Track record

HotSwap has since 2000 worked for over 300 customers, sometimes in very small assignments, sometimes in large projects. We have performed over 200 projects under our management. Below are some samples of products our engineers have participated in developing.

Implants
Making the human body accept implants is a challenging undertaking which involves choosing the right material for biocompatibility and designing mechanical structures which the body will accept. A single development iteration can require 3-6 months in animal trials, so minimizing the number of iterations is key to holding the total development time within an acceptable span. HotSwap employees have over 20 years of experience from implants for various purposes which reduces the time for trials by starting out with a good first candidate.

Analysis instruments

Measurement of a physical entity is the basis in a majority of products in medical- and biotechnology. They are commonplace in other fields too. Usually, the discriminating factor between leaders and followers in a field comes down to sensor principles and technology. HotSwap has experience from a wide range of sensor principles, optical, mechanical or electrical. Almost all measurement techniques require calibration, filtering, signal processing and data interpretation. HotSwap engineers have worked with a large number of different instruments which provides a wide base of measurement knowledge and several of our employees have doctorates in measurement technology.

CPU boards

Designing, testing, and making production-ready CPU boards for embedded systems are common activities in our projects. At the outset, balancing performance, development time, and production cost are important issues to solve in the early phases of a project. Component development is rapid so a constant eye on the offerings from suppliers is important. The latest hot microcontrollers have packed everything a small embedded device may need into a single chip, graphics, memory, USB, Ethernet and more. The new CPUs available also has the performance which can make embedded software development a whole lot easier as computing power is no longer a bottleneck.

Quality systems for medical device companies

All companies involved in production and sales of medical devices need a quality assurance system to make sure that the products are safe for patients and users. In the process of implementing a quality system many companies decide to incorporate many or all activities in the company. The end result is often a large, expensive and cumbersome system to follow and maintain. We started at the other end; what is the smallest set of procedures and roles that a small medical device company needs to assure that patients and users are safe? The result is a template quality system that we have adapted for numerous startup and small companies to get EC certificates and meet the FDA’s QSR demands.

CE mark medical device product in Europe

To market and sell a medical device product in Europe, the product needs to have a CE mark. To achieve this, the producer needs to assemble a collection of papers called a Technical File. The contents include project and quality plans, hazard analysis, requirement specifications, verification, and validations reports as well as many other documents. For turn-key projects, HotSwap engineers use our design controls and document templates to produce the right type of documentation during development that at the end are collected into the Technical File. For products introduced to the American market the corresponding documentation is called Design History File. There is substantial overlap between the contents of the two document assemblies.

Disposables

The syringe is a common device in medical treatment that has been around for a very long time. One way to break into this market is by innovation. HotSwap has developed several safety syringes which reduce the risk of sticks from the needle and prevents reuse of syringes in developing countries. The challenge is to develop mechanisms that are accepted by users, economical to manufacture and meets the safety demands of our customer.

Training products

It talks, it blinks, it cries, it breathes, it bleeds, it almost thinks… HotSwap’s team of engineers collaborated with the customer’s engineers to develop a training manikin that is filled with mechanics, electronics and software. The issues were in a wide range of engineering fields: quiet compressors, liquid flow measurement, RFID identification, real-time control, heat minimization and dissipation, training scenario handling, patient monitoring, test equipment, production adaptation, documentation; in short, a mechatronics project with many different technologies and challenges.

RFID

Identification of physical parts is done more and more by attaching an RFID tag on the part. There are several systems to choose from, differing in range, data storage and cost. RFID readers are commonly an OEM product, but the design of antennas is a careful balance between range, cost and mechanical integration. We have helped several customers integrate RFID reading capabilities by working with antenna design, OEM reader selection and software integration.

Award-winning design

In this project, the goal was to create a new brush which should satisfy consumer needs. The challenge was to combine economical, functional and aesthetic requirements. The result won an award for design excellence by the Norwegian design council. It is a typical example of how an integrated development approach can reach a compromise between different and sometimes contradictory demands and still be a design winner.

Telecommunication

A social alarm telephone is an important tool to provide safety in an independent living setting for persons with different kinds of disabilities. This product is sold in many different markets over the world and has to be adaptable for the particular communication demands of the respective local market. One feature of the project was to build automated testing scripts so that regression testing could be performed economically.

Water treatment

From 2009, all new ocean-going ships have to have equipment for cleaning their ballast water from biological organisms. In this particular project, UV-light and titanium is used in a patented method to achieve this. HotSwap developed a system as a turn-key project for the customer. It spanned a wide range of activities, from mechanical design, selection of pumps, production adaptation of titanium designs, electrical control of UV fluorescent tubes, PLC programming to test and installation on ships.

Catheters

A catheter is a tube that is inserted into the human body. It can be used to drain or inject fluids, measure parameters or perform procedures like angioplasty. One of many catheter projects HotSwap has performed involved designing a catheter for micro-dialysis in the blood stream. In micro-dialysis, a liquid is pumped past a membrane that will allow molecules to pass through. The liquid is collected and then analyzed for its contents. The project has come up with solutions for attaching a membrane onto a multi-lumen tube and designing a junction for separating the different channels of the multi-lumen tubing.

Graphical user interfaces

User interaction is more and more performed through graphical displays, ranging from small mobile phones to 21-in. touch screen monitors. Programming tools improve at a rapid pace as does technologies for incorporating sound, video, etc. A well-functioning user interface is however not about technology or flashy features. Coherency, understandable metaphors, and natural work-flows are key to building interfaces that users will understand. We have built graphical user interfaces on a variety of platforms with many different tools. The key to our successful results has been close cooperation with our customers and early users of the systems.

Anesthesiology

Sedation of patients is most commonly done either with gas-based anesthesia devices or with liquid injection devices. Our engineers have experience from working with both types of systems. We have worked in most anesthetic areas and with many different devices. The challenges of an anesthesia device lie in many different areas, control of gas flows, vaporization, material selection, flow measurements, control, user interfaces, alarm handling and many more.

Design for injection molding

Plastic parts are in products all around us. Above a certain production volume (sometimes surprisingly low) it is the most cost-effective way to produce. It also lends itself to complicated shapes and it is possible to build hinges, springs and other elements into them without additional parts. Our mechanical engineers are very experienced in how to design a part so that it suits an injection molding production method. Selection of plastic material gives additional parameters to realize the functionality.

Fluidics

In medical and biotechnological systems, pumping small and precise volumes of liquids are commonplace. In one project HotSwap designed a syringe pump that can give liquid flows in the range 0.1 – 20 µL with an accuracy of ±1.5%. Product cost and design were also important project goals. Although the project team was small, it was able to draw on input from other HotSwap engineers with experience from production methods, materials, and precision mechanics. Close collaboration with the customer ensured that the necessary technical requirements were met, market positioning established and production cost goals achieved.

Ventilation

Medical ventilators (helping the patient with respiration) come in a range of sizes and complexity. We have worked with devices from the simplest CPAP machines helping patients sleep at home to high-end intensive care machines. In some cases, production cost, ease-of-use or design are most important. In other cases it is high-end technical features such as particular ventilation modes or spontaneous breathing detection that sets the device ahead of its competitors. A ventilated patient does not typically have constant human surveillance. This means that the risk analysis of the device is extra rigorous; a failure in the device can very quickly lead to fatal consequences. Analyzing the device with FMECA and FTA are standard procedures for our engineers.

Measurement devices

The sympathetic nervous system of a human reacts to stress. One consequence is that we start sweating in the palm of our hands and feet. An active sweat-gland secrets salty water onto the skin. Measuring the change in electrical conductivity then is a measure of the stress level. A raised stress level can be caused by pain which – the avoidance of which, is important for patients.

The change in conductivity is very small so the device has to measure changes on the pico-ampere level. Use of a lock-in amplifier and filtering techniques made it possible to design a device that met these requirements.

Converting machined parts to injection molding production

Machined parts are typically an order of magnitude more expensive to produce than injection molded parts. With our expertise in injection molding we have been able to modify designs so that they can be produced this way. When the production volumes increase this gives our customers significant cost savings. The volumes at which investing in a molding tool becomes economically advantageous may be as low as a couple of hundred parts per year.

510(k) applications

A medical device that is to be sold in the United States has to get a market clearance from the Food and Drug Administration (FDA). If a similar device is already on the market, it is possible to file a 510(k) application which greatly reduces the amount of clinical testing needed. HotSwap works together with our customers in preparing the 510(k) application and the Design History File for the product. Our design controls are set up to make the project perform all critical activities at the right time and our document templates make producing the correct documentation easier. Sometimes we help customers with an already-finished product to assemble existing and fill in any gaps in the documentation.

Custom radio solutions

The frequency bands around 870 MHz in Europe and 915 MHz in North America are available for custom radio communication. HotSwap has developed, tested and put into production battery powered solutions with shifting frequencies and redundant radio protocols. Choosing the right hardware to meet the customer’s demands for cost, energy consumption and performance was the challenge of the project.