FROM R&D TO MANUFACTURING

Your team has the scientific and engineering expertise to develop new technology and innovative products. We can help you through the design control process to enhance your product development process.

Reduce product development cycle time
We will use our cross-functional experience in biomedical engineering, quality, regulatory, product development to help you improve:

  • your new product introduction process
  • the quality of your new products
  • the manufacturability of these new products
  • the cost of your new products
  • the preparation of the supporting documentation for regulatory submissions
We have hands-on experience to assist you in specific projects. We can review your design history file (DHF) and quickly provide you with a gap analysis in an easy-to-understand format that will tell you where your DHF stands with regards to compliance and current industry practice.

From there, if you choose to, we can assist you in rectifying your DHF to bring your records in full compliance.
Allow us assist you throughout the execution of your new product development process so that you can focus on your core competencies without sacrificing full regulatory compliance.

Value-added to design control
As part of your team, all aspects of design control will be addressed but only with value added activities. We can support you in some or all of the following aspects of your new product development:

  • Development planning
  • Requirements / design inputs development
  • Specifications development
  • Risk analysis
  • Design outputs
  • Design verification
  • Design validation
  • Design reviews
  • Design transfers
  • Assembling the design history file (DHF)

As indicated earlier, we will focus on value-added work. Here are some examples of how we can make the difference with you:

Design and development planning:

  • The regulations require that planning documents be in place throughout the development process and after the product is placed to market to demonstrate control of the design projects and compliance with the regulations.

  • Over the years, using a practical and hands-on approach, we have perfected techniques and methodologies to simplify the product development and documentation planning processes. The purpose is not to generate “paper work”, but instead to prepare a coherent package easy to review (and easy to receive approval for). We use a combination of templates and simple guidelines to make that aspect of product development painless.

Design inputs:

  • The concepts of design inputs are often misunderstood as being a set of specifications, and therefore of being a duplication with design outputs.



  • Instead, we can support you in developing early, a set of detailed requirements prior to engaging in the engineering work. This is essential in speeding up the overall development cycle time and get the right products to market faster than otherwise possible. By undertaking this effort upfront, you will become more competitive in today’s medical device environment by effectively combining marketing, engineering, quality and regulatory disciplines.

Transfer to Manufacturing
Too often, great products and great design are implemented poorly in manufacturing leading to excess costs and delays for launch. The new product design is transferred “over the wall” without clear accountability and little success. R&D considers that their role is completed and manufacturing considers that the design is not ready for production. We can help you fill the gap.

Successful availability of quality products for a clinical trial or launch without delays and excess costs depends on thorough planning and communication. It also requires a good understanding of the design, the specifications as well as of the manufacturing processes and equipment used to mass produce that design.

Successful availability of quality products for a clinical trial or launch without delays and excess costs depends on thorough planning and communication. It also requires a good understanding of the design, the specifications as well as of the manufacturing processes and equipment used to mass produce that design.

Work to transition from the R&D laboratory to production will start before finalization of the design and activities. Many activities to transfer from R&D into production will actually occur in parallel with product development, not once product development is completed.

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Gloster Biomedical International • 577 N. Hope Ave, Suite 101 • Santa Barbara, CA 93110 • USA • Tel: +1-805-679-1258
www.GlosterBiomedical.com

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