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La professione del Biologo tra Scienza e Industria Corso di Formazione “Professione Biologo” Roma, 14 Giugno 2012 Pasquale Mosella

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La professione del Biologo tra Scienza e Industria. Corso di Formazione “Professione Biologo” Roma, 14 Giugno 2012 Pasquale Mosella. La professione del Biologo tra Scienza e Industria. Lab. Analisi Acquisire competenza Acquisire conoscenza Accrescere esperienza Generare fiducia. - PowerPoint PPT Presentation

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Page 1: La professione del Biologo tra Scienza e Industria

La professione del Biologo tra Scienza e

IndustriaCorso di Formazione “Professione Biologo”

Roma, 14 Giugno 2012Pasquale Mosella

Page 2: La professione del Biologo tra Scienza e Industria

La professione del Biologo tra Scienza e Industria

Industria Acquisire

competenza Acquisire

conoscenza Accrescere

esperienza Generare

fiducia

Lab. Analisi Acquisire

competenza Acquisire

conoscenza Accrescere

esperienza Generare

fiducia

Ricerca Acquisire

competenza Acquisire

conoscenza Accrescere

esperienza Generare

fiducia

Page 3: La professione del Biologo tra Scienza e Industria

La professione del Biologo tra Scienza e Industria

Passione Determinazion

e Tenacia Coraggio Voglia di

esplorare vie nuove

Responsbilità & Rischio

Passione Determinazion

e Tenacia Coraggio Voglia di

esplorare vie nuove

Responsbilità & Rischio

Passione Determinazion

e Tenacia Coraggio Voglia di

esplorare vie nuove

Responsbilità & Rischio

Page 4: La professione del Biologo tra Scienza e Industria

Chi, come, dove, quando...

1980-2012 : spunti e riflessioni circa la professione, tra cambiamento e trasformazione dell’HealthCare.

Corso di Formazione “Professione Biologo”

Roma, 14 Giugno 2012Pasquale Mosella

Page 5: La professione del Biologo tra Scienza e Industria

All’interno degli ospedali, il Laboratorio analisi, proprio per il ruolo strategico che

svolge nella erogazione di servizi, viene sempre più chiamato a incrementare non

solo la capacità produttiva, ma soprattutto l’efficienza produttiva.

La necessità di migliorare la situazione finanziaria impone una elevata attenzione

alla razionalizzazione dei costi.

Page 6: La professione del Biologo tra Scienza e Industria

La riduzione dei costi va affrontata in maniera globale

prendendo in considerazione il processo di produzione attraverso

l’analisi dei flussi di lavoro e analizzando le singole necessità

DISEASE MANAGEMENTDISEASE MANAGEMENT

Page 7: La professione del Biologo tra Scienza e Industria

FASI PROCESSO PRODUTTIVO

PREAnalitica

POSTAnaliticaANALITICA

Page 8: La professione del Biologo tra Scienza e Industria

PREAnalitica

Analitica POSTAnalitica

Processo Produttivo

Analytical

Information data management

Sample handling

Page 9: La professione del Biologo tra Scienza e Industria

L’ANALISI DEL PROCESSO PRODUTTIVO, QUINDI DELLE

SUE VARIE FASI, E’ INDISPENSABILE PER

ARRIVARE AD UN PRODOTTO DI QUALITA’

LA LA QUALITA’ DEL PRODOTTOQUALITA’ DEL PRODOTTOE’ QUINDI IL RISULTATOE’ QUINDI IL RISULTATO

DELLA DELLA QUALITA’ DEI PROCESSIQUALITA’ DEI PROCESSI ATTUATI ATTUATI

Page 10: La professione del Biologo tra Scienza e Industria

SI PUO’ MIGLIORAREL’EFFICIENZA PRODUTTIVA

ATTRAVERSO L’AUTOMAZIONE

L’AUTOMAZIONE RAPPRESENTALA CONDIZIONE INDISPENSABILE

PER AVVIARE UN PROCESSODI RIDUZIONE DEI COSTI DI GESTIONE

Page 11: La professione del Biologo tra Scienza e Industria

Process improvement

Lab automation

Data management enhancement

Page 12: La professione del Biologo tra Scienza e Industria

AUTOMATION FOR THE CLINICAL LAB Bar coding Front end automation Work cell automation Total automation Remote control POC testing Mobile robots Robotic arms Separation and sorting

Page 13: La professione del Biologo tra Scienza e Industria

Automation is a Automation is a SYSTEMATIC PROCESS SYSTEMATIC PROCESS

and not simply the purchase of hardwareand not simply the purchase of hardware

Factors that will influence succesful use of automation are:

An enthusiastic workteam A well thought out strategic plan Standardization of specimen containers The reduction in exception specimens The widespread use of P.O.C. testing

Page 14: La professione del Biologo tra Scienza e Industria

Goals to define when establishing a fully automated clinical lab operation

Cost controls Increase capacity for testing throughput (increasing

productivity) Improved TAT FTEs reduction Return on investment (ROI)

Page 15: La professione del Biologo tra Scienza e Industria

Componenti del costo per campione

Preanalitica40%

Analitica45%

Postanalitica15%

60%degli errori

di laboratorio

Page 16: La professione del Biologo tra Scienza e Industria

QUALITA'

COSTO TEMPO

Page 17: La professione del Biologo tra Scienza e Industria

UN OBIETTIVO FONDAMENTALEDELL’AUTOMAZIONEDEL LABORATORIO

E’ QUELLO DIFORNIRE INFORMAZIONI

AL CLINICO

IN TIME TO DO ANY GOODFOR THE PATIENT

Page 18: La professione del Biologo tra Scienza e Industria

LA RIDUZIONE PIU’ CONSISTENTEDEI COSTI (QUELLI COMPLESSIVI

DELL’AZIENDA OSPEDALIERA)PUO ESSERE REALIZZATA

ATTRAVERSO L’OTTIMIZZAZIONEDELL’ATTIVITA’ DEI MEDICI DI REPARTO

COMPORTAMENTO “MANAGERIALE” DELLA PRATICA CLINICA

RIDUZIONE DELLE GIORNATE DI DEGENZA NON APPROPRIATE

Page 19: La professione del Biologo tra Scienza e Industria

QUALITA'

COSTO TEMPO

OFFERTAOFFERTA

BISOGNIBISOGNI

DOMANDADOMANDA

Page 20: La professione del Biologo tra Scienza e Industria

CONTINUOUS

PATIENT

REPORTING

C P R

Page 21: La professione del Biologo tra Scienza e Industria

LABORATORIO ANALISI

Chimica ClinicaChimica Clinica

ImmunochimicaImmunochimica

EmatologiaEmatologia

CoagulazioneCoagulazione

UrineUrine

Prot&Elettr.Prot&Elettr.

87%

Page 22: La professione del Biologo tra Scienza e Industria

Laboratorio fino agli anni 90 Singole aree in relazione alla tipologia degli esami

richiesti (elevato numero di strumenti) Personale vincolato alla propria area Campioni ai settori su richiesta cartacea Le tre fasi del processo ben distinte Costi gestione elevati Al settore urgenze aumenta l’attività

Page 23: La professione del Biologo tra Scienza e Industria

PROCESSO DI PRODUZIONE

7.30 8 9 10 11 12 13 14 15 16

PRE ANALITICA ANALITICA POST AN.

RICHIESTARICHIESTA REFERTOREFERTO

Page 24: La professione del Biologo tra Scienza e Industria

Laboratorio Analisi fino al 90

Microbiologia:

Isolamenti con metodi classici

ID e DS con strumenti semiautomatici

Tempi di risposta non inferiori alle 72 ore Sierologia:

Prevalentemente Ricerca Anticorpi con metodi

classici

Page 25: La professione del Biologo tra Scienza e Industria

Laboratorio dopo gli anni 90 Potenziamento LIS Richieste su schede ottiche Barcoding area Riduzione numero strumenti Ampliamento menù test Aspirazione da tubo primario Host query Tutti i settori interfacciati al gestionale centrale Riorganizzazione area ad alta automazione

(core lab)

Page 26: La professione del Biologo tra Scienza e Industria

Laboratorio Analisi dopo il 90

Microbiologia:

Strumentazione automatica per ID e DS

Sistemi per emocolture

PCR - LCRInterfacciamento al Gestionale Centrale

Sierologia:Ricerca anticorpi su micropiastre

Blotting e Amplificazione

Page 27: La professione del Biologo tra Scienza e Industria

PRE Analitica POST

Processo di produzione - Lab. Urgenze

0 12 24

PRE Analitica POST

PRE Analitica POST

PRE Analitica POST

PRE Analitica POST

PRE Analitica POST

PRE Analitica POST

Page 28: La professione del Biologo tra Scienza e Industria

Orario utile per la refertazioneRIAN 9UTIC 9ONCO 10.30MED 10OST 11INF 10P.S. entro 20-30 min.

Page 29: La professione del Biologo tra Scienza e Industria

SPECIMEN RECEIVED TIME9.308.00

7.30

0.00 12.00 24.00

Page 30: La professione del Biologo tra Scienza e Industria

CONTINUOUS PATIENTS REPORTING LAB. ROUTINE LAB. URGENZE

OPEN SPACEOPEN SPACE

CORE LABCORE LAB

C. P. R.C. P. R.

Page 31: La professione del Biologo tra Scienza e Industria

6 7 8 9 10 11 12 13 14

1°St. 2°St. 3°St. 4°St. 5°St. Campioni 100 200 350 650 Tutti

CONTINUOUS PATIENTS REPORTING

PRE Analitica POST

PRE Analitica POST

PRE Analitica POST

PRE Analitica POST

PRE Analitica POST

Page 32: La professione del Biologo tra Scienza e Industria

CONTINUOUS PATIENT REPORTING

Increase progressive automation through specimen matrix tube division

Sample handling Data management enhancement (LIS - HIS) Autovalidation 24 h ready Barcoding area department Buy work from other labs Patient-side testing system (next generation of POC

technology) Involving lab staff (FTEs)

CORELAB INTEGRATION

Page 33: La professione del Biologo tra Scienza e Industria

CORELAB LAYOUT

NEFELOMETRIA

IMMUNOCHIMICA URINE

EMOGAS

CHIMICA CLINICA

EMATOLOGIA COAGULAZIONE

Page 34: La professione del Biologo tra Scienza e Industria

Test di emergenza Rapido TAT Massima efficienza Riduzione dei costi Controllo remoto dal laboratorio

Patient-side testing system

Page 35: La professione del Biologo tra Scienza e Industria

IL LABORATORIO DOPO IL 2000

CPRCPR 85%85%

POCPOC

POC POC

Page 36: La professione del Biologo tra Scienza e Industria

IL LABORATORIO DOPO IL 2000

Microbiologia:Automazione per Isolamento, ID e

DSDiagnosi rapida con metodi diretti

Tempi di risposta 6 - 24 oreSierologia:

Automazione dei sistemi su micropiastra Consolidation su

analizzatori del corelab Prevalentemente Ricerca Antigeni

PCR - LCR - NASBA - b DNA

Page 37: La professione del Biologo tra Scienza e Industria

Ospedale

Territorio

Pochi e ad alta tecnologia Trattamento di patologie acute Interazione con il territorio:

collegamento in rete con le strutture ed i medici di medicina generale

Internet

Potenziamento compiti di supporto all’ospedale: riabilitazione, home care, distretto sanitario, hospice, ecc.

Ospedale del nuovo millennio

Page 38: La professione del Biologo tra Scienza e Industria

Protagonista dello sviluppo del nuovo

modello di Ospedale in rete sarà

INTERNET Health Care

Service Integration of POCT in LIS

E - mail

Page 39: La professione del Biologo tra Scienza e Industria

NEAR FUTURE

Point of Care Testing

Molecular Diagnostics

Page 40: La professione del Biologo tra Scienza e Industria

New Technologies for the new Millennium

GENE CHIPS

MINIATURIZATION and FLUIDICS

BIOELECTRONIC DETECTION OF DNA

Page 41: La professione del Biologo tra Scienza e Industria

2° Eurolab Automation - London - October 1999

M.J. WheelerSt. Thomas Hospital - London

… however, developments in nano- technology have opened up the possibility of more bed side testing.As this is likely to be a reality in the next three years there will be a movement of testing out of the core laboratory and into the wards.

Page 42: La professione del Biologo tra Scienza e Industria

2° Eurolab Automation - London - October 1999

Robin A. FelderUniversity of Virginia - USA

The central laboratory of the future is destined to become an esoteric testing center, while routine testing will be more economical when administered at the patient bedside.

Page 43: La professione del Biologo tra Scienza e Industria

POC

POC POC

POCPOC

POCPOC

POC

Testsesoterici

Il laboratorio dopo il 2010

Page 44: La professione del Biologo tra Scienza e Industria

Il Laboratorio dopo il 2010

MICROBIOLOGIA

POCT

LAB

HOME TESTING

Page 45: La professione del Biologo tra Scienza e Industria

E’ in atto un processo irreversibile

di cambiamento che prima ancora di essere

tecnologico è soprattutto culturale.

Ci si sta avviando verso la “società della

conoscenza” dominatadalla comunicazione

globale.

Page 46: La professione del Biologo tra Scienza e Industria

Today Agenda

- Medical Devices Domestic Market

- The Italian NHS- Healht Expenditure vs Finance- Public Sector’s Financial Crisis- Late Payments

- Key Aspects of Regional Governance- Public vs Private Healthcare Providers - Reimbursement schemes- HTA- Centralized Purchasing Policy

- Key Aspects of National Governance- Reference Prices- National Repository of Medical Devices

ASSOBIOMEDICA

BD Diagnostic Systems European Leadership Team Meeting- 16th December 2008 -

Page 47: La professione del Biologo tra Scienza e Industria

Assobiomedica is the Italian Federation of four National Associations

BIOMEDICALS

IVD

ELECTROMEDICALS

SERVICE &TELEMEDICINE

ORTHOPAEDICS, DYALISIS, CARDIO, SUTURES, INCONTINENCE, INFUSION, LAPAROSCOPY, WOUND CARE, UROLOGY, OSTOMY, ANAESTHESIOLOGY, TNT, NEUROSURGERY, BREAST PROSTHESIS, …

LABORATORY, SELF-MONITORING, ALLERGY THERAPIES, RADIOPHARMA

IMAGING, ULTRASOUND, EM, EM-PM, HEALTHCARE-IT

ASSOBIOMEDICA

Page 48: La professione del Biologo tra Scienza e Industria

Sources: Advamed, Eucomed, Assobiomedica

U.S.43%

Europe30%

Japan 11%

Rest of the World16% 21.100 companies

Europe (11.000) - U.S. (8.500) - Japan (1.600)

850.000 employeesEurope (435.000) - U.S. (350.000) - Japan (65.000)

€ 187 bill. salesEurope (56,1) - U.S. (80,4) - Japan (20,5)

France16%

Germany31%

Italy11%

EU New Members5%

U.K.11%

Spain9%

Switzerland2%

Rest of Europe16%

Medical Devices World Market 2007

ASSOBIOMEDICA

Page 49: La professione del Biologo tra Scienza e Industria

Assobiomedica Member Companies 2008

€ 6.200 million DOMESTIC MARKET75% PUBLIC DEMAND

30.000 EMPLOYEES

226 MEMBER COMPANIES

151 TRADING COMPANIES

75 MANUFACTURERS

TURNOVER SIZE

30%

43%

11%

16%

< € 5 million

€ 5-20 million

€ 20-40 million

> € 40 million

Source: AssobiomedicaASSOBIOMEDICA

Page 50: La professione del Biologo tra Scienza e Industria

Assobiomedica Member Companies 2008

Source: AssobiomedicaASSOBIOMEDICA

PRODUCTION 31%

IMPORT 69%TOTAL SALES

€ 7,4 billion

BIOMEDICALS + SERVICE & TELEMEDICINE € 3,2 billion

IVD € 1,7 billion

ELECTROMEDICALS € 1,3 billion

DOMESTIC MARKET 84%

EXPORT 16%

Marketing Side Manufacturing Side

Page 51: La professione del Biologo tra Scienza e Industria

Source: OASI Report, Bocconi University

Region Nr. Autonomous Public Hospitals Nr. ASL Nr. Hospitals

managed by ASL Nr. Contracted-Private

Hospitals Nr. Other Hospitals

Piemonte 8 13 48 40 7

Valle d’Aosta 0  1 1  0 0 

Lombardia 29 15 2 61 25

Veneto 2 21 57 16 12

Friuli Venezia Giulia 3 6 8 5 3

Liguria 3 5 10 3 5

Emilia Romagna 5 11 38 42 1

Toscana 4 12 26 27 5

Umbria 2 4 9 5 0 

Marche 2 1 31 12 3

Lazio 4 12 52 79 19

Abruzzo 0  6 23 13 2

Molise 0  1 6 2 2

Campania 8 13 47 71 8

Puglia 2 6 27 37 7

Basilicata 1 5 13 1 2

Calabria 4 6 33 38 1

Sicilia 17 9 50 62 5

Sardegna 1 8 29 13 3

ITALY 95 157 528 536 119

The Italian NHS 2007

ASSOBIOMEDICA

Page 52: La professione del Biologo tra Scienza e Industria

32,8 27,4 •12,6 •27,1

•0% •10% •20% •30% •40% •50% •60% •70% •80% •90% •100%•Human resources

•G&S

•Pharmaceuticals

•NHS Contracted-private providers

•Other

• Human resources 32,8

• Goods&Services 27,4

• Pharmaceuticals 12,6

• NHS Contracted-private providers 27,1

• Other 0,9

• Medical devices 4,7

• Other G&S 22,7

•0% •10% •20%

Public Healthcare Expenditure 2005 (%)

ASSOBIOMEDICA

Page 53: La professione del Biologo tra Scienza e Industria

1990 2005 min. Max

• Human resources 39,1 32,8 32,8 (2005) 43,3 (1997)

• Goods&Services 17,7 27,4 17,3 (1991) 27,4 (2005)

• Pharmaceuticals 17,6 12,6 10,7 (1995) 17,6 (1990)

• NHS Contracted-private

providers 24,7 27,1 24,7 (1990) 27,8 (2002)

• Other 0,9 0,1 0,1 (2005) 1,8 (1993)

Public Healthcare Expenditure 1990-2005 (%)

ASSOBIOMEDICA

Page 54: La professione del Biologo tra Scienza e Industria

Public Healthcare Expenditure vs Finance 1990-2007

Source: Assobiomedica

0

0,2

0,4

0,6

0,8

1

%

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Annual deficit on GDP

• All modern healthcare systems experience the same financial difficulties but this does not prevent suppliers in those markets from getting payment within a reasonable timeframe. • The point is that in other countries such deficits are promptly payed in full whereas in Italy this does not happen.

• The annual deficit on GDP is 0,35% on average.

• The ratio shows a rather limited variability.

{

ASSOBIOMEDICA

2007Expenditure € 103 billionFunding € 95 billionDeficit € 8 billion

Page 55: La professione del Biologo tra Scienza e Industria

The Italian Public Sector Financial Crisis

• The Italian public sector has been experiencing for long a financial crisis.

• Public expenditure has been growing for many decades faster than revenues.

• As a result, our public debt as % of GDP is the second highest in the European Union (and very far from the due parameter set by the Maastricht Treaty).

• There are not easy solutions for financial distress (and late payments) in the healthcare sector.

• Healthcare represents, on average, the 80% of the total current expenditure at regional level and it means that additional resources for healthcare cannot be expected to come from other regional budgets.

• We cannot any more have the third largest market in Europe, the second highest public debt on GDP, and the 75% of the domestic market made by public demand.

• Moreover, GDP is expected to decrease by 0,4% in 2008 and by 1% in 2009.

ASSOBIOMEDICA

Page 56: La professione del Biologo tra Scienza e Industria

• The finance of the NHS has never been effectively tackled by the National Legislator.

• Up to 1993, the State has been responsible for funding the healthcare expenditure and its approach has been to allocate less money than the regions needed so that to encourage them to pay attention on costs and expenditure.

• During this period the annual deficits were late payed by the State and the medical device market grew fast.

• Market leaders, by not claiming for interest for late payment, enforced the general opinion that prices include such interest computed on the basis of the expected DSO.

ASSOBIOMEDICA

Late Payments

Page 57: La professione del Biologo tra Scienza e Industria

Healthcare in(de)finite Demand vs limited Finance

• Since 1994 regions have been responsible for funding their own healthcare expenditure in excess over budget.

• Actually, most regions’ and local authorities’ fiscal autonomy is still inadequate: e.g. due to the abolition of the tax on the houses of residence in the last year, local authorities will get 850 million euro of fiscal revenues less in 2008; the Government (which disposed the abolition) seems to be willing to transfer only 260 million euro for compensation.

• If the problem were the same for any region, it would be easier to tackle. Instead, profound differences exist among regions (e.g. in terms of GDP per person).

BAS

FVGTR

VA

PUSA

UMMA

TO

MO

CA

SI

LI

VEPI

LO

ER

CA

LA AB

140-160 % of EU-25 average at PPP

120-139 % of EU-25 average at PPP

100-119 % of EU-25 average at PPP

70-99 % of EU-25 average at PPP

60-79 % of EU-25 average at PPP

Source: EurostatASSOBIOMEDICA

High DSO

Page 58: La professione del Biologo tra Scienza e Industria

At the moment, no “HTA-Requirements” for formal admission to reimbursement system. Utilization and dissemination of HTA Report is still quite limited. Lack of central (National) strong coordination. In the next future more and more RHAs will use HTA to influence the purchase

and diffusion of innovative medical devices within their boundaries.

Many decision makers think that so far innovation has been often adopted without sufficient information about its efficacy and costs related to alternatives.

In the next future more attention will be put on activities such as horizon scanning, priority setting and HTA.

ASSOBIOMEDICA

Health Technology Assessment

Page 59: La professione del Biologo tra Scienza e Industria

Friuli, Lazio

Institutional HTA in early developing phase.

Hospital-based HTA Units (Hospitals where specific skills and experience for procurement under HTA criteria have been developed).

ASSOBIOMEDICA

Health Technology Assessment

Emilia Romagna

Since the longest time structured HTA activity + high skills & experience inside the Regional Health Agency.

Veneto, Lombardia, Toscana, Piemonte

Well-defined HTA regional programs have been launched.

Page 60: La professione del Biologo tra Scienza e Industria

The regionally-centralizated (or driven) purchasing policy in Emilia Romagna

ASSOBIOMEDICA

• Intercenter is the Agency for the purchase of goods and services needed by health authorities in Emilia Romagna.

• The model is characterised by a central management which defines technical specifications of the goods and services to be acquired; logistic and administration aspects are managed by local health authorities which are obliged to adhere to the contracts stipulated by Intercenter.

Page 61: La professione del Biologo tra Scienza e Industria

ASSOBIOMEDICA

The National Governance of the Healthcare Service

Some measures adopted:

• Reference Prices• National Repository of Medical Devices• Late renewal of personnel contract• Enforcement of the role of the Central Agency (Agenas)

Page 62: La professione del Biologo tra Scienza e Industria

Medical Devices’ Reference Prices

ASSOBIOMEDICA

Official publications of the Reference Prices List

Decree of October 2007 Decree of January 2008 Decree of April 2008 The restyling of the list is expected in a short while: 26 references will be delisted (e.g. some

endovascular prostheses) and 23 new references will be added (e.g. some pediatric vascular prostheses); most prices will not be modified.

The products so far involved are very different from each other and the relative prices range from € 0,018 (for a non-surgical glove) up to € 6.939 (for a particular endovascular prosthesis).

Reference prices must be used by public hospital as base prices for public tenders.

• Assobiomedica proposed an amendment to the next National Budget Law 2009 which is still in discussion, with the objective to suspend the application of reference prices in 2009.

Page 63: La professione del Biologo tra Scienza e Industria

Medical Devices’ Reference Prices

ASSOBIOMEDICA

Critical issues

Risk of an extension of the reference prices published by the MoH even among Private Hospitals.

The so-defined “equivalent” classes of products actually do not correspond to equivalent supplies.

Risk that RHAs will keep on adopting their own reference prices even though the amendment to the next National Budget Law 2009 proposed by Assobiomedica will be successful.

Page 64: La professione del Biologo tra Scienza e Industria

The National Agency for Regional Healthcare Services (Age.Na.S, formerly A.S.S.R.), founded in 1993, supports and co-ordinates regional activities in cost monitoring, organizational challenges and HTA.

Coordinator Agency of National Plan for clinical guidelines. Strong endorsement by the Conference of the Regions on HTA. Important role of Agency in process of reference pricing for medical devices and key

stakeholder into the debate on alternative ways for governance of medical device sector. Commissioned by the MoH to produce HTA reports on orthopaedics, in vivo and in vitro

diagnostics; the aim of these reports was primarily to test the process for a systematic activity. Main Coordinator of “Progetto COTE”, a network for Horizon Scanning activities in Italy. The

project has been launched in september 2008 and is still in a developmental phase.

ASSOBIOMEDICA

Health Technology Assessment

Page 65: La professione del Biologo tra Scienza e Industria

Diagnostic Systems Italy

The new Go to Market The new Go to Market ModelModel

Lux 28/06/2007Lux 28/06/2007

Page 66: La professione del Biologo tra Scienza e Industria

BD Italy CONTEXT MAPBD Italy CONTEXT MAP

UNCERTAINTIESUNCERTAINTIES

•Merging and acquisitions, global Merging and acquisitions, global contractorcontractor

•Key decision makers shiftKey decision makers shift

•Regional hospitals mergingRegional hospitals merging

INTERNAL TRENDSINTERNAL TRENDS•Business consultant approachBusiness consultant approachScientific/therapeutic & Scientific/therapeutic & FinancialFinancial

•Break “lab barriers”Break “lab barriers”New stakeholder & wards New stakeholder & wards exploringexploring

•Profiles and skills diversity ex. Profiles and skills diversity ex. Workflow engineersWorkflow engineers

•Reorganization of strategic Reorganization of strategic centerscenters

POLITICAL CLIMATE•Strong uncertainty

•Focus on health care costs rather than investments

ECONOMICCLIMATE•DRG reduction

•Financial law negatively affecting companies (price monitoring) Focus on lower price inst.of quality

CUSTOMER NEEDS •Costs constraints

•Workflow analysis & KPI evaluation

•Quality/price balance

•High level after sales support

•Scientific development

•Management skills development

TECHNOLOGY TECHNOLOGY FACTORSFACTORS•Full & rapid automated systemFull & rapid automated system

•““Zoonosis” conversion diseasesZoonosis” conversion diseases

•Rapid Tests requestRapid Tests request

•Molecular TechnologyMolecular Technology

•Urgent need of modular instrumentsUrgent need of modular instruments

OUTSIDE TRENDSOUTSIDE TRENDS

•Purchase dept. Purchase dept. centralization (1 purchase centralization (1 purchase dept. for many labs)dept. for many labs)•Merging and acquisitions Merging and acquisitions (customers and companies)(customers and companies)•Price oriented tendersPrice oriented tenders•Competition conflictsCompetition conflicts•Raising awareness on HAIRaising awareness on HAI

Page 67: La professione del Biologo tra Scienza e Industria

Driving ForcesDriving Forces

Growing Concern for HC Worker’s Safety & Environmental Issues Increasing Public Exposure to Infectious Diseases Issues Uncontrolled HC Expenses Growth Exceeds GDP Increase Growing Challenges of Infectious Diseases Increasing Customer Education Increasing Aging Population Low regard and visibility of Clinical Microbiology Regulatory Pressure on IVDNew Financial law Lowering Attractiveness of HC ProfessionFocus on products and prices rather then on quality and solutions

Professional

Demographical

Economical

Political

FORCESFORCES TRENDSTRENDS

Page 68: La professione del Biologo tra Scienza e Industria

Driving ForcesCONSEQUENCES RESULTS

Expenses Control Program Continuous Budget

Pressure Higher Needs for Performance Increased complexity of the sales pathway Process Optimization Focus Integrated Global Approach Future Lab approach Customised Instrument Solution Higher Information technology request Expert System & Automation

Reimbursement & Budget Pressure Decision Shift to Admin & Finance (new stakeholders)Tender cost impact Rationing to Rationalising Lab Concentration, Satellites, Global Contractors

Staff Shortage for cost reduction

Growing Concern for HC Worker’s Safety & Environmental Issues

Increasing Public Exposure to Infectious Diseases Issues

Uncontrolled HC Expenses Growth Exceeds GDP Increase

Growing Challenges of Infectious Diseases

Increasing Customer Education

Increasing Aging Population

Low regard and visibility of Clinical Microbiology

Regulatory Pressure on IVD

New Financial law

Lowering Attractiveness of HC Profession

Focus on products and prices rather then on quality and solutions

Page 69: La professione del Biologo tra Scienza e Industria

Driving ForcesDriving ForcesCONSEQUENCES RESULTS

Educated & Sensitive customers/patients CT Screening Program

Mrsa Screening Programs

Primary Demand Patient

Initiatives

Targeted Co-Funding in

Emerging diseases

More accurate

Epidemiology Profile

Documented AB Therapies

Data Processing Capability

Influence on Diagnostic tests prescriptionRegional Political ProgramsImprovement of procedures in medicine Standardization

Focus on prevention

Growing Concern for HC Worker’s Safety & Environmental Issues

Increasing Public Exposure to Infectious Diseases Issues

Uncontrolled HC Expenses Growth Exceeds GDP Increase

Growing Challenges of Infectious Diseases

Increasing Customer Education

Increasing Aging Population

Low regard and visibility of Clinical Microbiology

Regulatory Pressure on IVD

New Financial law

Lowering Attractiveness of HC Profession

Focus on products and prices rather then on quality and solutions

Page 70: La professione del Biologo tra Scienza e Industria

Driving forcesDriving forcesCONSEQUENCES RESULTS

Higher Sensitivity to HCW Safety Risk Management

Safety Educational

Campaign

Preventive Programs & Cost

Epidemiology / Data

Management

Value Opportunity for

Clinical Micro Lab

Politically and Economically driven processes

Increasing focus on Nosocomial Inf.

Growing Concern for HC Worker’s Safety & Environmental Issues

Increasing Public Exposure to Infectious Diseases Issues

Uncontrolled HC Expenses Growth Exceeds GDP Increase

Growing Challenges of Infectious Diseases

Increasing Customer Education

Increasing Aging Population

Low regard and visibility of Clinical Microbiology

Regulatory Pressure on IVD

New Financial law

Lowering Attractiveness of HC Profession

Focus on products and prices rather then on quality and solutions

Page 71: La professione del Biologo tra Scienza e Industria

The reason of The reason of changementchangementLAB

PATIENTCONTROLLER

CLINICAL

COMPANY

1980

•Focus on products•customer = lab•only sales rep needed with a little support from HQ FAS• 100% personal relationships

Page 72: La professione del Biologo tra Scienza e Industria

The reason of The reason of changementchangement

LAB

PATIENTAdm. dept

CLINICAL

COMPANY

1990

•Focus on products and instruments•customer = lab + adm dept•sales rep + FAS•Tender process focus• 85% personal relationships

Page 73: La professione del Biologo tra Scienza e Industria

The reason of The reason of changementchangement

LAB

PATIENT/cust omer

GMAdm. deptHy. dept

CLINICAL

2000

COMPANY•Focus on products and solutions•customer = lab + adm dept + clinical dept + CIO•sales rep + FAS + pm + management•Tender and project process focus• 75% personal relationships

Page 74: La professione del Biologo tra Scienza e Industria

FROMFROMSimple selling processSimple selling processFew competence neededFew competence neededFew resources neededFew resources neededFocus on productsFocus on productsSale and management of resultsSale and management of resultsDatasDatasMicrobiolgy LabMicrobiolgy LabDiagnosisDiagnosisPrevalence of products and TechnologyPrevalence of products and TechnologyProduct and service managementProduct and service managementTest as diagnostic supportTest as diagnostic supportFocus on results (lab centralization)Focus on results (lab centralization)

1980 – 20071980 – 2007TOTO

Complex selling processComplex selling processMany competences neededMany competences needed

Many resources neededMany resources neededFocus on projectsFocus on projects

Sale and management of informationsSale and management of informationsConsultingConsulting

Cio, Clinical, General ManagementCio, Clinical, General ManagementPrognosis and TherapyPrognosis and Therapy

Prevalence of OrganisationPrevalence of OrganisationProject and performance managementProject and performance management

Test as prevention supportTest as prevention supportFocus on Process (POC + decentralizazion to wards)Focus on Process (POC + decentralizazion to wards)

Page 75: La professione del Biologo tra Scienza e Industria

The reason of changementThe reason of changementNational/regional Govnmt

LabHospital Management(GM, ADM dept, Hy dept)

Clinical, wardsPatient/Customer

Family Physician

(guidelines and financial goals)(guidelines and financial goals)

KPI

KPI

KPI

Page 76: La professione del Biologo tra Scienza e Industria

AssoDiagnostici 2011-2012OUTSIDE TRENDS

UNCERTA

INTIE

S

INTERNAL TRENDSPOLITICALCLIMATE

ECONOMICCLIMATE

CUSTOMER NEEDS• Qualità e sicurezza

contrapposti al razionamento

• Screening e prevenzione

• Scarsità di risorse e ottimizzazione dei flussi

• Contenimento dei costi e ridefinizione degli investimenti

• Valorizzazione del ruolo e riconoscimento della centralità del Reparto

• Conclamata fase recessiva

• Attesa del comparto Industriale per maggiore disponibilità di risorse

• Massima pressione fiscale

• Spending review in funzione degli investimenti

• Attenzione immotivata e inappropriata ai dispositivi medici

• Difficoltà a coniugare rigore economico e necessità di crescita

• Solvibilità del debito della P.A.

• Ricambio culturale e del Management della P.A.

• Difficoltà ad individuare I giusti interlocutori

• Spending review in chiave punitiva (ancora CONSIP)

• Revisione nomenclatore e tariffari

• Gestione gare in chiave razionamento (all.P ecc.)

TECHNOLOGY

FACTORS

• Creazione di solidi

network di stakeholder:

clinici, Direzioni ASL e

Ospedaliere, Associative

sia Scientifiche che di

settore che di Pazienti e

Cittadini…..

•Maggiore efficacia nel

processo di guarigione del

paziente

•Ruolo dell’HTA quale

valore aggiunto

•Innovazione e tecnologia

• Definitiva consapevolezza della crisi

• Tregua responsabile a sostegno del Governo

• Politica locale verso Regioni

• Politica Regionale verso Governo Centrale

• Precarietà nei riferimenti (a tempo fino al 2013)

• Conflittualità sui costi della politica verso cambiamento

• Trend 1 Sostenibilità del

sistema

• Trend 2 Concentrazione delle

strutture sanitarie e degli

acquisti

• Trend 3 Debolezza strutturale

e culturale della Pubblica

Amministrazione in tema di

pagamenti

• Trend 4 Tendenza ulteriore al

razionamento delle risorse in

tema di acquisti

• Trend 1 Sostenibilità delle imprese

• Trend 2 Necessità di bilanciare le minori entrate e la crisi della domanda

• Trend 3 Rinnovamento delle risorse in funzione della domanda e non solo dell’offerta

• Trend 4 Coerenza e coesione

nella visione e nel comportamento

Page 77: La professione del Biologo tra Scienza e Industria

GRAZIE!!!