MedTech: Trends and Product Design

Introducing the technology readiness chart

What are Technology Readiness Levels?

There are many stages in the process of designing and developing a new MedTech product.
Moving through all of these stages ensures that the product works as it should, meets a clinical
need, and is safe for patients and clinicians.

Technology Readiness Levels (TRLs) are a useful way to measure the development of a new
technology.

TRLs were originally created by NASA as a method of measuring the development of their
space exploration technology. Many different industries, including MedTech companies, now
use this model. Depending on the technology the specific TRL steps may differ, but the
principles remain the same.

Let’s look at a TRL model commonly used in MedTech. This model has ten different TRLs which
describe the development of a new MedTech device. These TRLs are described in detail below:

Customer and clinical needs are identified, and

many potential solutions to the identified
TRL 1
problems are listed. At this stage there will be
many different options.

Technical concepts, based on some of the

different options suggested in the previous
step, are developed. A small number of these
are selected to be taken forward into the next
TRL 2 step. Various hypotheses, research ideas and
experiments are defined, with the aim of
addressing the problem identified in TRL 1.
There is a basic understanding of the potential
of the technology, material or process.

TRL 3 Active (experimental) development begins, for

 example, hypothesis testing, data collection,
identification and evaluation of critical
techniques and components. Proof of concept
is verified to ensure that the technology deals
with the core clinical need – this is carried out
in a laboratory environment.

Active development is ongoing. User

requirements are investigated and verified.
System solutions are investigated and the
TRL 4 addition of different subsystems into relevant
lab environments begins, in order to ensure
thorough testing of all components and
progressively reduce risk of device failure.

Further development of selected technologies

and components begins. Verification of system
solutions and processes in relevant laboratory
environments and/or in animal experiments
takes place. The product requirements are
TRL 5
known and verified. Outline regulatory
classification of the device is confirmed. Costs
of product development are calculated and
built into a business case in which expected
returns (sales revenues) are also stated.

TRL 6 The device function is verified in preclinical

conditions and a final prototype design is
selected. The regulatory process begins.
Production technology is investigated and the
process validated. Clinical testing is designed
 and submitted for approval.

Customer verification and/or clinical verification

are underway with a complete product
prototype. Final product design is determined
and the product is tested again. When clinical
TRL 7
data is available the submission for regulatory
approval can be made. All assumptions in the
business plan are examined in detail and
verified if possible.

The product, service or process is ready for

launch and regulatory approval is granted.
TRL 8 Launch stocks are built up, the marketing
strategy is developed and sales channels are
agreed.

The product is launched and the first sales are

TRL 9
made.

TRL 10 Post-marketing studies and surveillance begin.

IKC Technology Readiness Levels

Throughout this course you will explore these different TRLs.

Although there are many interpretations of the TRL system, you can select the image below to
examine the model which we will be using in this course.
This model was developed by the Medical Technologies Innovation and Knowledge Centre
(IKC), based at the University of Leeds.

There are seven IKCs around the UK, focusing on different industries. These have been
established to encourage and support the commercialisation of new technologies. The Medical
Technologies IKC works specifically within the MedTech industry.

Select the image to open the interactive TRL chart. You can find an accessible PDF version of
the TRL chart in the Downloads section.

As you can see from the chart, the first

few TRLs fit into a phase aimed at
developing a ‘Proof of concept’. The rest
can then be described as ‘Collaborative
development’.

What has historically driven innovation in healthcare?

In this step, you will learn about five different factors which have driven innovation over time,
and which are still important today. These five factors are:

 Demographics

 chronic diseases 

 market  

 affordability and availability

 regulatory environment.  

Let’s now look at each of these in turn.

Demographics
Demographics is the study of different sections of the population. This involves grouping people
in a number of different ways, for example by age, ethnicity, gender or income, in order to
gather useful data.

The ways in which certain groups have moved around or changed in size at a national and
international level has been a major factor in driving innovation in healthcare.

For example, historically, poorer people carried out harder, more labour-intensive tasks than
wealthier people. Poor people were more likely to die from their illnesses due to their inability to
receive treatment. Nowadays, this is still the case in poorer countries, though innovation has led
to more affordable treatments.

Another demographic consideration is life expectancy among different groups. Awareness of

high mortality rates has led to a focus on innovations aimed at eliminating certain diseases, for
example smallpox, polio and malaria.

A key driver both historically and today is ageing.

Life expectancy among older adults combined with declining fertility rates among younger adults
have led to an ageing global population. According to the World Health Organization (WHO), the
number of people aged 60 or more will increase from 900 million in 2015 to 2 billion in 2050.
This is a change from 12% to 22% of the global population.

By 2020, there will be more people over the age of 60 than under the age of five. Therefore a lot
of medical innovation focuses on prevention of disease in the elderly, and ensuring quality of life
by reducing symptoms.

Chronic diseases
The ageing of populations around the world has resulted in different types of disease and
disability.

Although on average we are living longer than our ancestors, poor mental health and
musculoskeletal disorders are rapidly increasing in both children and adults, leading to more
people living their extra years of life in poor health.

Chronic diseases have always driven innovation due to the longevity of the illness; in such
cases alleviating symptoms has been vital in ensuring improved quality of life.

Long-term conditions have a number of symptoms which need to be managed. For example, in
the case of diabetes these could include foot ulcers, poor wound healing, blurred vision and
increased blood pressure. All of these would need separate treatment if the diabetes could not
be controlled.

Managing symptoms such as these is a major driver of innovation.

Market
In the western world, increasing population size has always driven the market due to the high
demand from patients.

When the number of patients increases, the market increases. Innovation occurs to make
changes and to meet needs, which is why new solutions are continuously being developed to
eliminate or to at least reduce problems.

In the past, factors such as war, epidemics and poverty have shaped the market, as new
solutions were developed to treat the affected patients. Since war and poverty were occurring
on a large scale in a short period of time, fulfilling the demand was urgent hence innovation was
continuous despite limited resources.

Discoveries and advances were often made due to urgency. For example, wound dressing
techniques and technologies went through many developments in a short period of time during
World War I.

In regions around the world where war, epidemics and poverty are still present, these factors
are major drivers of innovation – both in the affected countries and for those from outside who
seek to provide solutions.

Affordability and accessibility

Historically, cultures around the world have had their own methods of treating people, such as
holistic or herbal methods. However wealth has also played a big part in treatment, as poor
people could not afford more expensive treatments.

Today, the increasing availability and affordability of healthcare resources have been driven by
the needs of the increasing number of people seeking healthcare. Therefore emerging markets
are often large drivers of innovation.

Solutions to healthcare problems have had to be developed so that people who need the
treatment are able to afford and access it. This has often involved redeveloping and redesigning
manufacturing processes so that medical products can be produced on a larger scale to reduce
costs.

In terms of reducing healthcare costs, improving diagnosis is also a driver of innovation. Better
diagnosis of patients can enable the prevention of disease at an earlier stage. Prevention is
considered better than cure due to the high costs involved in creating a treatment. This need
has therefore driven innovation in the area of diagnostic technologies.

Regulations
Another driver of innovation is the need for products to conform to regulations that govern
patient safety and device reliability. This has led to research into new materials and processing
techniques.
For instance, sterilisation techniques have been vital in ensuring devices do not carry an
infection risk for the patient. Regulations have been put in place to ensure devices can be
sterilised to the required standard. This has resulted in increased innovation in biomaterials
research and development.

In general, regulations have also driven innovation as manufacturers need to conform to specific
guidelines put in place to ensure that products work well and are safe for patients and clinicians.

A history of innovation in MedTech

Below, you can explore a timeline of innovation in the field of MedTech. These innovations
come from all of the different areas covered by the five courses in the MedTech series from the
University of Leeds.

As you look through these examples, think about which factors have driven these innovations.

Now that you have looked at what drives innovation in healthcare, in the next step you will
examine three key examples of innovation in MedTech.

A history of innovation

From these examples you can see that medical devices can change over time in three main
ways:

 the design of the device

 the materials used to make the device

 the manufacturing process used to produce the device.

These three characteristics are all dependent on one another, and together determine how
effective the device is. Changes in these areas are mainly driven by the needs of patients and
clinicians. 

Let’s look briefly at the three medical devices that Mike presents in the video. 

Stethoscope 
Stethoscopes have become so iconic that they are now associated with the image of a doctor,
but the design and capabilities of this instrument have changed considerably over the past 200
years. 

In 1816, Rene Laennec, a French physician, invented the stethoscope. The name comes from
the Greek words Stethos meaning chest and Skopein meaning to view or see. His instrument
was a hollow wooden tube, which amplified the sounds of a patient’s heart or lungs.
The use of the stethoscope spread internationally, and physicians and instrument makers
continued to improve on the design. In 1849, the wooden tube was replaced with a rubber
tube which provided better amplification and was more comfortable to use. Subsequently, the
rubber tube was replaced with plastic and was given two earpieces as well as a bell-like end.  

In the 1960s, David Littmann, a Harvard Medical School professor, invented a new stethoscope
with improved acoustic properties. Littmann stethoscopes have now become the gold standard
by which all other stethoscopes are mediated. Gold standard is the term used in the medical
devices industry to describe an instrument that acts as a point of reference against which others
of its type are compared.

Wound dressings
The type of dressing used for a wound is an important part of the healing process. The role and
function of a dressing is to provide an environment that protects the wound and promotes
healing.

Absorbent dressings
In 1880, a British surgeon called Joseph Sampson Gamgee invented a new type of absorbent
dressing. It was made from a combination of cotton wool and gauze. This dressing was named
after Gamgee, and is still used today.

Absorbent dressings are particularly important in cases of high blood loss.

However, absorbent gauze has the disadvantage of shredding fibres when cut which may be left
in the wound. Another disadvantage is that it dries out, which results in the dressing sticking to
the wound, causing pain on removal.

Moist wound healing

In 1962, George Winter published his theory on moist wound healing. He realised that wounds
which were prevented from drying out healed at a faster rate and with less scarring.

Cells require moisture to migrate from the wound edges to close the wound with ‘good’ tissue
following the formation of a scab (which also provides a barrier to the entry of foreign bodies).
They cannot migrate on a dry wound bed – in this case healing will be delayed and the
formation of fresh tissue will be reduced.

Moist wound healing requires hydrating substances and dressings which manage or promote an
optimal moist environment. These include foams, alginates, hydrogels, hydrocolloids,
transparent films, and some topical treatments.

Hip implant 
Today, hip replacement surgery is a common procedure. However, in developing this area of
medical technology, practitioners and innovators have experimented with a range of
different methods and materials.  
Sir John Charnley, an orthopaedic surgeon at the Manchester Royal Infirmary, is known as the
father of the modern total hip arthroplasty. Arthroplasty is the surgical reconstruction or
replacement of a joint.

Charnley created a low friction implant that consisted of three parts: a polyethylene
acetabular cup, a metal femoral stem and acrylic bone cement. The bone cement was borrowed
from dentists who had been using it for fillings. In Charnley’s case it was used to fix the
implant within the femur, to ensure good adhesion.  

The original design is still used today with the use of a smaller femoral head. This reduces wear
due to its smaller surface area. 

Modern developments
The Institute of Medical and Biological Engineering (IMBE) at the University of Leeds has
continued to develop the hip implant through research, including using modelling to predict the
wear behaviour under long-term conditions.  

Some implant models have a rough surface on the outer layer of the metal acetabular cup. This
is to improve osteointegration. Osteointegration is the formation of a bond between an implant
and bone, without intervening soft tissue. Good osteointegration reduces the risk of
implants loosening. This in turn reduces the risk of needing another surgery. 

Nowadays orthopaedic implants are designed to increase longevity inside the body in order to

avoid the need for further surgery. This requires new materials and surface textures to
be developed and tested. 

For more on the development of hip implants, you can read the document ‘The development of
the hip implant’ in the Downloads section.

Summary
In this step you have learned about how the needs of patients and clinicians have driven
innovation in the case of three different devices. In the next step you will explore in more detail
what counts as a medical device, and what does not.

What is a medical device?

Does a toothbrush count as a medical device?

How devices are classified determines the different sets of regulations which apply to them. In
this step you will learn about the different classifications of MedTech devices.

The classification of a device will depend on the perceived risk associated with the device, and
the clinical condition the device is designed to treat. This classification will then determine the
standards and requirements it must meet.
In Step 1.2, you were introduced to technology readiness levels: classifying a device is TRL 5.

Let’s now look at how MedTech devices are classified.

What’s the difference between a medical device and a pharmaceutical product?

The pharmaceuticals industry is one of the most highly regulated industries in the world. Drugs
undergo very thorough testing, from preclinical and clinical trials to post-market surveillance.

Preclinical trials involve testing the drugs in laboratories. This is usually carried out on animals
or cultivated cells. Once sufficiently positive results are obtained, the drug then goes through to
clinical trials where it is tested on human patients. The patients are constantly monitored and
results are recorded.

Once it is deemed safe to release the drug onto the market, post-market surveillance is carried
out, whereby clinicians monitor patients who are prescribed the drug. If there are too many
cases where the drug has had a negative effect, it is taken off the market. However, because of
the thorough testing process this is quite rare.

Even though medical devices go through a similar process, the trials typically are not as large
(due to the difficulty of introducing a placebo device). This means that the new product
development process for medical devices is shorter and less expensive than that for
pharmaceuticals.

The organisation which regulates medical devices in the UK is called the Medicines and
Healthcare products Regulatory Agency (MHRA). The MHRA defines a medical device as “any
health care product that does not achieve its primary intended purposes by pharmacological,
immunological or metabolic means”, (MHRA, 2019).

Medical device classes

Medical devices are separated into classes that include general controls and definition of risk.
As the class or risk increases so does regulatory control.

This means that the classification or risk defines the regulatory requirements that a device
should conform to.
‘General’ medical devices are grouped into four classes:

 Class I: generally regarded as low risk – for example medicine measuring

cups, syringes, stethoscopes or thermometers.

 Class IIa: generally regarded as medium risk – for example tracheostomy or tracheal

tubes connected to a ventilator, fibre optics in endoscopes connected to surgical lasers,
or suction catheters or tubes for stomach drainage.

 Class IIb: generally regarded as medium risk – for example intensive care monitoring
and alarm devices (eg blood pressure, temperature, oxygen saturation), biological
sensors, blood gas analysers used in open heart surgery, or diagnostic X-ray sources.

 Class III: generally regarded as high risk – for example spinal needles, cardiovascular
catheters, neuro-endoscopes or total hip, knee and shoulder joint replacement systems
and components of systems.

The classification of a medical device will depend upon a number of questions, as listed below: 

 How long will the device be in continuous use? Longer term devices, such as for
example orthopaedic implants, are likely to require more stringent regulations.

 Is the device invasive or surgically invasive? An invasive device enters the body, but
does not require surgery, such as for example a PICC line. A surgically invasive device
is one which requires surgery, such as an orthopaedic implant.

 Is the device implantable or active? The British Standards Institute (BSI) defines an

active device as a “medical device relying for its functioning on a source of electrical
energy or any source of power other than that directly generated by the human body or
gravity and which acts by converting this energy” (BSI, 2019).

 Does the device contain a medicinal substance, which has action ancillary to that
of the device? An ancillary medicinal substance is “[a] medicine that is incorporated
within a medical device where the main mode of action is due to the device” (European
Medicines Agency, 2019). 

Non-medical devices  
It is quite easy to mistake a non-medical product for a medical device. A few examples of non-
medical devices are:

 toothbrushes
  baby nappies

 mouthguards  

 Intense Pulsed Light (IPL) therapy (for example, for hair removal)  

  sunglasses (which are covered under the Protective Personal Equipment Directive)  

 breathalysers  

 consumer products aimed at comfort 

 products for sport

 cosmetic products, including tooth whitening products.  

Regulatory bodies around the world 

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the
main organisation which regulates medical devices as well as pharmaceuticals. Even though
most regulatory bodies regulate both medical devices and pharmaceuticals, some countries use
separate regulatory bodies.

You can find the link to their website in the See Also section. 

Notified bodies  
A notified body’s role is to carry out full quality assurance as well as an examination of the
design.

A verification process is also completed, whereby tests are carried out on every batch of
products before they are released onto the market.

One example of a notified body is the British Standards Institute (BSI) in the UK. You can find
the link to their website in the See Also section.

What are the current driving forces in MedTech?

Now that you have thought about what has driven MedTech innovation in the past, and
understand what medical devices are, in this step you will explore the factors driving
innovation in today’s MedTech industry.

Patient needs have always been a driver of MedTech innovation; however, medical and

environmental conditions have changed dramatically. 
Some of the factors driving innovation today include: 

 ageing

 lifestyle

 new technologies emerging in other sectors

 challenges faced by developing countries. 

Let’s now look at each of these in turn.   

Ageing population
As medical knowledge and technologies improve, we are able to cure many diseases which in
the past would have been fatal. 

However, this means that people are living longer, and many are suffering from long-term
conditions such as heart disease, kidney disease and diabetes. Long-term conditions require
long-term solutions, and this is a big driver for innovation.  

Modern lifestyle choices
Due to significant changes in our lifestyle choices, such as our diet, we are now
experiencing negative consequences that perhaps need more complex solutions. 

Smoking has serious long-term health implications. In the western world, our modern
diet has also had a negative impact on our health. Factors including drinking excessive
alcohol and poor nutrition have led to increased health issues, including obesity.

Obesity results in many long-term diseases, and it also influences our joints, resulting in
decreased mobility. Since more and more young children are becoming obese, prevention is
also something innovators must consider.  

New technologies 
When developing new devices, it is important to ensure technical compatibility, especially within
healthcare. Many devices need to be used in conjunction with one another, which requires them
to use up-to-date, compatible technologies.

Not all medical devices require such complex technology, however they must still be compatible.
This is another driver for innovation. 

Developing countries
Even though technology has been improving worldwide, developing countries still may not have
the means for such complex technologies. This is due to both the cost and the availability of
such products.
Major programmes funded by organisations such as the World Bank and the Gates Foundation,
as well as the aid programmes of most western countries, work to improve this situation. In
doing so they seek to address the Sustainable Development Goals (SDGs) of the United
Nations Development Programme (UNDP) – a number of which have health and the provision
of healthcare as their focus.

You can read more about the UNDP’s Sustainable Development Goals in the See Also section

When producing technological solutions for medical problems in the developing

world, innovators need to understand the needs of all users. One implication of this is that they
need to keep costs to levels agreed with stakeholders in the countries in question, and use
readily available materials if possible.

This not only benefits developing countries, but it can also benefit healthcare providers in

developed countries by providing new cost-effective, time-saving medical devices using
appropriate technologies and materials. These can have a huge impact on the health of the
population. 

What could the future hold for healthcare?

In the video, experts from academia and from the MedTech industry talk about the impact which
they think current developments in MedTech could change how we think about our health. They
discuss five key themes:

 tracking daily activities

 mapping your genome

 personalised medicine

 AI and robot doctors

 cultivated organs

These themes are also explored further in the other courses in the MedTech series from the
University of Leeds.

Let’s look at each of these in turn.

Tracking daily activities  
Technological advances have given us better opportunities for diagnosis and
treatment. However, when MedTech is not used or understood properly it may not be beneficial
for certain users or groups of users.
For example, new devices for tracking daily activity have sensors which monitor and track heart
rate, steps taken, and other statistics. They also measure duration and quality of sleep, and
so claim to be able to recognise sleep problems.

The problem with these sensors is that they are intended to ‘fit all’. Depending on the number
of sensors, these devices will only collect data from one area of the body. However, the sensors
are likely to change position if the strap moves around during exercise, which means that these
readings may not be consistent or accurate. This can give people false perceptions if they rely
too heavily on the output, or it could potentially jeopardise their health from constant worry. 

Another concern is anxiety resulting from the availability of medical information on the

internet. People are often quick to search their symptoms online and may ‘self-diagnose’
themselves with a condition which they do not have. 

Mapping your genome  
Genome sequencing may show us what conditions we are at risk of developing.

For example, a patient could be told that they have a 60% chance of developing breast
cancer at some stage of their life. Knowing this information may mean that they can take
precautions and the necessary steps to manage or reduce this risk. 

However, there are certain conditions that cannot be currently cured, such as

Hunter’s Syndrome (in which a missing or malfunctioning enzyme leads to respiratory, cardiac
and joint complications). Would having this information at birth be beneficial when there is no
cure?

Some patients may not see a benefit of knowing that they were at risk of developing a
certain condition, particularly when there is also a chance that they may not develop
it. Again, worrying about it might lead to other problems such as depression and anxiety. 

The need for good communication between the clinician and patient is crucial to eliminate
unnecessary concern and to provide the best care.  

Personalised medicine  
In the future we may have the ability to map genomes at birth, and to create personal health
plans designed around the conditions you are predicted to suffer from. In addition, this could
also be useful for older patients as it would allow them to make choices about their lifestyle, for
example, their diet, to protect them from the known risk.  

Personalisation of healthcare would be a huge step forward which could decrease costs and
wastage of costly services. However, in order to achieve full and accurate personalisation, a
huge amount of data would need to be collected across the population, as well as for each
person.

Although this may bring benefits, it also highlights the need for advanced security to keep this
data safe and protected. 
AI and robot doctors  

With improvements in artificial intelligence (AI) technologies, the process of diagnosis and

treatment could be much quicker, eventually even replacing clinicians. 

This could improve reliability and efficiency across all specialties, but definitely gives cause for

concern if human intervention is to be significantly reduced or eliminated. Would you feel
comfortable being treated by a robot?  

Cultivated organs 
Current research is leading to the possible cultivation of organs in the future such
as human tissues, skin, cartilage and bladder, and the production of organs such as liver and
heart.

Although challenging, this should one day be achieved. Eventually this could become available

for all patients, and organs could be made to order. Using stem cell therapy, whereby a person’s
stem cells are collected, sorted and cultivated, it may be feasible to grow almost any tissue and
certain solid organs for repair and transplantation surgery.

Summary
In this activity you have been introduced to some of the possibilities which new MedTech
devices can offer. In the next activity you will think about the challenges that these new
MedTech devices will need to overcome in order to be successful.

The impact of public perception

Do you feel you can trust medical devices? 

In the previous steps, you have learned about innovation in the MedTech industry – both past
and current – and about how medical devices are classified and regulated. 

In this activity you will learn about four different challenges which manufacturers and designers
in the MedTech industry need to face in order to continue to be successful: 

1. The impact of public perception. 

2. The automation of the healthcare profession. 

3. Negative perceptions of ‘big data’. 

4. Getting technologies to ‘talk’ to each other.   

In this step you will learn about the impact which public perceptions can have on the success or
failure of a new device.
Why is it important for designers and entrepreneurs to think about the public perception
of their product?
Keeping public perceptions positive is key to ensuring a successful product or service. 

Negative public perception can jeopardise the success of the product, because nobody will want

to use it. In order to reassure the public that products are safe to use, manufacturers test their
products thoroughly before marketing them in order to comply with regulations. As well as
protecting all stakeholders, including patients, regulations also serve to establish trust in the
medical devices industry.   

Intensive testing sets medical devices apart from non-medical devices, meaning there’s a focus
on thoroughness and quality to ensure reproducibility and accuracy in use. But how
do manufacturers inform the public about this? 

Marking  
Labelling and marking are one way to let the users know how safe the product is to use. For
example, medically regulated products have a CE (Conformité Européenne) mark. 

The CE mark is required for many products, especially when being sold in the European
Economic Area (EEA). 

The CE mark shows that the manufacturer has confirmed that these products meet EEA safety,
health or environmental requirements, before being released onto the market. It is also an
indicator that the product complies with EU legislation. This allows it to be sold within the
European market and throughout the EEA (and beyond).

This also applies to products made in third countries, which are sold in the EEA and Turkey. Not
all products need to have a CE mark to be sold in the EEA. A list of all the products that do need
this marking is available in the Downloads section.

The US equivalent is the FCC mark, indicating compliance with the requirements of the Federal
Communications Commission. However, this is also used on all electronic devices. 

What happens when things go wrong? 

In 2010 there was extensive news coverage of problems with a particular brand of breast
implant.

PIP implants were silicone breast implants manufactured in France by a company called Poly

Implant Prostheses (PIP). Approximately 47,000 British women had PIP implants fitted, and
most of them are still living with them today. 

In 2010, the PIP breast implants were withdrawn from the UK after it was found that they had
been fraudulently manufactured and were prone to splitting more than other available breast
implants at the time.  
Instead of silicone which had been approved for medical purposes, the implants used
unregulated industrial grade silicone gel. When the implants split they caused extreme pain and
inflammation, and further surgery was required to remove them.   This incident had a huge
negative impact on public perception, which in turn threatened sales of breast implants across
the industry. The media was also responsible for influencing public perception, as the story
received extensive international coverage. 

However, this story also had a positive impact as it led to the reinforcement

of medical legislation, ensuring thorough manufacturing checks and new regulations.  

The automation of the healthcare profession

Is a fully automated healthcare system a good thing? 

Understanding the impact which developments in automation may have on the healthcare
profession will enable you to deliver appropriate solutions to new medical or technological
problems which might arise as a result. 

Autonomous systems 
Autonomous systems use artificial intelligence to make decisions, allowing them to operate with
little to no input/oversight from humans. More and more tasks and processes in our daily lives
are being automated, from ATMs to self-service checkouts to thermostats and auto park assist.  

Automation in healthcare is also growing, despite some concerns. For example, the da

Vinci surgical robot is a semi-autonomous system, controlled by both a human surgeon and an AI
system. These systems are in the process of becoming fully autonomous to decrease the
workload of clinical and healthcare professionals. 

However, this suggests that in future there may be fewer jobs, with some roles being

eliminated altogether. Another concern is trust: do patients trust a machine to operate on them
without human assistance? 

What do clinicians think? 

Clinicians may approve of these MedTech advances if they ensure quicker patient care and
better treatments, but they may be concerned about the loss of jobs. 

However, in some areas such as genomics these developments are driving the need for new
clinical roles. These technologies could therefore lead to major changes in the infrastructure of
healthcare provision. 

These topics are covered in more detail in two other courses in the MedTech series from the
University of Leeds: MedTech: AI and Medical Robots, and MedTech: Exploring the Human
Genome.
GP apps  
Quicker patient care may be what patients think they need. However, when using AI and
technology to speed up a process, it may not be optimum. In this case, it means cutting out a
step: usually when going through a clinical pathway, the patient will at some point have a face-
to-face conversation with their GP or Consultant. However, many people, especially those who
work full time, now use online GP apps as they don’t have time to visit one in person.  

For example, PushDoctor is an app where the patient is asked to fill out a short questionnaire
about their symptoms. The answers are sent to an available online GP where a quick call is
made between the GP and the patient. The patient tells the GP about all their symptoms and
their concerns. If medication is required, the GP sends out a prescription to their nearest
pharmacy, which the patient can collect within a few hours. In some cases, a video call is made
to allow the GP to see the issue and to help them to recommend the correct care or treatment.
Even if this gets the job done, does the patient feel they have received proper care?  

Human interaction  
When it comes to health issues, how clinicians and patients communicate about problems, such
as serious diagnoses, is important. When being diagnosed, especially with a terminal illness,
you would probably want to hear it from a person rather than a robot.

Despite technology ensuring a quicker process of diagnosis and treatment, it lacks the
emotional capabilities that only a human can provide. Human interaction is an important part of
the patient-clinician relationship which imparts a sense of security and builds trust.

Does big data have a bad name?

What are the dangers of collecting large amounts of patient data? 

Understanding what data is and how it is used enables researchers and developers to respond
to public concerns about data collection and management.

What is data? 
Data is information. The term big data refers to extremely large, complex data sets. These can
be analysed using special software to extract information about patterns, trends and
associations – for example about people’s spending habits. In healthcare this can improve the
speed and accuracy of diagnosis, identify patient risk factors, and manage drug interactions.

This may seem intimidating, but many of us do not realise quite how much data about ourselves
we make available online in our everyday lives. This might include our internet search data, or
information we put onto social media platforms. 

In recent years, data-related scandals such as the Cambridge Analytica case have encouraged

us to think more carefully about what we share online. On social media platforms people
willingly share data to connect with friends, to share a photo of their pet, or perhaps to send out
invites for their next birthday party.
In 2018 the General Data Protection Regulation (GDPR) was introduced in the EU to help
consumers to be more aware of what data they were sharing online. GDPR also allows people
to opt out of sharing certain types of information, for example by giving users more control over
the use of computer cookies.

Computer cookies are designed to hold large amounts of data specific to a client and website.
This data can be accessed either by the web server or the client’s computer, which allows the
server to deliver a page tailored by the data that they can see. For example, if a person has
been searching to purchase a kettle, tailored adverts start to appear of more kettles. However
this can be stopped in most cases by deleting these cookies from the web browser.

Marketing 
Is big data good when it is benefiting marketing agencies?

Data in marketing is valuable because it tells companies about their audience’s interests,
allowing them to better understand their customers’ purchasing habits and motivations. They
can then use this information to tailor their services, which could potentially increase their
revenue.

Companies can gain value from their own data, but they can also purchase it from other sources
too. If a company has high-quality data, they can sell it. However, most citizens are unaware of
their data being shared and sold.

Since the introduction of GDPR, many people have become more cautious. Therefore, the idea
of sharing data has been perceived as being negative by the general public, making it difficult for
medical providers to conduct beneficial research.  

Genomics 

Genomics is the study of genomes, and genomes are our complete set of genes. Genomics
currently relies heavily on big data. Without data from many people within a population, it is
difficult to identify genetic risk factors.

The bigger the set of genomic data (DNA data), the better the chance of identifying a gene of
interest, which in turn results in better diagnosis. Collecting vast amounts of data can be
challenging, as it needs to be stored securely to prevent the hacking of sensitive information.

There is a risk that data provided to a third party might be leaked to competitors and customers.
There are also privacy concerns, as many patients are not comfortable with the collection and
storage of such detailed information about their identities and characteristics. This is especially
the case with genomic data, as this may comprise a map of their entire genetic code.

Getting technologies to 'talk' to each other

Can technologies talk to each other? 

It may seem like a bizarre concept; however, we are currently using more and more
interconnected devices in all areas of our daily lives. In this step you will explore what this could
mean for the healthcare sector.

The Internet of Things 

The internet has had a largely positive impact on healthcare, from patient monitoring to online
GPs.

The internet of things (IoT) is a term used to describe networks of devices that comprise
software, sensors, actuators and connectivity. This allows these devices to form networks using
the internet. In doing so, they can interact and work collaboratively.

Cloud robotics
Robots and machines use the internet to transfer data through servers. Servers are used to
distribute data. More data can make the robot more precise in function. However the downside
to this is that vast amounts of data can overwhelm the robot, and storing this data can be
challenging due to the space needed. If the data and programmes that the robot needed were
all stored on the robot itself this would require a large processor which would take up lots of
space.

One solution to this challenge is the use of cloud robotics. Cloud robotics uses programmes and
data which are hosted on remote servers, independent of any one particular robot, to improve
performance. These remote servers are known as ‘the cloud’. The advantage of connecting
robots to the cloud is that the robot will have access to more data, programmes or processing
power, all of which can be stored on servers rather than the robot.

Cloud-connected robots can also share data with each other, and each robot can use and learn
from this information. Additionally, another benefit is that human operators can intervene and
operate the robots remotely.

Artificial intelligence
Artificial intelligence (AI) can learn to identify patterns in data (algorithms) to automate tasks.
For example, in a medical application, AI can be used to examine scanned images from a
person’s MRI scan, where it can outline the shape of a cancer based on the shapes and colours
that it detects. This process is cost effective as it saves time, since medical professionals do not
have to do this manually.

Another example of this is biometric systems where human features are scanned and recorded
which are then used to unlock or use certain devices. The potential implementation of
biometrics is vast since most devices can use this process, from ATMs to drug delivery.

Sensors
Another application of the IoT in healthcare is the smart inhaler.
Asthma is a respiratory condition that makes breathing difficult. Inhalers are used for relieving
asthma and other bronchial or nasal congestion.

Smart technology is beginning to give patients increased insight into and control over their
symptoms and treatment, thanks to connected inhalers. Smart inhalers have a sensor that
attaches to the inhaler or Bluetooth spirometer. It connects to an app, which helps people with
asthma to track their symptoms and to understand what might be causing their symptoms.

Security  
As more devices are interconnected, security becomes a bigger concern.

Even though many systems have barriers put in place, this does not always prevent hackers
from entering these domains. Currently most devices are compatible with each other, and this
makes them all more vulnerable to attack. In most cases, if one device has been compromised,
it opens the door to the other connected devices such as wireless devices.

Hackers can either steal or sell data, and could also plant viruses. Viruses contaminate and can
corrupt sensitive data, which could for example, cripple a hospital. This is one of the many
dangers of the IoT, and must be considered when designing new technology.

Therefore, companies are using machine learning, AI systems which learn and adapt, to ensure
better security. This in turn means a greater reliance on AI, which as you have seen in a
previous step also raises its own challenges.

This is a good example of how a challenge can be used as part of a solution, but also of how
the solution to a problem can present new challenges.

Summary
In this activity you have looked at some key challenges which new MedTech devices need to
overcome in order to be successful. Companies need to adhere to official standards and ensure
that their products are adequately regulated and certified. They must also ensure that data is
managed and stored safely and securely.

It is then equally important that companies communicate these precautions to the public in order
to alleviate concerns and avoid damaging negative publicity.

A risk based approach to regulations

How are MedTech regulations formulated? 

In this activity you will explore how the industry uses regulations to tackle these challenges and
to guarantee patient safety. 

Step 1.5 introduced the topic of how MedTech devices are regulated and how they are classified
into levels of risk. In Step 1.8, you read about the PIP implant scandal and the risk that these
devices posed to patients. This is a good example of what can happen when developers and
manufacturers don’t follow regulations.  

Now you will learn about the regulations that should have been applied to this implant, and the
regulatory process that it should have gone through. Regulations are intended to reduce risk to
patients. This is why risk often determines the standards applied to the device.

Determining regulations
The Medical Devices Directive (MDD), is a legal framework that came into effect in the 1990s
and consists of three directives that regulate the safety and marketing of medical devices in
Europe. The three directives are the:

 Active Implantable Medical Device Directive (AIMDD 90/385/EE)

 Medical Device Directive (MDD 93/42/EEC)

 In Vitro Diagnostic Medical Device Directive (IVDMDD 98/79/EC).

As well as these directives, a document called the Annex is an addition to the MDD that
provides a series of rules outlining basic principles for certain circumstances. For example, if
more than one rule applies to a device, the highest classification stands. This enables regulators
and innovators to identify which category their device fits into.

According to Annex IX, breast implants are a Class IIb product. However, in some instances
they are a Class III device, representing a higher level of risk. This is due to the risk associated
with the surgery, as well as the implant itself.

In May 2020 the MDD will be replaced by the new Medical Device Regulation (MDR). You can
read more about MDR and about this transition in the See Also section.

Even though thorough testing is carried out on all MedTech devices, there is always some
degree of risk. Regulations seek to manage and reduce this risk to acceptable levels, as it is
never possible to eliminate risk entirely.

In terms of the technology readiness levels, introduced in Step 1.2, the regulatory process starts
at TRL 5 and 6, and is finalised by TRL 8 or 9 when the MHRA agrees to the proposed device
classification.
Setting standards 
The silicone used in the PIP implant was an industrial grade silicone, not suitable to be placed
inside the human body. Medical grade silicone is regulated to ensure biocompatibility. This
reduces the risk of rejection by the body.   

But how do these materials earn their medical grade designation? 

Let’s look at the different types of testing that devices go through to help minimise the risk of
failure, as well as the organisations that regulate them. 

USP testing 
The purpose of USP (US Pharmacopeial Convention) testing is to find out whether the material is
biocompatible, ie suitable for use inside the human body. This is used in more than 140
countries. 

The USP is a scientific organisation that sets standards for food ingredients, medicines, medical
materials and dietary supplements that are manufactured, distributed and consumed globally. It
regulates their identity, strength, purity, and quality. Their standards are enforced in the US. 

Material grading 
 Materials are classified, or ‘graded’, according to their characteristics and intended functions.

For example, silicone manufacturers produce different grades of silicone. Using grades to
indicate different types of silicone helps medical device manufacturers to select the right type of
material. Different grades of silicone are tested to see whether the material is suitable for short-
term (less than 30 days) or long-term (greater than 30 days) implants.   In the case of PIP
implants, these regulations were not followed, allowing an inappropriate grade of silicone to be
used in implants.

Original Equipment Manufacturer

Original Equipment Manufacturers (OEMs) manufacture parts that are used in other companies’
products. The company that places the device on the market selects the OEM on the basis of
their knowledge of the field and their ability to supply components that meet the approved
standards for the overall end product.
The International Organization for Standardization (ISO) 
The International Organization for Standardization (ISO) develops and publishes documents that
provide requirements, guidelines and specifications. This is to ensure that materials, products,
processes, and services are fit for purpose, again reducing the risk of failure. 

For medical devices, the central ISO standard is ISO 13485 ‘Medical Devices, Quality
Management Systems’. Other standards, eg ISO 14971, which governs risk management for
medical devices, must also be complied with.

You can find a link to the ISO website in the See Also section.

ASTM International 
ASTM International is a globally recognised standard organisation. They develop testing
guidelines using engineers, clinicians, scientists and technical experts to ensure product safety.
Materials and parts also go through separate vigorous testing as well as the whole device itself. 

You can find a link to their website in the See Also section.

Summary
In this step you have learned about the tests that materials undergo for regulatory approval. In
the next step you will learn about how these materials are validated within a product before
entering the market.  

What are the regulators looking for?

How do regulators determine whether a medical technology is safe? 

When designing for manufacture, the manufacturing regulations are just as important as the

manufacturing processes. However, before thinking about either of these points, designers need
to make sure that users’ needs are met.    

Manufacturing validation and verification 
There is a trend for medical devices to be much smaller and more complex in design. In many
cases, advanced engineered materials such as polymers are used.  

In order to comply with regulations, and to ensure high quality design of the part and of the

production process, manufacturers use a process called validation and verification (V&V).  

Validation (checking that you are doing the right things) is making sure that you have unbiased
evidence that the device and the processes used to produce it and test it
are suitable for their intended uses.

This is done through tests, inspections and analysis. The point of this process is to ensure
that user needs are met, and that the medical device provides the intended benefits in actual use
conditions.  
Verification (checking that you are doing things right) is ensuring that you have fair evidence that
you are meeting the specified requirements with the desired level of accuracy.

Good validation and verification result in:

 improved repeatability  

 fewer mistakes  

 less rework and redesign 

 faster time to market  

 lower production costs. 

The three key stages in testing a product to ensure that it is safe to use are:

 pre-clinical trials

 clinical trials

 post-market surveillance

Let’s now look at each of these in turn.

Pre-clinical trials 
Once the manufacturing process has been developed to produce satisfactory prototypes, it is
important to test the quality of the product by exposing it to conditions that it would be subjected
to during use. 

For example, in the case of orthopaedic implants, manufacturers use simulations to understand

the performance of a device without having to implant it within a human. 

These could be either mechanical simulations, or virtual simulations. Let’s examine each of
these in more detail. 

Mechanical simulations 
 One example of testing a medical product is by using a simulator. For example, a hip simulator
is a machine for testing artificial hip joints. A hip simulator simulates 5 to 10 million walking
cycles, which represents 5-10 years of walking. The wear rate will show how suitable the hip
implant is for implantation within the body.  
Even though the public are assured that these implants have been fully tested, other factors
could also cause failures, for example the surgical procedure; this is where other regulations
come into place. 

Materials have separate standards and will undergo separate testing to ensure that the material
is safe to use. Manufacturers will then purchase regulated materials to create their products,
unless they are creating a new material all together.  

Virtual simulations 
The US Food and Drug Administration (FDA) has approved simulated clinical trials, which would
otherwise be performed in humans – and usually still are.

The process of conducting real-world clinical trials can take years. To make this process more

efficient, the FDA has approved the use of virtual, simulated clinical trials in order to cut down
time and cost. However, these still need to be rigorous and discriminating so that the public, as
well as clinicians, are able to trust the reliability of results generated by computer simulations.

Usually, only 5% of emerging technologies make it past the trials stage due to the lengthy
trialling process.  

Clinical investigations (clinical trials) 

Once the product has made it through pre-clinical trials, it can then be tested using real
patients.  Regulatory bodies, for example the MHRA or FDA, have rules to ensure the safety
and protection of the participants. Companies need to design their trials so that they are
consistent with these rules.

Some trials compare two or more treatments, and people taking part are put into a treatment
group at random. Randomised trials are usually the best way to get reliable information about
how well a new treatment works.

Reports are then analysed by scientists and engineers using the data collected and if
the product has performed well, it is approved. 

Clinical investigations are performed at TRL 7 on the technology readiness chart.

Post-market surveillance 
Because drugs and medical devices are approved based on clinical trials, which involve small
numbers of people on a selective basis, post-market surveillance is crucial to ensure the safety
of users after product has been launched. 

Post-marketing surveillance uses various approaches to monitor the safety of a drug or device
when it is in use. These include: 

 patient registries 

 prescription event monitoring 

 health databases 

 electronic health records. 

This enables the company to monitor the performance of the device, and means they can issue
product recalls and move quickly if necessary.

Post-market surveillance is TRL 10 on the technology readiness chart.

Improvements in patient safety and outcomes

How are orthopaedic implants tracked and recorded? 

In the previous step you saw how companies carry out post-market surveillance to monitor the
performance of their devices after they have been launched. In this step you will see how this
process works in the field of orthopaedic implants.

Monitoring the performance of artificial joints after they have been implanted into patients is
particularly important because of the longevity of these devices, and because patients rely on
them for their mobility and their daily activities.
Keeping records of implants is a legal requirement for manufacturers under the Medical Devices
Directive (MDD) and the new Medical Device Regulation (MDR), which you learned about in
Step 1.13.

Failed implants 
Even though implants go through vigorous testing, it is not certain that they will last. Many are
likely to fail at some point. 

Depending on the type of implant, artificial joints can be expected to last for 15 or even 25 years
before they need replacing. This could be due to many factors, for example:   

 the surgical technique used to fit the implant  

 the lifestyle and diet of the patient 

 illness. 

Younger patients are usually prescribed partial replacements, and then have total joint

replacements in the future. Partial replacements require less surgery and reduce patients’
recovery times.

Record keeping  
When an implant fails, most people undergo a revision surgery where another implant is
fitted. Because many patients will undergo multiple replacements, keeping a record of this is
crucial to minimise failure. 

Every implant has an individual identifier code. This code provides important information about
the implant. This includes when and where it was manufactured as well as the model number,
and the precise details of the procedure during which it was implanted.  

Orthopaedic joint registries   
Registries collect information about various replacements such as: 

 knee replacements 

 hip replacements  

 ankle replacements 

 elbow replacements.  

Registries were initially used to record the performance of the implant, and the surgeon

responsible for the procedure. The aim has now been extended to record the effectiveness of
different types of surgery and of different implant designs in order to improve clinical standards.
In doing so, it benefits patients, clinicians and the entire orthopaedic sector. 

There are many different registries established around the world. These also measure patient

reported outcomes. Patient reported outcomes are the experiences of the
patients, collected using a series of questionnaires. This gives the patient’s perspective to
complement the clinician’s point of view. 

The organisation that supports the development and maintenance of different registries around
the world is the International Society of Arthroplasty Registries (ISAR). The ISAR is a
professional association where joint registries come together to share their records and
findings. 

You can learn more about artificial joints in the course MedTech: Orthopaedic Implants and
Regenerative Medicine from the University of Leeds.

Summary
In the last three steps you have seen how regulations and standards are set and adhered to,
particularly with regard to PIP breast implants and orthopaedic implants.

This has given you an overview of the regulatory processes which ensure that MedTech devices
are safe to use. These processes are based on the potential risk that a particular device is seen
to pose to patients, and determine the way in which companies develop their products to be as
beneficial as possible to patients and clinicians.

The benefits of MedTech innovations

Who benefits from MedTech?

Medical technologies have come a long way through lots of research, development and
investment. But how have these technologies benefited us? In this step you will learn about the
benefits of MedTech, and how it has impacted different stakeholders. 

In the video, several experts from academia, industry and healthcare talk about the different
benefits they have seen in their fields, especially to HCPs (healthcare professionals). These
benefits include:

 digitised medical records

 communication within healthcare systems

 mobile health apps.

Let’s now examine each of these in turn.

Digitised medical records 
When patients use a health service, their personal details along with the treatments received
are recorded.

Initially all record keeping was done using paper that was stored away using a filing system.
Even though this process is still done today, for example in dentistry, most healthcare providers
have turned to using electronic medical records. This ‘paperless’ method has not only
decreased our carbon footprint but has also ensured a much quicker service since files are
retrieved almost immediately.

Electronic health records have benefited many clinical roles including nurses, bioinformaticians,

billers and medical receptionists to name a few. Clinicians are now able to input data such as
test results into a central digitised system, keeping the records safe and easy to trace.

This system also benefits patients since submitting medical claims is also much faster due to the
collection of data and evidence. 

Communication within healthcare systems  

 Mobile devices such as smartphones have allowed clinicians to work in remote areas. For
example, smartphones can be used to access a patient’s electronic health records, also
allowing the clinician to issue prescriptions electronically.

Files and messages are easily transferred through a cloud-based service.  A cloud is a
computing platform made up of multiple servers that are connected to the internet, allowing us
to share data even in remote locations. Emergency services often rely on this technology due to
the fast paced environment in which they work. 

Clinicians also use mobile devices such as pagers as a form of communication.  Inside a
hospital, clinician A may need another clinician B who is in another ward. Clinician A uses the
pager by sending the alert, which makes a bleep sound on clinician B’s pager, alerting them that
they are needed. A message is also displayed on the device to let them know where they are
required. These devices have been beneficial since time is limited in most scenarios.   

Although pagers are an old technology, they are still widely used in the NHS. You can read
more about why this is the case in the See Also section.

Mobile health apps 

Not all patients have the time or means to travel to see their doctor.

Mobile health apps have benefited both clinicians and patients in many ways from prescriptions
to aftercare. One example is Pocket Physio, a mobile phone app that features
advice about breathing exercises, managing pain and post-surgery physiotherapy exercises.
Patients can track their progress and input their results, which can be sent off electronically to
their doctors.
The use of these apps has the potential to decrease the strain on healthcare providers. If they
are used more widely, they could eventually save both money and time, which could be used to
improve other services. Healthcare infrastructures could change as a result, leading to a
decrease in patient waiting times and wasted appointments. 

Summary
Now that you have learned about some of the benefits of MedTech to different stakeholders, in
the next step you will conduct your own research into the positive effects which MedTech can
have on individuals and society.

Key points revisited

Medical technologies
Medical technologies have many applications within healthcare. Over the years, medical
technologies have developed based on many drivers, such as societal expectations of being
healthy for more years, the burden of chronic diseases, and the demand for improved but less
expensive products. You have explored key historical innovations such as wound dressings and
the various product developments stages. You were also introduced to TRLs and how they are
used to develop a device/technology from concept to market.

Regulations
Regulations are put in place to ensure safety and compliance. Devices are tested at all stages
of development, and clinical investigations are conducted to minimise the risk of harm to the
patient and the risk of the device failing in its intended use. You were also asked to think about
virtual trials. You were introduced to different regulatory processes, including the recall of
medical devices when failures occur.

Public perception
Public perception can have a huge impact on how a treatment procedure is perceived. You
were introduced to the PIP scandal, which attracted extensive media coverage and had a major
impact on public perception. You were given the opportunity to read media articles about the
scandal where alarming language was used. The thought that something could go wrong with a
device could have implications for similar treatments in future, even when regulations have been
reinforced. It is important to understand the consequences of negligence and lack of
compliance.

By reflecting on these key points, and completing the further steps in this activity, you will be
better placed to complete the test at the end of this course.