Not only will the industry see changes with the EU MDR, but we're glad that patients will recognise changes for the better, too. Patients can expect to make more informed decisions before using medical devices, as more information will become publicly available. And we think this is a big step in the right direction! Read more about our thoughts on involving patients more in the medical device clinical trial process:

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08
Improving patient
engagement in
medical device
clinical trials

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Improving patient engagement in medical device clinical trials
will achieve greater success if
they’re designed with the
PATIENT IN MIND
MEDICAL DEVICE
CLINICAL TRIALS

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Improving patient engagement in medical device clinical trials
1. World Health Organization.
Medical Device – Full Definition,
https://www.who.int/medical_
devices/full_deffinition/en/
[Accessed: July 2020]
2. U.S. Food & Drug Administration.
How to Determine if Your Product is
a Medical Device. December 2019.
https://www.fda.gov/medical-
devices/classify-your-medical-
device/how-determine-if-your-
product-medical-device [Accessed:
July 2020]
3. European Medicines Agency.
Medical Devices. https://www.
ema.europa.eu/en/human-
regulatory/overview/medical-
devices#:~:text=Medical%20
devices%20are%20products%20
or,regulated%20at%20Member%20
State%20level.&text=Medical%20
devices%20in%20the%20EU,s-
afe%20and%20perform%20as%20
intended. [Accessed: July 2020]
With technological advancements and increasing innovation, the medical
device industry is constantly evolving. Across the world, many types of
devices are developed for patients and used for various medical procedures, in
prevention, diagnosis, treatment, and care of diseases.
Medical devices are products or equipment intended generally for medical use.
While they range from simple to complex, a medical device is officially defined by
any instrument, apparatus, material or other similar article, intended to be used for:
+ diagnosis, prevention, monitoring, treatment or alleviation of disease
+ diagnosis, monitoring, treatment, alleviation of or compensation for an injury
+ investigation, replacement, modification, or support of the anatomy or of a
physiological process
+ supporting or sustaining life
+ control of conception
+ disinfection of medical devices
+ providing information by means of in vitro examination of specimens
derived from the human body
A medical device does not achieve its primary intended purposes through
chemical action, in or on the human body, but its intended function may be
assisted by such means1,2,3
.
So, whether it’s an oxygen mask, a complex MRI machine, or a digital health
app, it’s thanks to the medical device industry that diseases can be detected and
diagnosed earlier, and treatment and patient monitoring can improve. Medical
devices provide opportunities to improve patient care and quality of life, and allow
healthcare professionals (HCPs) to have a greater understanding of diseases.
While it’s amazing what technology can do, how can we truly know what will
improve a patient’s life, if we don’t hear from the patient themselves?
When a medical device is developed, depending on the potential risks, a clinical
trial may need to be carried out to find out how well the medical device works
and any possible side effects it may cause. Traditionally, medical devices
have been developed without patient input, especially at the earliest stages
of development. And as a result, the medical device – whether it’s wearable
Introduction

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Improving patient engagement in medical device clinical trials
4. Qualio. How Long Does the FDA
Medical Device Approval Process
Take? December 2019,
https://www.qualio.com/blog/fda-
medical-device-approval-process
[Accessed: July 2020]
technology, a digital health app, or any other type of device – can fail to engage
patients and therefore not achieve optimal health outcomes.
While HCPs are ultimately looking at the device’s safety and effectiveness to
make sure the device is appropriate – how are the patients themselves feeling?
Are they willing to tolerate the risks of the device? Will the device help them in
their day-to-day life? Will they need training on how to use the device? Will they
need to visit the hospital frequently? This is where improving patient engagement
in medical device clinical trials come in.
From the way medical devices are classified, to the way the trials are designed
and implemented, there are some differences between drug and medical
device clinical trials, some of which can impact the way we engage with
patients throughout the process.
Classifications..................................................................................
Unique to medical devices, is that they are classified by their risk. And as the risk
increases, this determines the regulations that are required4
:
Comparing
medical device
and drug
clinical trials
Class I
devices
Non-invasive and present the lowest risk to patients, including devices
such as oxygen masks or electric toothbrushes
Class II
devices
In the moderate-risk category, and include devices such as contact
lenses, syringes, and catheters.
In the European Union (EU), Class II devices are differentiated further:
Class IIa = low to medium risk Class IIb = medium to high risk
Class III
devices
Present the highest potential risks to patients and require the strictest
regulatory process. Devices include defibrillators and implanted prostheses.

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Improving patient engagement in medical device clinical trials
Rules and regulations.....................................................................
Before gaining market access, drugs generally go through a clinical trial of at
least three phases. Whereas for medical devices, it’s slightly different; in order to
be able to be marketed within the United Kingdom, a medical device must have
a valid CE marking, but sometimes a clinical trial isn’t even needed
Plus, the rules and regulations for getting a medical device to market also differ
between the United States (US) and EU
In the US, the approval of a medical device relies
on one, centralised agency: The Food and Drug
Administration (FDA)
In the EU, medical device approvals are regulated
at a Member State level and go through a network
of notified bodies
+ Changes to the The European Medical Device
Regulations (EU MDR) are expected to be
implemented in May 20215
. These changes aim
to: create more harmonisation between the
regulations across Europe, increase trust in the EU
regulatory system by increasing transparency and
public information about devices on the market,
and to strengthen the notified body system6
In both the US and EU, Class III devices have the most stringent approval process;
more clinical evidence is required, and therefore patient engagement strategies
become vital.
Clinical trial design and sample sizes........................................
When a clinical trial is required for a medical device, it doesn’t follow the same
standard framework as drug clinical trials. Table 1 highlights the differences
between the stages of drug and medical device clinical trials:
5. Gov.uk. Medical devices:
EU regulations for MDR and IVDR.
August 2017. https://www.gov.
uk/guidance/medical-devices-
eu-regulations-for-mdr-and-
ivdr#overview [Accessed: July 2020]
6. Patient Engagement & Medical
Devices Webinar. Patient
Engagement Open Forum,
June 2020

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Improving patient engagement in medical device clinical trials
Table 1: The differences between the phases of drug and medical device clinical trials (Genesis Research Services, 2018)7
Drug clinical trial Medical device clinical trial
Purpose Patients Phase Patients Purpose
Test a small dose
of a new drug to
study its effects
Not all drugs
undergo this phase
10–15
0
Pilot
Exploratory
Pilot
Early feasibility
First-in-Human
10–30
Small study to collect
preliminary safety and
data in humans
Guides decide
modifications and/or
future study design
True first-in-human
study to test safety
and toxicity
Usually includes
healthy humans
10–100
I
Safety and
toxicity
Traditional
Feasibility
20–30
Assess safety
and efficacy of
the near-final or
final-device
in patient
Guides the
pivotal studyAssess efficacy and
safety in patients
100s
II
Safety and
efficacy
Confirm clinical
efficacy, safety and
adverse events
Compare the
new drug to
standard of care
100s –
1000s
III
Clinical
effectiveness
Pivotal 100s
Large study to
confirm clinical
efficacy, safety
and risks
Statistically driven
Monitor long-term
effectiveness and
safety in the
general population
1000s
IV
Post-Market
Surveillance
Post-Market 1000s
Monitor long-term
effectiveness and
safety in the general
population

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Improving patient engagement in medical device clinical trials
Medical device clinical trials generally have smaller sample sizes than drug
clinical trials, being in the hundreds rather than the thousands. But while this
might seem beneficial, patient recruitment can be more difficult, as there’s a
need to find patients who have the necessary need for a device and are willing
to be involved. This means the pool is a lot smaller compared with drug trials.
While drug clinical trials often use a placebo, this is rarely possible for medical
device clinical trials and there is often controversy on this topic7
. This is because
the standard placebo would be sham surgery or implantation of a sham device,
which are high risk and may be considered unethical.
When designing a medical device clinical trial, the additional steps that might be
required (for both patients and HCPs) compared with drug clinical trials should
also be considered. For example, more time will need to be accounted for device
training, installation, and visits from other HCPs, such as device technicians.
Development timeframes..............................................................
There is also a difference between the time it takes for patients to access a
medical device, compared with a drug treatment. On average, it takes
12 years for a drug to complete the journey from concept to market,
whereas, the same process for medical devices takes an average of
3–7 years8
. However, the follow-up period for medical device clinical trials is
generally longer (of up to 10 years)9
, and this should be considered when
designing the trial and when communicating what is needed from patients.
0 1 2 3 4 5 6 7 8 9 10 11 12
Drug
clinical trial:
12 years
Medical device
clinical trial:
3–7 years
Years
7. Genesis Research Services.
Clinical Trials – Medical Device Trials.
September 2018,
https://genesisresearchservices.
com/clinical-trials-medical-device-
trials/?doing_wp_cron=1592993
487.4494030475616455078125
[Accessed: July 2020]
8. Gail A. Van Norman MD. Drugs,
Devices, and the FDA: Part 1: An
Overview of Approval Processes for
Drugs. JACC: Basic to Translational
Science 2016;1:170-179
9. Clinical Trials Arena. Outlining the
key differences between medical
device and drug trials, August 2015.
https://www.clinicaltrialsarena.com/
news/outlining-the-key-differences-
between-medical-device-and-drug-
trials-to-determine-how-device-
trials-can-best-be-run-effectively-
4644599-2/#:~:text=Drug%20
trials%20are%20testing%20
for,much%20more%20patient%20
focused%20outcomes.
[Accessed: July 2020]

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Improving patient engagement in medical device clinical trials
Despite the differences between drug and medical device clinical trials, the
end goal is the same: to provide safe and effective products to patients, as
quickly as possible. And to achieve this, not only is clinical evidence needed,
but also a positive patient experience. Therefore, patient engagement strategies
are required to improve recruitment, retention, and the overall experience in a
medical device clinical trial for the device to achieve optimal health outcomes
for the patient, just like a drug treatment.
The end goal is the same: to provide safe and
effective products to patients, as quickly as possible
The barriers to patient engagement in medical device
clinical trials.....................................................................................
It’s no secret that recruiting patients for any clinical trial is a challenge; costly
delays and unachieved enrolment goals are unfortunately the norm for many
clinical trial sites. Plus, retaining patients isn’t much easier, particularly for trials
with long follow-up periods like medical device clinical trials.
Patient
engagement in
medical device
clinical trials
of clinical trials
don’t meet patient
enrolment deadlines
of clinical trials
fail to meet
enrolment goals
of sites don’t enrol
a single patient
80% 37%
10%
An estimated Around
More than Delays in product launch
cost an average of
$8m
per day
The approximate
dropout rate across
clinical studies is around
30%
10. Outsourcing-Pharma. Patient
recruitment services market to
reach $5.3bn by 2030. June 2019,
https://www.outsourcing-pharma.
com/Article/2019/06/20/Patient-
recruitment-services-market-to-
reach-5.3bn-by-2030
[Accessed: July 2020]
In the US, these
numbers speak for
themselves10
:

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Improving patient engagement in medical device clinical trials
And what’s the reason behind these numbers? Just some of the reasons
can include:
Lack of awareness around clinical trials
Many patients don’t know that a clinical trial is available for them.
Yet, surveys indicate that if they were informed, they’d be willing to
take part11
Overly complex clinical trial materials
Clinical trial protocol designs are becoming more and more complex,
which can be reflected in the materials for patients or caregivers. This
often leads to lack of understanding around the clinical trial designs
and what patients are required to do
A non-targeted recruitment campaign
While advertising campaigns aim to increase patient recruitment,
sometimes the result can be the opposite of the intention. Research
suggests that clinical trial study sites struggle to keep up with
the referrals they get from patient recruitment campaigns, with
one-third never being processed12
. Plus, some advertising campaigns
are not efficient enough for patients to understand whether they’re
eligible or who to contact to find out
Inefficient screening process
With phone calls and emails remaining unanswered, lack of patient
engagement throughout the screening process can lead to dropouts
before a patient even enrols onto the trial
And although factors such as a complex protocol design and non-targeted
recruitment campaigns can negatively affect enrolment, most of these barriers
could be avoided by simply planning ahead and improving engagement with
patients and caregivers. The good news is, there are plenty of strategies that can
be put in place to do this.
11. Institute of Medicine (US) Committee
on Cancer Clinical Trials and the
NCI Cooperative Group Program,
Nass SJ, Moses HL, Mendelsohn J.
2010. A National Cancer Clinical
Trials System for the 21st Century:
Reinvigorating the NCI Cooperative
Group Program. National Academies
Press. Washington (DC).
12. Outsourcing-Pharma. Strapped
for time, not patients? Enrollment
assistants aim to unclog the
recruitment bottleneck. February
2019. https://www.outsourcing-
pharma.com/Article/2019/02/06/
Clinical-trial-enrollment-assistants-
aim-to-unclog-the-recruitment-
bottleneck [Accessed: July 2020]
Group Program. National Academies
Press. Washington (DC).

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Improving patient engagement in medical device clinical trials
The solutions to patient engagement in medical device
clinical trials.....................................................................................
Typically, the process of recruiting patients for a clinical trial goes something
like this:
13. U.S. Food & Drug Administration.
Patient Engagement in the
Design and Conduct of Medical
Device Clinical Investigations.
September 2019. https://www.
fda.gov/regulatory-information/
search-fda-guidance-documents/
patient-engagement-design-and-
conduct-medical-device-clinical-
investigations [Accessed: July 2020]
Throughout this process, during which stages are patients involved? Or, on
the other hand, during which stages should patients be involved? It should be
every single step of the way. In fact, there are even additional steps that could
be added into this process to improve patient engagement, such as gaining
patient insights before advertising the clinical trial to understand what resonates
with them.
As mentioned previously, medical devices are traditionally developed without
input from patients in the earlier stages of the clinical trial, without capturing
outcomes that are important to patients, or without communicating the results
to the patients. Improving patient engagement can help to address many of the
common challenges that medical device clinical trials face. And as a result, can
lead to13
:
+ Faster and increased patient recruitment
+ Higher patient retention rates
+ Fewer protocol revisions
+ Fewer protocol deviations/violations
+ Improved data quality
+ More relevant data on outcomes that matter to patients and
demonstrate value to regulatory bodies, payers and healthcare systems
Design
clinical trial
Advertise
clinical trial
Screen
patients
Gain informed
consent
Enrol
patients

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Improving patient engagement in medical device clinical trials
There is an abundance of opportunities to engage with patients and their
networks to gain key insights: surveys, interviews, focus groups, advisory
boards, workshops (co-design), social listening, and many more. Take a look
at how some of these methods can be put into practice to improve patient
engagement, below.
1. Involve patients when designing the clinical trial
“Nothing about us, without us” is a phrase that’s often used when talking about
involving patients in the clinical trial process. It reflects the reality that clinical
trials – the process of developing a medical product or device for patients – are
being designed without them.
By involving patients and caregivers during earlier stages of clinical trials, not only
is there an opportunity to co-design the protocol, but also to gain insights when
designing the clinical trial materials, such as to explain the informed consent
process. That way, you can ensure the information is easily understandable and
that all questions around the medical device and clinical trial process are being
answered, such as “how does the medical device work?” and “where does my
data go and who will be able to access it?”
In September 2019, the FDA recognised the importance of patient engagement
during the clinical trial design process, and issued proposed patient engagement
guidance which calls on clinical trial leaders to incorporate input from “patient
advisors” into medical device clinical trial designs. Commissioner of FDA,
Norman E. “Ned” Sharpless, MD, said14
:
I believe that when we engage patients,
their families and caregivers, throughout the
medical device clinical investigation process,
we will have more patient-centric clinical
investigations and ultimately timely access to
innovative, safe and effective medical devices
14. Patient Engagement Hit. FDA Issues
Guide for Patient Engagement in
Medical Device Trials. September
2019. https://patientengagementhit.
com/news/fda-issues-guide-for-
patient-engagement-in-medical-
device-trials [Accessed: July 2020]

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Improving patient engagement in medical device clinical trials
The FDA understand that by not involving the patients’ voice, not only is it
possible for researchers to not have optimal trial participation, but they could
also miss out on key factors that are important to patients, which could impact
the eventual end product.
Their guidance proposes the idea of a “patient advisor” - an individual with
a lived experience with a certain disease and who can inform specific areas
researchers should investigate while designing a device’s clinical trial. For
example, patient advisors can help to design informed consent documents
and inform study sponsors about the outcomes that will be most valuable to
the patient. The draft guidance document also provides some examples of
patient engagement activities13
:
+ Gathering patient perspective on the enrolment criteria (both inclusion
and exclusion)
+ Designing a flexible follow-up schedule with patients and clinicians that
may accommodate patients traveling farther distances, such as remote
data collection
+ Working with patients to design and improve the informed consent
document to ensure patients understand the information presented for
the clinical studies
+ Organising a focus group with underrepresented patients at a site to better
understand their values and how best to communicate and recruit these
patients for the trial
+ Discussing with patients what endpoints are clinically meaningful in the
treatment of their disease/condition
+ Including patient-reported outcomes as study endpoints to better reflect
outcomes that are important to patients
+ Considering the use of mobile technologies for virtual or remote follow-up
evaluations and data collection
+ Conducting a patient preference study to help understand the
benefit-risk trade-offs among patients for the proposed treatment or
multiple treatment options used for the condition
+ Collaborating with a patient advocacy group to understand the optimal
way to communicate the research results from the trial with the patient
research participants and the patient community.

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Improving patient engagement in medical device clinical trials
These are just some examples of patient engagement activities that can be
carried out to improve clinical trials, but are not limited.
And it isn’t just the FDA that recognises the importance of patient engagement.
In the EU, The European Medicines Agency (EMA) and patients have been
actively interacting since the creation of the Agency in 199515
. And public-private
organisations, such as The European Patients’ Academy (EUPATI), Patient Focused
Medicines Development (PFMD), European Patients’ Forum (EPF) and the European
Federation of Pharmaceutical Industries and Associations (EFPIA) support patient
engagement, by providing education and training to patients, the industry, and
other stakeholders, to help turn patient engagement into reality.
The need for patient engagement is becoming more evident: more and more
people are talking about it, and the rules, regulations and guidance set out by
organisations and regulatory bodies are increasingly reflecting the importance
of it. That being said, as rules and guidance begin to change, now is the time for
the pharma industry and clinical trial sponsors to take action. By ensuring they
are adopting effective patient engagement strategies now, this will help them
to stay ahead of the game, improve the chances of medical device approval, and
ultimately improve patient health outcomes.
2. Improve the screening process by improving patient engagement
By improving patient engagement through the clinical trial screening process,
this can increase the likelihood of recruitment, decrease the chances of dropouts
before enrolment, and speed up the process to avoid costly delays. And not only
will this reduce the burden on clinical trial sites, but it will also help to build
trust between the patient and the sponsor before the clinical trial even begins.
One way of improving patient engagement during the recruitment process is by
remembering the F.A.S.T technique16
:
+ Finding and engaging patients
+ Assessing or pre-screening them according to inclusion and exclusion
criteria contained in the study protocol
+ Scheduling them for screening visits at sites
+ Tracking them throughout the process
15. European Patients’ Academy.
Patient involvement in EMA
regulatory committees. November
2013, https://www.eupati.eu/
regulatory-affairs/ema-regulatory-
committees/ [Accessed: July 2020]
16. Mark Summers. ThreeWire.Inc.
Accelerating Patient Recruitment
For Medical Device Clinical Trials.
https://cc2639.inmotionhosting.
com/~wcgcli5/threewire/wp-
content/themes/ThreeWire/pdf/
Accelerating-Patient-Recruitment-
for-Medical-Device-Clinical-Trials.pdf
[Accessed: July 2020]

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Improving patient engagement in medical device clinical trials
The assessment stage to pre-screen patients for their eligibility is an important
step to getting the right patients on the clinical trial. Not only that, this interaction
between the patient and the sponsor counts, and is likely to leave a lasting
impression, so a strong process should be put in place. For example, a two-step
pre-screening process: start with a pre-screening questionnaire, followed by
a telephone interview, before referring the patient to the clinical trial site. By
doing this, only those who are highly qualified for the trial will be referred to
site, meaning it’s less likely that time will be wasted for both patients and HCPs.
Plus, ensuring that dedicated professionals are responsible for each step of this
screening process is essential. With this approach, each patient’s response can
be handled in a timely and professional manner, resulting in patients feeling
more valued, informed, and willing to take part.
3. Continue patient engagement following enrolment
Once the recruitment box is ticked, many sponsors can forget about the
importance of continuing patient engagement throughout the rest of the clinical
trial. And when this is the case, it’s no surprise that retention rates are low.
There are many reasons why patients might drop out of a clinical trial, some of
these include17
:
Inconvenient
location
Forgetting visitsSchedule conflicts
Fear and
anxiety
Personal/family
matters
Condition not
improving
17. Forte Research. Retention in
Clinical Trials – Keeping Patients on
Protocols. January 2020. https://
forteresearch.com/news/infographic/
infographic-retention-in-clinical-
trials-keeping-patients-on-protocols/
[Accessed: July 2020]
Physically unable
Financial
constraints
Side effects Refusal to comply
Lack of
appreciation
Misunderstood
expectation

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Improving patient engagement in medical device clinical trials
While some of these reasons may be inevitable, there are some that are
preventable by taking a more patient-centric approach. For example:
+ Say ‘thank you’ – with lack of appreciation being one of the reasons for
dropping out of a clinical trial, a simple thank you can go a very long way to
recognise the time and commitment that patients are making. Especially
with medical device clinical trials having a longer follow-up periods, thank
you cards (and even birthday cards) are a nice touch to show your patients
that you appreciate their time
+ Regularly ask for feedback – whether it’s a short conversation or asking
your patients and their caregivers to fill in a survey, by regularly checking in
on their progress and asking for feedback can help to overcome any issues,
if and when they arise
+ Share real-time updates, while considering how each patient prefers to
receive information - would an app that gives patients timely notifications
be helpful?
+ Consider remote data collection – could patient visits take place at their
home? does the medical device support remote monitoring, so patients
can access their data remotely?
+ Consider electronic patient reported outcomes (ePRO) platforms – with
the new EU MDR guidelines, manufacturers will have to proactively gather
input and data about their device safety and clinical efficacy18
. So, an ePRO
platform can not only help with follow-up and gaining patient feedback,
but to gather relevant clinical and device information too.
All of these patient engagement activities will have a positive impact on the
patient experience – from the beginning of the trial, right until the very end.
Just by planning ahead and taking the time to regularly engage with patients
and caregivers during medical device clinical trials, these changes will help to
improve retention for your medical device clinical trial.
18. SMART-TRIAL. How ePRO can help
comply with EU MDR Post-Market
Surveillance. May 2019.
https://www.smart-trial.co/blog/
how-epro-can-help-comply-with-
eu-mdr-post-market-surveillance/
[Accessed: July 2020]
All of these patient engagement activities will
have a positive impact on the patient experience

16. www.couchhealth.co
Improving patient engagement in medical device clinical trials
Overall, by putting these solutions into practice from co-design during the
earlier stages of the trial, to retention techniques, the process can then start
to look more like:
Gain patient
insights during
design of the
clinical trial
Conduct a
pre-qualifying
screening
questionnaire
Continue patient
engagement
throughout the
clinical trial
Enrolment
Engage with
patients during
the follow-up
period
Create a
targeted
recruitment
campaign
Carry out
telephone
pre-screening
Refer
high-qualifying
patients to the
clinical trial
study site
With the rapid pace of technological advancements in the healthcare industry,
the future of the medical device industry looks bright. And fortunately, more
organisations are beginning to recognise and address the importance of engaging
with patients throughout the process to achieve optimal health outcomes.
As the medical device industry continues to evolve, the industry and patients are
always looking for innovative ways to improve patient engagement. For example,
in 2019, a dialogue meeting between EUPATI and MedTech Europe took place
to understand the landscape and patient engagement possibilities in medical
technologies. As a follow up of this meeting, EUPATI is currently developing
educational material to ensure that the patient community understands the
current landscape of the regulation of medical technologies in the EU, as well
as their role in medical technologies development and market access6
. And with
upcoming changes to the EU MDR, improved engagement and transparency of
clinical trial outcomes are on the horizon.
Future outlook

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Improving patient engagement in medical device clinical trials
19. HealthcareITNews. Trends to
look for in patient engagement in
2020. January 2020. https://www.
healthcareitnews.com/news/trends-
look-patient-engagement-2020
[Accessed: July 2020]
As we look to the future, innovative products, services and solutions are likely to
evolve, and with more patients understandably wanting to take control of their
own data, patient engagement initiatives will increase. As a result, in 2020 and
beyond, it’s expected that health systems will move quickly to adapt to patients’
needs, providing new opportunities for improved engagement, speeding up the
process to patient access, and increasing trust in the healthcare system19
.
It should be highlighted that as patients become more actively engaged with
HCPs and have more access to more data, there will be increased opportunities
for privacy and data security risks. However, technology will be developed and
laws and regulations updated, to manage and reduce these risks and safeguard
patients from the evolving digital landscape19
.
Medical device clinical trials will achieve greater success if they’re designed
with the patient in mind. While there are clear differences between drug and
medical device clinical trials, there are similarities in the barriers to recruitment
and retention, and the patient engagement strategies that are required.
Patient engagement is vital to improving the medical device clinical trial
experience and ultimately, patient outcomes. As organisations and regulatory
bodies begin to recognise this and update their guidance and processes,
it’s important that sponsors act now. By making a positive change, such as
involving patients and caregivers earlier in the study design process, improving
the screening process, and continuing engagement strategies throughout the
clinical trial, the impact will be huge. Recruitment and retention will improve,
costly delays are less likely, relevant data will be collected on outcomes that
matter most to patients, greater value demonstrated to regulatory bodies, and
patients will have a more positive experience.
At COUCH Health, we’re here to help you with your patient engagement
strategies to ensure optimal outcomes for clinical trials. Want to find out
more? Let’s talk.
Conclusion

18. Say hello
e. clinical-trials@COUCHhealth.co
t. +44 (0) 330 995 0695
a. Suite 2.10, Jactin House, 24 Hood Street,
Manchester, M4 6WX, UK
www.couchhealth.co
© WE ARE COUCH LTD • July 2020