T. David Pyron

Risk Management for Medical Device Projects

Device Development Risk ManagementMy goal as a medical device development program manager is to save time while managing risk. I save time by reinforcing a concept you likely apply every day, but might not use in your medical device development project.
In my experience, dealing with the fires of the day always take precedent over managing things that might not happen in the future. (spoiler alert: those fires might have been prevented by project-managing the things that haven’t happened yet).

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Julian Grove

High Level Program Planning: A Journey, Not the Destination

Developing innovative and life-changing products provides a wellspring of inspiration as our “destinations.” But “anything worth doing is never easy” and this is a pretty accurate capture of medical device product development. If we are going to spend most of our time on the journey, wouldn’t it be a whole lot more enjoyable if we have trust in and feel comfortable with our travel companions?
The reality is that when we invest in our relationships and appreciate the journey, we are much more likely to reach our goals. Ironically, focusing too much and rushing towards the destination may be the single biggest obstacle to getting there.

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Arash Samimi

Creativity, Collaborations and Culture from the Lens of a Systems Engineer

Medical Device Systems Engineer Creative CollaborationsI have learned the most important lesson about innovation through my role as a medical device systems engineer: invention and adoption of new ideas is only possible through coherent and feedback driven collaborations. Indeed, building a new product is more than the product. It is about creative teams working together and navigating ambiguity in relentless pursuit of a shared goal. Within this context, systems engineering exists to enable creativity and nurture a collaborative culture by focusing on the bigger picture.

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Kashif Siddiqui

4 Hidden Medical Device Development Costs

Hidden Costs Medical Device DevelopmentUnnecessary repeated effort is an insidious source of hidden costs. In medical device development, an iterative work process is fundamental to creating a successful product, but if the iterative process is not performed with careful consideration, it can become the source of a lot of hidden costs.
Transitioning from one team to another, distributing work, or passing the baton typically involves some overlap in tasks and activities performed. Even within a single team, repeated work or practices could be optimized.

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Ryan Field

Medical Device Camera Image Sensor Considerations

Medical Device Camera SensorProduce the most high-fidelity images and/or cleanest data possible

Part 3: Types of Image Sensors

Camera sensors are common components of medical devices. This blog covers various types of image sensors. Generally, image sensors consist of an array of photosensitive pixels. In typical camera applications, such sensors measure the spatial pattern of light focused by a lens (i.e., an image). In some applications (for example, digital holography or shadow imaging), image sensors may be used without a lens.

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Alex Gunson

When Tolerance Studies Add Value in Medical Device Development

Device Design Tolerance Studies Coming from a high volume and high precision electronics manufacturing background, I lived in a world where every design required a tolerance study. Entering the low volume world of biomedical entrepreneurship, I’ve been surprised by clients telling me that tolerance studies are too expensive and that they are happy to proceed without them. This led me to consider when a tolerance study actually adds value to a medical device design.

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Thor Tronrud

Tips to Avoid Medical Device AI Pitfalls

Tips on AI PitfallsRoughly 80% of human brain volume is made up by the neocortex, a set of highly interconnected layers of neurons that controls our higher brain functions, such as perception, cognition, motor control, and language. This massively parallel architecture is the initial inspiration for Deep Learning – a neural network paradigm that excels at pattern recognition and classification.

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Alexandra Reid

Preparing EUA Medical Devices for Post-Pandemic Use

EUA Medical Devices TransitionThe US Food and Drug Administration (FDA) published a draft guidance document in December 2021 outlining transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency (PHE). The FDA has issued EUAs for a vast array of medical devices during the pandemic including ventilators, infusion pumps, personal protective equipment, in vitro diagnostics and more.

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Nigel Syrotuck

XYZs of Medical Device Vibration Testing

Medical Device Vibration TestingMedical devices, especially complex ones with electronics, almost always undergo shipping testing before they are considered safe enough for market. We use 3rd party testing services to run typical load profiles on devices in their packaging. These usually include impact, drop and vibration testing, amongst others. Vibration testing is a particularly interesting subject, which we’ll discuss here. You should also take a look into our blog on Medical Device Drop and Push Tests per IEC 60601-1.
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Astero StarFish

8 Tips to Manage Medtech Stakeholder Expectations

Manage Medtech Stakeholder ExpectationsManaging medtech stakeholder expectations is an important element of medical device development success. Investors, Internal stakeholders, KOLs, Clinicians, Scientists and Engineers will all play a part in shaping and delivering a successful medical device. We asked key members of our team to share their best tips and lessons learned. Here are 8 tips to manage medtech stakeholder expectations from our engineers, regulatory and quality assurance, and system engineers, and project managers.

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Alexandra Reid

Regulatory Science Tools Reduce Risk in New Medical Devices

Regulatory Science Tools ReviewThe FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) is a part of FDA’s initiative to speed up medical device development and patient access to safe and effective medical devices by producing tools using innovative science in the assessment of new medical devices.
A Catalog of Regulatory Science Tools (RSTs) was developed by OSEL to expand the scope of science-based approaches used in the development of emerging medical technologies. These RSTs can be used by the industry to drive innovation and assess emerging medical technologies. The Catalog includes more than 100 RSTs, including laboratory methods, tissue-mimicking phantoms, and computational modelling and simulations.

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