Search Results for: Contact
-
-
5 Patterns That Make or Break Medical Device Commercialization
Commercialization can mean different things depending on where you are in the journey. Ultimately, medical device commercialization is about taking something proven to work and turning it into a product that meets user needs, can be manufactured at scale, and makes business sense. 1. Build a Reliable Benchtop Prototype Before You Outsource If you’re still…
-
Raytheon – C-FAST Rapid Covid-19 Diagnostic
Raytheon – C-FAST Rapid Covid-19 Diagnostic Working with a world-class multidisciplinary team to deliver low-cost, lab-grade COVID-19 testing at home. The COVID-19 pandemic has raised a global need for tests that are fast, accurate and accessible. High-complexity lab-based PCR tests are accurate, but getting them to a centralized lab creates delays. Low-cost POC antigen tests…
-
Investment
To de-risk and build capacity and competence within our portfolio companies, we leverage our deep experience in design, engineering, prototyping, testing, manufacturing, and commercialization strategy. Overview The Foundry We operate under our exclusive venture studio model with designers, engineers, founders, entrepreneurs, strategists, and investors all under one roof. We proactively engage with founders on their…
-
Manufacturing
Page Sections Manufacturing can be a daunting consideration. If you’re just getting started in the product design process, it can seem far off. You might be looking for a design firm now and thinking that you’ll find the right manufacturing partner later. But design has a long tail: decisions made at the design stage must…
-
Process
Phases Phase 0 – BaseCamp BaseCamp by Cortex™ We ask the question “Should we build it? to validate and de-risk the solution as described to us by you. We consider the business case, technology stack, product use-case and workflow, manufacturing concerns, and regulatory and quality implications. We evaluate the risk of each element before we…
-
Precision Tools for Medtech Manufacturing
As the healthcare sector emerges from the pandemic, providers and their medtech manufacturers face a much-changed economic, commercial, and competitive landscape. But one thing remains true – the decision to invest in cutting-edge tools isn’t merely a choice; it’s the cornerstone of successful medtech manufacturing. In this article, we delve into the transformative power of…
-
Navigating Medtech Hardware Investments: Key Considerations
As the healthcare sector rebounds from the pandemic, providers and medtech manufacturers encounter a transformed economic landscape. For over a decade, hardware investments consistently outperformed S&P rates. Despite a recent COVID-19-induced slowdown, the medtech hardware sector – resilient and poised for disruption – once again holds significant value for investors. Context and Industry Trends in…
-
New eBook: Cortex Manufacturing Services
A new eBook from Cortex, distilling 20 years of manufacturing experience into actionable advice for entrepreneurs and product champions. The hardware world is too used to seeing manufacturing as the last step of the product development process. Manufacturing comes at the end, so it should be the last thing you plan, right? You identify a…
-
What’s My FDA Medical Device Classification?
A primer from Cortex Design. All medical devices marketed in the U.S. are regulated by the Food and Drug Administration (FDA). The FDA classifies any new medical device as either Class I, Class II, or Class III, depending on the device’s risk, invasiveness, and a number of other factors. If you want to market a…
-
Privacy Policy
Non-personally identifiable information We collect certain details that help us constantly improve our website’s user experience and refine our service offerings. These details are considered non-personally identifiable, in that they do not identify the user. By collecting this anonymous information, including browser type, pages viewed while on the site, the referring website, language preference and…
-
How we won an XPRIZE when they said we’d already lost
If the tech world was a baseball game, the rules would change every time a new player stepped onto the field, a seasoned pitcher unveiled a new pitch, or a spectator entered the stadium. That’s basically how we won $100,000 + $5.4 million in R&D for the XPRIZE we’d already been disqualified for. Here’s how…
-
Hardware Startups: Design for Manufacturing Summit
Heads up hardware startups; I am a panelist at two upcoming Design for Manufacturing Summits in Brooklyn NY Oct 6 2016 and Toronto Nov 3 2016.
-
Human-Centered Design Course Completed by Cortex Team
Design Kit: The Course for Human-Centred Design is a seven-week curriculum that introduces you to the concepts of human-centered design and how this approach can be used to create innovative, effective, and sustainable solutions for social change. Working in teams of 2-6 people, we learned this design process by applying it to one of three…
-
What it takes to become ISO-13485 design compliant
“It creates a discipline and an internal corporate culture that can help you grow. -Robert Kaul Medical products are entering the consumer space at a growing rate, providing safer and more effective health outcomes for the public. For prospective device manufacturers, it’s important to understand the impact that quality certifications like ISO-13485 have on the…
