- Electrical
- Software
- Mechanical/Industrial
- Regulatory
Types of Services Offered
- Analog/Digital Circuit Design
- Digital Signal Processors
- Embedded Processor Design
- Telemetry & Instrumentation
- Battery Operated Equipment
- Manufacturing Test Equipment
- Sensors and Control Systems
Electrical
- Embedded Software Design
- Signal Processing Software
- Algorithm Development
- Data Acquisition
- Windows Development
- Motion Control
Software
- Mechanical Design
- Conceptual Design
- Prototype Fabrication
- Mechanical Hardware
- Material Review and Test
Mechanical / Industrial
- Electrical Validation & Verification
- Software Validation & Verification
- Reliability and Failure Analysis
- EMC Compliance Engineering
- Safety Compliance Engineering
- FDA 510(k) Submissions
Regulatory
Addressing today's engineering challenges in a timely and effective manner is essential to maximize the growth and profitability of an organization. Unfortunately, in many cases this can be difficult due to the lack of time and available resources. Reduced competitiveness, growth, and profitability are often the result. Alternative solutions must be found to address the organization’s needs.
Design Solutions can assist you at these critical times by providing solutions to close gaps and provide you with a competitive advantage. Working with Design Solutions provides you with benefits well beyond what you would typically expect from contract engineering.
The two most commonly mentioned benefits of working with outside engineering resources are lower costs and/or an accelerated time schedule.
By choosing Design Solutions as your strategic partner, you will see benefits during the early phases of defining the opportunities and developing strategies and concepts. These benefits will continue through to the design and the development, product integration, and product introduction phases, should you decide to include us at all stages of your product development cycle.
Portfolio
- Sleep Apnea Screener
- Oximetry Analysis Software
- Cardio Pulmonary Exercise Recorder
- Software Design Review
- Regulatory Review, Testing, and Reports
- Impedance Cardiography (ICG) Monitor
- First Responder Vital Signs Monitor
- Compartment Syndrome Monitor
Sleep Apnea Screener
Opportunity: A multinational medical company based in Europe required a sleep apnea screener to replace an older technology product they were purchasing from another company.
Solution: Working with the client's marketing and engineering departments, Design Solutions created a design concept and did full software and electrical design of the product. In addition Design Solutions worked with the client's manufacturing department to bring the product through the initial manufacturing phases by providing functional test equipment, test software and manufacturing procedures.
Results: Met the criteria of the product specification, which met marketing requirements and allowed the customer to update their technology and increase sales margins with the elimination of the previous vendor. Product is currently being sold worldwide.
Oximetry Analysis Software
Opportunity: A pulse oximeter development company required a Windows based software program to replace a program they were purchasing from an outside vender.
Solution: Working with the client's marketing department, Design Solutions created a Windows application that transferred data from the customers oximeter products, performed advanced analysis, and provided customized reports. Data was then archived into a database for later review. Software was written to allow for multiple language use.
Results: Met the criteria of the design and allowed the customer to provide their customers with a more advanced tool to analyze and store oximetry data. Sales margins on this product were increased with the elimination of the third party software. Product is currently being sold in the US and Europe.
Cardio Pulmonary Exercise Recorder
Opportunity: The client needed to develop a ambulatory recording device to store and wirelessly transmit cardio pulmonary heart and lung function parameters.
Solution: Working with the client's engineering staff, Design Solutions designed a battery operated ambulatory recorder that interfaced to the clients proprietary sensor system. The device allowed for the recording of heart and lung function parameters during mobile exercise with wireless transmission to a base station.
Results: The product is currently being successfully introduced into the US and European markets.
Software Design Review
Opportunity: A medical device company was in need of objective design review of their software design practices.
Solution: Design Solutions evaluated all aspects of software design including coding techniques, documentation, testing, release and build procedures.
Results: With some recommendations the review assured upper management that the software being developed followed good medical device software practices.
Regulatory Review, Testing, and Reports
Opportunity: A client approached Design Solutions because they were not sure if their current product which met the UL944 standard was compliant to the newer UL2601 standard.
Solution: In addition to conducting a full pre submission review of the product, Design Solutions prepared the documentation necessary for submitting the device to the local UL testing laboratory. At the conclusion of the testing, Design Solutions completed the test reports required for the customer's in house documentation system.
Results: Client's product obtained UL2601 certification.
Impedance Cardiography (ICG) Monitor
Opportunity: A customer purchased an older proven prototype technology for measuring impedance cardiography. The design while proven, was only in prototype form and needed to be brought up to modern standards for medical product development, documentation, and manufacturing.
Solution: Working with the customer, Design Solutions completed a total redesign of the monitor into a single board system that could be interfaced to a laptop.
Results: The company obtained FDA clearance for the new design and is currently selling the a new modern device for measuring ICG.
First Responder Vital Signs Monitor
Opportunity: As part of a government grant, a company specializing in textile manufacturing developed a shirt with integrated sensors for monitoring emergency first responder personnel. The company needed a wireless system to measure and transmit signal such as heart rate, activity, position, respiration and body temperature to a portable base station for monitoring.
Solution: Working with the customer, Design Solutions designed and developed an ambulatory monitor that interfaced with the customer’s shirt sensors. This monitor continuously wirelessly transmitted the signals to a base station portable computer so the emergency coordinator could monitor each first responders vital signals. A graphical interface using colors for warnings alerted the emergency coordinator if a first responder was in trouble.
Results: These units were successfully tested with the Arlington County Virginia first responder teams under simulated disaster situations, allowing the customer to successfully demonstrate their sensor shirt.
Compartment Syndrome Monitor
Opportunity: A medical startup company developed a catheter for measuring pressure and draining excess fluid from traumatized muscle tissue. The company needed an instrument to supply periodic vacuum, measure blood pressure, and calculate/record/ graph compartment pressure.
Solution: Working with an outside industrial design firm, Design Solutions designed and developed a custom integrated instruments that included an integrated TFT display with touch screen that could provide the necessary monitoring. Simple menu driven software allowed clinicians to monitor patients while graphing and recording the pressure profiles. Data for each patient was archived. A USB interface was provided to allow for the transfer of data to a USB memory stick for archival and analysis on a personal computer.
Results: Twelve production prototype units were built and the customer is currently conducting clinical testing.
Design Solutions was founded in 1998 by engineers Jim Smith and Greg Schultz. Between them, Jim and Greg have over 40 years of experience developing medical devices.
Design Solutions has experienced steady growth since 1998 and now has 9 employees. Our employees are experienced, senior level engineers and technicians. Our senior level engineering staff has over 100 years of experience.
We are located in Watertown, Minnesota USA. Watertown is on the western edge of the Minneapolis/St. Paul Metropolitan area. The Minneapolis/St Paul area is home to many high tech industries. With its close proximity to the Mayo Clinic and the University of Minnesota Hospital, it has become the center for medical technology development in the United States.
Jim Smith
VP Engineering
605 Lewis Avenue North
PO BOX 549
Watertown, MN 55388-0549 USA
phone: (952)-955-3694
fax: (952)-955-3695
email: info@design-solutions.com
