects.

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