Medical DeviceQualified Supplier Directory

Stratos Product Development LLC

World Trade Center North
2401 Elliott Ave, 5th Floor
Seattle, 
WA  98121  us
Tel: 206/448-1388
Fax: 206/448-7830

 

Stratos: Delivering the Power of Possible

For over 25 years, Stratos has been the trusted resource for science and technology innovators. Our team has decades of experience spanning drug delivery systems, minimally-invasive surgical devices, patient monitoring and cost-sensitive, high-volume disposables. With our systems-based approach and efficient, ISO 13485 design controls, our dedicated medical device design and engineering teams bring broad application experience and technical versatility to each medical device development effort. Whether solving complex technical challenges or bringing market opportunities to fruition, our team can be counted on to deliver. Contact Stratos to take your next medical device idea from possibility to reality.

 

From The Stratos Blog

How Medical Device Characteristics Determine Their Classification

Product Designer Spotlight: Adam Storey, Senior Mechanical Engineer

5 Key Elements Required of Medical Devices Prior to Regulatory Submission in the EU

   

 

Services and Expertise

>> YOUR TEAM IS ASSEMBLED AND READY. WELCOME TO THE STRATOS ECOSYSTEM OF INNOVATION.
 

 

Product strategy originates from a vision of where you want to take your company. The products your organization ultimately offers are that vision made real through execution of the product strategy. Establishing a well thought-out strategy is the key to maximizing return on your product development investment and ultimately delivering the products your customers really want.
 
Stratos enriches and empowers your strategic thinking. Our team brings broad experience and proven approaches like our “Phase Zero” framework to your product strategy programs. Our work is both collaborative and applied. We deliver real value by providing external analysis of product opportunities and synthesizing a strategic approach that best utilizes design innovation, technology and engineering to position your product portfolio for success. Our goal is to deliver competitive strategies that embrace innovative and feasible product concepts which are uniquely positioned to meet your customer needs and will drive significant growth in your business.

Applied Research

 

At the heart of many truly innovative products is a key new technology. The fundamental challenge for industrial R&D is to unlock the underlying product potential of these new technologies. These programs are risky endeavors requiring careful methodology and thorough application diligence.  Only once application performance is demonstrated in a real world environment and a product strategy established should the transition to development be made. With this approach, new technology can be successfully moved through R&D and efficiently incorporated into great products that result in maximum return on investment.
 
Stratos’ Applied Research methodology includes crafting a close and ongoing relationship with the original research group. This collaborative approach is critical to successfully maturing the research into a product application. The extensive industry application experience of our staff of scientists and engineers helps to bridge this transition. Using performance design of experiments and system architecture differential studies, the preferred embodiments for commercialization are identified. These embodiments – along with risks and economic opportunities – are evaluated as part of Stratos’ unique “Phase Zero” process and finally presented to management for approval and inclusion in the product development portfolio.

 

Industrial Design

 

The Stratos design team’s approach is simple: understand the user’s needs and create meaningful, purpose-driven products that connect technology at both a functional and  visceral level to achieve business success. Design at its most basic level is problem solving. We strive to inform our process with meaningful input that lays the foundation for an informed design solution. Teamwork is essential, and we work closely with our technical team to deliver solutions that meet our customer's business needs and the user's product needs.
 
Intuition is not to be discounted as part of the design process—it's the magic that’s hard to quantify. It gives a deep connection between artifact and people. When properly translated into a product, intuition is the ingredient that creates desire, puts a smile on the user's face, makes the job easier and creates efficiency. Design is more than just the product. It is a system that the product is a part of. Design is a process of reduction, focusing on the most essential elements from business, technology and human needs to create the most elegant solution to the problem.

Mechanical Engineering

With an average of 16 years in mechanical engineering, Stratos engineers ensure your product is in the best of hands. From proof-of-concept through design and assembly, we know how to assess and adapt. Stratos ME’s are adept at cross-collaboration among disciplines and work well with internal and external stakeholders to navigate appropriate trade-offs to meet schedules that result in high-quality solutions.

 

Electrical Engineering

 

We combine our extensive electrical engineering experience and the latest technologies to ensure quality and cost-effectiveness in the development of critical electronic systems.
 
We have expertise in analog and digital design, electro-mechanical, audio, instrumentation, telecom and mobile computer system design, asic design, digital signal processing, and high volume/cost engineered systems.

 

Software Engineering

 

Stratos provides software solutions with a focus on the end-user experience. The Stratos team communicates with clients to establish a clear set of requirements and a design approach to meet market, functional and end-user needs. We rely upon talented developers and a proven process to deliver high-quality and timely results.
 
We offer software solutions for a wide range of applications and devices, from deeply embedded software to mobile and PC applications. We develop custom software for medical devices, consumer devices, scientific instruments, wireless devices and many other types of products.

 

Quality Engineering

 

 

Navigating the regulatory landscape in medical device development is no small feat. Our team of quality engineers is here to help every step of the way. Stratos boasts an FDA 21CFR820 and ISO 13485 compliant Quality System that employs a product development process proven to produce medical devices and documentation appropriate for 510(k) and PMA applications that meet FDA requirements and CE submittals for the European Union. 
 
The Stratos Quality Engineering group is comprised of experts in medical device design controls. Our Quality System allows us the flexibility and adaptability necessary to meet the unique product development needs of each medical device client. The QE group consists of specialists in hardware and software quality engineering, as well as trained and qualified testers.  A QE is assigned to each medical device project and stays on the team from development of requirements through completion of verification.  The QE works closely with the project teams to ensure compliance to our Quality System and applicable regulatory requirements.

Project Management

 

 

There are project managers, and then there are Stratos Project Managers. Every PM at Stratos is an engineer who has worked on the development of countless products. They are experts in proactive planning and re-planning, removing obstacles to development along the way, enabling our multi-disciplinary project teams to focus and work efficiently.  
 
We are committed to a collaborative and iterative approach that ensures client expectations are met, and often exceeded. We make our clients a member of the project team, communicating often to facilitate timely, concise and organized communication. Our project managers are the voice of our clients, making sure your needs are considered every step along the way, so you can sleep well at night.
We do all the expected things – actively manage project cost, schedule and performance. We also provide a depth of experience in product development that enables us to present many options for meeting project goals, allowing you to choose the path that works best for your specific situation. 
 

Manufacturing Strategy

Stratos works with our clients to determine the best manufacturing solutions. We know that not all products are the same, and a well-researched manufacturing strategy and implementation is an important piece of the product development puzzle. Our team of design and manufacturing engineers can tailor a strategy that will best suit your product, budget, timeline and market delivery objectives, then work closely with you to evaluate and select the right manufacturing partner to insure the design transfer goes smoothly and the finished product meets expectations.

Medical Product Development

View more projects, peruse our client list, or contact us to get your project underway today!