Pushing the boundaries of design.
Bringing medical, health and wellness products to market requires skill. We have skills in abundance and a strong track-record of making products which bring societal change from start-ups to seasoned entrepreneurs.
Finding routes to market in the NHS and beyond is challenging and requires innovative and efficient products that meet regulatory requirements and perform at the highest level. Our EXPLORE, DESIGN, MAKE process brings together the right people at the right time to achieve that route to market and make those products happen.
Our Explore stage is about asking the right questions. We will delve into your brief to understand the context and ambition and get to the heart of what really matters to you. Once we’re clear on your vision, we can assess all corners of your market, scrutinise your competition and examine how your product will be developed and manufactured.
Our team’s experience in human-centred design means we’re well placed to help you with usability research. We can explore all elements of who your potential users are, allowing us to MAKEyour end product genuinely effective, relevant and easy to use.
We can also draw on our expertise to guide your approach to investment, sharing our knowledge of what they’ll be looking for, as well as giving you opportunities to trial your pitches and get feedback in a supportive environment.
Our Explore process helps to strengthen your design ideas. We will look at the product from new angles and produce concept sketches and some first stage prototypes to trial different solutions.
Whatever stage your project is at, our services are designed to tease out the best direction for your product and help set a clear path through the design process. This ensures that when you take those vital next steps, you are heading in the right direction.
Explore with us to ask the right questions, even if they’re difficult ones.
Triteq are excited to collaborate with a global innovation consultancy working with individuals to develop and strengthen their knowledge to create opportunities to enable innovation. We look forward to sharing more exciting news on this in the next few months.
Human centred design
Problem solving through design
We produce complex, innovative product designs that are manufacture ready, user tested and regulatory approved.
Our industrial design development services address all elements of the appearance, functionality and manufacturability of your product whilst keeping in mind the people we are designing for. The needs of your users will be EXPLORED early in the process. From there, every sketch, idea and prototype will be carefully designed and tested to keep your users at the heart of the process.
We begin by working with you to build a clear understanding of your product requirements. The sketching of initial concepts and ideas then allow for the development of a design direction. Working from these sketches and utilising the latest 3D CAD software, we will DESIGN, feedback and assess until your model is ready to be prototyped.
Our design for manufacture approach means your design is optimised for full scale manufacture from the first prototype. Our in-house facilities are a perfect resource for the development and testing of early prototypes and we have an exceptional manufacturing team that are able to assist with a variety of low volume manufacture projects. We also have trusted third party connections that can assist us with larger volume manufacturing.
The design and development of medical devices requires expert knowledge of quality standards and regulations. We have vast experience in working to these standards and we understand the challenges, pitfalls and time it takes to gain CE marking and FDA certification. We are therefore well placed to help you get your product onto the market.
Our recent work has included designing the next generation of diagnostic devices which can remove subjectivity, increase accuracy and deliver results in real-time across clinics world-wide. These devices have safety and quality at the heart of their development and our approach has ensured that the products we deliver exceed expectations.
Triteq have been working super hard on producing a suite of reports to support our Explore, Design, Make process. These take into consideration all the important aspects required, whatever stage you are within your product development. If you are interested to know more about our reports why not get in touch.
Building a game changing medical App
Developing Apps of the future
Into the Fire(base)
Triteq’s Senior Mobile Application Developer shares his own experiences of developing game changing medical Apps.
Prior to joining Triteq, I had 18 years’ experience as a software developer in the defence, e-commerce, telecommunications, and financial sectors. I was a proficient full stack Java developer with some native mobile app development experience. When offered, I jumped at the opportunity to develop mobile apps at Triteq as I felt I could turn my skills to a worthy cause.
At the time it was unknown to me how to develop a medically certified app. However, it soon became clear that, at least at the code level, it wasn’t all that different to how you develop a commercial app. The difference lies in the regulatory aspects, which have to be at the heart of development from the very beginning to delivery of the product and beyond. Triteq have a proven track record of developing medical products for almost 3 decades, with expertise and experience in house to get medically certified products and software onto the market.
Over the past 5 years at Triteq, I have been involved with a number of mobile apps across the medical and commercial sectors. One app in particular I have been involved with from the very start is a potential game changer in the medical app space. This project has given me significant insight into the challenges of developing a medical app. Below I am going to take you through some of the considerations required in the development of a medical mobile app.
What is a medical mobile app?
In order to understand the requirements for developing a medical app, you must first consider what a medical app is defined as.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) considers a medical mobile app as a medical device and refers to the EU Medical Devices Regulation (MDR) for its definition. The MDR classifies a medical device as a device in combination with software for use on human beings intended for the purpose of diagnosis, prevention, monitoring or treatment of a disease or injury.
In the US, the FDA defines a medical mobile app as software running on a mobile device such as a smartphone or tablet that functions as an accessory to a regulated medical device or if the mobile app software transforms the mobile device into a medical device.
Examples of medical mobile apps include:
- Reference apps which offer drug dosage and medicine recommendations.
- Apps which attach to a medical ECG device to measure heart activity in order to diagnose Atrial Fibrillation.
In order to begin developing a medical software, an organisation must have a Quality Management System (QMS) in place. This is a set of processes, audited to ISO62485, which an organisation must follow to deliver a safe, quality product.
Software Development Lifecycle
Once you have determined that your app fits under the category of a medical mobile app and your organisation has a QMS in place, you must then ensure that you are familiar with the software development lifecycle of such an app. Luckily, IEC 62304 is an international standard which defines what processes, plans and technical documentation you need to produce throughout this lifecycle in order to comply with regulatory requirements.
The extent of the requirements needed depends on the safety classification (Class A-C) of the software being created. Class A is defined as software that would cause no injury or damage to the health of the user whereas Class C is software that could cause death or serious injury. It is important to get this classification right and sufficiently justified from the very start as it determines what is needed to comply with the regulations from there on in.
A risk management process can be used to determine and justify the software safety classification as a whole. During this process, plausible scenarios and events which may cause harm to the user must be identified, recorded and analysed. If necessary, a Risk Control measure, such as displaying a warning on the app, will then be put in place to mitigate the risk. It is important to correctly identify and mitigate these risks to determine an accurate safety classification. When asked what the main difference between medical and non-medical app code is, I say, it’s all in the Risk Control measures applied to it.
Verification and Testing
It should be fairly obvious that verification and testing are an important part of the development of medical software. Right at the very start of the development lifecycle you will have captured a list of product requirements, which in turn will trace to a list of software requirements. Each software requirement will need to be verified in order to ensure that the end product operates as intended.
As with non-medical mobile development, verification should be completed against a variety of devices running a range of operating system versions. Obviously, it isn’t possible to test against the huge number of device and operating system combinations, especially on Android. Therefore, you must produce a rational justifying your approach to verification and how you decided which devices are used for testing.
After each verification, a report must be produced which records details of the verification, its conclusion and any issues found must be recorded and assessed against verification procedures.
Testing should not stop there. Verification against requirements only uncovers issues as a direct result of executing the requirements verification method. To uncover issues and artefacts in the app which aren’t linked to a specific requirement, QA testing must be carried out. For example, soak tests which are designed to emulate prolonged and excessive use might reveal issues that otherwise wouldn’t have been found until it is in the hands of the user. This isn’t specific to medical app development, it’s good practice.
Any software used by your mobile app, directly or indirectly, that you didn’t create yourself under your software development lifecycle is known as Software of Unknown Provenance (SOUP).
When developing mobile apps, its commonplace to use 3rd party libraries to provide certain pieces of functionality within the app as it saves time and brings down costs. Whether you’re using Realm to provide persistent storage for data, Firebase for collecting analytical insights into the usage of the app and crash report or a charting library to display graphical charts. In the unusual cases where 3rd party libraries aren’t used, an app will still be utilising the framework provided by the operating system to run the app and, at the very least, you will have the iOS and Android operating systems that the app is running on along with drivers to control the hardware on the device. All of this should be considered as SOUP.
IEC 62304 requires us to carefully consider the risks that using these items may pose to the medical app and it’s users. Generally, SOUP items are not under your control and they may contain bugs causing unexpected behaviour or malicious code. As such, it’s required that you take a risk-based approach to ensure it is safe and acceptable to use and to determine how it can be verified.
Over the past few years, security of medical apps and devices have become a focal point for regulatory bodies such as the FDA. Cybersecurity is generally a concern in all apps, but medical apps are especially exposed as they generally run on a device connected to the internet and tend to use a lot of SOUP items. Although it is unlikely that every threat can be eliminated, part of the risk management process will consider cybersecurity risks and the controls that can be put in place to mitigate them.
A few examples that may be considered include;
- A malicious app is installed on the user’s device and attempts to access the medical apps database.
- An attacker attempts to intercept the Bluetooth traffic between the medical app and a medical accessory using a man-in-the-middle attack.
You must also have a process for cybersecurity analysis and testing of your app, whether that be running penetration testing tools or using 3rd party security testing services. Regulatory bodies will require evidence in the form of cybersecurity test reports which show any issues found along with rational on what you intend to do about it.
I hope this has given you a brief insight into some of the challenges faced during the medical app development process. Please get in touch if you think we can help your app to become the next game changer.
We design, engineer and produce superior products to make a dynamic impact on target markets.
Triteq are a product design consultancy with over three decades of experience bringing medical, health, and well being products to market. We can offer assistance whether you are a start-up, seasoned entrepreneur or established company, at any stage of your product development. When you work with us, we become part of your journey.
Nurturing new ideas from concept all the way to market presents challenges which need to be assessed, EXPLORED and understood. Our Explore, Design, Make process gathers the right people at the right time to deliver intelligent design and skilful engineering – bringing practical, imaginative products which can enhance lives.
This process is circular. We research, design, feedback, prototype, test, measure and assess. This tried-and-tested approach delivers products with functionality and form, built from appropriate materials, and engineered to achieve a defined purpose.
At the start of every project we brief the team, ask questions and brainstorm ideas. This initial investigation will define a design direction that ensures your path to market is future-proofed and meets regulatory standards. Our process allows you to be connected and closely involved with the team through every stage of your project.
Our team boasts a wealth of knowledge and accumulated experience, with a proven track record of managing breakthrough projects; from life-changing medical devices to apps which harness technology to improve health.
Get in touch with us to take the next steps in your product development journey.
Smart, efficient and beautiful design.
We bring ideas, products and innovations to life through flawless, life-changing design underpinned by technical skills and industry experience.
Based on a razor-sharp brief, honed through our comprehensive EXPLORE phase, our designs follow a human-centred, design-for-manufacture approach that will help you get everything you need to MAKE your product a physical reality.
Our goal in this phase is to get a clear, detailed, and robust set of designs through an extensive, iterative process. We work through ideation, testing and refinement to produce innovative designs of your idea.
The best designs consider the manufacturing process at an early stage. That’s why we explore your project realisation route before getting creative. It’s about designs that are fit for mass production and distribution.
We then scrutinise the details. We spot and solve potential problems as early as possible with computer simulations that analyse every element of your design. Our usability experts test your design on real people and use their feedback to ensure that your product provides a desirable experience for your users.
If you’re looking for material to support a grant application, to keep stakeholders up to date, or simply to show off your idea, we can produce visually stunning animations, videos and images of your product design.
Whether we’re providing an inventive 3D design or bringing your product to life through animation to support global investment, we can steer you through your design journey. We have been there before; we know what questions to ask.
Design with us to ensure every decision is made for the right reasons.
Triteq supports innovative design and as part of this, we sponsor a number of the Undergraduate/Master poster competitions.
Software electronic engineering
Software superior by design
Our skilled developers produce smart, bespoke software solutions to enhance your product design.
The crowded digital market and complexities of bringing a new product into the NHS means your idea needs to stand out. Our software and electronic engineering services can provide you with functionality that can take your product to the next level. From PCB design and software integration, to testing, verification and release, we can assist you with the full life cycle of development.
Every project is carefully planned out. Our initial stage will capture your software requirements and develop a system architecture plan which will form a solid foundation for our development. During this stage, we will determine the most appropriate development models, scripts and languages and EXPLORE the application and integration of new technology.
Our experts are well-equipped to create unique PCB designs and develop a wide variety of both hardware and software. We keep safety at the heart of development by incorporating risk management, cybersecurity and the removal of unsafe and unstable software into our process. Once your software has been DESIGNED, tested and verified, we can support you through commercial software release and ongoing software maintenance.
At each stage, our regulatory team align with our software developers to ensure we adhere to the relevant regulations. We have expertise in release management and software verification, well-established partnerships with external test houses and are accredited to ISO13485 and ISO9001. We can also help you to fully implement quality management systems to a range of requirements, which include providing training for you and overseeing notified body audits.
Our team keep abreast of the latest technology and relish a challenge. We recently completed the incorporation of complex electronic functionality into a pre-developed drug delivery device. The high level of functionality required plus the restricted space for components, meant this project was not without stumbling blocks. However, our team of knowledgeable electronic engineers rose to the challenge, explored every possibility and were able to overcome these obstacles to develop a solution that doesn’t just work, but works well.
Due to our vast regulatory expertise Triteq were invited by Medilink and WEAHSN to present a regulatory webinar, introduction to ISO13485. This was a resounding success which has led to further webinars which we look forward to sharing with you soon.
Supporting start ups
Passing on knowledge, expertise, and experience.
We believe in starts-up. They are dynamic, imaginative and passionate and we love working with them. At Triteq, we are proud of our track-record of supporting start-ups.
As well as the work we do in helping entrepreneurs not just in exploring, developing and designing their products, we also continue to support key growth schemes and provide free advice.
In 2018/2019,we worked with start-ups at the IMAGINE IF innovation event , The Design Council and also sponsored Young Entrepreneur of the Year Award for OET.
Participating in these events and working directly with many start-ups has helped us create our Explore Workshops.
We use these workshops to pass on invaluable knowledge, expertise and experience to budding entrepreneurs, identifying the many different elements to bringing a concept to life and taking that concept to market.
We invest in talented, passionate people who are committed to designing innovative products that can make a difference.
We have a diverse range of talent in our team and a friendly, collaborative atmosphere.
But if you are looking for a career in product design, we are always on the lookout for brilliant people to join our tribe. If you have some awesome skills we would still like to hear from you, as you never know, you might be just what we are looking for.
Contact us at firstname.lastname@example.org
If you are a recruiter, please note that we don’t accept unsolicited applications or CVs from third-party recruiters. Anything submitted to Triteq by a third-party will be considered to be unsolicited and our property, without further obligation.
Seamless Design for Manufacturability.
Our design for manufacture approach means your DESIGN will be optimised for full scale production right from the first prototype. The size and expertise of our team allows us to conduct this process in-house. Together they EXPLORE, develop then rigorously test and refine every element of your product to make sure the design is working as it should be.
Our cutting-edge 3D-printing and rapid-prototyping technology allows us to produce prototypes at an early stage of your product development. Our skilled engineers can create bespoke software solutions and integrate complex electronic functionality into your design. We can also bring your product directly into your user’s pockets with sophisticated and functional mobile applications across a range of platforms and devices.
To cover every skill required for every project, we have trusted third party collaborators that can complete specific areas of work to keep your project moving and to stay on budget.
Our expertise in designing products for use in a wide range of medical, healthcare and commercial areas means we’re clear on exactly what it takes to satisfy vital industry regulations and quality standards. We also work with external test houses to manage and support regulatory processes such as CE Marking and FDA approval, so nothing stops your product getting onto the market and into the hands of the people who need it.
From working with a diverse range of clients in highly-specialised industries, we have built a comprehensive process which exceeds expectations and ensures your project achieves targets for time, quality, reliability and regulatory compliance.
Make with us for solutions that work for the people of today and tomorrow.
We recently completed our ISO13485 audit, the first one to be done remotely. Working alongside the lovely people from BSI UK has made this possible and has ensured our Quality Management System continues to work for us.
Embracing the digital world
We can bring your product directly into people’s hands by developing sophisticated and functional mobile applications across a range of platforms and devices.
New opportunities in the digital age have allowed health products and systems to become more intelligent and mobile. For emerging technology to be successful in the market, it needs to be ready for the future now. Our app development services can MAKE that happen.
Our EXPLORE phase will shape the foundations of your idea and build a picture of your vision. The requirements developed in this stage will then be turned into something that is functional and cohesive to your user. The DESIGN of your app will be developed from wireframes and visual images and then tested and refined using focus groups.
Our experts employ an agile approach to development using the latest app development tools, frameworks and languages. Whether you require a hybrid app to work across both Apple and Android platforms, or a fluid native app, we can lead you down the best route for your requirements. Our services can also maintain and support your existing legacy apps or migrate them to modern frameworks and languages.
Our journey with you doesn’t end once your app has been developed. We work closely with you through launch and to solve those initial teething issues when your app first goes live. We can also perform regular maintenance cycles to fix issues, provide new functionality and keep up with operating system updates.
Our extensive regulatory experience gained through years of medical software development means you can be assured we are able to deliver an app which meets your regulatory requirements whether that be CE marking for the EU market or FDA approval for the US.
Privacy of personal data has gained focus over the years which is why we also consider the regulatory impact of HIPAA and GDPR requirements when developing apps for market, whether they be medical or non-medical.
Our most recent post further explores the impact of regulatory requirements on medical app development.
Opening more doors
A new location in Oxford and the launch of The Engine Room
Bringing a new and unique product to life at Triteq is all about collaboration.
Bringing a new and unique product to life at Triteq is all about collaboration. Our UX designers talk to our app developers, our industrial designers work alongside our regulatory experts and our project managers make plans with our production team. We talk to ensure we form a successful whole, with individual brilliance.
We’ve always made collaboration a top priority, priding ourselves on avoiding the outsourcing so many companies rely on and managing a project in-house from end to end. In the past ‘in-house’ literally meant that everything happened in our Hungerford home, with all our collaborators working in one space. But the Triteq team is growing so much that we are now opening more doors for our clients. We have created The Engine Room in Hungerford and we are excited to move into our new Oxford home very soon.
Investing in our dynamic workforce.
The ambition and diversity of experience in our team allows us to take on a range of challenges.
Our electronic engineers are critical thinkers with extensive development experience in a variety of programming languages and skilled at fully integrating systems.
We have masterful Web and App developers experienced across a wide range of operating systems and devices.
Our creative industrial designers translate ideas into detailed design. They tackle every challenge with a design for manufacture, human-centred approach to produce sleek, well thought-out products.
Our human factors experts carefully study the interaction of human behaviours, capabilities, and limitations to ensure we work in harmony with technology.
For every project we bring together a mix of talent, skills and knowledge. We believe in order to work well together, we have to do just that.
Work. Well. Together.
Our app designers share ideas with our electronic engineers. Strategists work with regulatory experts. Software developers discuss opportunities with account managers. Every project brings together key people who remain connected through every stage.
The Oxford Trust Enterprise Awards recognise and celebrate the breadth of innovative science and technology companies and entrepreneurs working in the region. Triteq were sponsors of the Young Entrepreneur Award– celebrating the outstanding performance of the young founder/s (under 40) of an innovative science and tech company.
Bringing life changing products into the hands of tomorrows users
During these challenging times we are proud to have remained open supporting our wonderful customers bring life changing products into the hands of tomorrows users.