Appunti - Innovation in Health and Social Care

Innovation in Health and Social Care (A.Y. 2021/2022)

Innovation in Health and Social Care

NOTES AND SUMMARY

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Prof. Emanuele Lettieri

MSc in Management Engineering

Politecnico di Milano (A.Y. 2021/2022)

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All the material included in this paper is related to the notes taken during the

lectures of the course (no copyrights have been infringed)

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Innovation in Health and Social Care (A.Y. 2021/2022)

TABLE OF CONTENTS

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Page 3 Lecture 01: Preliminary Course Information and Setting the

Stage

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Page 6 Lecture 02: Guests speakers

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Page 9 Lecture 03: Technology Lifecycle in Healthcare (day 1)

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Page 12 Lecture 04: Technology Lifecycle in Healthcare (day 2)

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Page 14 Lecture 05: Participatory Approaches (Guest)

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Page 16 Lecture 06: From Clinical Research to Systemic Reviews

and Meta-Analysis (Guest)

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Page 18 Lecture 07: How to assess innovation and the Cost-Utility

Analysis

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Page 24 Lecture 08-09: HTA and MCDA

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Page 28 Lecture 09-10: MCDA, Disinvestment for Investment, HB-

HTA and Acceptance of innovations

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Innovation in Health and Social Care (A.Y. 2021/2022)

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Lecture 01 (part 1) Preliminary Course Information

There are 4 stages about healthcare product development and different decisions have to be made at every

level. The Golden Thread (see slides) will be the fil rouge of the course.

The technology readiness level (or TRL scale) is a framework that defines 7 levels of technology

maturity, and it will be frequently mentioned during the course because of its crucial importance.

The course will try to answer different questions, among which we can highlight this one: why is it so different

to design a business model in healthcare if compared to other industries? Because of data

doesn’t

commercialization, regulations etc. and so the traditional diffusion theory apply to this field, which is a

very regulated and knowledge-intensive industry with a lot of bureaucracy. Also, freemium models can’t be

it’s a

applied here (so, for example, the business models of Google and Facebook don’t fit). In this sense,

“selective”

very industry and healthcare systems are also very different worldwide.

Some examples of business models (again, also in this case these models will be better explained later in

the course) are the institutional model (i.e., in which the state pays the health services) or the out-of-

pocket model (i.e., in which the state asks the customers to pay). However, note that every country has its

own rules and ways of doing when it comes to healthcare.

EXAM INFORMATION

All the material will be provided by the professors (no books to buy).

There will be 2 different assignments:

• →

Written Individual essay or group work. The modalities of the individual essay are:

people that can’t participate to the physical classes.

o It is

o The grading system is the same of the project work (i.e., group work).

o The topic is agreed with the professors (e.g., innovative procurement, namely how we can

buy innovations in healthcare, or welfare technologies…).

It’s

o not about real problems and current projects with real professionals (which is for the

group work).

o A Google spreadsheet will be provided: write there the preference about the assignment.

o No more than 15 pages and 6,000 words in Times New Roman, 12pt (annexes and

references are not included in the count).

o Virtual reviews will be arranged, and the essay will have to be uploaded on WeBeep.

o Peer-to-Peer evaluation is just for group assignments.

• → is very easy: it’s

Oral It simply a conversation about the topics covered in class, with very broad

questions and some exercises. It will be done remotely or face-to-face. It will be about 20 to 30

minutes and it typically includes two broad questions and short cases about what has been

and always think about the “WHY”.

discussed in class. Be concrete and provide examples,

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Lecture 01 (part 2) Setting the Stage

The healthcare systems have different problems they need to deal with. More in detail, which are the

challenges for the healthcare system?

• Accessibility (which is a key problem).

• Sustainability (in terms of social, environmental and financial sustainability).

• Lack of positions (nurses and physicians, for example): the professionals are not enough!

• Overcrowding (e.g., in the emergency department). “perfect” storm

When we talk about challenges in healthcare, we usually refer to the concept of the (see

slides): this means that if one takes problems one by one, their solutions are known, but the combination of

such factors leads to solutions which are often unclear, thus generating a complicated situation. In other

by one these elements are easily manageable, but all together it’s not easy for decision-makers

terms, one

to address all of them.

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Innovation in Health and Social Care (A.Y. 2021/2022)

The main goals for any healthcare system are to generate value (even if the concept of value is still unclear

don’t have

and we any commonly accepted formulas to calculate it) and the financial sustainability (which

is very problematic for many countries).

1. Value generation.

2. Financial priority.

In this context, a first problem is related to the GDP (1). Indeed, for many countries healthcare is tax-based,

meaning that if the economy is not growing, this constitutes a problem, because there is the so-called

“stagnation”. Here, some points emerge:

• What is the minimum service package that a system has to deliver? You need to limit the package

of services and to reduce it if the economy is not growing.

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Out-of-pocket contribution When we ask people to pay for health (note that, unfortunately, this

is increasing year after year...).

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New business models There are many constraints here, also because of legislation.

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Technology assessment We can’t buy every technology, but just the more relevant ones: what

“value-for-money”?

are the technologies that are

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Disinvesting for investing Disinvest and cut in some areas to fund other areas (to make an

example, Canada is currently adopting this strategy).

Another problem is about age (2):

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New clinical and social needs Elderly have different needs and isolation, more specifically, is

becoming a relevant issue.

• Quality of Life.

• Caregivers and burnout.

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Health literacy and Self-medication Knowing and understanding your health.

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Digital literacy How to empower people, and elderly in particular, to have a digitalized healthcare

system?

Then, we have activation (3). Indeed, citizens want to be more and more engaged and take responsibilities

for their health, discussing and debating with physicians:

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Patient engagement Patients want to have an active role and share decisions with doctors.

• Responsibility and accountability problems: if we fail, who’s responsible

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Adherence to therapy

for this? The hospital? The physicians?

• “retail

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Consumerization of care delivery Healthcare as a industry”: we decide to buy as in a shop

and prescribe to ourselves treatments. It’s also becoming a consumer industry and there are also

some influencers acting on health.

• →

Quantified self From the wearables we are collecting a huge amount of data (how many steps

level of stress…).

we have done, the

• →

Patient innovation (i.e., lead user innovation) Citizens have started to develop medical

“democratization

technologies (the of resources” is playing a key role here) through, for example, 3D

printing. People are modifying already existing technologies or creating new ones. Now, innovation

doesn’t come only form laboratories, but citizens themselves develop digital technologies or medical

devices (they should not, of course, develop drugs).

Finally, technology (4) represents a problem, too:

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Booming of new patents Every 36 minutes we have a new patent and consequently a lot of

technologies that need to be evaluated.

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Innovation is becoming incremental, not radical We are trying only to improve what we already

have in order to be fast to reach the market.

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Open Innovation The Chief Open Innovation Officer (COIO) plays a role since open innovation is

becoming a must to reduce the risk of developing new technologies which afterwards could fail.

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Innovation in Health and Social Care (A.Y. 2021/2022)

• They try to collaborate, but it’s not easy:

→

Startups and incumbents startups are often not aware

of the complexity of healthcare systems.

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Digital Transformation It deals with telemedicine, blockchain, 3D printing, robotics etc.

We have just saw the challenges for the healthcare systems. Now, which are the challenges for the

LifeScience industry? LifeScience is composed of 3 main blocks:

1. Pharmaceutical companies. that “med-tech”

2. Med-tech and biomedical companies (note considers the part of the biomedical

industry that connects medical devices with digital technologies, i.e., biomedical + digital and data).

3. Biotech companies (very similar to the pharmaceutical companies, and often overlapping).

The whole value chain is under a radical transformation in this period (for example, it is moving from product

to service companies, like the well-known Roche is doing) (see slides to visualize the model):

→

1. Discovery It is the research phase.

→

2. Pre-clinical research It goes from pure research to prototypes.

→

3. Clinical trials Trials that aim at validating the results.

4. Post-Marketing activities.

Some examples of this new transformation are reported below (note that we are talking about industry 4.0):

• organs, develop tissues…).

3D printing and bioprinting (print

• Digital twins (reproduce models of our body, of our organs).

• In-silico trials (test effects of molecules with simulations, which are not real).

• Remote clinical trials (understand how to collect evidence from patience not in the hospital, but

outside).

• Real world data (all the data collected in real life, every day).

• AI and Quantum Computing.

• Lab and organ-on-chips (capability to model elements to facilitate the study of new products and

services).

From a managerial perspective, the two main priorities are open innovation (to reinforce R&D portfolios,

find new competences and reduce risk) and financial transactions and M&A (to buy competences and

networks). So, what are the products companies are working on? Below, the current priorities for the

LifeScience industry:

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Digital therapeutics Types of therapy which could be delivered through smartphones: care is

based on algorithms (especially, regarding specific diseases that are managed through cognitive

“CBT”).

behavioral therapies, namely Companies are and will indeed develop software instead of

products. Note how this point is the most interesting one for us and for the whole course.

• →

Robotics Possibility to empower surgeons and physicians in their activities.

• Implantable sensors ad biosensors.

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Point of care technologies Our home will become our hospital for minor injuries.

• Percutaneous therapies.

happening in Europe due to the pandemic of the “Digital

In this setting, what’s (part taken from the slides

Innovation in Healthcare Observatory”)? We are having a tremendous acceleration along the patient

journey, which is completely changing in terms of:

• →

Lifestyles and prevention It’s about searching for health information, collecting and managing

data, while raising importance of searching about information and ways for a healthy lifestyle.

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Access It deals with search for doctors and facilities, book and pay. We will need to access to

care in a different way!

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Cure It deals with the use of available healthcare services (e.g., examinations, tests,

hospitalization, treatments, etc.).

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Follow-up It’s about treatment continuity, monitoring and new lifestyles.

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Innovation in Health and Social Care (A.Y. 2021/2022) to use, but for them it’s very important that these

Physicians are starting to recommend and prescribe apps

apps are approved, by passing through all the phases of a real medical approvement (in fact, about the 90%

of the available apps are literally garbage!). Also, will people trust these apps? For sure, we absolutely need

a change in mindset!

Telemedicine is growing, too: the percentage of physicians against it is very low if compared to past years

and patients are now ready for it. Moving to telemedicine will save time and space!

→

Case study Noom is an app based on personalized cognitive behavioral therapies (CBTs). It helps

all based on psychology.

people to lose weight through a personalized coach and it’s Simply, the algorithm

an app, it didn’t pass

tries to understand who you are and helps you to lose weight. But this app is still

not a medical device and there’s no proof that it’s safe, no evidence, no

through the approval phases. It’s no guarantee, the physicians don’t recommend it

clinical studies: the algorithm is unknown, there is and we

we don’t know how the app will use our data, it’s unclear.

have no results about the long-term. Moreover, “consumerization”

This is so not part of the healthcare system, but of the trend. We need to avoid it

and this course will help you to understand how to do it. From the financial perspective, this app still

represents a great success, but it’s a disaster from the healthcare system perspective and we should protect

our citizens from this kind of information.

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Lecture 02 Guests speakers: Milena Vainieri (1) and Luca Minotti (2)

Guest 1. The Characteristics of the Healthcare Systems and its Performances (Professor Milena

Vainieri)

Every time we introduce an innovation is an innovation both for the organization and for the professionals.

Part 1: How to finance Healthcare?

We can divide financing for the healthcare system in 2 big tiers. A system can be financed:

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Directly People directly pay to receive healthcare services.

o Out of pocket: the more you need care, the more you pay, but this can lead to inequities and

inequalities.

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Indirectly (which is mainly related to the insurance system) Somebody pays for you the care that

you need.

o Voluntary subscription: you pay without nobody asks you to do so (it’s the case of the

private insurances). it’s mandatory for you to be

o Compulsory subscription: insured by someone (by all citizens,

which all pay through taxation to receive coverage from the healthcare system, or by

referring to the “medico della mutua”,

employees, here or health insurance doctor).

The 3 big types of healthcare systems are (note that these systems are in reality hybridized):

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Voluntary insurance It’s the case of the USA model (this model is focused on quality, rather

than on quantity).

o Contribution: premium.

o Insurer: insurance companies.

o Providers: independent providers (public, private, not for profit organizations…).

o Who is covered? People that want to pay and to have this coverage (it’s the most inequitable

system).

o Which services are covered? Specialist care and hospital services, but not always for don’t

prevention and rehabilitation: why not prevention? Because people in the USA usually

care about prevention, even if this would be positive in terms of costs. Anyway, citizens are

covered by the state in case of Covid-19 (although this is an exception). Students are

usually not covered by any insurance because they feel to be healthy, but there are also

problems of affordability.

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Innovation in Health and Social Care (A.Y. 2021/2022)

• →

Social insurance (which is related to the compulsory part of being covered by insurance) It’s the

“Bismark

so-called model”, paid by employees or employers (it’s a form of social protection for

people that work and for security/productivity reasons).

o Contribution: employer and employees.

o Insurer: health funds.

o Providers: independent.

o Who is covered? Workers and their families.

o Which services are covered? Acute care and rehabilitation

• “Beveridge

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NHS (paid by citizens) It’s the model”, established after WWII to support UK citizens

and provide an equal access to care (anyway, this is paid by all the people through taxes).

o Contribution: taxes.

o Insurer: the state (single payer system).

o Providers: mainly embedded (in most of the cases hospitals are led by the regions).

o Who is covered? Everybody (in this sense, it can be related to the SD Goal).

o Which services are covered? From prevention, to acute care and rehabilitation.

To memorize these models, remember the B letter! Bismark system (social insurance and social

protection) and Beveridge (NHS, systems mainly led by the state). Note that moving from a system to

another is mainly a political choice, even if some indicators exist.

Indicators to choose between social vs NHS system:

• Health care expenditure per capita.

• Health outcome.

• Labor market.

• % Permanent work.

In this scenario, a lot of USA presidents proposed to move from a voluntary to an NHS system, but they

is yours and health is a personal choice of humans’ beings,

failed, mainly for cultural reasons (“life in which

the state should remain apart”). However, there was one president that partially succeeded. He was Lyndon

Johnson:

• →

Medicare To protec