Development

With a long history of developing kitted reagents and IVD solutions for multiple molecular technologies under full design control, we have placed ourselves among a very small and select group of companies. Combining this capability with our development process agility, and proven speed of product development, makes us a unique partner for projects where quality and time are of the essence.

We focus our approach to product development on three major areas of need:

IVD Expertise
Design Control Process
Integrated Development Process

IVD Expertise

We engage our commercial operations team with our partners early in the development phase to ensure that product design requirements reflect customer and market needs from an analytic performance, end-user and economic perspective.

In taking this approach, we aim to ensure that you are able to leverage our long history of IVD development to best support your project needs.

As we partner with your commercial organizations to optimize your product, we also drive a rigorous product launch readiness process that ensures development-thinking also incorporates commercial and market readiness requirements. We focus our readiness preparation on 4 major areas:

  1. KOL engagement planning
  2. Reimbursement planning
  3. Health Economic Outcome Research (HEOR) study development
  4. Marketing readiness

Design Control Process

Our design control process retains all of the rigor required to be in accordance with 21CFR§820 and ISO 13485, yet retains the scalability required to ensure rapid commercialization of new products in a 6-9 month timeframe.

Integrated Development Process

Our philosophy of creating products for our customers that are true end-to-end solutions for the laboratory has resulted in the creation of an integrated development process. This process leverages continuous voice of customer (VOC) input to align reagent, assay and software development with customer needs.

The use of VOC, coupled with our broad molecular technologies, bioinformatics and design control approach, ensures that our product choices are predicated on a combination of the best technical solution and end customer need. This platform and chemistry agnostic approach enables us to deliver solutions that match the right technology to the right result.


Reagent Development

  • Proprietary chemistries that streamline workflow
  • Integrated QC assays that leads to accurate results with low quality samples

Assay Development

  • Develop assays for real world clinical samples which are typically low amount and low quality
  • Modular kit components for streamline changes

Bioinformatics

  • Data analysis pipeline that is optimized for Asuragen proprietary chemistries and for 3rd party platforms
  • Custom standalone and add-on software development

Development

With a long history of developing kitted reagents and IVD solutions for multiple molecular technologies under full design control, we have placed ourselves among a very small and select group of companies. Combining this capability with our development process agility, and proven speed of product development, makes us a unique partner for projects where quality and time are of the essence.

We focus our approach to product development on three major areas of need:

IVD Expertise
Design Control Process
Integrated Development Process

IVD Expertise

We engage our commercial operations team with our partners early in the development phase to ensure that product design requirements reflect customer and market needs from an analytic performance, end-user and economic perspective.

In taking this approach, we aim to ensure that you are able to leverage our long history of IVD development to best support your project needs.

As we partner with your commercial organizations to optimize your product, we also drive a rigorous product launch readiness process that ensures development-thinking also incorporates commercial and market readiness requirements. We focus our readiness preparation on 4 major areas:

  1. KOL engagement planning
  2. Reimbursement planning
  3. Health Economic Outcome Research (HEOR) study development
  4. Marketing readiness

Design Control Process

Our design control process retains all of the rigor required to be in accordance with 21CFR§820 and ISO 13485, yet retains the scalability required to ensure rapid commercialization of new products in a 6-9 month timeframe.

Integrated Development Process

Our philosophy of creating products for our customers that are true end-to-end solutions for the laboratory has resulted in the creation of an integrated development process. This process leverages continuous voice of customer (VOC) input to align reagent, assay and software development with customer needs.

The use of VOC, coupled with our broad molecular technologies, bioinformatics and design control approach, ensures that our product choices are predicated on a combination of the best technical solution and end customer need. This platform and chemistry agnostic approach enables us to deliver solutions that match the right technology to the right result.

Development
Reagent Development

  • Proprietary chemistries that streamline workflow
  • Integrated QC assays that leads to accurate results with low quality samples

Assay Development

  • Develop assays for real world clinical samples which are typically low amount and low quality
  • Modular kit components for streamline changes

Bioinformatics

  • Data analysis pipeline that is optimized for Asuragen proprietary chemistries and for 3rd party platforms
  • Custom standalone and add-on software development
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