La professione del Biologo tra Scienza e Industria Corso di Formazione “Professione Biologo” Roma, 14 Giugno 2012 Pasquale Mosella
Feb 06, 2016
La professione del Biologo tra Scienza e
IndustriaCorso di Formazione “Professione Biologo”
Roma, 14 Giugno 2012Pasquale Mosella
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
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
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
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.
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
FASI PROCESSO PRODUTTIVO
PREAnalitica
POSTAnaliticaANALITICA
PREAnalitica
Analitica POSTAnalitica
Processo Produttivo
Analytical
Information data management
Sample handling
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
SI PUO’ MIGLIORAREL’EFFICIENZA PRODUTTIVA
ATTRAVERSO L’AUTOMAZIONE
L’AUTOMAZIONE RAPPRESENTALA CONDIZIONE INDISPENSABILE
PER AVVIARE UN PROCESSODI RIDUZIONE DEI COSTI DI GESTIONE
Process improvement
Lab automation
Data management enhancement
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
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
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)
Componenti del costo per campione
Preanalitica40%
Analitica45%
Postanalitica15%
60%degli errori
di laboratorio
QUALITA'
COSTO TEMPO
UN OBIETTIVO FONDAMENTALEDELL’AUTOMAZIONEDEL LABORATORIO
E’ QUELLO DIFORNIRE INFORMAZIONI
AL CLINICO
IN TIME TO DO ANY GOODFOR THE PATIENT
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
QUALITA'
COSTO TEMPO
OFFERTAOFFERTA
BISOGNIBISOGNI
DOMANDADOMANDA
CONTINUOUS
PATIENT
REPORTING
C P R
LABORATORIO ANALISI
Chimica ClinicaChimica Clinica
ImmunochimicaImmunochimica
EmatologiaEmatologia
CoagulazioneCoagulazione
UrineUrine
Prot&Elettr.Prot&Elettr.
87%
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
PROCESSO DI PRODUZIONE
7.30 8 9 10 11 12 13 14 15 16
PRE ANALITICA ANALITICA POST AN.
RICHIESTARICHIESTA REFERTOREFERTO
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
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)
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
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
Orario utile per la refertazioneRIAN 9UTIC 9ONCO 10.30MED 10OST 11INF 10P.S. entro 20-30 min.
SPECIMEN RECEIVED TIME9.308.00
7.30
0.00 12.00 24.00
CONTINUOUS PATIENTS REPORTING LAB. ROUTINE LAB. URGENZE
OPEN SPACEOPEN SPACE
CORE LABCORE LAB
C. P. R.C. P. R.
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
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
CORELAB LAYOUT
NEFELOMETRIA
IMMUNOCHIMICA URINE
EMOGAS
CHIMICA CLINICA
EMATOLOGIA COAGULAZIONE
Test di emergenza Rapido TAT Massima efficienza Riduzione dei costi Controllo remoto dal laboratorio
Patient-side testing system
IL LABORATORIO DOPO IL 2000
CPRCPR 85%85%
POCPOC
POC POC
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
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
Protagonista dello sviluppo del nuovo
modello di Ospedale in rete sarà
INTERNET Health Care
Service Integration of POCT in LIS
E - mail
NEAR FUTURE
Point of Care Testing
Molecular Diagnostics
New Technologies for the new Millennium
GENE CHIPS
MINIATURIZATION and FLUIDICS
BIOELECTRONIC DETECTION OF DNA
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.
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.
POC
POC POC
POCPOC
POCPOC
POC
Testsesoterici
Il laboratorio dopo il 2010
Il Laboratorio dopo il 2010
MICROBIOLOGIA
POCT
LAB
HOME TESTING
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.
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 -
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
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
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
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
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
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
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
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
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
• 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
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
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
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.
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.
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)
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.
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.
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
Diagnostic Systems Italy
The new Go to Market The new Go to Market ModelModel
Lux 28/06/2007Lux 28/06/2007
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
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
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
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
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
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
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
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
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)
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
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
GRAZIE!!!