Astero StarFish

Tips for Better Medical Device Product Definition

Medical Device Product DefinitionThe medical device product definition process can make or break a novel medical device. Our experts discussed the topic and offered tips in a recent medical device product definition roundtable. Their tips range from general guidelines to regulatory, reimbursement, lean startups, architecture, and hazard management.

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Raje-Virginia

ALARP to AFAP, the MDR and ISO 14971:2019+A11:2021

Medical Device Risk ManagementThe risk management approach

ALARP (As Low As Reasonably Practicable) to AFAP (As Far As Possible) and medical device risk management has always been a tricky one. The nature of the products, their intended use, and the markets in which they are sold influences the approaches in controlling risk. When it comes to risk, the first thing to consider is the ISO 14971 standard. MDR and IVDR changes bring a new alignment in terms of risk.

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Lorenzo Gutierrez

Cancer detection technologies on microfluidic chips

Cancer Detection Microfluidic TechnologiesWhen you hear the word cancer, it conjures up sad feelings. Most patients think that if they have it, they have less chance to survive and it’s the start of a countdown to death. Most people only know of the most common treatments such as – chemotherapy, which uses drugs to kill cancer cells, radiation which is used to destroy cancer cells and damage cancer cell’s DNA to stop dividing and growing, and surgery which remove the cancer tissues. They imagine losing hair and being in the hospital for weeks or even, months. But what is cancer, really? Is there a cure? What’s the chance of survival?

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Emily Hayhurst

How to get the most out of medical device user testing

Medical Device User Testing Do you know the most overlooked step in creating a useful medical device?

It might sound surprising, but if we were to look at a graveyard of failed products, more often than not they fail because, while they deliver their promise, they fail the user. Do not underestimate how critical it is to seek user feedback in the design process. User feedback is essential for making educated design decisions.

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Nadia Routhier

Cardboard Mock-Ups Vs. 3D Printing for Rapid Iterations

Rapid Prototyping Human FactorsWhen I joined StarFish Medical I was pretty stoked about the 3D printer and marvelled at the prints created by the Mechanical Engineers and Industrial Designers. As a Human Factors Engineer in product development my favorite challenges are the ones that call on imaginative solutions for investigating and testing use-related ideas and concepts for new products.

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Morna-Sunghyun

XR is about to Revolutionize Medical Device Design

XR Medical Device Design

Extended Reality (XR) is going to fundamentally shift how medical devices are researched, designed, and promoted. In this post, we’ll discuss how XR changes the future of medical device development and the benefits of employing XR. But first, let’s clarify what XR is and why now is the time to pay attention to it.
Long ago, Virtual Reality was hyped as the next disruptor technology. Up until this point, it has failed the hype. However, with recent advancements in software and cheaper headsets, this is about to change. There now exists a spectrum of real-to-virtual combined environments that are more accessible.

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Diana-Holden

FAQs for Potential EE Co-ops

Electrical Engineering Co-op ExperiencesCo-op students answer FAQs and share their experiences

Want to experience the Biomedical Device industry from a front row seat? Consider doing a co-op term with an Electrical Engineering (“EE”) team. Diana Cancelliere and Holden Jones answer FAQs that potential EE co-ops may have.
“The hands-on industry experience gained during our co-op term at StarFish Medical this summer gave us the opportunity to apply Electrical Engineering concepts to real-life Biomedical Engineering challenges. We want to share this experience with other students with answers to questions they should ask when considering an EE co-op.”

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Kevin Meric

Why Laser Cutting is My New Go-To Iterative Design Tool

Laser Cutting Device Design The design process is all about making design decisions. Whether the outcome is good or bad, the faster you can validate these decisions, the better your design becomes because you are iterating and learning. My new favorite tool to iterate is our laser cutting machine.
I must admit that before joining StarFish, laser cutting was not one of my “go-to” tools as I found it difficult to dial in precise tolerances.

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Deborah Pinchev

UK Medical Device Brexit Implications

Medical Device Brexit ImplicationsOn June 26, 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released the Government response to consultation on the future regulation of medical devices in the United Kingdom. This response will effectively guide the UK’s post-Brexit implementation plan for medical device regulation. The following are high-level key points that are sure to be of interest to medical device manufacturers.

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Raje Devanathan

Digital Health Technology (DHT) for Clinical Investigations – FDA Draft Guidance Analysis

 FDA DHT Clinical Investigations Smart phones build a digital profile by tracking and monitoring our behavior and activities. Digitalization is happening all around us and COVID-19 has brought even more digital technologies into our lives. It is encouraging to see how data is being integrated into health care systems.
The FDA thinks we can use these kinds of data for better and safer medical devices. They have built a set of rules around what and how that data can be generated and used.This blog examines their draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. You should also read our previous blog on the future of DHT.

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Maria Gonzalez

Quality Management System Regulation (QMSR) Alignment with ISO 13485:2016

QMSR ISO 13485:2016 AlignmentMany organizations have struggled to comply with ISO 13485 and FDA regulations because the FDA did not formally recognize the ISO 13485 standard in their regulations. Now, the FDA is taking a step forward to incorporate ISO 13485 into their Part 820. This will potentially reduce the confusion manufacturers have experienced in the past.
The FDA aims to accomplish this via a proposed rule in which manufacturers are allowed to create a robust Quality Management System (QMS) that complies with a single set of requirements. It also increases international collaboration between the FDA and major markets (Europe, Canada, Australia, Japan, etc.) by minimizing the country specific requirements needed to comply with the Federal Food, Drug and Cosmetic Act (FD&C Act).

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