Medical DeviceQualified Supplier Directory
Stratos Product Development LLC Company Profile
Qualifications: ISO 13485, Supplier to Medical Manufacturers
Markets Supplied: North America, Europe, Worldwide
Since 1987, 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, point-of-care diagnostics and digital health technologies. With our systems-based approach and efficient, ISO 13485 certified design controls, dedicated medical device design and engineering teams, we 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.
Stratos designers and engineers work with our clients to turn a product idea into a product design that is commercially viable. We are different from many other product design and development firms in that we go beyond simply providing design concepts – we work diligently throughout the entire product development process to ensure that we deliver designs that will actually be successful once they’re in the marketplace.
We partner with clients worldwide, from start-up companies to Fortune 500 corporations, to bring meaningful, functional, easy-to-use and thoughtfully designed technology to life. Our tenured, highly-skilled product development experts address every element of development, including:
- Product Strategy
- Applied Research
- Industrial Design
- Interaction Design
- Mechanical Engineering
- Electrical Engineering
- Software Engineering
- Quality Engineering
- Project Management
- Manufacturing Strategy
Safe and effective delivery systems to achieve the intended therapeutic effect.
Stratos engineers understand that pharmaceutical compounds are unique with specific administration requirements to be most effective. We collaborate with our clients to develop the drug delivery solution that is best suited to their specific delivery modality and pharmaceutical. We have an expansive breadth and depth of experience in developing drug device combinations including transdermal patches, inhalers, iontopheresis, single tablet dispensing, and vending machines. Our depth of experience in drug/device combinations makes us an excellent partner for drug developers and manufacturers in need of a custom delivery solution.
Developing point-of-care and in vitro diagnostic systems for global markets.
Stratos brings over 20 years of experience developing point-of-care instruments to our clients' projects. Drawing from our full complement of in-house engineering and design talent we create integrated system solutions that enable operators to reliably run your assays and provide fast diagnostic results to healthcare providers and patients. Stratos specializes in developing new instrumentation to support advanced assays designed to bring new diagnostic capability to point-of-care environments. We have worked with cartridge suppliers around the world to translate assay chemistries into robust, cost competitive cartridges suitable for use in challenging environments. Our user interaction and software teams understand how to create interfaces that allow efficient work flow and seamless communications with electronic health records, cloud-based back ends and mobile apps.
Providing digital tools to improve health, lower healthcare costs and prevent chronic illness
The healthcare landscape is changing. Traditional healthcare costs are rising, and emerging Digital Health technology helps battle that trend by providing valuable healthcare and wellness solutions at consumer prices. Digital Health is the convergence of traditional healthcare technology and consumer electronics, and Stratos has the experience and expertise that make us a leading service provider in this industry. Stratos has the deep knowledge in relevant technologies, including wearable devices, mobile applications, low-power design and ultra-sensitive sensors to solve the most complex challenges for our clients. Stratos also understands the regulatory challenges facing this fledgling industry. Digital Health technology is expanding rapidly and Stratos has been at the forefront for clients in the personal wellness and digital health feedback markets.
Creating new precision tools designed to delight users and deliver great patient outcomes.
Interventional tools are fast becoming increasingly complex. Yet even with this additional complexity, operators are demanding simple, intuitive user interfaces that allow them to focus on efficiently delivering therapy to their patients. The Stratos approach to systems design and usability allow our clients to bring new, sophisticated therapeutic features to their catheter products while ensuring they are easy to manipulate, control and actuate. Stratos specializes in combining mechanisms, electronics and sensors into high-reliability disposables and reusables that enable fast, cost effective procedures with outstanding patient results.
Providing monitoring solutions across environments, providers and users.
Today’s monitoring market is dynamic. Big data, the proliferation of use environments, advanced analytics and the falling cost of acquisition and storage is quickly changing what is possible. Stratos brings deep experience and a full spectrum of development services and technical expertise to our clients in the monitoring market. We have executed projects targeted at the home, pre-hospital, emergency department, OR, critical care, in-patient wards, ambulatory, office and home settings. Product configurations include fully integrated consumer wearables, bed-side monitors and ruggedized portable devices. Our engineers fully understand the importance of robust signal acquisition and processing to parameter quality and user centered clinical decision making. Our designers are committed to clear, easy to understand interfaces that are both efficient and intuitive for health care providers and patients to use.
As part of Intellectual Ventures’ Global Good program, Intellectual Ventures Lab (IVL) approached Stratos for help in developing an insulated container to strengthen and extend vaccination services in developing countries. The resulting Passive Vaccine Storage Device is designed to keep vaccines at the appropriate temperatures for a month or more with repeated vaccine retrievals and no need for electricity. To do this, the device relies on only a single batch of ice. Previously, in order to receive vaccines, individuals may have to walk many hours if they were able to receive the vaccines at all. With the new devices in place, the vaccines are now more readily accessible to more populations, and more children are able to be vaccinated.
The Datascope Patient Monitoring Group recognized the need to identify a cardiac arrhythmia event in patients who were not typically monitored. The challenge was to create a patient monitoring device that would reliably alert hospital staff, move easily throughout the hospital with the patient and be affordable enough to monitor all patients in the hospital.
The product required a full system design and engineering approach to carefully consider all tradeoffs in usability, functional performance, site management, and total cost of ownership. The resulting NetGuard Patient Monitoring System includes a reusable, body-worn device with extremely low-powered wireless electronics and a wireless network access point. The low-cost, resource-constrained wearable device contains software for ECG signal acquisition and analysis, as well as IEEE 802.15.4 wireless networking protocols, power management and a disposable ECG adhesive electrode.
Located in Silicon Valley, AcelRx Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx was founded to solve the problems of post-operative intravenous patient-controlled analgesia (IV PCA) by addressing the unmet medical need to reduce the side effects of morphine, address the invasive IV route of delivery and eliminate the inherent potential for programming and delivery errors associated with the complexity of IV PCA pumps. The company had a strong mechanical engineering team but had limited software and hardware technical resources to respond to the product development challenges associated with programming and delivery errors. AcelRx turned to Stratos, who represented a similarly creative approach and technical depth, to respond to the challenges of electrical and software engineering solution development.
For more information contact Stratos Product Development LLC