trio-smart®
Gemelli Biotech
Revolutionary Breath Test Technology
StarFish Bio Services support three core areas:
We commercialize client assays in a wide range of formats including ingestible, point of care and microfluidics. Our experienced team of dedicated professionals ensure quality at every phase of product development.
We provide complete turnkey development services or expertise focus on a critical subsystem. Our engineers, physicists, industrial designers, regulatory and manufacturing experts work with your team to ensure an optimal outcome.
Bio Services works on many types of medical device product development projects, ranging from handheld diagnostic tools to highly automated lab equipment, autonomous sampling and assay technologies for infectious disease diagnostics.
Nick Allan
Bio Services Manager
Lorenzo Gutierrez
Microfluidics Manager
Gary Skarja
Bio Services Program Manager
Maharshi Trivedi
Bio Services Program Design Lead
Joris van der Heijden
Bio Services Program Manager
Nick Allan
Bio Services Manager
Nick Allan is the Bio Services Manager at StarFish Medical. Allan joined the company as a Project Manager, becoming Bio Service Manager in 2016. He has provided innovative solutions to client issues ranging from proof-of-concept studies for rapid detection point of care assays to full scale regulatory submission studies, and designed and facilitated more than 500 Unique Research Protocols. Allan is President of Chinook Contract Research, co-founder and former GM of The Institute for Applied Poultry Technologies, and former Contract Research Manager at Innovotech Inc. Allan holds an MS in Microbiology and BS in Biology from the University of Guelph.
Lorenzo Gutierrez
Microfluidics Manager
Lorenzo Gutierrez is Microfluidics Manager and Interim Toronto Site Director at StarFish Medical. Gutierrez has over 30 years of product development experience in semiconductor, consumer electronics, and medical devices at companies including Mirux, ChipCare, and Kapplex. His microfluidic applications include cell-based, immuno and molecular assays. Lorenzo specializes in overall system design, hardware engineering, integration, and translation of assay workflow to consumable cartridges. Gutierrez earned his PhD in Bio-Process Engineering at the University of Tokyo.
Gary Skarja
Bio Services Program Manager
Over his 20+ year career in the commercial life sciences sector, Gary has led the development of new medical materials & devices, regenerative medicine technologies and single-use biomanufacturing tools at companies ranging from pre-revenue start-ups to a multibillion dollar global organization.
Gary holds over 15 patents (applied & issued) related to medical polymers & devices and single-use biomanufacturing tools and methods. Gary serves on the commercial advisory board of the Nanomedicines Innovation Network, a Canada-wide research network dedicated to developing & commercializing next-generation nanomedicines. Gary holds a B.Eng. and M.Eng. in Chemical Engineering from McMaster University and a Ph.D. in Chemical Engineering from the University of Toronto.
Maharshi Trivedi
Bio Services Program Design Lead
Maharshi Trivedi is the Bio Services Program Design Lead at StarFish Medical. He brings over 15 years of global strategy and operations experience in the field of medical devices and life sciences from companies including Ancera, Medtronic, and Boston Scientific. Trivedi earned an Executive MBA from Yale School of Management, an MS in Mechanical Engineering from Illinois Institute of Technology, and a BS in Mechanical Engineering from Gujarat University.
Joris van der Heijden
Bio Services Program Manager
Joris van der Heijden is the Bio Services Program Manager at StarFish Medical. He joined StarFish from Spartan Bioscience where he was the Director of R&D leading product development of Point of Care diagnostics for pharmacogenetics and detection of infectious diseases. He managed projects all the way from concept to market entry including managing the supporting clinical trials. Prior to this, he was the R&D and Manufacturing Manager at a contract manufacturing facility overseeing assay and process development for the manufacturing of viruses and vaccines destined for clinical research. In this capacity he helped build the infrastructure for the first Canadian Car-T cell therapy trials. Joris earned his PhD in Microbiology and Immunology from the University of British Columbia and holds a MS and BS from the Universities of Leiden and Delft in the Netherlands.
As we worked through the project, it was not only an engineering firm developing an instrument, but it was a consultancy, as well, that allowed us to do it properly to make sure that the CLIA-certified laboratory was happy with the LDT that was developed at the lab.
We also envision the use of these instruments going through 510(k) approval to be sold to external laboratories, academic institutions, or large GI practices, so they can use them outside of our CLIA lab post-510(k).
And we know that StarFish has the capabilities to help us through that journey.
Encouraging a company to go down a development path that is realistic from a design, regulatory, and indication for use perspective is really important. StarFish Medical identified major risks in developing the medical device and made sure we tackled those first. They understand small details which go into developing a medical device that a first time research team wouldn’t consider.
Working with StarFish provided us access to lots of talented engineers—electrical, biomedical, mechanical, and software—and structured project management. Our microbiome sampling project and prototype had been going on for 4 years. We handed the project to StarFish and have made great progress since.
They took a very methodical approach based on determining indication for use that helped us identify new peripherals, add functionality and enable manufacturability.
February 3, 2022
February 2, 2022
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February 2022
Microfluidics Issue
July 2021
BioTech News & Insights
April 2021
BioTech News & Insights
February 2020
BioTech / Regenerative Medicine Insights & Videos
January 2019
BioTech Blogs & Videos
February 2018
Our hiring is highly flexible – we engage full-time employees, contractors (fixed duration and as-needed) and on-call staff. To apply, please submit a cover letter outlining your interest, availability and rate to [email protected].