Blog posts - Thaumatec

There are for sure many women who changed the technical and technological world, but here is a selection of 10 women- researchers, technicians and engineers which did remarkable investigations which strongly boosted the progress on computers, networking, programming and computing.

These technology inventions provide besides for many other industry domains the base for development of innovative products in the areas of digital Health, medical devices, production in the medicine industry and many other puzzle parts of the current and future HealthTech.

Ada Lovelace: The World’s First Computer Programmer

Ada was the daughter of romantic poet, Lord Byron, and his wife, Anna Isabella-Byron. Her mathematical talent shone through in her early life, and her skills and interest in machines lead to a working relationship with Charles Babbage. Babbage was the inventor of the “Analytical Engine”, a complicated device that was never actually created, but resembled the elements of a modern computer. As a result of her work on the project, Ada is often referred to as the “world’s first computer programmer”. It was Lovelace’s notes on the Analytical Engine that Alan Turing used as a form of inspiration for his work on the first modern computer in the 1940s.

Ada Lovelace

Grace Hopper: The Esteemed Computer Scientist

Undeniably famous in the tech world, Rear Admiral Grace M. Hopper was an esteemed computer scientist and one of the first computer programmers to work on the Harvard Mark I. Her work led to the development of COBOL, an early programming language we is still used to this day. In 1947, she recorded the worlds first ever real computer bug, and it is also said that she coined the phrase: “it is often easier to ask for forgiveness than to ask for permission.”

Grace Hopper

Hedy Lamarr: The Inventor of WiFi

Hedy was a self-taught inventor and film actress, who was awarded a patent in 1942 for her “secret communication system”, designed with the help of the composer George Antheil. This frequency hopping system was intended as a way to set radio-guided torpedos off course during the war, but the idea eventually inspired Wi-Fi, GPS and Bluetooth technology commonly used today.

Hedy Lamarr

Annie Easley: The NASA Rocket Scientist

Annie was a NASA rocket scientist, and a trailblazer for gender and racial diversity in STEM. When hired, she was one of only four black employees at the Lab. 34 years later, she had contributed to numerous programs as a computer scientist, inspired many through her enthusiastic participation in outreach programs, and broken down barriers as equal employment opportunity counsellor. Easley’s vital work on the Centaur rocket project while at NASA laid the foundations for space shuttle launches in the future.

Annie Easley

Mary Wilkes: The First Home Computer User

Mary is a former computer programmer and logic designer. She is best known for designing the software for the LINC, one of the earliest systems of an interactive personal computer. Her use of the LINC at home in 1965 made her the first ever home computer user, and her work has been recognised at The National Museum of Computing, Bletchley Park.

Mary Wilkes (at home with the LINC)

Adele Goldberg: The Inspiration For GUI

Adele was instrumental in the development of the programming language Smalltalk-80, which inspired the very first Apple computer. Adele is said to have referred to the decision to show Steve Jobs Smalltalk as a way to “give away the kitchen sink”. She was probably right! The concepts that Adele and her team set in motion became the basis for graphical user interfaces (GUI) we use every day.

Adele Goldberg

Radia Perlman: The Mother Of The Internet

Nicknamed “Mother of the Internet”, Radia’s invention of the algorithm behind the Spanning Tree Protocol (STP), was instrumental in making today’s internet possible. Her work made a huge impact on the way networks self-organize and move data, and put the basic rules of internet traffic in place. Radia has delivered keynote speeches across the world, and is still a computer programmer and engineer for Dell EMC.

Radia Perlman

Katherine Johnson: The NASA Mathematician

Katherine’s trajectory analysis as a mathematician for NASA was crucial to the success of the first ever US space flight. Her complex manual calculations were also critical in fuure space missions, including the first American in orbit, John Glenn. Katherine ran the numbers programmed into the computer at NASA for the flight by hand, at the request of Glenn. Katherine remembers him saying “if she says they’re good… “then I’m ready to go.” At age 97, she was awarded the Presidential Medal of Freedom, America’s highest civilian honour, by President Obama.

Katherine Johnson

Karen Spaerck-Jones: The Pioneer in Information Science

Karen was a pioneer in information science, and her work is some of the most highly cited in her field. Her development of Inverse Document Frequency (IDF), a weighting factor which evaluates how important a word is to a document, is now standard in web search engines and used to rank a document’s relevance to a search query. She received the highly acclaimed Lovelace Medal in 2007!

Karen Spaerck-Jones

Elizabeth Feinler: The Original Search Engine

Between 1972 to 1989, Elizabeth ran the Network Information Center in California, which was a bit like a “pre-historic Google.” The NIC was the first place to publish the resources and directories for the Internet, developing the original “white pages” and “yellow pages” directories. Her group also developed the domain naming scheme of .com, .edu, .gov, .net, and many more that we use so commonly today.

Elizabeth Feinler

HealthTech Industry Update | Femtech Innovation on Postpartum Depression (PPD)

What is PPD: Though most new moms recover and begin to adjust to motherhood within a couple of months, up to 1 in 3 will also struggle with postpartum depression.

Giving birth is undoubtedly one of the most natural of all physiological experiences and many moms struggle with postpartum depression and its effects leave many lingering physical and psychological footprints on new mothers’ lives.

Quite different from the transient “baby blues,” PPD can last for months. PPD has been a recognized and stigmatized, possibility during the so-called “fourth trimester of pregnancy” for generations.

⚕️Now it is being firmly addressed through Femtech innovations⚕️.

About Femtech first

Women are being heard like never before, and it is absolutely incredible. The #MeToo movement has created a domino effect of sorts, as company policies that address women’s needs and long-shuttered opportunities for women are increasingly flooding into the mainstream. That includes the tech world, where a newfound emphasis and expectation on coding, software development, and entrepreneurship has been placed on aspiring women.

Not only are women being welcomed into the industry, but they’re also suddenly at the forefront of creating technology that serves and benefits them.

Femtech — apps, devices, services, and other products that focus on women’s health and wellness — is becoming a key player in tech discussions. Femtech ideas have received more than $1 billion in funding between 2015 and 2018, and the industry is poised to become a $50 billion market as soon as 2025, according to a 2018 report by Frost & Sullivan.

Investment in Femtech is certainly growing, but it’s at a shockingly slow pace, considering its potential. The U.S. Food and Drug Administration has cleared more and more femtech applications and products over the past few years, so companies are definitely aware of the buying power of women. However, companies and funders need to recognize the growing power and potential of this new growing category, too.

(readwrite.com, Femtech Is Becoming More Influential. But Is the Market Healthy?)

About Postpartum Depression (PPD) which is now being firmly addressed through femtech innovations.

Postpartum depression (PPD) is a type of depression that happens after someone gives birth.

After childbirth, a dramatic drop in the hormones estrogen and progesterone in your body may contribute to postpartum depression. Other hormones produced by your thyroid gland also may drop sharply, which can leave you feeling tired, sluggish and depressed.

Postpartum depression doesn’t just affect the birthing person. It can affect surrogates and adoptive parents, too. People experience hormonal, physical, emotional, financial and social changes after having a baby.

Here some overview and risks:

🧑‍🍼 PPD affects 1 in 9 women

🧑‍🍼 PPD can last for months

🧑‍🍼 Other medical conditions often reflecting pre-existing illnesses, infection or sepsis.

🧑‍🍼 Excessive bleeding after giving birth (hemorrhage)

🧑‍🍼 A disease of the heart muscle that makes it harder for your heart to pump blood to the rest of your body (cardiomyopathy)

🧑‍🍼PPD with Femtech health solutions improve mothers situations

Femtech Innovation Application Examples :

➡️️ She Matters platform, which makes talk therapy more accessible (and budget-friendly) for Black moms as according to the Centers for Disease Control and Prevention the mortality rate is almost three times the rate for White women.

➡️ Poppy Seed, empowers women, especially marginalised women, diagnosed with (or with suspected) PPD to take charge of mapping their postpartum care plan and feel more in control in a new and important time of their lives. Poppy Seed provides on-demand and chat-based pregnancy, postpartum, and loss support.

➡️️ LactApp and MyLee focus on the postpartum and lactation needs of new parents. Both are app-based solutions set up to help mothers gain a deeper understanding of how they’re lactating.

Femtech: Birthing breakthroughs for new moms

Healthcare is challenging to navigate under the best of circumstances. But when you have a new crying baby at home and are managing new mental health and physical challenges, it is completely exacerbated.

With Femtech health solutions, mothers have more avenues to improve their situations during the postpartum period and can hopefully start to recognize that they are not alone! 💪

Here the whole article by MedCity News: https://medcitynews.com/2023/09/how-femtech-is-filling-historical-gaps-in-the-postpartum-space/

Other interesting blogs: https://thaumatec.com/knowledge/

HealthTech Industry Update | Healthcare Technology Trends in 2023

From virtual care to artificial intelligence and robotics, to the Internet of Things, there are emerging technologies that will shape the healthcare industry in 2023 and beyond. Here an overview of the technologies which have the most impact on the global healthcare and medical systems.

Internet of Medical Things (IoMT) will transform Medicine

IoMT devices connect patients and physicians
real-time condition patient data is available
Technology manufacturers and suppliers with health technology providers to provide best treatment
IoMT e.g. drives the growth for heart monitoring, Health alerts and fitness
In-home patient monitoring
smart clothes and wearable devices with new and more accurate sensors
IoMT in health care facilities for Patient Monitoring

Artificial Intelligence and Machine Learning supports:

Diagnosis & Monitoring
track patients health and personalised care
Predictions & trends
Accuracy of remote diagnosis
Medical Image Analysis
Accelerate research and drug discovery and drug treatment adjustments
The global AI Market reached 11 billion in 2021, till 2030 a growth of 37% is expected.

Cloud usage for medical and healthcare data and documentation

Hospitals
non-emergency medical transport providers
Medical billing services
real time tracking
Robust encryption and security systems needed and secure data backup.

Data Sharing and Interoperability between Healthcare organisations

From own providers database to universal database
Comprehensive picture of patients of diagnostics and treatments
Secure Access to medical information

Data breach prevention due to IoMT and digitalization

Special solutions and measures by governments and technology companies

Facial Recognition

Deep Learning facial algorithms
Medical facilities use it for security, control and data access

Smart technology, implants and robotics

Regenerations, Implantations, Prosthetics
Personalized
Cost reduced
3D printed
New lightweight materials

Growth in demand of Healthcare Software, connectivity, accessibility and digitalization

Devices and Tools
Patient portals
Telehealth
Hospital Management
Patient monitoring, 24 hours
Medical billing and invoicing
Diagnostics
Non-emergency transport
growth in mobile devices and applications
5G access, speed and improved latency

Nano Medicine

Biocompatible nanoparticles and nanoelectronic devices
Study diseases on cellular level
Self-replicable bots

Virtual and Augmented Reality

Education of medical students
Remote treatment and therapy
Patient interaction
Digital twin of the body

Healthcare and Medical industry will continue to grow in 2023 and beyond, with research and new technology which will foster digital tools, connected devices and remote consultations and monitoring, patient supply with medicine and fast help in case of emergency and many new features and improvements more.

Have a look at the video from iSi technolgy:

HealtTech Industry Update | Top Medical Innovations 2023

The Medical Futurist Dr. Bertalan Mesko published beginning 2023 the prognosis of Top 7 medical innovations. There a lot of activities around healthcare digitalization and electronical medical devices ongoing, some in the trial state some for piloting.

Now, after almost 9 Month we can say that most of them are globally many steps further.

The 7 innovation and areas are:

Async telemedicine
- Consutlation which is not taking place live
- medical data is sent for analysis
- Reply will be later
Ambient and emotions A.I.
- does not disrupt your attention but makes you feel comfortable (light, music,..)
- A.I. conversation makes you feel good (transfers emotions)
Skin patches for measurements of vitals
- wireless measures
- vital signs and health parameters
- blood pressure, glukose, …
Affordable vein scanners
- hand held devices
- monitoring veins under skin with UV light
- chose which veins for blood samples
- preventions of mistakes
Synthetic medical records (e.g. GAN)
- data quality improvement
- GAN Generative Adversarial Records
- Data used in Clinical Trials anonymized
Blood draw devices in clinical trials
- Remote blood testing from home
- Delivering all needed data to the clinical trial organization
- Easy to use
- Trials ongoing
smart TVs for remote care
- Smart TVs used as remote care platforms
- many pilots around the world

Thanks a lot Dr. Bertalan, great selection! End of the year we will see which ones are already certified, operational and used.

Here the complete video:

HealthTech Industry Update | Telehealth Visits Lead to Fewer Follow-Up Visits Than Office Visits

The Epic Research study found that 16 out of 24 specialties had higher follow-up rates within 90 days of an initial office visit than a telehealth visit.

This concerned the medical areas:

mental health
physical medicine and rehabilitation
pain medicine

with more than 20% higher follow-up rate after an in-person office appointment than after a telehealth appointment.

For the medical domains:

ophthalmology
obstetrics and gynaecology
podiatry
ear, nose and throat
dermatology
allergy
paediatric
internal medicine

had an at least 9% higher in-person follow-up rate after telehealth appointments than office appointments.

In future studies it will be checked as well both the complexity of visits between telehealth and in-person care and the effect that insurance coverage has on telehealth utilization.

Recommendations:

The government and policymakers should use them to inform future regulatory and funding efforts that affect the adoption of telehealth services.
For payers, these findings suggest that telehealth can be a sufficient way to provide care, something that should be considered when determining coverage.
Health systems, meanwhile, should continue offering telehealth as it may be patients’ preferred way of receiving care.

Have a look at the article in MedCityNews and the comments of Jackie Gerhart, chief medical officer of Epic Research.

https://medcitynews.com/2023/07/telehealth-healthcare-virtual-mental-primary-care/

HealthTech Knowledge Guide | What you should know about Clinical Trials

In EU for medical devices and Software of Class 2b and Class 3 and Class 3 in USA/FDA have to prove that all criteria of the:

MDR (Medical Device Regulation) https://thaumatec.com/knowledge/blog-posts/healthtech-knowledge-guide-healthtech-standard-highlights-mdr-iso/
IVDR (In Vitro Diagnostics Medical Device Regulation) https://thaumatec.com/knowledge/blog-posts/healthtech-industry-update-in-vitro-diagnostics-device-ivd-regulation-implementation/
FDA (United States Food and Drug Administration) https://thaumatec.com/knowledge/blog-posts/healthtech-knowledge-healthtech-standard-highlights-iec-fda/

is fulfilled.

One point in this Regulation is to undergo Clinical Trials (or Clinical Studies or Clinical Investigations).

The safety, function and value-add of the Devices must be Bench testing, Technical testing, Computer simulations, Animal studies must be checked and documented. Pre-clinical activities do not use human subjects in this case.

There are different pathways for the US and EU.

In the US, medical device manufacturers that want to pursue a clinical trial must obtain an Investigational Device Exemption (IDE).

Here as well a blog post by Thaumatec where you can have a look about the processing: https://thaumatec.com/knowledge/blog-posts/healthtech-industry-update-from-the-idea-to-a-medical-device/

In the EU MDR has 20 articles for clinical investigations of medical devices that are relevant. Within these articles, the regulation lays out three regulatory pathways manufacturers can take

During the premarket and postmarket phases of the device clinical trials may be executed.

Early Pilot studies

in the device development when nonclinical testing is unable to provide information on device functionality and clinical safety at this point of time.

Pivotal studies

are used to gather definitive evidence of the safety and effectiveness of your medical device for a specific intended use.

post-market surveillance

includes both confirmatory and observational types of clinical activities.

Observational clinical activities

Many post-market clinical activities are categorised as “observational” and they use non-interventional methods to collect data.

Some devices may need:

clinical data from all of these categories
many will not.
low risk devices relying on well-known technology may not require any clinical investigations

Here a nice video about clinical trials globally…

And here an article “Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained” from Jon Bergsteinsson in Greenlight Guru:

https://www.greenlight.guru/blog/medical-device-clinical-trials

Knowledge Database | IOT Connected Prototypes

Thaumatec had experienced a lot about the steps during the deployment of an IoT innovation and the prototyping phase. Most of our prototype projects have been done in an iterative and often rapid way.

There are several methods of industrial design prototyping: iterative, parallel, competitive, and rapid. These different methods of prototyping produce varying models of proof-of-concept during the product development process.

Iterative

Iterative prototyping involves creating a prototype from the product design, testing it for usability and functionality, and then revising what didn’t work. After testing has concluded, the research team will design a new iteration and manufacture it for testing. The old iteration is then thrown out or set aside. Iterative prototyping is practical and allows for quick identification of challenging design problems but can be expensive and wasteful depending on the number of iterations required.

One kind of iterative prototyping is evolutionary prototyping, that removes the need for more than one iteration. The idea behind evolutionary prototyping is to gradually refine the first iteration as improvements are identified based on incoming feedback. Eventually, the first and only prototype becomes the final product after extensive machining and revising.

Rapid

Rapid prototyping is a more recent product design testing method that incorporates some aspects of the iterative process. This method is fast and accessible for product designers who can access CAD software and 3D printing technology in-house. Rapid prototyping utilizes innovative technologies—CAD software and 3D printing—to create seamless data transfer from computer to printer. This method is an affordable way to run usability and functionality tests on newly printed mockups.

Previous methods might take a few days to manufacture and compare iterations of the product depending on fabrication technology and communication requirements. Rapid prototyping is a process that could be minimized to a daily cycle where the new product iteration is designed/revised during the day and then printed overnight.

Parallel

On the other hand, parallel prototyping is a concept-based method where several design concepts are compared concurrently. Multiple designs are drafted and then compared to find the best versions before a physical prototype is manufactured. This method promotes creativity and conceptual ideation. Parallel prototyping can be expensive due to a large number of contributing factors.

Subsequently, there is a parallel prototyping version — competitive prototyping — where multiple design teams develop concepts independently. Competitive prototyping is useful for larger projects that have the potential for higher risk factors.

Competitive

Competitive prototyping is an approach in which two or more competing teams (organizations) develop prototypes during the early stages of a project (acquisition or procurement phase.

The competing prototypes are compared, and ultimately the one that best addresses the issue(s), problem(s), or challenge(s) is chosen).

Prototype PoC projects can be handled like this:

Here are the main steps, we found out, which are the most important ones in this method.

How come from the idea to a concept ?

Every IoT project starts with an idea. Nowadays for producers it is possible to quickly turn those ideas and concepts into something real.

For the concept it is important to have the most important requirements and key data is defined and checked, the details can be fine tuned later.

In many cases, a cheap processing board like Raspberry Pi or Arduino is enough for this purpose. For Connectivity often a physical cable to link the sensor to an standard IoT gateway is enough, although Wi-Fi, LoRa, NB-IOT or other radio technologies are essential already needed and the more likely option. The selection of the right connectivity technology is very important as it influences the IOT system behaviour and bottlenecks should be found, even in simple configuration.

Which Prototype variant to choose ?

Often rapid prototyping is used as it has become easier and cheaper. The Chinese manufacturers are even building in volumes of one.

But once you bring the proof of concept from your lab to the field can you really rely on the solution and chosen connectivity? Depending on the environment, you might think cellular connectivity is your best option but the investor or client does not like to have monthly fees and costs. So maybe to invest in a private LoRa network. Anyway it is better to find such conditions out as early as possible.

So better to have an approach which takes more time but allows more iterations and prevents failure.

Iterate and gain confidence in your idea

If you have already made the proper investigation of the connectivity in Step 1 or you did a fine tuning in Step 2 then you have in most cases no big adaptations in front of you.

The most important questions are: can your chosen connectivity handle all issues around security, authentication, authorization, safety, performance, reliability, costs, useful feature set and final production ?

But in case you still find out that there are gaps due to changing target and adapted ideas you run in new questions very fast and have to tune the plans and design.

Define scenarios, field tests and proof confidence

By design, IoT devices are constrained which implies limited processing power, storage and bandwidth.

Where you plan to physically deploy will be a factor: if you aim to put a miniature computer on every streetlight, it isn’t practical to visit every one of them every Tuesday to install a patch. Or, if you fit a sensor in the road which is then embedded under concrete, you only have one time to get it right.

Important for scale | do’s and dont’s

If you want to ship your product all over the world, you have to take steps 1,2 and 3 already. Care that you’ve built in connectivity that works for your global application and markets.

Here the topics are e.g. in case of cellular connectivity useability of SIM Cards in certain countries:

In Saudi Arabia, and a U.S. SIM won’t necessarily work in France.
In some of the biggest growth markets, Saudi Arabia, Turkey and Brazil, governments don’t permit global or permanent roaming.
In case of LPWAN systems the question is are in the target markets public LoRa providers or do you have to create a private network.
Similar constraints are maybe due to country specific regulations in the field of confidentiality, security and safety.

The model now which applies to connectivity, to let you link services and IOT-devices over the internet at industrial scale that you can start small and then flex your network as you go through the subsequent steps.

When considering what technology to enable your IoT project to scale the network connectivity you need to look to the models developed for infrastructure as a service and computing elasticity.

For establishing private connectivity networks use mesh solutions as Wirepas or ZigBee to prevent costs on network or spot planning or look for technologies that can automate the set-up of an IoT network topology via simple API calls and that remove the manual, time consuming bespoke steps.

Consider technologies that can aggregate different bearer networks so that you can mix and match multiple different connectivity types, and avoid lock-in from one single communication service provider.

Knowledge Database | Test and Test automation | Different types and measures overview

How to find the problems, bugs and leaks before the clients, users or hackers do

With the growing technology, there has been a massive change in the software testing industry with the help of newly upgraded tools and trends. These changes are aiming for shorter cycle times, a better product quality providing products to the market, and reduction of costs in development and maintenance. Looking at the evolution in the field of test technology and testing processes a lot of skills and expertise is required from the software testers as well in adapting due to the changes and challenges every day.

There are a lot of different types and approaches of testing the different systems to be released, considering:

Dependencies on the used development process and development phases of the product
Different conditions and states of the product in these phases
Interactions with surrounding systems and interfaces
Conditions of the environment in which the product will operate
Criteria of related standards and regulations
Usability and user experience
Safety and security aspects
Compatibility with previous versions of the product
Proof of delivery, meeting requirements and quality assurance

Main steps of defining and following the test process

Set the test requirements according to the contractual requirements (hardest requirements first to be considered)
Break it down and consider to create a special test framework
Test Strategy & project governance definition
Define special tests and as well partners for the execution (e.g. from Client, special skills, trial & friendly users, regulatory support, …)
Team setup
Reporting tools setup
Documentation setup
Test Environment setup
Test Case Generation
Test Case Execution
Result and Analysis
Bug fixing
Re-test
Final documentation

BASE TEST TYPES

4 main types of testing approaches

The decisions of selecting the several types of how to test a given HW and/or SW product must be made during the general test planning as they are important related to requirements, effectiveness needed and available test environment, budgets, test time and available tools.

Manual testing

Manual testing is the process of manually testing the software for defects. It requires a tester to play the role of an end user whereby they use most of the application’s features to ensure correct behaviour. It refers to a test process in which a QA manually tests the software application in order to identify bugs. To do so, QAs follow a written test plan that describes a set of unique test scenarios.

Automated testing

Automated tests provide much faster feedback when things go wrong. Faster feedback from automated tests (whether run locally or on a build server) makes it easier for developers to ensure that their changes don’t break existing work, and reduces the time wasted during integration.

Black box testing

Black box testing involves testing a system with no prior knowledge of its internal workings. A tester provides an input, and observes the output generated by the system under test.

White box testing

White box testing is a software evaluating method used to examine the internal structure, design, coding and inner-working of software. Developers use this testing method to verify the flow of inputs and outputs through the application, improving usability and design and strengthening security.

PROGRESS AND STAGE RELATED TYPES

during product development test phases.

PoC Proof of Concept test

Is proofing and justifying the ideas and design approaches for the new product. These tests are executed on a (simple) pre-product version which is tested to check if the assumptions are fulfilled and the main base functions of the planned solution are properly working and harmonised between each other.

See as well out article: IOT Connected Prototypes | Overview and Experience

SW Module test

Module testing is a process where you need to test each unit of these modules to ensure they adhered to the best coding standards. Unless a module passes the testing phase, it cannot go for the application testing process. Module testing, component testing, helps to early detection of errors in application testing.

Bring up test

Board bring-up is a phased process whereby an electronics system, inclusive of assembly, hardware, firmware, and software elements, is successively tested, validated and debugged, iteratively, in order to achieve readiness for manufacture.

End to End testing (E2E)

End-to-end testing is a methodology used in the software development lifecycle (SDLC) to test the functionality and performance of an application under product-like circumstances and data to replicate live settings. The goal is to simulate what a real user scenario looks like from start to finish.

Field test

Field Validation Table (FVT) is a test design technique, which mainly helps for validating fields present in the application. This technique adds value to an application or project and gives very good test coverage for field validation. And this technique easily helps to find defects lying in the system or application.

Field trials

Field trials are real-life experiments which test directly whether proposed interventions actually work. This makes them powerful tools for gathering evidence for making policy. But, as with all research methods, they come with costs, such as time and resources.

Clinical trials

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioural intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people.

Usability tests

Usability testing refers to evaluating a product or service by testing it with representative users. Typically, during a test, participants will try to complete typical tasks while observers watch, listen and take notes.

Acceptance test

This is a type of testing done by users, customers, or other authorised entities to determine application/software needs and business processes.

Acceptance testing is the most important phase of testing as this decides whether the client approves the application/software or not which has mostly direct impact to payments, reputation and further engagement.

Test plan example | overview

If a new product is to be developed which consists of HW (e.g. one or more devices) and one or more SW parts, this HW is needed in early stages of the product and of course its development cycle has to start earlier as well to get the first samples for the protype. The SW devliveries have to be scheduled in several phases which make the code available in-sync with the HW stages of PoCs, first samples and prototype phase, and HW ready for production. The Integration and first testing scenarios have to focus on these areas which prevent expensive HW changes in the later stages. The special test cases to ensure use-ability, performance, KPIs and reliability could be in parallel with or part of the E2E real system configuration tests. The acceptance tests to proof the requirements have to be aligned with the customer before hand and are starting at Ready for Acceptance and ending with the acceptance approval which is as well allowing payments according the terms.

STRATEGY & INFRASTRUCTURE RELATED TYPES

Different scenarios on test infrastructure and supporting nodes at the different development stages and strategies

SW offline test / SW test with interface simulations

An offline exam means an exam that can either be administered paper-based or offline using examination software systems, like Qorrect, in which the test is run within an examination facility with computers only locally connected, for example.

Program branch coverage tests

Branch coverage is a metric that indicates whether all branches in a codebase are exercised by tests. A “branch” is one of the possible execution paths the code can take after a decision statement (e.g., an if statement) gets evaluated. Special debugging tools or markers in the code can determine whether the branch was visited or not.

To calculate Branch Coverage, one has to find out the minimum number of paths which will ensure that all the edges are covered. In this case there is no single path which will ensure coverage of all the edges at once. The aim is to cover all possible true/false decisions.

Environment or testbed

A testing environment is a setup of software and hardware for the testing teams to execute test cases. In other words, it supports test execution with hardware, software and network configured. Test bed or test environment is configured as per the need of the Application Under Test.

SW in the Loop test SIL

Software-in-the-Loop testing, also called SiL testing, means testing embedded software, algorithms or entire control loops with or without an environment model on a PC, thus without ECU hardware. In fact, SiL Testing is an integral part of automotive software testing.

HW in the Loop test HIL

Hardware-in-the-loop testing provides a way of simulating sensors, actuators and mechanical components in a way that connects all the I/O of the ECU being tested, long before the final system is integrated. It does this by using representative real-time responses, electrical stimuli and functional use cases.

Product test with Simulators

A simulator creates an environment that simulates interfaces, content and protocols of a real device.

It is a software or Software/Hardware that helps to test your product to test the interfaces, functions, and features not be connected to the real nodes and interfaces during operation.

The system reactions are pre-programmed per test case and need the full call flow scenario- and data model know-how from the test designers and programmers. Protocol test equipment is used to monitor and store the test results in compliance with interface standards and parameters.

Product test with Emulators

An emulator creates (emulates) an environment that mimics the behaviour and configurations of a real device (it acts like a real connected device, but sometimes in a more simple way).

It is software and Hardware that helps to test your product via the interfaces, functions, and features not connected to the real nodes and interfaces during operation. Examples are test equipment from Anritsu or Tektronix.

The emulator is e.g. supporting the interface standards and logic flow reactions during an early stage to help product vendors to test their products as long as no partner and corresponding nodes are still on the market or company internally available.

Real equipment E2E test

TARGET & COVERAGE RELATED TYPES

Important are the definitions which targets are needed to achieve for the best product quality. I must be aligned with the whole QA system and as well be focused on the key areas of clients requirements and expectations.

Basic operation tests

Operational testing is a type of non-functional acceptance testing that confirms that a product, service, process or system meets operational requirements.

Examples are Load & Performance Test Operation, Security Testing, Backup and Restore Testing, and Failover Testing.

Functional tests

Functional testing is a type of software testing that validates the software system against the functional requirements/specifications. The purpose of Functional tests is to test each function of the software application, by providing appropriate input, verifying the output against the Functional requirements.

Non functional tests

Non-functional testing is the testing of a software application or system for its non-functional requirements which means the way a system operates, rather than specific behaviours of that system.

Functional requirements explain how the system must work, while non functional requirements explain how the system should perform.

Error / Scenarios tests

Scenario testing is a software testing activity that uses scenarios:

hypothetical stories to help the tester work through
a complex problem or test system
The ideal scenario test is a credible, complex, compelling or motivating story.
The outcome of which is easy to evaluate.
Error scenarios like power outage, alarms, data corruptions or wrong interface approaches can be be created by using simulators

Regression tests

Regression testing is testing existing software applications to make sure that a change or addition hasn’t broken any existing functionality.

Load testing

Some basic examples of load testing are: Testing a printer by transferring a large number of documents for printing. Testing a mail server with thousands of concurrent users. Testing a word processor by making a change in the large volume of data.

Stress tests

Stress testing (sometimes called torture testing) is a form of deliberately intense or thorough testing used to determine the stability of a given system, critical infrastructure or entity. It involves testing beyond normal operational capacity, often to a breaking point, in order to observe the results.

Performance tests

Performance testing is the practice of evaluating how a system performs in terms of responsiveness and stability under a particular workload. Performance tests are typically executed to examine speed, robustness, reliability, and application size.

Interaction tests

Interaction-based testing is a design and testing technique that emerged in the Extreme Programming (XP) community in the early 2000’s.

Focusing on the behaviour of objects rather than their state, it explores how the object(s) under specification interact, by way of method calls, with their collaborators.

Interface tests

Interface Testing is defined as a software testing type which verifies whether the communication between two different software systems is done correctly. A connection that integrates two components is called interface. This interface in a computer world could be anything like API’s, web services, etc.

In the telecommunication are often interoperability tests between the different telecom vendors executed which are proof that the signalling standards are filufilled.

Certification tests

Justifies the usage of a product in a specified environment and under defined conditions. The process for certification of a product is generally summed up in the steps:

Application (including testing of the product)
Evaluation (does the test data indicate that the product meets qualification criteria)
Decision (does a second review of the product application concur with the Evaluation)

This is a very important step and test type for Medical Devices (according MDR) and Common criteria for High Security requirements.

HARDENING TYPES

Hardening tests – security

In computer security, hardening is usually the process of securing a system by reducing its surface of vulnerability, which is larger when a system performs more functions; in principle a single-function system is more secure than a multipurpose one.

Examples: Side channel attacks and channel attacks; Security measures: Secure SW writing which allows to mask and hide exchange of security keys and fault injection systems which simulate a breach.

Hardening tests – environmental

Hardening of an electronic product concerns the resistance of this product against surrounding environments and effects like earthquake danger, theft danger, radiation impacts, mechanical load, extreme temperatures, humidity, usage in water and vacuum.

To test the stable performance of such products, the operation in a climatic chamber, systems to check robustness and simulating earthquakes, vacuum, water basins and generators for radiation and electromagnetic pulses.

Radiation-hardened electronics, also called rad-hard electronics, are electronic components (circuits, transistors, resistors, diodes, capacitors, etc.), single-board computer CPUs, and sensors that are designed and produced to be less susceptible to damage from exposure to radiation and extreme temperatures (-55°C to 125°C).

In case of questions do not hesitate to contact us!

Healthtech Industry Update | Clinical Trials Have A Data Problem

Digital technology has a big advantage in clinical trials not to rely on patients’ paper intake forms and manual data entry into clinical systems only. Digitised processes present new opportunities to enhance the clinical experience e.g. virtual visits or e-Consent applications but adding disconnected tools increases complexity and costs, making it harder to get a holistic view of trial data.

While more data can lead to greater insights, it can also overwhelm and confuse research sites and data managers if managed incorrectly.

Here are some key challenges facing the industry today—and recommendations for overcoming them:

➡️️ Taming data overload because the overwhelming number of data sources and lack of access to the data originator make it difficult for study teams to determine which information to use and how to use it.

➡️ Enabling standardization: Without the proper measures and systems in place, standardization would require constant monitoring and updating for alignment across stakeholders.

➡️ Accelerating information flow for timely adjustments: Delays caused by manual data processes, however, could slow these necessary dosage adjustments.

➡️ Establishing a data foundation for digital trials: By working together to standardize data documentation processes and leverage advanced systems, sponsors, CROs, and research sites can access and interpret data faster and better than ever.

This expedites data collection and reduces human error, enabling processes to be automated and reconciled efficiently.

To maximize the digital clinical trial opportunity, it is imperative to establish a solid foundation of data collection and management best practices and capitalize on the advancements in data management technologies. Only then will we see the true potential of medical innovation as new treatments get to patients at an unprecedented pace.

You would like to know more details …
https://medcitynews.com/2023/07/clinical-trials-have-a-data-problem-heres-how-the-industry-can-solve-it/

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