Develop Products Faster, Cheaper, and Better? Yes!
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25+ years of product development experience, primarily with medical devices, distilled into one 400-page book.
Latest Posts
Development Sin #1: Leaving “Serious” Testing Until the End
“We’ll develop the device, then we’ll test it.” Do this, and your project’s timeline will explode. As product developers, we often fall…
Faster, Cheaper, AND Better? Impossible?
In product development there’s an old adage: “Fast, cheap, good: you can only pick two.” The idea is that for any…
The 11 Deadly Sins of Product Development: Is Your Project at Risk?
As a veteran of product development, I’ve seen my share of projects succeed—and fail. In my book Prototype to Product:…
About the Author
Alan Cohen is a medical device development engineer with more than 25 years of experience in developing FDA regulated devices as an individual contributor and leader. He’s worked in a variety of medical device types in areas including cardiology, neurology, imaging and radiation therapy.
Alan helps organizations minimize the cost, effort, and hassle of medical device development. Most importantly, he helps to ensure that project cost and timeline are predictable with a minimum of surprises.
How can I help to maximize
your success?
IEC 62304 Coaching
I can help you to develop processes that minimize the effort and hassle of complying with the medical software standard recognized by the FDA and other regulatory bodies.
Design for Regulatory
Thoughtful device design can reduce the safety classification per FDA and other regulatory bodies. This can greatly reduce required documentation and testing.
Requirements Planning
“Expectations are the sole source of disappointments.” Good requirements ensure that everyone’s expectations are in sync — but they can be challenging to develop.
Project Planning
Along with good requirements, detailed and realistic project plans are the key to predictable development efforts. Like good requirements, they are challenging to create but pay back many multiples of their cost.
Independent Review
An independent expert for design reviews and documents helps to demonstrate care in decision making. This can be important during inspections and litigation.
Resource Acquisition
Whether you need an expert in a specific area or an experienced team who can hit the ground running, I have a solid network of people and organizations that I can bring in to help solve problems quickly.