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Design Healthcare Innovation is the result of a research project started in 2017, developed alongside Sanofi with the support of Fondazione Politecnico. Its main goal was to build a theoretical framework and a methodological structure in order to identify, map, and systematize projects and innovative product-service experiments able to illustrate the ongoing transformation of the healthcare field in Italy.

This research activity was later extended to involve several subjects who are the main characters of this transformation: patients and their associations, caregivers, institutional scientific research facilities, university spin-offs, medtech start-ups all the way up to the huge network of manufacturers in the biomedical field, and also new entities, such as makerspaces and Fab Labs, which have officially become part of this transformation.

All that has made it possible to devise an overall scenario of transformation of the healthcare field and its main directives: from the dissemination of digital technologies capable of enabling the transformation of custom products and services, up to the increasingly important role of patients in healthcare innovation processes. As a matter of fact, the latter volunteer ever more frequently as active subjects (think of the patient innovation phenomenon) who, often starting from an individual need and collaborating with other subjects, are able to trigger innovation processes that will later impact the whole community.

This research has ultimately made it possible to shape and graphically view the whole of subjects and solutions of the healthcare system (the Ecosystem) and the design project underlying the development of new products (the Ladder).

The Ecosystem

Through the Ecosystem the scenery of contemporary healthcare can be seen as a complex whole within which there are three main, often converging areas: research and scientific care, development and new manufacturing (also digital), and finally people with special needs, patients and caregivers.

These three main fields intersect outlining four overlapping areas; the central area comprises the patients’ needs and requirements, the responsibilities of institutional care and scientific/technological research, and the resources of new enterprises involved in designing, prototyping, and manufacturing products and services. This central core is called Area MakeToCare.

Outside the Ecosystem there are two concentric areas where we find those subjects who, though not strictly connected to the healthcare sector, contribute by supporting (Enabling System) or managing it (Policy Level).

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Patient & Caregiving System

System of stakeholders and needs (patients and caregivers).

  • Patients
  • Caregivers

Healthcare & Research System

Institutional system of care and scientific research.

  • Hospitals
  • National Health Service Research Institutes
  • Public Research Bodies
  • Professionals and Healthcare Institutions
  • Universities

Making, Manufacturing & New Entrepreneurship System

System for the design, development and production of products and services.

  • Start-ups and Innovative Companies
  • Artisans, SMEs, Businesses
  • Designers
  • Fab Lab

Public & Community Innovation System

A system that brings together the world of patients and their needs with the institutional world of healthcare and scientific research.

  • Patient Associations
  • Associations and Cooperatives

Medtech System

A system that combines research and an operational approach geared towards finding solutions.

  • Start-ups and businesses (medical sector)
  • University spin-offs and start-ups
  • Laboratories and research and testing centres
  • Training centres
  • Multidisciplinary teams

Advanced DIY System

A network of innovative patients and carers who have been able to transform a specific need into a solution.

  • Innovative patients
  • Innovative carers

MakeToCare Area

A group of individuals characterised by patient-centred care, a medical-scientific approach and project development.

  • Start-ups, businesses, associations founded by innovative patients and/or carers

Enabling System

A group of entities that support the ecosystem from an economic, regulatory and communication perspective.

  • Regulatory bodies and certifying bodies
  • Support subjects
  • Promotional bodies

Policy Level

A group of entities that oversee the functioning of the ecosystem.

  • Administrative and territorial bodies

The Ladder

Through the Ladder it is possible to analyze projects that stem from an early, often individual concept, and develop into a comprehensive solution intended for more end users, within a wider innovation perspective. In fact, the generative phase often takes on the dimension of an individual experiment aimed to meet a strictly personal need.

The Ladder graphically displays the development process necessary to translate the solution from the individual into the collective, shared plan, until it is ready to be placed on the market and consequently available to multiple end users. Thus, this tool synthetizes the path from idea to market divided into four main phases: concept, development, testing, and distribution.

Ideally, the Ladder also displays the degree of development (or maturity) of the solution from a project-oriented and distributional point of view, through the following steps: concept, prototype, single product (also released under a cc license), marketed product (for free or internal use).

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Ladder

A. Design & Prototyping

Setting up the initial concept, design and prototype development.

1. Concept Ideation
2.Prototype Development

B. Entrepreneurial Development

Engineering and Solution Production.

3. Unique product
4. Limited serie
5. Serial production

C. Regulatory Inspection

Audits and inspections in order to enter the market.

6. Device Classification
7. Declaration of Conformity
8. Pre-marketing clincial investigation and evaluation
9. Manufacturers registration and devices registration

D. Distribution and Supply

Access to the market and to the end user.

10. Visit and prescription
11. Authorization and Supply
12. Testing
13. Post-market survey