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WESTPAK Inc.

Company Headquarters

83 Great Oaks Boulevard
San Jose, CA 95119
United States

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Company Description

WESTPAK, Inc. is a leading, 3rd-party, independent test laboratory in San Diego and San Jose, California, specializing in package testing and validation for the medical device industry. Expertise also includes cold chain / thermal package validation for biotechnology, ISO 11607 guidance, and reliability testing. Founding WESTPAK in 1986, Herb Schueneman placed integrity and customer service at its core. Over 30 years later, and now 100% employee-owned, that tradition proudly continues with 70+ employee-owners. As a team, we pull together and work diligently to deliver the best testing and customer experience available. One result: our clients include most of MPO's Top 30 Medical Device manufacturers.

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In-Vitro Diagnostic Categories

Product Testing

Medical Device Categories

Content From WESTPAK Inc.

Testing

Accelerated Aging ASTM F1980-21 Protocol: Changes and Impact—MPO Videobites

Mark Escobedo of WESTPAK provides an overview of the revisions made to the latest protocol and how they could affect medical device manufacturers.

Videos Released on 02.08.2022
Packaging & Sterilization | Testing

Importance of Company Values in Medtech Testing—MPO Videobites

Nora Crivello of WESTPAK Inc. speaks to the role corporate values and integrity play in serving the medical device industry as a package testing specialist.

Videos Released on 10.12.2021

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Spectrum Solutions Collaborates with UCLA School of Dentistry

Commences study on using saliva in early lung cancer detection and analysis.
Charles Sternberg, Assistant Editor 01.27.21
At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities

Public health officials need to stress the importance of mass testing and contact tracing even with several vaccines approved.
Michael Barbella, Managing Editor 01.25.21
QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner

Transmission ultrasound breast imaging now to become available in EMEA markets.
Michael Barbella, Managing Editor 01.25.21
Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

Company initiates VFE testing for its porous polymer-based materials; results show components protect against certain aerosolized viruses.
Michael Barbella, Managing Editor 01.22.21
Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection

The new detection method can help determine whether patients have had COVID-19 and if they might still have immunity to the disease.
Michael Barbella, Managing Editor 01.22.21
TPI Partners with Zeiss

Enables TPI to deliver 3D X-Ray Measurement capabilities for Quality Assurance for its clients.
Charles Sternberg, Assistant Editor 01.21.21
Eitan Medical Receives FDA Clearance for Sapphire Infusion System

Upgraded infusion system provides advanced performance and customization capabilities within hospital, pre-hospital and ambulatory environments.
Eitan Medical 01.20.21
Diagnostics

High-Volume COVID Antigen Test Receives FDA EUA

Ortho’s Vitros can run up to 130 tests per hour and helps address testing backlogs, supply shortages, and delayed results.
Ortho Clinical Diagnostics 01.13.21
Diagnostics

ForaCare Suisse AG Launches COVID-19 Antigen Rapid Test

Provides fast, accurate, and easy-to-interpret test results.
PRNewswire 01.11.21
MGS Acquires Formteknik

Expands the MGS team to 1,500 employees, with 11 facilities globally.
MGS 01.08.21
Diagnostics

CareDx Partners with IDbyDNA

Will develop AlloID, a transplant patient-specific metagenomic infectious disease test platform.
Globe Newswire 01.08.21
Diagnostics

Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA

Helps identify severe inflammatory immune responses in patients confirmed to have COVID-19.
Siemens Healthineers 01.08.21
Solvay Partners With PrinterPrezz on 3D Printing for Medical Devices

Companies are collaborating on 3D printing selective laser sintering (SLS) solutions for implants and other medical devices.
Solvay 01.08.21
Neurological

BioSerenity Achieves FDA Clearance for Wearable Device System

Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.
PRNewswire 01.07.21
Greenlight Guru and Nelson Labs Partner

Alliance helps customers mitigate risk and go to market faster.
Greenlight Guru 01.06.21
Thyroid Function Tests Market in India to Reach $125 Million in 2025

Thyroid stimulation hormone tests are expected to account for more than 75 percent of the market.
GlobalData 01.06.21
Diagnostics

EKF Introduces Accurate Quantitative COVID-19 Antibody Test Kit

The test kit is one of first to detect both the presence and precise levels of COVID-19 neutralizing antibodies.
EKF Diagnostics 01.05.21
Diagnostics

Mologic COVID-19 Rapid Antigen Test Receives CE Mark Approval

Preliminary results show 92% sensitivity and 100% specificity, compared with RT-PCR.
Mologic Ltd 01.05.21
FOREFRONT MEDICAL TECHNOLOGY ANNOUNCES UNIQUELY-DESIGNED COVID-19 TEST SWAB

...
Philips Buys BioTelemetry for $2.8 Billion

With 2019 sales of $439 million, BioTelemetry annually monitors over 1 million cardiac patients remotely.
Royal Philips 12.18.20
Diagnostics

FDA Authorizes Abbott's Rapid, $25 COVID-19 Test for At-Home Use

Telehealth service will take users step-by-step through the sample collection process.
U.S. Food and Drug Administration 12.17.20
4D Biomaterials Awarded Funding for 3D Tissue Scaffolds

The company's new polycarbonate-based resins can be formed into materials that have good shape memory, and tuneable mechanical and chemical properties.
4D Biomaterials 12.16.20
Diagnostics

FDA Authorizes First OTC Fully At-Home Diagnostic COVID-19 Test

The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test.
U.S. Food and Drug Administration 12.16.20
Diagnostics

FDA, EU Nods for POC Testing on Siemens Healthineers' epoc NXS Host Mobile Computer

Provides critical test results at the point of care in less than a minute.
Siemens Healthineers 12.15.20
Cardiovascular

Innovative Health Obtains Patent for Microlumen Reprocessing Technology

Paves the way for future innovation in the field by the company.
Innovative Health Inc. 12.11.20
Preparing Your Design Controls for FDA Approval

Design controls are a set of procedures to build into medical device design and development.
Adam Freeman, Freelance Medical Device and Combination Product Design Specialist, Kolabtree 12.09.20
Diagnostics

CRISPR-Based COVID-19 Test Uses Smartphone Camera

The rapid, one-step mobile test could help combat the pandemic and fully reopen communities.
PR Newswire 12.07.20
Machining & Laser Processing

Social Distancing Badge Lights Way to Return to Work

Fleetwood Electronics’ Instant-Trace system uses machining, on-demand injection molding to speed to market.
Rob Young, Sr. Manager—Injection Molding, Protolabs 12.04.20
Digital Health

Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

Industry experts share their advice on factors medical device manufacturers need to consider for the coming year to stay ahead.
Nick Tippmann, Vice President Of Marketing, Greenlight Guru 12.04.20
Molding

Tooling Precision is Key to Micromolding Success

Tool quality dictates part quality for all sizes of medical components.
Michael Barbella, Managing Editor 12.03.20
Materials

Setting the Standard: Protective Nanocoatings for Today's Medtech

Ensuring medical products are safe from the outside environment is a significant challenge that nanocoatings can help resolve.
Zsolt Pulai, EVP, Technology & Development, HZO Inc. 12.02.20
TRIMEDX Acquires Centurion Service Group

Expands TRIMEDX’s comprehensive clinical asset management solution.
TRIMEDX 12.02.20
Cardiovascular

VitalConnect Lanches VitalPatch RTM Cardiac Monitoring Solution

Monitors for 21 cardiac arrhythmias through a unique AI-based ECG analysis solution and captures data on four key vital signs.
Business Wire 11.23.20
THE DETROIT FREE PRESS NAMES PTI Engineered Plastics

A WINNER OF THE DETROIT TOP WORKPLACES 2020 AWARD
Diagnostics

FDA OKs Hologic's Aptima HIV-1 Quant Dx Assay for HIV Diagnosis

First FDA-approved assay for both qualitative diagnosis and quantitative viral load monitoring.
Business Wire 11.20.20
New Study Validates the Efficacy of Ethicon’s LINXReflux Management System

LINX eliminated daily dependance on acid-reflux medications in 79% of GERD patients.
Ethicon 11.20.20
Molding

Miniaturization of Medical Devices Creating Big Assembly Challenges

Extremely tight tolerances leave no room for error.
Michael Barbella, Managing Editor 11.20.20
Graham Partners Acquires Teamvantage, CMD, Paradigme

Will provide operational resources to foster a strong growth trajectory for the companies.
Teamvantage 11.19.20
The Big Challenges of Medical Device Miniaturization

Demand for micro-sized products is prompting micromolders to develop new processes and methods that are outside the norm of standard injection molding.
Michael Barbella, Managing Editor 11.17.20
Diagnostics

QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test

Can accurately analyze over 30 samples per hour.
Business Wire 11.12.20
Alucent Biomedical Closes $35 Million Series B Financing Round

Funding will support clinical trials to evaluate the company’s treatment for peripheral artery disease.
Business Wire 11.11.20
University Develops AI Algorithm to Analyze Chest X-Rays for COVID-19

Academic team created algorithm using 100,000 X-rays of patients who did not have COVID-19 and 18,000 X-rays of patients who did.
Globe Newswire 11.10.20
Patient Monitoring

Prevounce Health Launches Remote Patient Monitoring Module

The module combines digital spirometry, smart nebulizers, and pulse oximetry.
PR Newswire 11.10.20
Diagnostics

Smartphone-based Solutions Boost Infectious Disease POC Testing Market 70.2 Percent

Study reveals that digital POC platforms will enable diagnostic testing beyond the clinic, transforming how assay results are gathered and analyzed.
Frost & Sullivan 11.10.20
R&D & Design

Collaborating with Full-Service Design and Development Providers—A Medtech Makers Q&A

Spectrum Plastics Group’s Paul Melnychuck speaks about the advantages of working with a full-service supplier and contract manufacturer.
Report: Nearly Three-Quarters of mHealth Apps Vulnerable to Data Breach

Findings also conclude that a majority of mHealth apps contain multiple security issues with data storage.
Business Wire 11.05.20
Chronic Disease

Pharmaceutical Focus: A Look at Combination Products

Combination products and drug delivery devices aid in patient compliance and a movement toward point-of-care at home.
Mark Crawford, Contributing Writer 11.04.20
3D/Additive Manufacturing

The Printed World: Additive Manufacturing in Medtech

Medical additive manufacturing experts discuss key factors impacting the market both during and post-pandemic.
Sam Brusco, Associate Editor 11.04.20
The Lost Year: 2020 Year in Review

Lessons learned from the global coronavirus pandemic.
Michael Barbella, Managing Editor 11.04.20
Fixing Face Mask Form and Function

Masks for the general public are varied in both style and effectiveness.
Sam Brusco, Associate Editor 11.04.20
Virtually the Same? The Challenges of Online Conferences

Like everyone else on the planet, I’m turning increasingly to virtual solutions to our physical challenges in the midst of a pandemic.
Dawn A. Lissy, Founder & President, Empirical 11.04.20
Quality Assurance When Supply Chain Disruptions Arise

From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020.
Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.04.20
Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes

The legislative year is nearly coming to a close as Washington survives yet another tumultuous election cycle.
Jeffrey J. Kimbell, Eric P. Juhl, JD and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 11.04.20
3D/Additive Manufacturing

Additive Manufacturing: Debinding Fluids Must-Haves

As the pressure to produce more complex biomedical parts increases, medical device manufacturing using 3D printing is gaining widespread acceptance.
Venesia Hurtubise, Technical Chemist, MicroCare Medical 11.04.20
Diagnostics

How COVID-19 is Reshaping the Diagnostics Testing Sector

The short-term impact on the diagnostics sector is readily apparent as the pandemic has fueled overwhelming demand for effective SARS-CoV-2 testing solutions.
Eric Williams, Managing Director, Capstone Headwaters 11.04.20
Babson Diagnostics Closes $13.7 Million Series A Financing

Money will be used to democratize blood testing.
Business Wire 11.03.20
GLEAMER Raises 7.5 Million Euros to Develop AI Radiology Product Line

Company is seeking FDA clearance of its traumatic injury detection tool.
GLEAMER 11.03.20
Electronics

Addressing the Non-Magnetic Inductor Need in Medical Electronics

A proprietary non-magnetic material developed by Gowanda Electronics provides inductance qualities.
Michael Barbella 11.03.20
Cardiovascular

Robocath Creates Joint Venture with MircroPort

Enables the commercialization of Robocath’s R-One platform in China.
Robocath 11.02.20
Diagnostics

Imec Developing Five Minute COVID Test

Approach will use virus particles in exhaled breath to identify positive cases and confirm contagion risk.
Imec 10.30.20
Diagnostics

Agena Bioscience's High-Throughput, Low-Cost SARS-CoV-2 Panel Gains EUA

Thousands of samples can be processed each day for less than $10 per sample running the assay on a single MassARRAY instrument.
PR Newswire 10.28.20
Diagnostics

FDA OKs Cognita Labs' PulmoScan Home-Usable Lung Assessment device

The first-of-its-kind lung assessment device measures airway resistance and elastance.
PR Newswire 10.28.20
Antigen Testing is Crucial in Fight Against COVID-19 in India

Antigen testing can be easily done on the spot in doctor’s clinics, day care centers, hospitals, home care settings, and industries.
GlobalData 10.23.20
Supply Chain Study Offers Insights on Medtech Recovery

Concerns remain about data accuracy, distribution, surge-related delays, and shortages.
Supplyframe 10.22.20
BD Makes Executive Leadership Appointments

Names Patrick Kaltenbach as executive vice president and chief technology officer.
BD 10.22.20
Heated Face Mask Filters and Inactivates Coronaviruses

Includes heated copper mesh powered by a battery and surrounded by insulating neoprene.
Anne Trafton, MIT News Office 10.22.20
First Patients Treated in Trial for Liver and Pancreas Sealant Patch

The patch is optimized to significantly reduce fluid leakage during the critical healing period after hepato-pancreato-biliary procedures.
B3C Newswire 10.22.20
Diagnostics

Spectrum Solutions Secures EUA for Saliva Collection Device

The SDNA-1000 offers a safe sample collection approach for detecting COVID-19 infections.
Spectrum Solutions 10.20.20
Diagnostics

Examining the COVID-19 Detection Kits Market

RT-PCR has become second to none in the global healthcare systems for testing COVID-19.
Sunil Jha, Research Content Developer, Global Market Insights 10.16.20
Diagnostics

DnaNudge, Jabil Healthcare Partner on COVID Test Kits

Key production arrangement will enable high-volume manufacture of CovidNudge testing cartridges on a global scale.
DnaNudge 10.16.20
Patient Monitoring

Ingestible Capsule May Help Demystify the Gut-Brain Axis

A platform that can monitor and model gut microbiome serotonin activity.
University of Maryland 10.16.20
ArchiMed Acquires Majority Interest in NAMSA

Investment to accelerate NAMSA’s global growth and strategic vision.
Business Wire 10.14.20
Electronics

Capacitor Considerations for Medical Applications

Careful selection of even the smallest electronic components can make a significant difference in a device’s capabilities.
Rich Bestafka, Key Account Manager—Medical, Knowles Precision Devices 10.12.20
Diagnostics

Abbott Shares ID NOW COVID-19 Interim Clinical Study Results

ID NOW performance of 95 percent sensitivity, 97.9 percent specificity within seven days of symptom onset.
Abbott Laboratories 10.07.20
Diagnostics

FDA Expands Authorization of Hologic Aptima COVID-19 Test

Now authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.
Business Wire 10.07.20
Qosina Partners with Resolution Medical to Offer a 3D-Printed Sterile Nasal Swab for COVID-19 Testing

...
Contract Manufacturing | Electronics

Innovation, Miniaturization are Top Priorities for Electronic Components Manufacturers

But many companies are hesitant to start new development projects while the coronavirus is still rampant.
Michael Barbella, Managing Editor 10.05.20
Diagnostics

Beckman Coulter's Access IL-6 Test for COVID-19 Earns EUA

Access Interleukin-6 (IL-6) assay assists physicians in identifying severe inflammatory response in COVID-19 patients.
PR Newswire 10.02.20
Contract Manufacturing

Expediting Time to Market—A Medtech Makers Q&A

Donatelle’s Mike Kaiser and Todd Owens provide insights on speeding up development to get products out to market more quickly.
Diagnostics

Hologic Granted EUA for Asymptomatic COVID-19 Testing

Testing of pooled samples also authorized; new claims expected to help limit spread of COVID-19, open economy and schools.
Business Wire 09.28.20
Diagnostics

A Breath of Fresh Air for COVID-19 Testing

One of the latest COVID-19 testing innovations has recently emerged from Israel’s Technion-Israel Institute of Technology—a coronavirus breath test.
Sam Brusco, Associate Editor 09.01.20
New Approach to Extend Shelf Life for N95 Mask

Purdue University researchers are focusing on the elastic band that attaches to the mask front.
Purdue University 08.14.20
Diagnostics

Hologic Launches Validated COVID-19 Test Pooling Protocol

Helps labs deliver greater quantities of highly accurate test results, reduce turnaround times.
Business Wire 08.11.20
Chronic Disease | Diagnostics

Diagnostic May Bring Faster, Cheaper Cancer Testing to Remote Settings

The CytoPAN is used to study breast cells gathered with fine-needle aspiration, a less invasive alternative to standard biopsies.
American Association for the Advancement of Science 08.07.20
The Criticality of Process Validation

By: Todd Owens and Raghu Vadlamudi
Diagnostics

Fujirebio Diagnostics Initiates Testing of Fully Automated COVID Antigen Assay

The Lumipulse SARS-CoV-2 Antigen assay will be available for use on the LUMIPULSE G1200 instrument.
Business Wire 08.05.20
Diagnostics

FDA Authorizes New Quest Lab Technique to Boost COVID-19 Testing Capacity

Speeds the process of extracting viral RNA from specimens.
PR Newswire 07.31.20
Diagnostics

AdvaMed Creates National COVID-19 Testing Registry

Since the beginning of the pandemic, over 65 million tests have been manufactured and shipped nationwide, says AdvaMed.
AdvaMed 07.29.20
Diagnostics

Color Earns EUA for Unmonitored COVID-19 Testing

Alleviates demand on healthcare workers from having to administer test samples.
PR Newswire 07.28.20
Diagnostics

Rapid PCR COVID Testing Trialed in London Care Homes

Queen Mary University of London is leading a clinical trial of a new rapid COVID-19 testing system that delivers results in under an hour.
Queen Mary University of London 07.23.20
COVID-19 Testing Provider Curative Acquires KorvaLabs

Accurate and rapidly scalable oral fluid test will continue to be produced and processed in KorvaLabs’ California facilities.
Globe Newswire 07.17.20
Diagnostics

EKF, Tosoh Europe N.V. Distribution Agreement Expands HbA1c Testing

Three-year agreement will expand the reach of EKF's Quo-Test HbA1c point-of-care (POC) analyzer in the Middle East and Africa.
EKF Diagnostics 07.15.20
Diagnostics

BD Helps U.S. Government Increase COVID-19 Testing Capacity

Government commits to use of BD Veritor Plus System and 15-minute SARS-CoV-2 test kits.
PRNewswire 07.15.20
Diagnostics

Eurofins Launches 10-Minute POC COVID-19 Testing Devices

The serology-based, finger-prick tests detect virus antibodies with a sensitivity of 94.5 percent.
Business Wire 07.01.20
Medable, AliveCor Partner on In-Home ECG Testing

Union marks an important step in the growth of decentralized clinical trials.
Business Wire 06.30.20
Diagnostics

Abbott’s COVID-19 Antibody Blood Test Gains EUA for Use on Alinity i System

Plans to ship nearly 30 million antibody tests globally in May across its Architect and Alinity i platforms.
PR Newswire 05.11.20
Cardiovascular

HRS 2020 Science: Mobile VPG Technology Used to Monitor Pulse Rates

New study shows AI-based facial recognition can enable patient mobile devices to detect AF.
Heart Rhythm Society 05.08.20
Diagnostics

FDA Update: COVID-19 Antibody Test Validation and Education

Results from these tests can help identify who has been infected and developed antibodies.
U.S. Food and Drug Administration 04.20.20