Science | Engineering | Design | Quality Management | Regulatory | Clinical Trials

End-to-end Development

Areas of Expertise

Product Design

Assay Development

  • Nucleic acid extraction and purification from challenging samples such as blood, stool and urine. 

  • Multiplex PCR, isothermal amplification & surface phase amplification

  • Next-gen sequencing library prep

  • Assay re-design for automation and integration into consumables

  • Lyophilization and integration into consumable

  • Analytical method development

Consumable Design

  • Cartridge design, build and test 

  • Process development using heat sealing, ultrasonic welding & laser welding

  • Integration of assay chemistry into consumables & cartridges

  • Design for manufacturing, including QC methods

  • Reliability & yield improvements

Platform Design

  • Instrument design

  • Automated workflow development

  • Optics Design & image analysis 

  • Industrial design & usability testing

  • GUI design

  • Systems engineering, including risk management & requirements

  • Root cause analysis 

Product Launch

V & V

  • Creation and implementation of ISO 13485:2016 and 21CFR820 fully-compliant QMS, gap analysis, internal audits & remediations

  • Clinical strategy and protocol writing; development of EDC; clinical validation studies

  • ICH/GCP/BIMO Audits

  • Analytical verification studies to support regulatory submissions

  • Regulatory strategy and submissions; POC, OTC, moderate & high complexity

  • Procurement of clinical specimens to support feasibility to validation

Sustaining

  • High volume design updates

  • Root cause investigation and remediation

  • Design optimization & Process characterization to improve yields

  • QC method development

  • MTBF analysis and improvement

“I have used Arete to help support multiple projects in my program when I did not have the internal resources to cover the need.  I found Arete to be easy to work with (including the contract negotiation phase), highly professional, well-organized and responsive.  I also was impressed with the scope of available resources they offer and their high level of technical expertise and experience.  Over the course of the projects, they delivered on-time, high quality, well-documented results that provided significant value to the program.  I highly recommend using Arete’s services.”

Norm Nelson
Former Sr. Director of Discovery Research at Gen-Probe

Norm Nelson, Former Sr. Director of Discovery Research at Gen-Probe

At Arete Bioscience, our experts’ knowledge and experience, combined with industry best practices, will deliver seamless support through the entire product lifecycle.

Arete's mission is to positively impact health and well-being by equipping partners to enhance patient care. Our experienced team specializes in in vitro diagnostics, offering guidance through failures and successes to adopt best practices across the product life cycle. We work closely with partners to understand their needs, form effective teams, and execute plans. With expertise in designing and developing diagnostic devices, managing cross-functional teams globally, and aiding various diagnostic companies, we are adept at helping both start-ups and established firms meet their product objectives. Our strength lies in our extensive network of medical device professionals, enabling us to provide comprehensive development support for any company.

Why Arete?
Ask yourselves this:

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  1. Do you have the right product requirements?

  2. What technologies are available to realize your product?

  3. How will you automate your assay workflow?

  4. How will you prove out feasibility quickly?

  5. How will you move from feasibility to development to manufacturing?

  6. Do you have sufficient resources?