MEDTECH: AI and Medical Robots

Why do we need robots in healthcare?

There are currently more demands on the healthcare sector than ever before.
Improvements in the quality of living, scientific breakthroughs and the discovery of new
treatments mean that people are living longer and requiring care for more complex
conditions. This combined with challenges relating to budgetary cuts and the need to
find savings through increased efficiency, creates an environment where healthcare
providers are increasingly looking to AI and Robotics to assist them in treating and
caring for patients.

Why are robots used?

Robots are being increasingly used in healthcare settings because they can be designed to
meet specific clinical needs and challenges. They can be designed specifically for purposes for
which they are better suited than more traditional human-based methods. There are a number
of ways in which robots can be seen as better than humans in certain circumstances:

1. Robots are able to carry out tasks which carry large degrees of risk or have the potential
to cause harm to a human. This allows for a wider choice of treatment options which can
be explored by clinicians.

2. Robots can be designed to take any form or shape allowing them to access and explore
areas which humans physically cannot reach.

3. Robots do not suffer from fatigue. The standard of their work and their precision never
decreases because of tiredness. This enables them to continue to work almost
continuously which improves efficiency.

4. Robots are well suited to perform tasks which require a high level of accuracy and
precision. This makes them well suited to assisting or conducting surgery on particularly
small areas or areas which require immense precision such as heart or brain surgery.

Current uses of robots in healthcare settings

Currently, robots are used to assist both clinicians and patients in a range of healthcare
settings. They are used as a surgical tool to assist surgeons in carrying out complex surgeries
which require accuracy and precision. But robots are also used as an assistive device to provide
care, support and improve the health and lifestyle of patients. As such, robots currently can be
used in a variety of different ways:

As an aid with rehabilitation

A rehabilitation robot is designed to improve the movement of a patient with impaired physical
functioning. There are two main types of rehabilitation robots, the first type is an assistive robot
that substitutes for lost limb movements. The second type of rehabilitation robot is a therapy
robot.

Therapy robots include mechanical animals which imitate domesticated animal behaviours,
such as mechanical cats that purr and meow. Other therapy robots such as Pepper can read a
user’s emotional cues. This is done by tracking user’s facial expressions, body language and
the words they use.

To assist patients to maintain their independence

Robots can be developed to have a similar mobility structure to that of humans along with a
friendly humanoid face. Robots can be programmed to perform tasks such as accompanying
patients around their homes and reminding them when to take their medication. Artificial
intelligence can be incorporated into the design of robot enabling humans and robots to have
conversations to help keep ageing minds sharp and reduce loneliness.

To deliver meals and medication in the hospital

As robots can work tirelessly and are always precise and accurate, tasks that are considered to
be the most menial and boring can be made easier with the use of automated systems. Robots
can help processes such as the delivery of medicines, food, meal trays and patient records.
This can then free up employees to focus on more important tasks related to patient care.

To be used to perform surgery or provide assistance to surgeons whilst operating

Robots can be used in surgery to provide a surgeon with more precision, control and flexibility in
comparison to conventional methods. This is why robotic surgery is often used for minimally
invasive procedures, where surgery is performed through a small incision.

To be used for telemedicine

Robots can transmit and receive video, audio and navigation directions, and also take
measurements by connecting to other devices like otoscopes and ultrasound. This can assist
healthcare professionals who require a second opinion in rural areas. It can also be helpful in
time-sensitive emergencies like a stroke, where every second counts and instant assistance is
required.

What is a robot?

A robot is an electromechanical system, which is a combination of electrical or electronic circuits

and a mechanical system. A robot is an autonomous machine which can move independently
by sensing its environment, or the movement can be dependent on the user. A robot can also
carry out computations enabling the robot to think on its own and make decisions to perform
actions in the real world.
 Before anything can be identified as a
robot it needs to have these four essential
characteristics: sensing, movement, energy
and intelligence.

 Sensing – a robot must be able to

sense its environment. Sensors are
used to provide a robot with an
awareness of their surroundings.
These sensors are specific to light,
touch, pressure, chemical, sound
(including sonar), and radio waves
(eg radar).
 Movement – a robot is required to perform the desired movements efficiently within its
environment.
 Energy – a sufficient power source such as mains, battery, solar or wireless is required
so a robot can power itself.
 Intelligence – a robot must be programmed to perform tasks that it is required to do.

The method in which a robot takes information into its system is referred to as an input. Robots
receive information from sensors that convert information about their local environment into an
electrical signal. The application of a sensor is specific and depends on the application scenario
and the system infrastructure. Different sensors are required to detect the vast array of
physiological signals, human behaviour and the surrounding environment.

A microcontroller is a single integrated circuit chip used for a specific application and designed
to implement a certain task, commonly combined with sensors. A microcontroller gathers input
information obtained from sensors. It then processes the information and delivers the output.
This is in the form of a specific action based on the collated information.

Once a robot understands the information it is required to translate the information and create
an output. An output can be either a movement, a sound, light or wireless communication.

The robot’s control system can also affect the type of output it produces and enable it to
respond to inputs without the assistance of a computer.

Robot control systems

Control systems allow for the movement and function of various parts of the robot. They also
allow a robot to execute a specific set of motions and forces in the presence of unforeseen
errors.

Robots can be controlled in several different ways:

  Poses control – the movements of a robot are pre-programmed. The robot playbacks a
sequence of poses and tasks. An example of this could be a humanoid robot that can be
pre-programmed with an assortment of poses such as pepper robot.
 Standalone control – allows a robot to function without the assistance computer. A
computer is used initially to set up and program the robot, but afterwards, the computer
is no longer required. An example could be household companion robots that function
without support from a separate computer eg BUDDY.
 Wireless Control – allows a robot be controlled wirelessly. A telepresence robot that can
be controlled remotely, and can act as a user’s stand-in whilst they are in a different
place is one example of wireless control eg PadBot U2.
 Cloud control – allows a human to delegate a task to the robot remotely through cloud
computing technologies eg Sphero BOLT App-Enabled Robot.

Teamwork is also essential in robotics. The level of interaction between human and machine
determines how versatile and adaptable a robot is.

Cloud computing enables this teamwork to take place between different humans and robots
through the Internet of Things.

The Internet of Things (IoT)

The internet of things (IoT) refers to the connection of physical devices to the internet, enabling
users to collect and share data. This level of digital intelligence enables robots and other
devices to communicate with each other in real-time without any human involvement. This has
led to the merging of the digital world with the physical world.

As the IoT becomes bigger, the number of connections between devices will grow. This will
generate a substantial amount of data. One way to make use of all the gathered data is to feed
the data into AI systems. These can then use the data gathered from the IoT to make
predictions about people’s health and also diagnose patient’s illnesses and conditions.

The IoT can impact the healthcare system by encouraging individuals to proactively manage
their health. It also enables healthcare professionals to understand the day-to-day patterns and
needs of patients that they care for. The IoT can also be used to review and store large
amounts of medical information such as; every medical journal, symptom, case study of
treatment and response around the world. This provides healthcare professionals with access to
more knowledge than before.

How does a robot make decisions?

At their simplest, robots can be built and programmed to respond in a certain way to a
specific stimulus. In many cases this is all that is needed, however, as robots continue to
be used for increasingly complex tasks, there becomes a need for them to be able to
‘think’ for themselves. This ‘thinking’ is where Artificial Intelligence (AI) comes in.
What is AI?

AI is a branch of computer science which aims to create intelligent machines. This involves
developing computer programs to complete tasks that would otherwise require human
intelligence.

Knowledge is a core part of AI; machines are only able to replicate human reactions and
behaviour if they have enough information relating to the world. AI aims to provide machines
with knowledge capacity – this is the capacity to store large amounts of knowledge, such as
journals, case studies and reviews. This enables robots to perform functions such as learning,
perception, problem-solving, understanding language and logic reasoning without human
intervention.

For robots to perform tasks efficiently they are required to understand information and translate
it into an understandable output. The method in which robots commonly receive information is
through sensors that convert information about their environment into electrical signals. Once a
robot understands the information it is required to translate the information and create an output
to change something in the physical world. An output can be either a movement, sound, light or
radio waves.

How do robots use AI?

Robots are programmable machines which carry out a series of autonomous or semi-
autonomous actions. When you introduce AI to robotic technology it enhances the capabilities of
a robot, making robots more efficient and capable. These include:

 Computer Vision – AI can help robots to detect objects which they have never seen
before in much greater detail.
 Grasping – Using AI robots can grasp items which they have never seen before. They
can also determine the best position and orientation to grasp an object.
 Data – AI helps robots to understand physical and logistical data patterns. This means a
robot can respond proactively and act accordingly.

How do robots make decisions using AI?

An artificially intelligent robot collates information about a situation through sensors and human
input. This information is compared to previously stored data. The AI robot uses this stored data
to decide what the new information signifies. Based on the collected information the AI robot will
run through possible actions and predictions to decide on a course of action that will be the
most suitable.

Some robots can learn through recognising that a particular action will achieve the desired
result, without performing the action itself. This information is stored, and the robot will attempt
the successful action when the same situation is encountered again.
Unlocking human-robot interaction

Using AI and robotics in healthcare settings requires designers to specifically focus on

how robots and humans interact with each other.

If robots are used to assist humans, then they must be designed ergonomically and with a clear
vision for how humans will interact with them and how they will interact with humans. So how do
humans and robots interact?

In this video, Shane Xie, a Professor at the University of Leeds, introduces Human-Robot
Interaction (HRI), how humans and robots communicate and interact with each other. Shane
highlights the differences between remote interaction, where are human and robot interact when
separated spatially and temporally. As well as proximate interaction, when a human and robot
are co-located together in the same space.

When a human interacts with a robot, the motions of the human and robot generate two types of
interaction: cognitive and physical.

Physical interaction

Physical interaction is related to the forces generated between the musculoskeletal system and
the rigid body of the robot. The robot must understand the desired motion of the user from the
forces it measures, and the command signals for the robot must be generated accordingly. The
different scenarios in which physical interactions between a robot and human would occur are:

 when humans and robot work closely together in a shared environment

 when robotics are integrated with human limbs (exoskeleton)
 Robots and humans work together to change the environment and teleoperation.

Cognitive interaction

Cognitive interaction is the interaction related to bi-directional cognitions. This is the inference,
planning and actions between a human and a robot. This consists of spatial reasoning,
anticipation, temporal reasoning, intentionality and focus of attention.

 Spatial reasoning is the capacity to understand, reason and remember the spatial
relations among objects or space.
 Anticipation is to understand the intent and anticipate future actions.
 Temporal Reasoning is to conceptualise the three-dimensional relationships of objects
in space and to mentally manipulate them as a succession of transformations over a
period of time.
 Intentionality is the mind’s capacity to direct itself on things such as mental states like
thoughts, beliefs, desires and hopes.
  Focus of Attention is the robot’s ability to concentrate its attention on a target stimulus
for any period.

The cognitive and physical interactions of a robot are dependent on each other. How the robot
interacts with the physical world can help it to set rules for evaluating the environment
cognitively. This in turn can help to improve physical interactions by helping the robot to set
suitable control parameters.

When this process is combined with design with interacting with human in mind, it leads to
smooth interactions between human and robots. This is important when a robot is going to be
used in a healthcare or clinical setting, as robots whose interaction with humans are clunky or
counter-intuitive could impact negatively on a patient outcomes and wellbeing.

Features of human robot interaction

In the previous step, you saw that humans and robots interact in two ways; physical and
cognitive. You will now go on to explore the main themes of HRI.

Themes of HRI

There are four main themes of HRI: level and behaviour of autonomy, nature of information
exchange, the structure of the human-robot team and design and shaping of tasks for human-
robot collaborations.

1. Level and behaviour of autonomy – describes to what degree a robot can act on its own
accord, from a robot being directly controlled by a human to the robot being autonomous
(no input of actions or approval is required from a human).

2. Nature of information exchange – is the way the

information between the robot and human is
exchanged. There are two key dimensions in
the exchange of information between a robot
and human: the medium and the format of
communication. The primary medium is
characterised by three senses: visual, audio and
tactile. Here is a table identifying the medium
and the format of communication. 

3. Structure of human-robot team – Is how many

humans it takes to efficiently manage a fixed
number of robots. This allows for the possibility of adaptable autonomy and dynamic
handoffs between humans.

4. Design and shaping of tasks for human-robot collaborations – Robotic technology is

introduced to a domain either to allow a human to do a task that they could not do
before, or to make the task easier or more pleasant for the human. Task-shaping is a
 term that emphasizes the importance of considering how the task should be done and
will be done when new technology is introduced.

Understanding and being aware of the features of human-robot interaction helps designers and
developers create robots that are fit for purpose and meet the user’s needs.

Human centred design

What implications does HRI have on the design of robotics?

Robots need to be designed with humans in mind. But it’s not just the patients, robots need to
be designed to allow for the best experience for their operators. This includes healthcare
professionals that need robots to be easy to use and beneficial. It is also important to healthcare
professionals that robots help to simplify their work, and do not make it more complicated.

Design thinking provides a solution-based approach to solving problems. This is done by

understanding the human needs involved and re-framing the problem in a human-centric way.
The Hasso-Plattner Institute of Design at Stanford developed a five-stage design thinking
model; Empathise, define, ideate, prototype and test.

Empathise

The first stage of design thinking is to gain an empathic understanding of the problem that the
designer is trying to solve. This involves consulting experts to understand the area, and the
designer immersing themselves in the environment so they can gain a deeper personal
understanding of the issues involved. Empathy is crucial to the human-centred design
approach. Empathy enables a designer to set aside their own assumptions in order to gain an
insight into the user and their needs. At this stage, the designer will understand the features that
are most important for the user such as longevity, ease of use, and any preference relating to
the product’s weight and material.

Define

The define stage involves putting together all the information that has been created and
gathered during the empathise stage. This stage is where the designer will analyse the
observations to define a core problem, as a human-centred problem statement. The define
stage will help the designers to establish the features and functions of the product.

Ideate and prototype

The ideate stage is where designers generate ideas to solve the problem. Once the design
team have pinned down the features of the product, they can then develop prototypes to be
shared and tested. At this stage, the design team will have an understanding of how real users
would behave, think and feel when interacting with the end product. At this stage, it is key to
involve the end users to provide feedback as they will ultimately be using the final product.

Test
The testing stage is the final stage of the 5-stage model and is an iterative process. The testing
stage is used to redefine one or more problems, understand the conditions of use and to see
how people think, feel, behave and empathise with the final product. The testing stage can
sometimes lead to the development of a new prototype depending on the feedback from the
users.

You will now be introduced to a case study which looks at the design and development of the
first exoskeleton garment. It was designed to enhance arm mobility for children with movement
impairments.

Case study – Cerebral Palsy

Cerebral Palsy (CP) is a common disability identified in childhood. It is a permanent disorder

that places limitations on daily living. CP is commonly associated with sensory deficits, cognition
impairments, communication and motor disabilities, behaviour issues, seizure disorder, pain and
secondary musculoskeletal problems.

Exoskeletons can help to normalise the movement of a child suffering from CP. The
exoskeleton also needs to help perform functional everyday activities. These activities include
self-care such as grooming and dressing, and fine motor skills such as writing and drawing.

Current assistive devices used for CP patients with leg movement impairments are scooters,
crutches and wheelchairs. There are few commercially available devices to assist children with
arm movement impairments with their mobility.

New strategies are required to limit the dedication and assistance required from care givers to
enable a patient to have a higher level of independence. This is why robot-assisted therapies
are required. Exoskeletons can help patients by being adaptive to the special needs of the user
such as being adjustable or made to measure. They can also provide the additional support
required. For example, an arm exoskeleton helps its user move their arms against gravity,
providing additional support with the user in full control of their movement.

The downside to using most arm assisting exoskeletons are that they are expensive, difficult to
obtain, unattractive and require specialised technicians to control and maintain the
technology.  Arm exoskeletons are also not feasible for use in the natural environments children
typically experience. This is due to the bulkiness of the exoskeleton which makes it difficult for
the child to play and restricts the child’s mobility. It can also be difficult to carry and can be
incompatible with devices such as car seats and strollers.

When designing an exoskeleton with the patient in mind, the patient’s comfort while using the
exoskeleton must be considered. The patient also needs to be able to independently use the
exoskeleton without any additional support.

While the patient is the ultimate end user, healthcare workers and clinicians will also need to be
able to interact with the exoskeleton. These interactions could include assembling and
maintaining the exoskeleton.
One example of an exoskeleton which has been designed for use by children with CP, using a
user-centred approach, is the Playskin Lift.

Playskin Lift

The PlaySkin Lift is an exoskeleton garment which assists and facilitates movement for children
with arm movement impairments. It is also the first exoskeletal garment designed for
rehabilitation.

To develop the Playskin Lift, a user-centred design process was used. The design process for
this project used an interdisciplinary approach and kept engagement with the users central
throughout.

In order to address the users’ needs related to function, expressiveness, aesthetics, and
accessibility, design approaches from engineering and apparel design were combined. The
apparel design process focuses on three stages:

1. Problem definition: the team defines the problem according to the user, then researches
existing solutions and safety standards, and redefines the problem
2. Creative exploration: the team ideates initial design solutions, creates prototypes and
evaluates them
3. Implementation: the team refines the prototypes in order to produce a design solution for
comprehensive evaluation.

This project demonstrates the importance and impact of a user-centred approach to medical
device design. The solution was a novel and innovative device.

Challenges when designing a robot

Robots are being used more often within a healthcare setting and will frequently interact with
patients and medical staff. When designing a robot, a designer must address many
considerations.

These considerations include:

 Patient safety: the design of the robot must have no adverse effects on the patients’
health. This is achieved by limiting possible errors that can occur with the robot.
 Control: a robot must instantaneously respond to control commands from the user. The
designer must also consider who will control the robot.
 Operation: the robot is required to perform actions or functions as desired by the user.
This needs to be in an easy and efficient manner with minimal complexity.
 Accessibility: designing a robot which is easily understood and used is essential within
healthcare as the robot can have many users.
  Level of autonomy: the robot must be designed with a safe level of autonomy. The
level of autonomy in robots refers to how much guidance is given to the robot to perform
a task. A high level of autonomy would be that a robot is able to carry out tasks without
human guidance and assistance. A low level of autonomy would require human
guidance and involvement.
 Loss of personalised care: the patient needs to have a choice and have control over
the way their care is planned and delivered.
 Loss of human care: a concern is that robots may remove the human element from the
care process.

The challenge of incorporating all of these considerations in a design is that one factor can
restrict another. However, if a design successfully considers all of the factors it will be safe and
user friendly, and will be better prepared to meet medical device standards.

Why do robots need regulating?

Using robots in healthcare can have many advantages, as you’ve already seen. But
introducing robots into a healthcare setting can create a number of risks which need to
be carefully considered. In order to ensure the safety of both the patients and the staff
operating the robots, there is a need to create rules which govern the use of robotics in
healthcare.

A robotic device used in a medical application is subject to medical device regulations.

Regulations are needed to promote safety at every point in the design, development, production
and use of robots with humans. Standards need to be set which guarantee the quality of the
equipment, product safety, clinical safety and quality systems compliance to ensure the safety
of the patient and robot users.

The U.S. food and drug administration (FDA) and the Medicines and Healthcare products
Regulatory Agency (MHRA) in the UK regulate medical devices but not the practice of medicine,
this is left to the medical societies. Handling the overlap between a regulated medical robot
along with a competent user is challenging. It requires orchestrated effort from all stakeholders
to ensure that the user is capable of functioning the regulated robot.

Before you investigate how regulations and regulatory bodies are used to reduce the risk of
harm caused by robots, you need to understand what can go wrong even if a medical device is
regulated. The following case study shows an incident where a lack of training on a regulated
robot caused harm to a patient.

Case study: The da Vinci Robot

The da Vinci Robot is a surgical robot which can perform

minimally invasive surgeries.
In 2015 Stephen Pettitt was the first to undergo robotic heart surgery using the da Vinci within
the UK, at the Freeman Hospital in Newcastle. He died after the operation led by Dr Sukumaran
Nair.

If Mr Pettitt had conventional surgery (without the use of a robotic surgeon) there was only a 1-
2% chance of the operation leading to his death. Stephen Pettitt died as a direct consequence
of the operation using the da Vinci, and the subsequent complications.

After an inquest, a statement was released revealing that there had been a catalogue of errors.
These included a lack of training of the surgeon who led the operation. The surgeon had not
received any one-to-one training on how to use the da Vinci device.

The Da Vinci robot is a regulated device but still managed to cause harm to the patient through
a lack of surgical training. This example shows that the safety of a surgical robot requires
licensing and/or certification from the FDA to certify of the device is safe to use, but no
regulations are in place for a surgeon using robotics in surgery.

A concern for the future of medical robotics is the training of those that use them. Just as a
device is robustly tested to ensure it is safe for human use, humans should also be tested to
ensure that they can safely use the robotic device. In the following steps, you will learn about
the regulations and regulatory bodies in the UK and US. As you go through the steps think
about how the regulations can be applied to training as well as devices.

Regulations for safety

Medical device regulatory bodies are there to ensure that medicines and medical devices
work and are acceptably safe. In the UK the regulatory body is the Medicines and
Healthcare products Regulatory Agency (MHRA). In the United States, the regulatory
body is the Food and Drug Administration (FDA) who examine, test and approve a wide
range of items for medical uses.

There are different safeguards in place to guarantee that robots are safe to use and will avoid
placing patients at risk. Before a robot can be used with patients, it needs to undergo risk
management, pass rigorous testing and meet industry standards. These all ensure that a
medical robot is safe to use with patients.

Risk Management

Risk is the combination of severity of harm and the probability of it occurring.

To minimise risk, a risk management process is implemented to ensure safety. This is a

systematic application of management policies, procedures and practices. These are developed
with the aim to analyse, evaluate, control and monitor any identified risks.

When developing a medical robot, a risk management procedure is implemented to:

  Ensure the safety of the product, this includes moral, ethical, legal and brand image
implications.
 Ensure the product complies with regulatory agencies. This is the law and if a device is
non-compliant with the regulations serious ramifications will occur.
 Use as a decision-making tool as it can help to understand roles, responsibilities and
authorities. This also assists in a standardized approach to drive confidence.
 Capture business risks as well as mitigate risks.

Risk management is a process of five steps:

1. Risk analysis – is the process of identifying hazards and estimating risk.

2. Risk evaluation – is the comparison of estimated risks to pre-established acceptability
criteria.
3. Risk control – are the actions taken to reduce risks to acceptable levels and to validate
or verify their effectiveness.
4. Overall residual risk evaluation – is the summary of all individual risks remaining after
risk control measures have been implemented
5. Production and post-production information.

Risk management happens throughout the project, from the initial idea to monitoring the
released product. Before a product is released, it must go through testing to ensure it is safe for
use with patients.

Testing process

During the testing process, a medical robot will undergo rigorous checking to ensure that it can
become a successful product with minimal risks. Testing medical robots is critical as they can
have a direct impact on human lives. Medical device manufacturers are required to follow
testing, verification and validation processes to ensure the quality and reliability of the medical
device. This is to ensure that safe and effective healthcare devices are delivered to the end
users such as patients and healthcare professionals.

Clinical safety evaluation is an ongoing process and tests which are conducted throughout the
entire lifecycle of a medical device, from initial product design and development through to
regulatory review and approval. This process allows regulators to receive assurance from the
manufacturer in regard to the safety and efficacy of the device. Examples of particular clinical
safety evaluations of a medical robot are the assessment of robotic-specific functional safety
which can be found in ISO 13849, evaluation of clinical investigation for compliance to ensure
thoroughness and accuracy with the requirements of ISO14155 and biocompatibility testing to
evaluate the effect of the device through contact within the body which are detailed in the ISO
10993 series of standards.
Manufacturers should implement testing processes of devices from the design stage to detect
any ineffectiveness and inefficiency at this early stage of development. There are two testing
stages; pre-clinical and clinical trials.

Preclinical trials are where robots undergo testing in a controlled laboratory, as the device
prototype is not ready for use on humans. This type of testing will help to refine the prototype
and provide further information about the functions of the device from the user.

Clinical trials occur when a medical robot has successfully passed all pre-clinical trials and the
device can now be tested with humans.

For a robot to be released onto the market after clinical trials it needs to be ensured that it
meets the right standards.

Standards

A standard is a document established by consensus and approved by a recognised body. It

provides for common and repeated use, rules, guidelines or characteristics for activities or their
results, aimed at the achievement of the optimum degree of order in a given context.

An international standard is a standard adopted by an international standardising/standards

organization and made available to the public. ISO 13485 specifies requirements for a quality
management system where an organization needs to ensure that the design, development,
production, installation and delivery of a medical device is safe for its intended purpose.

The commercialisation process

Having designed a product which has taken human-robot interaction into consideration,
developed and tested the robot to make sure that it is safe to use and meets the
standards, how do you then introduce it to the healthcare market and hopefully make
money from it?

In this video, Janos Kalmar from Expert Prosthetic Solutions and Strategy at Ottobock
discusses the process they follow when designing and creating a product. Ottobock is a world-
leading manufacturer and supplier of prosthetic limbs, orthotic supports and wheelchairs.

What is commercialisation?

Commercialisation involves several processes which ensure that the product is fit for purpose
and has been ‘de-risked’. De-risking is minimising the probability that the device could cause
harm to users and reducing the severity of that harm.

There are 11 steps to a product reaching commercialisation. Following each step ensures that
the final product has been de-risked.
1. Planning: planning the design process from concept to release. ISO 13485 is an
international organization for Standardisation to ensure that the design, development,
production, installation and delivery of a medical device is safe for its intended purpose.
Both ISO 13485 and the FDA require a design plan, this is to plan and control the design
stages, the review, verification, validation and design transfer activities. The plan
provides a clear assignment of responsibilities and authorities with a clear structure and
coordination of all activities and subprocess. This includes risk management and
usability followed by identifying critical pathways and establishing how changes can
impact the process. The plan also includes sub-processes such as risk management
activities, human factors, specification development, verification, testing, validation and
design release requirements. All plans must be maintained and controlled.
2. Identify user needs: provides an initial level of detail to the concept and gives
objectives. This includes developing a business strategy and identifying the user and
patient needs from evaluation of similar devices and feedback. Within this section,
clinical input assists in refining information to define the intended use of the final product.
Having a clinician involved in the identification of need and design of the robot enables
the designer to establish medical benefits and acceptable risk. This step also
investigates the regulatory environment to understand what regulatory actions have
been taken on similar devices and what the regulatory requirements are such as
language, testing. This step also involves an initial risk analysis to identify the high-level
functions and potential hazards, harm and risks.
3. Identify product requirements: for each user need and design input a technical
product must be created to assure that the needs and inputs will be addressed. For each
identified risk an action to reduce the severity of the risk must be translated into the
product design. Usability requirements are also identified at this stage, this is based on
the user and patient profiles. All design requirements developed must be testable.
4. Device design and specification: this is the stage where the creation of the design
begins with verification plans being developed, specifications and drawings are refined,
alongside updating risk analysis and implementing a problem resolution process. The
product specification should include information about the material, dimensions,
electrical safety, warnings, cautions, alarms and user instructions.
5. Verify requirements are met: verification is the process of determining, through the
provision of objective evidence that the specified requirements such as compliance with
standards have been fulfilled by means of product specifications.
6. Validate user needs are met: is the process of assuring that users and patients interact
with the device as anticipated this will determine whether the specifications achieve the
goals set out in the design inputs.
7. Design transfer: is the translation of product design into process requirements and
specifications. At this stage, the designer must verify that the final design incorporates all
specifications and that the documents that will be used to manufacture the device. This
will include detailed specification and drawings for components subassemblies and
assemblies.
8. Managing Risk with Process design and specification: is where the designer can
pinpoint the causes or combination of causes which could lead to an undesired response
causing harm or a hazardous situation.
 9. Verify and validate process: is validating the manufacturing systems that will be used
for production.
10. Commercialisation: at this stage, the technology developed is ready for production. All
risks have been analysed and reduced as far as possible and all the documentation of
the device design and production is available, this is a critical factor as it is difficult to
gain regulatory approval without documentation showing a structured process with all
aspects of safety being considered.
11. Production and Post-production monitoring: is a system used to collect and review
information about the product in the field and is needed to ensure the quality of the
product into the future.

Commercialising a device can be a lengthy process which is why it can take many years for a
product to become readily available for public use.

Pepper Robot
A semi-humanoid robot which can detect emotions and can analyse expressions and voice
tones. Pepper can be used commercially, in the home and in academia. Its ultimate purpose is
to facilitate relationships, have fun with people and connect people to the outside world.

Ingestible origami robot

A tiny robot that can unfold itself from a swallowed capsule. It is steered by external magnetic
fields and can remove swallowed button batteries or patch wounds.

Medical Exoskeleton
Designed to help people with mobility disorders to be upright and mobile. An exoskeleton is a
wearable mobile machine that is powered by a combination of technologies that allow for limb
movements to increase strength and endurance.

Artificial intelligence and robotics in healthcare

AI is a branch of computer science that aims to create intelligent machines that can complete
tasks that would otherwise require human intelligence. AI can be used on its own or with
robotics to assist in the healthcare setting. This is because they both can be designed to meet
specific clinical needs and challenges.

Human robot interaction

You gained an understanding about how robots and humans interact. You also saw the key
themes of human robot interaction; level and behaviour of autonomy, nature of information
exchange, the structure of human-robot team and design and shaping of tasks for human-robot
collaborations. You discussed and shared your opinions and experiences on the quality of
interactions with robots and AI.

Human centered design

Human centred design aims to develop a solution to a problem by involving the human
perspective in all steps of the problem-solving process. This is necessary when developing a
robot as they need to be designed to allow for the best experience for their operators. This is
especially important in the healthcare sector, so robots needs to be designed so that they are
easy to use, beneficial and do not complicate things further.

Commercialisation

You were introduced to the commercialisation process of a device by Janos from Ottobock.
Janos explained how regulations are in place to promote safety at each point in the design,
development and production of a robot. You also saw how these regulations apply when the
robot is used with humans. It was also highlighted that the bodies that regulate medical devices
are the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, and the Food
and Drug Administration (FDA) in the USA.