How can medical device startups avoid costly mistakes when navigating the FDA submission process to successfully bring their idea to market?

Startups are the lifeblood of medical device development and innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop prototype medical devices that could help patients, the future technologies needed to help save lives wouldn’t happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected

Here are the 5 biggest mistakes medical device startups make when going down that road and advice from Bruce Swope, VP of Engineering, who has over 25 years’ management experience in medical device development, and Erik Hilliard, Director Business Development, who has over 10 years of experience working with clients to see their ideas come to market, on how to avoid these mistakes and save money. 

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How is mobile technology revolutionizing the medical device industry?

The trend in the medical device marketplace is moving rapidly toward incorporating mobile technology. Medical iPhone apps, medical Android apps, and medical Windows apps have made digital health exciting and opened a new world for doctors and patients. But there has been some hesitancy by regulators, who are concerned about the potential risks to patients.

Jamme Tan, with over 9 years of experience as a software developer, and Erik Hilliard, Director of Business Development with over 10 years of experience, introduce how Apple, Android and custom mobile devices interact with medical devices. They also discuss how Sterling Medical Devices has been successful getting FDA approval for mobile medical devices.

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What does Agile Project Management mean for the medical device industry?

There are a lot of unknowns during the medical device development process. Agile project management is a technique to make sure those unknowns don’t lead to time being wasted. Agile is all about adapting to change. Customers are able to change their minds and take a different direction as they learn more about their device’s core functions.

Sterling Medical Devices uses the Agile process to build incremental pieces of the application, review those pieces with stakeholders, collect feedback, and then get that feedback into the development life cycle immediately. This ensures that the most important features are being implemented and any problems are fixed. The Agile process provides great ROI and is recognized by the FDA.

There has been a lot of attention recently about Agile project management in the medical device industry. Engineer Ben Holt, Project Manager with over 7 years of software engineering experience for medical devices, Erik Hilliard, Director of Business Development, who has over 10 years of experience, and Jamme Tan, also an engineer project manager at Sterling for over 9 years, discuss how the Agile project management process works in medical device development, including medical device software and mobile apps.

Contact Erik Today.