Medical Device Engineering Services from Credentialed Experts

Medical Device Engineering Services from Credentialed Experts

The intricate world of medical device development demands more than technical expertise alone. Getting to a successful product requires a multi-faceted approach, encompassing not just engineering know-how, but also project management, regulatory compliance, and a deep understanding of the medical device industry. It’s important that your medical device engineering services are provided by well-rounded, multidisciplinary, credentialed experts.

At Root3 Labs, we take pride in having a team made up of highly credentialed engineers who bring a diverse range of expertise to the table. This ensures that every project we undertake benefits from a comprehensive understanding of the device development lifecycle, from ideation to mass manufacturing.

It also ensures that you’re sure to see an alphabet soup of letters behind our names! PE, MSE, MTE…What do they all stand for? Each of these abbreviations of academic and professional credentials reflect our passion for engineering, so we’re proud to highlight them and how they’re such a valuable asset for our team!

Root3 Labs' Credentials for Medical Device Engineering Services

Professional Engineers for Regulatory Expertise

Our team boasts two Professional Engineers, or PE’s. PE is a qualification license issued by a State’s Board for Professional Engineers. Professional Engineers must first earn a Bachelors degree from an ABET-accredited engineering program and take the FE (Fundamentals of Engineering) Exam. This 110 question exam takes 6 hours and covers a variety of engineering topics. After at least four years of professional experience under the supervision of one or more Professional Engineers, candidates apply to take the PE Exam in a specific discipline.

Chad, our founder, and Christina, one of our Senior Engineers both took their PE Exam in the Mechanical discipline. Specifically, Machine Design and Materials, which is an 80-question, 8-hour exam that requires months of preparation! Having their expertise when it comes to product safety, efficacy, and regulatory requirements means that we can provide qualified and professional work to all of our clients.

Solving Complex Problems with MSE Backgrounds

Several members of our team also hold Masters of Science in Engineering (MSE). The MSE is a 2 year graduate program that often involves both academic classes and original research with a thesis project. They can focus on one of many engineering disciplines, or integrate multiple disciplines to study something complex like robotics.

Chad, our founder, also has a MSE alongside his PE license! Todd and Christopher are two of our senior engineers that also both have their MSE. Although, Todd’s focus is on mechanical engineering and Christopher’s is electrical and computer engineering. Having their degree of expertise spread throughout different engineering disciplines means that we’re always able to handle multidisciplinary project and device needs! And with the ever evolving technology of the modern world, device needs continue to become more and more complex with many intersecting engineering disciplines required.

Entrepreneurial Training for Engineering Expertise

A unique strength of our team lies in the presence of members with Masters of Technical Entrepreneurship (MTE) qualifications. This background fosters a comprehensive understanding of the entire device development lifecycle. That encompasses intellectual property protections, prototyping, and ultimately, successful manufacturing and productization.

With knowledge of regulatory requirements, manufacturing materials, and market fit we can assist with developing product roadmaps, crafting strategic positioning, and ensuring a smooth path to market.

Diversifying Disciplines to Collaborate for Success

At Root3 Labs, we strongly believe that collaboration between a close, multidisciplinary team is the best way to succeed at product development. A great example of this philosophy at work is our Smart Badge project. With a tight development window of only one month, we knew the only way to get there was to leverage the diverse expertise of our engineers by having them work in tandem from start to finish.

Imagine the roadblocks we might have encountered if we relied solely on the expertise of just one engineering discipline. The PEs on the team, for example, brought their regulatory knowledge and mechanical know-how. Meanwhile, the MSEs, with their deep understanding of complex medical technologies, helped tackle intricate design challenges between electrical and mechanical. Ultimately, they were able to best optimize the Smart Badge’s functionality by streamlining the development process and collaborating closely.

This collaborative development process was the cornerstone of the project’s success! By constantly communicating and working in tandem, we were able to overcome obstacles quickly, adapt efficiently, and ultimately deliver the Smart Badge within that challenging time frame.

Collaborative spirit is at the heart of Root3 Labs’ approach to Device Development. By fostering a culture that values diverse perspectives and encourages teamwork, we empower our clients to bring their innovative ideas to life. Are you ready to embark on your own medical device project? Download our comprehensive Product Development Guide to gain valuable insights and learn how Root3 Labs can help you achieve success.