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Digital Hospitals - Sweden
Market Report
December 2015
Nya Karolinska Hospital : 33 700 MSEK!
”In the future we procure healthier citizens!”
About 100 open Medtech tenders right now!
Digitalisation of Swedish healthcare is still ahead
=> A big opportunity!
Health economical benefit of growing importance!
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
By Robert Harju-Jeanty
www.medicallead.se
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
 Over 10 large hospital projects are ongoing in Sweden, for instance in Linköping,
Helsingborg, Uppsala, Örebro, Luleå, Malmö and the biggest of them ”New
Karolinska” with a record budget of 3 600 million €.
 In several places acute care, traumatology and operating rooms are to be renewed.
Diagnostic imaging and all ITC-support connected is another example.
 The lack of doctors and increasing healthcare costs are opening for telemedicine
solutions. Health economical cost effectiveness is of increasing importance.
 ”Green hospitals” is a trend focused on energy saving.
 Three major regions have started 3R, a hospital digitalisation project, which will be
guiding for the country’s remaining 17 regions/counties.
 Digitalisation of healthcare leads to patient-empowering, for instance in Uppsala
the patient has the possibility to read his/her own patient records on internet.
 Innovation procurement is implemented in many regions, and in the future, instead
of medical inventory, the total healthcare function with final result will be bought.
 Private healthcare is growing, and is an opportunity, especially in primary care and
some medical specialities. This target group might have lower entry barrier, due to
shorter decision processes compared to public tenders.
Executive Summary
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
Background and Aim
Digital Hospitals Program
• The Digital Hospitals export program is designed for Finnish companies working
with technology that improves the quality of care.
• The export program is focused on the Nordic countries, due to the massive
hospital constriction and refurbishment projects ongoing and planned in the
region.
• The companies participating in the program can enter international markets as
a larger group with the help of the program.
This document
• The purpose of this market study was to give an overall picture of the Swedish
healthcare market, with focus on healthcare technology and the opportunities
for Finnish companies operating in this sector.
• The results will be used to plan further activities in the export program.
• The market study was prepared by Fintra and Medical Lead.
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
Public and Private Healthcare
• Public healthcare is far
regionalized in Sweden. 70% is
financed by local taxes.
• Just like in all Nordic countries,
100% of the population is covered
by public healthcare.
• Public healthcare covers 80% of
the total healthcare costs in
Sweden.
(ref 9)
Responsible for care
Organizer
Public
companies
Taxes
Municipalities
Landstingen
(Regions)
Organizer
Hospitals
Health
centers
Dentists
Elderly
care
Child
care
Social
care
Public management
Regions Municipalities
Procurement
Free choice system
Private
companies
3rd sector
Responsible for healthcare
Public and Private Healthcare
Public Buyers
• 20 counties (Swe: landsting)
or regions (#21 on the map
is formally a municipality).
• 290 municipalities.
• The Swedish state.
• Sometimes the
counties/regions make
tenders together, for
instance ”7-klövern” or
”5-klövern”.
County/Region Inhabitants
11 Stockholm 2 200 000
12 Västra Götaland 1 600 000
20 Skåne 1 300 000
14 Östergötland 440 000
10 Uppsala 350 000
13 Jönköping 340 000
16 Halland 310 000
8 Örebro 290 000
6 Gävleborg 280 000
5 Dalarna 280 000
15 Sörmland 280 000
7 Värmland 270 000
2 Västerbotten 260 000
9 Västmanland 260 000
1 Norrbotten 250 000
4 Västernorrland 240 000
19 Kalmar 240 000
17 Kronoberg 190 000
18 Blekinge 150 000
3 Jämtland 130 000
21 Gotland 57 000
”7-klövern” > 2 million inhabitants
Counties and Regions
Each region publishes their own tenders, often via their own systems. (There is no national
tender site such as Hilma in Finland). Below are links to the regions’ procurement
departments, with up to date information on contact persons and procurement plans.
County/Region Homepage - Procurement
Stockholm http://www.sll.se/om-landstinget/upphandling/
Västra Götaland http://www.vgregion.se/inkop
Skåne http://www.skane.se/organisation-politik/Att-gora-affarer/upphandling/
Östergötland http://www.regionostergotland.se/Om-regionen/Att-gora-affarer-med-oss/Aktuella-upphandlingar/
Uppsala http://www.lul.se/sv/Landsting--politik/Utveckling-och-ansvar/Upphandling/
Jönköping http://www.rjl.se/Om-regionen/verksamheter/ledning-och-stodverksamheter/verksamhetsstod-och-service1/inkop/
Halland http://www.regionhalland.se/om-region-halland/organisation/aktuella-upphandlingar/
Örebro http://www.regionorebrolan.se/sv/Om-regionorebrolan/Detta-ar-landstinget/Lednings--och-verksamhetsstod/Upphandling/
7-klövern www.7-klövern.se
Gävleborg http://www.opic.com/upphandlingar/gavleborgs-lan/?gclid=CJ7-3tLErskCFebhcgod6GQNAg
Dalarna http://www.ltdalarna.se/Om-landstinget/Ovrig-landstingsverksamhet/Upphandling/
Sörmland http://www.landstingetsormland.se/Utveckling-forskning/Miljo/Testsida-Miljo/Upphandling/
Värmland https://www.e-avrop.com/liv/e-Upphandling/Default.aspx
Västerbotten http://www.vll.se/default.aspx?id=64535&refid=3009
Västmanland http://www.ltv.se/Om-landstinget/Ekonomi/Upphandlingsenheten/Var-verksamhet/
Norrbotten https://www.nllplus.se/For-foretag/Upphandling/
Västernorrland http://www.lvn.se/Om-landstinget/Landstingets-organisation/Landstingsservice/Upphandlingsenheten/
Kalmar http://www.ltkalmar.se/om-landstinget/detta-gor-landstinget/upphandling/
Kronoberg
http://www5.ltkronoberg.se/Om-
landstinget/Arbomr/Upphandling/?_t_id=1B2M2Y8AsgTpgAmY7PhCfg%3d%3d&_t_q=upphandling&_t_tags=&_t_ip=78.67.218.177&_
t_hit.id=EPiServer_Find_Framework_BestBets_ExternalUrlBestBet/TOFWGvk5TvyXpC5Cd5_bmA&_t_hit.pos=1
Blekinge http://ltblekinge.se/Om-landstinget/Upphandling-och-avtal/
Jämtland http://www.regionjh.se/omoss/upphandling.4.4dc3b946126df75d1b38000188.html
Gotland http://www.gotland.se/upphandling
Hospitals in Sweden
Ranking of the 7 university hospitals:
1. Universitetssjukhuset i Linköping
2. Norrlands universitetssjukhus
3. Universitetssjukhuset Örebro
4. Akademiska sjukhuset i Uppsala
5. Skånes universitetssjukhus
6. Sahlgrenska universitetssjukhuset
7. Karolinska universitetssjukhuset
Ranking of 36 middle-sized hospitals:
1. Länssjukhuset Ryhov, Jönköping
2. Vrinnevisjukhuset, Norrköping
3. Visby lasarett
4. Värnamo sjukhus
5. Blekingesjukhuset, Karlshamn
6. Örnsköldsviks sjukhus
7. Länssjukhuset i Kalmar
8. Lasarettet i Ystad
9. Sunderby sjukhus, Luleå
10. Västmanlands sjukhus, Västerås
11. Centralsjukhuset, Kristianstad
12. Södra Älvsborgs sjukhus, Borås
Ranking 2014, by Dagens Medicin (ref 23)
Depending on how a hospital is
defined, there are around 100
hospitals in Sweden of which
about 60 perform surgery.
Public and Private Healthcare
Private Buyers
• In 2014, the local units, counties or regions bought ca 13% of the healthcare
services from private companies. Additionally, the counties and regions buy
services from other public healthcare units. (ref 10)
• In Stockholm the privatization trend has gone further than in many other places,
and over 30% of the healthcare belongs to private companies, but the public
healthcare, Stockholms Läns Landsting, is anyhow the biggest purchaser.
– The primary care of the metropolitan area of the capital of Sweden is to the
majority privatized. However, primary care makes up only 17% of the whole
healthcare cost for the region.
• The biggest private companies are (ref 22):
– Capio (13 bn SEK in turnover 2014), that for instance run
• Capio St Görans sjukhus in Stockholm (1,7 bn SEK 2014).
– Praktikertjänst (10 bn SEK 2014)
– Attendo (Attendo Sverige AB 3,6 bn SEK 2014)
– Aleris (Aleris AB 1,7 bn SEK 2014)
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
Purchasing Processes
Public Tenders
• Public tenders (Swe: offentliga upphandlingar) follow the law ”LOU” (Swe:
Lagen om offentlig upphandling, 2007:1091), corresponding to Finnish JYSE.
• The aim of the law is to stimulate a better use of the society’s resources. This
means the tenders have to have professional and neutral demands, in a way
that the outcome (the winning offer) can not be predicted. They have to be
announced in special publishing places connected to the caregiver. Note that
Sweden does not have a national publishing site, such as HILMA in Finland.
• The monetary thresholds follow the EU-regulations, currently 1,8 MSEK or 0,2
MEUR requires a full public tender procedure. A simplified procedure can be
done with tenders of value between 1,8 and 0,5 million SEK. These public
tenders have to be announced in TED, Tenders Electronic Daily, the European
online version of European public procurement. Direct purchase has the
threshold 505 800 SEK. Purchase below this value do not have to be announced,
but there is still requirement of professional procurement processes. (ref 3, 13)
Purchasing Processes
Public Tenders
• Like elsewhere in the EU, CPV-codes are used to identify the products.
• Year 2014 there was a total of 856 tender ads in Sweden of the CPV-group 33,
medical equipment, drugs and hygiene articles (ref 4).
– Medical equipment (Swe: Medicinsk utrustning) has code: 33 10 00 00.
Note that some Medtech may fall under a different code, for instance
laboratory equipment belongs to CPV-group 38.
– The distribution of all 94 open tenders of CPV-group 331 in Sweden,
week 47, 2015 (ref 3):
• Tenders below 0,5M: 17%
• Tenders between 0,5M-1,8M: 26%
• Tenders above 1,8M: 57%
• The proportion is roughly the
same throughout the year.
17 %
>0,5 M
26 %
0,5-1,8 M
57 %
>1,8 M
Examples of tenders open now
Year 2015, week 47, all Swedish current tenders of CPV-group 331 (ref 3)
Urologiska hjälpmedel Medicinska förbrukningsartiklar
Tvätteritjänster Mobila röntgensystem med digitala trådlösa detektorer
Drogtester Bröstproteser
X-Ray Equipment for mice Miscellaneous medical devices and products
Produkter för Urinvägar, mag-tarm inkl inkontinensprodukter Desinfektionsutrustning
Materielförsörjning Apparatur för röntgenbehandling
Läkemedelsförsörjning Medicinska förbrukningsartiklar
Invasiv tryckmätning Medicinsk utrustning, läkemedel och hygienartiklar
APAP Utrustning för medicinsk bildbehandling med ultraljud och doppler
Upphandling av två stycken kabinettdiskdesinfektorer Medicinsk utrustning
Cellfördelare Sårbehandling special 2016 del 2, SLL572
Operationsmikroskop för mikrokirurgiska ingrepp 201-420 A och 301-420B Lustgasdestruktion Eksjö och Värnamo
Upphandling av en kompakt röntgendiffraktionsspektrometer, även kallad en benchtop XRD Medicinsk utrustning
Användarstöd i samband med distribution och konsumtion av taltidningar Patientövervakningssystem
Smådjursklinikutrustning Bröstimplantat
Röntgenapparatur Röntgenapparatur
Medicinsk utrustning, läkemedel och hygienartiklar Diverse medicinktekniska produkter
Medicinsk utrustning Utrustning för sterilisering, desinfektion och hygien
Synhjälpmedel Medicinsk utrustning, läkemedel och hygienartiklar
Medicinsk utrustning, läkemedel och hygienartiklar Medicinsk utrustning, läkemedel och hygienartiklar
Extern remiss avseende personburen strålskyddsutrustning Medicinsk utrustning, läkemedel och hygienartiklar
Insulinpumpar och tillbehör Medicinsk utrustning, läkemedel och hygienartiklar
Medicinsk utrustning Medicinsk utrustning
Oftalmologisk utrustning Stel Endoskopi/ Artroskopi 3D
Medicinsk utrustning Bildsystem för ultraljudsbilder
Gånghjälpmedel Endoskopiutrustning
Apparatur och instrument för transfusion och infusion Patientövervakningsutrustning
Utrustning och instrument för tandvård och underspecialiteter A High Content Imaging System
Allergiinstrument Injektion och infusion
Punkthjälpmedel och programvaror Medicinsk utrustning
Lågdosrat brachyterapi: utrustning och förbrukning samt frön Kontrastinjektorer för CT regiongemensam 2015
Uppgradering MR utrustning och MRgFUS-utrustning Hjälpmedel för funktionshindrade personer
Injektion/Infusion del 2 Spoldesinfektorer och diskdesinfektorer
Medicinsk utrustning RFI avseende antibakteriella suturer
Delar och tillbehör till hörapparater Hearing avseende material för patientnära analyser
Hörapparater Utrustning för immunfärgning 2015
Delar och tillbehör till hörapparater Ventilatorer SÄS och NU-sjukvården
Hörapparater DBS System
Röntgenapparatur Inplanterbara läkemedelspumpar för neurologiska behandlingar
Laparoskopistaplar MILOU Centralövervakningsystem med lagring för CTG
Infusionsutrustning Transportventilatorer IVA 2015
Hörapparater för personer med lätt till grav hörselnedsättning Elastografiutrustning 2015
Hörapparater m.m. Utrustning för tillverkning av Technegas 2015
Hörapparater för barn inklusive tillbehör och reservdelar Operationshandskar, SLL471
Patientövervakningssystem Instrument och sjukvårdsartiklar, SLL480
Hörapparater för personer med grav till uttalad hörselnedsättning Koloskopi- och gastroskopiutrustning, Lasarettet i Enköping
Medicinsk utrustning, läkemedel och hygienartiklar Kassettmärkare
Example of an open tender
http://www.offentligaupphandlingar.se/sv/konto/oversikt/
Purchasing Processes
Public Tender – National Medtech Guidelines
• There are no binding national requirements for Medtech, but below is the
closest to national guidelines (ref 1).
– Additionally to all basic requirements (by law) that are valid for public
procurement, the specifications for a medical device shall contain:
• Requirement the product has a CE-mark,
• Other specific requirements the user or the operation have on the product,
• Product review requirement,
• Requirements on specific functions,
• Performance requirements,
• Documentation requirements,
• Requirement of reference to suitable standards,
• Requirements the supplier has sufficient abilities to fulfill the contract.
Purchasing Processes
Continued, Public Tender – National Medtech Guidelines
– The following questions must also be taken into account in the specifications
(ref 1):
• Is the product suitable for the intended use?
• What desinfectants can the product withstand?
• May the equipment be used with current or planned equipment?
• What training for users and medtech personnel is existing or planned?
• What are the resources for preventive service and acute service?
• Has all concerned personnel been able to say their opinion?
• Does the product fulfill all potentially relevant requirements?
• What is the judgement of the supplier/s? Is there a long-term commitment?
• Is the function control automatic and easy to perform?
Purchasing Processes - Example
Example: Stockholms Läns Landsting (ref 15, 18)
• Purchasing of healthcare can be divided into three groups:
– Vårdens varor och tjänster (consumables and drugs), Jan Mattson
– Medicinteknisk utrustning (Medtech), Petra Hållander (new person Jan 2016)
– Enhet för sjukvård, special cases
• Almost all purchases are over >0,5 MSEK, and hence public tenders:
– Analysis and specifications are done according to needs of the ”client”, many
times in collaboration with suppliers:
• Request for Information, RFI, is a proactive request towards suppliers to
provide info of solutions that may be used for making specifications.
• Hearing is a competitive dialogue with suppliers.
• “Extern remiss” (Eng: external referral) is when potential suppliers may
leave their opinions on a preliminary specification.
– RFIs, hearings, tenders and current contracts are published on
http://www.sll.se/om-landstinget/upphandling/, and bigger ones in TED.
Purchasing Processes - Example
Example: Västra Götalandsregionen (ref 6)
• Purchasing of Medtech devided into two
main units and 32 subareas (see picture):
– Medicinsk och kirurgisk sjukvård
– Indirekt material och tjänster
• Process for all public tenders >0,5 MSEK:
– Analysis and specifications are done in
project groups with representatives from
different healthcare units.
– The purchasing department compiles the documents and announces the
tender in TendSign (Visma) database and TED (Tenders Electronic Daily).
– The supplier is chosen, signing of contract, and the result becomes public.
• Also purchasing below 100 000,- SEK has to follow certain criteria:
– Does the product/service fulfill the needs and specifications?
– Are there alternatives, other suppliers with similar product/service?
Purchasing Processes - Example
Example: Region Skåne (ref 27)
• The annual investments of Medtech + related IT is around 0,5 bn SEK.
Everything is not published, because some are upgrades.
• Procurement trends are ”circular business models” (involves recycling),
”innovation procurement”, and generally speaking the supplier is invited earlier
into a dialogue than before. No longer will stand-alone products be bought, a
partnering will lead to contracts including a whole functionality.
• Region Skåne uses TendSign for announcements of public tenders. Larger
investment decisions are political decisions with separate protocols, which
means the information of a future project can be public long in advance.
• Smaller investments below 5 MSEK can be decided by local healthcare
administration, and these are done continuously.
• From a Medtech point of view, the hospital project in Helsingborg will be the
most extensive.
Purchasing Processes - Example
Example: Region Örebro County
• The University Hospital of Örebro is constructing the so called “H-Huset”
offering e.g. highly specialized otorhinolaryngology-care, ready by 2020. (ref 26)
• The cost for the 27 500 m2 construction project is estimated at 1 bn SEK.
• The Medtech procurement, such as surgical equipment, laser, post operative
monitoring equipment and anesthesia will start in 2018/2019.
• Karlskoga lasarett, also located in Örebro county is currently procuring for the
reconstruction of their surgery unit.
• Besides these current hospital projects the county council of Örebro purchases
Medtech for 100-110 MSEK annually. Purchases exceeding 0,5 MSEK are
announced in Visma Opic.
• 1/3 of all purchased are < 0,5 MSEK, wherefore direct marketing of products to
relevant Medtech units is advisable.
• Requests and further information: mt.upphandling@regionorebrolan.se
Purchasing Processes - Example
Example: Medtech at Norrlands Läns Landsting (ref 19)
• The most Northern county of Sweden makes 10-20 public tenders annually with
announcements. Below the current tender frame agreements.
• Additionally, NLL makes
hundreds of smaller,
direct purchases, some
with a competitive dialogue.
• Future needs:
– Expansion of Sunderby
Hospital, Luleå.
Emergency room,
Diagnostic imaging,
Operating rooms.
• Contact person:
Niklas Ranneberg, Director
Public Procurement, NLL
Public Tender Frame Agreement
(Ramavtal)
Start End Option
Dentalutrustning 2012-09-01 2016-08-31 2016-08-31
Centrifuger 2013-09-23 2016-08-31 2017-08-17
Blodtrycksmätare 2012-04-01 2015-11-30 2015-11-30
Undersökningsutrustning för mottagning 2012-01-01 2015-11-30 2015-11-30
Fysioterapiutrustning 2013-04-17 2016-04-16 2017-04-16
Endoskopiutrustning 2014-05-01 2017-02-28 2018-02-28
Infusionspumpar 2013-07-09 2016-07-09 2017-07-09
Dialysmaskiner 2011-11-02 2016-05-31 2016-05-31
Diagnostiskt ultraljud 2012-02-01 2016-01-31 2017-01-31
Digital diktering 2012-03-01 2016-02-28 2016-02-28
Infusionspumpar 2013-08-21 2016-08-21 2017-08-21
Avancerat ultraljud kardiologi 2013-04-15 2016-01-31 2017-01-31
Spoldesinfektorer 2014-01-24 2017-01-24 2018-01-24
Fysioterapiutrustning 2013-08-01 2016-04-16 2017-04-16
Defibrillatorer 2013-06-24 2016-05-31 2017-05-31
Diskdesinfektor mindre verksamhet 2014-01-31 2017-01-31 2018-01-31
Diatermiapparater 2013-10-01 2016-09-30 2017-09-30
Diskdesinfektorer 2013-11-11 2016-11-11 2017-11-11
Example: Stockholms Läns Landsting – Innovation Procurement
• Total county healthcare budget 2016: 54 bn SEK
• During next 10 years,
extra 42 bn SEK invested
to meet higher demands
from growing population.
• Innovation procurement
New Karolinska + Philips,
concerning medical
imaging: value 1,9 bn SEK.
– Process start 2011,
Master Calibration
Agreement in 2014.
– Agreement signed for
14 + 6 years.
Purchasing Processes - Example
Purchasing Processes - Example
Example of a private hospital, S:t Görans Sjukhus, Stockholm (ref 18):
• Capio S:t Görans is the only privately
owned emergency hospital in Sweden.
– 77 000 yearly visits at the ECU (2012)
– 31 medical specialities
• Total procurement 3-400 MSEK / year.
• Hospital makes proactive procurement,
and no announcements. Independent
processes from other parts of Capio.
• Established suppliers at SLL (Stockholm
County Council) are also used at S:t Görans, and the hospital has the right to join
in public tenders at SLL.
• Needs within 1-2 years: operating rooms, ultrasound, and automatic check-in
systems.
• Contact person: Purchasing Director Henrik Andersson, tel +46 8 587 01 000.
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
Market Access in Sweden
The export of medical technology to Sweden is easy from a regulatory point-of-
view from another country belonging to the EU, such as Finland.
• The CE mark is valid within the whole EU, and therefore the formal
requirements are automatically fulfilled. The majority of Medtech in hospitals is
covered by department budgets.
• The Dental and Pharmaceutical Benefits Agency, TLV (Swe: Tandvårds- och
läkemedelsförmånsverket), is a central government agency whose remit is to
determine whether a pharmaceutical product or dental care procedure shall be
subsidized by the state. 30% of the healthcare in Sweden is paid by the state.
• TLV has been commissioned by the Swedish Government to conduct health
technology assessments of medical devices. The aim is to produce assessments
that can support the organizations responsible for healthcare in deciding
whether to introduce new methods and in procurement processes.
• Therefore, certain Medtech products, such as dental care and ostomy-pouches
that are given to patients against prescription, are approved by TLV in a
separate process where health economical aspects are crucial.
(ref 14)
Market Players in Sweden
Entering the market can be considerably more efficient with the right partner.
• Many international healthcare companies have their Nordic headoffice in
Sweden, such as Novartis, Bayer Healthcare, Philips Healthcare and Alere.
• Sweden is also the home of some major global players like Getinge, Elekta, Astra
Zeneca and Thermo Fisher Scientific Phadia.
• The big logistic companies and wholesalers within healthcare, such as Tamro,
OneMed and Mediq, can also influence the success of their partners.
• Consider partnering with smaller and mid-sized distributors within your specific
area, for instance Trio Lab, ACC Nordic, Mediplast, Instrumenta and Stille.
• Trade associations may contribute with support in business and partnering.
– Swedish Medtech is the Association for Medical Technology in Sweden, with
170 member companies, representing ca 90 % of the national turnover.
– Sweden Bio has about 200 Life Science companies as members.
– Swedish Labtech is mostly focused on diagnostics and analysis.
– LIF is the trade association for the research-based pharmaceutical industry.
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
Business Challenges in Sweden
 Understand the process
• “Samat haasteet kuin suomalaisessakin julkisessa sektorissa: hankintalain
puitteissa on toimittava ja julkiset hankinnat ovat hitaita etenemään.”
• “…päätöksenteon aikajänne, hankintojen "perinteisyys" tai vanhat ratkaisut…”
 Understand the business culture
• “Ruotsissa ei tehdä päätöksiä, ns, keskusteleva kulttuuri.”
• “Kumppani oltava ruotsalainen, jolloin kulttuurillisesti tulee tilanne, jossa
kaupalliset asiat hoituvat huomattavasti nopeammin.”
• “Ruotsissa on vahva kotimarkkina sairaalasektorilla ja totuttu käyttämään
kotimaisia toimijoita.”
(ref 5)
Business Challenges in Sweden
 Have the right contacts or partner
• ”Osaavien tahojen löytäminen paikallisella tasolla on kuitenkin haasteellista.”
• “Oikean kumppanin löytäminen.”
 Choose strategy
• “Kokemuksemme mukaan suunnitteluryhmät ja projektinjohtourakoitsijat voivat
saada merkittävää kilpailuetua jo tarjousvaiheessa käyttämällä prosessi- ja
logistiikkasiantuntijoita.”
• “Kypsä markkina. Suomen toimijalle ei ole tilaa.”
(ref 5)
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
Future Opportunities
Stockholms Läns Landsting (ref 15, 16)
• Nya Karolinska Hospital is one of the biggest hospital projects in Europe, with a
total investment of 33,7 bn SEK 2015–2019. 730 new hospital beds, 36
operating rooms and 2 helipads are built.
• Many of the procurement processes are already done, but concerning medical
devices there are still a lot to be purchased (ref 15).
• In specialized care the hospital itself has needs in cancer and cardiac care, acute
trauma and childrens’ healthcare.
• Additionally, SLL will before 2020 renew all operating rooms and intensive care
units at Huddinge, Danderyd and Södertälje hospitals (ref 15).
Future Opportunities
Stockholm, Göteborg and Skåne in collaboration (ref 8)
• Program 3R Framtidens vårdinformationsmiljö (3R Fvm) is going on until 2019
and should lead to:
– Increased safety in patient care, i.e. a common medical record system,
– Improved conditions for development of healthcare processes,
– Possibilities for patient involvement in his/her own care,
– Possibilities for more effective working procedures.
• ”FVM is by far the most comprehensive project right now. It includes a complete
renewal of the hospital ICT-system, and one part of it will involve all medical
devices connected to it.” Carin Sjösten Nilsson, Västra Götalandsregionen (ref 9)
The Swedish Digital Hospital!
Future Opportunities
Gävleborg, Västmanland, Norrbotten and Västerbotten:
• Today Sweden has about 4800 specialized doctors in primary care, and this is
1400 too few from the goal of 1500 inhabitants/doctor (ref 11). This means all
methods that can improve the efficiency of the primary care physicians could
potentially have a high demand in those geographical areas with biggest need
of doctors. Stockholm area has the smallest need.
• Telemedicine and digital health solutions to
decrease patient time per doctor will have
important market opportunities is some regions.
– In Norrbotten (northernmost Sweden) is a
project involving electronic stetoscopes and
video conference (ref 19).
Future Opportunities
Region Östergötland and Linköping’s
University Hospital (ref 21):
• The biggest project in the region is
”Framtidens Universitetssjukhus”
in Linköping (4 bn SEK). See picture right.
The more important parts are:
– Urgent and intensive care,
– Diagnostic imaging,
– Clinical chemistry.
– It has come far already, but some Medtech will still be purchased.
– Procurement uses often RFI’s and these and the tenders are published in
Visma TendSign. E-mail: upphandling@regionostergotland.se
• Another hospital project in the region is ”Vision 2020 – Framtidens
Vrinnevisjukhus” in Norrköping. Among other things, energy-saving solutions
are in focus, for instance in ventilation and Medtech.
Future Opportunities
Landstinget i Uppland and Uppsala University Hospital:
• The biggest project in the county is ”Framtidens Akademiska Sjukhus” in
Uppsala (6,2 bn SEK). The project is ongoing and will be ready in 2022.
• In Medtech there will be need for operating room equipment, infusion pumps
and diagnostic imaging.
• Tenders are published in Visma TendSign. Tel: +46 18 611 0000.
Other Hospital Projects
Of those not mentioned before, other hospital
projects ongoing or prospected in Sweden:
• Helsingborg wants to create the most modern
acute hospital in Sweden with a total budget
of 4,8 bn SEK. The project time is 2013-2023.
See picture to the right. (ref 25, 27)
• Skåne University Hospital in Malmö will invest
over 6 bn SEK in renewals and expansion.
In the first phase, in 2016, new buildings for
internal medicine, endocrinology, surgery,
opthalmology, and respiratory medicine. (ref 25)
• Skåne University Hospital in Lund will renew laboratory medicine. (ref 25)
• The University Hospital in Umeå is constructing a new psychiatric unit,
“Psykiatrisjukhuset” in Umeå. Construction costs of the project is estimated at
600 MSEK and to be finalised earliest in 2018/2019.
Hospital Projects
Sunderby Sjukhus
Framtidens Akademiska Sjukhus
Södertälje Sjukhus
Huddinge Sjukhus
Nya Karolinska Sjukhuset
Framtidens Vrinnevisjukhus
Framtidens Universitetssjukhus
Psykiatrisjukhuset
Danderyds Sjukhus
H-huset, Örebro
Helsingborg
Malmö
Future Opportunities
Future trend in healthcare procurement (ref 20):
• “Healthcare is costing too much. The society can’t accept higher costs in
comparision to other expenses. We have reached the roof with current 10-15 %
of GNP.”
• ”Nya Karolinska has procured function, this means we have a long-term
commitment (decades) and our partners are resposnibel for the function.
However, for example, this doesn’t mean that all MR-equipment will come from
Philips, even though they have the contract.”
• ”We buy a result, just like Rolls Royce gets paid by flying hour of their motors.”
• ”In the future we procure healthier citizens!”
Stefan Vlachos
Head of Strategic Innovation
Karolinska Universitetssjukhuset
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
Market Entry Recommendations
What business model will work for you? Some tips:
• Analyse your market. Look at old public tender results. Find out when the next
are coming. Contact procurement managers on your prime market and be
proactive to find out how your product and/or service fit the clinical needs.
– Who are the competitors?
– What are the entry barriers?
– Are there important subtitutes?
– Is your product reimbursed in Sweden?
• Decide about your market access strategy.
Use a consultant to help out with partnering.
Choose a distributor/partner or decide to
open up your own office. Local presence
always makes business easier. A big partner,
such as an international company with Nordic
headquarters in Sweden, or one of the big healthcare
logisitics companies may leverage the business in a substantial way.
Michael Porter: The Five Forces
Market Entry Recommendations
What business model will work for you? Some tips:
• Consider influencing local opinion leaders. If you have a disruptive technology,
this might be the best way to introduce it to the healthcare system. Remember
Henry Ford’s quote: ”If I had asked people what they wanted, they would have
said faster horses.” Create your own market! Influence in hearings and RTIs!
• Following Swedish public tenders is more demanding than in Finland, because
there is no national database like HILMA. Consider buying tender surveillance*.
Note that procurement below 57 000 € do do not have to be publicly available.
• Sweden is the home of consensus. The hierarchy is flatter than
elsewhere and all coworkers may influence a decision. Therefore,
it may be important to remember to have presentations and
way of influencing all layers in an organisation. Remember that
tender documents are in Swedish, and even though most Swedes
understand and speak English, communication in Swedish will
make business processes smoother.
*commercial service providers include Visma and Offentligaupphandlingar
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
Contact Persons
Eero Toivainen
Growth Program Director
Finpro
eero.toivainen@finpro.fi
+358 40 343 3357
Finpro
www.finpro.fi
Robert Harju-Jeanty
CEO
Medical Lead
robert@medicallead.se
+46 702 662 999
Leena Pesu
Senior Consultant
Fintra
leena.pesu@fintra.fi
+358 45 105 7950
Finnish Trade Organisation Fintra Oy
Tammasaarenkatu 5
00180 Helsinki
www.fintra.fi
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
References
1. Vårdhandboken, 2015. www.vardhandboken.se/Texter/Medicintekniska-produkter/Upphandling/
2. Swedish Medtech, October 2015.
3. Christian Riddarlo, Offentliga Upphandlingar AB, 20151116.
4. Konkurrensverket & Upphandlingsmyndigheten, Rapport 2015:9.
5. Questionnaire to participating companies in Digital Hospitals, 2015.
6. Ingemar Sesevic, Västra Götalandsregionen, 20151119.
7. Statistiska centralbyrån, 2014.
8. http://3rfvm.se/
9. Carin Sjösten Nilsson, Västra Götalandsregionen, 20151119.
10. Ekonomifakta, 2014. www.ekonomifakta.se/sv/Fakta/Valfarden-i-privat-regi/Vard-och-omsorg-i-privat-regi/.
11. Läkartidningen, 2013. www.lakartidningen.se/Functions/OldArticleView.aspx?articled=19378.
12. Patrik Puhony, Karolinska Hospital, 20151117.
13. www.upphandlingsmyndiheten.se
14. www.tlv.se/In-English/in-english/
15. Gunnar Goblirsch, Stockholms Läns Landsting, Upphandlingsenheten, 20151124.
16. www.sll.se/verksamhet/halsa-och-vard/framtidsplanen/
17. www.sll.se/om-landstinget/upphandling/
18. Henrik Andersson, Inköpschef, Capio S:t Görans Sjukhus, 20151125.
19. Göran Eriksson, Medicinteknisk strateg, Norrlands landsting, 20151125.
20. Stefan Vlachos, Head of Innovation, Nya Karolinska Hospital, 20151120.
21. Örjan Lehnberg, Gruppchef, Upphandlingscentrum, Region Östergötland, 20151125.
22. www.allabolag.se
23. http://www.dagensmedicin.se/artiklar/2015/01/14/har-ar-hela-listan-over-basta-sjukhusen1/
24. Patrik Lindmark, Project Leader, Framtidens Akademiska Sjukhus, LUL, 20151126
25. http://www.skane.se/framtid-och-utveckling/framtidens-sjukhus/
26. http://www.regionorebrolan.se/h-huset
27. Charlott Wictor, Strategisk inköpare, Enheten för läkemedel och medicinsk teknik, Region Skåne, 20151207
Digital Hospitals - Sweden
Contents
1. Executive Summary
2. Background and Aim
3. Public and Private Healthcare
4. Purchasing Processes with Examples
5. Market Access
6. Business Challenges
7. Future Opportunities
8. Market Entry Recommendations
9. Contact Persons
10. References
11. Medtech Appendix
Medtech Appendix 1/7
• Medical Devices or Medtech is regulated in the EU Directive 2007/47/EC, and in
Sweden it is harmonized with the Swedish law SFS 1993:584:
“Any instrument, apparatus, appliance, software, material or other article,
whether used alone or in combination, together with any accessories, including
the software intended by its manufacturer to be used specifically for diagnostic
and/or therapeutic purposes and necessary for its proper application, intended
by the manufacturer to be used for human beings for the purpose of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an
injury or handicap,
– investigation, replacement, or modification of the anatomy or of a
physiological process,
– control of conception,
and which does not achieve its principal intended action in or on the human
body by pharmacological, immunological, or metabolic means, but which may
be assisted in its function by such means.”
Medtech Appendix 2/7
Medtech
=
A human healthcare product
that is not a medicine or a vaccine.
Medtech Appendix 3/7
• Medtech products can therefore be a wide variety of products,
ranging from simple single-use products, such as band aid, to
complex active implantable devices, such as pacemakers. From
April 2010, also information technology products and programs
dealing with patient data are included (ref 1).
• If the product’s principal intended action is in or on the human
body by pharmacological, immunological, or metabolic means,
the use is defined in other laws and by other regulations.
Medtech Appendix 4/7
• The documentation of medtech products is very important. It has to contain all
information for safe use by patients, care takers and healthcare professionals.
• The documentation has also to include information about installation, service
and maintenance, so the personnel taking care of the products can deal with
them for optimal use.
• The documentation has to include (ref 1):
– User’s (patient’s) guide in Swedish,
– Instructions for use in Swedish,
– Instructions for cleaning and care in Swedish,
– Full technical documentation in Swedish or English.
Medtech Appendix 5/7
Export, import and net export of Medtech in Sweden, bn SEK (ref 2).
Of 17 billion SEK in Medtech import, ca 3% is imported from Finland.
Medtech Appendix 6/7
The Swedish Medtech industry
• 620 Medtech companies with at least 5 employees and turnover over 1 MSEK.
In 2013, around 180 also did research and development. Additionally, there are
a lot of smaller companies (1-4 employees).
• 23 000 employees in the Swedish Medtech industry in total. (ref 2)
Medtech Appendix 7/7
The three largest export segments are medical technical instruments, in vitro
diagnostics and orthopedic implants (ref 2).

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Digital Hospitals Sweden Report

  • 1. Digital Hospitals - Sweden Market Report December 2015
  • 2. Nya Karolinska Hospital : 33 700 MSEK! ”In the future we procure healthier citizens!” About 100 open Medtech tenders right now! Digitalisation of Swedish healthcare is still ahead => A big opportunity! Health economical benefit of growing importance!
  • 3. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix By Robert Harju-Jeanty www.medicallead.se
  • 4. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix
  • 5.  Over 10 large hospital projects are ongoing in Sweden, for instance in Linköping, Helsingborg, Uppsala, Örebro, Luleå, Malmö and the biggest of them ”New Karolinska” with a record budget of 3 600 million €.  In several places acute care, traumatology and operating rooms are to be renewed. Diagnostic imaging and all ITC-support connected is another example.  The lack of doctors and increasing healthcare costs are opening for telemedicine solutions. Health economical cost effectiveness is of increasing importance.  ”Green hospitals” is a trend focused on energy saving.  Three major regions have started 3R, a hospital digitalisation project, which will be guiding for the country’s remaining 17 regions/counties.  Digitalisation of healthcare leads to patient-empowering, for instance in Uppsala the patient has the possibility to read his/her own patient records on internet.  Innovation procurement is implemented in many regions, and in the future, instead of medical inventory, the total healthcare function with final result will be bought.  Private healthcare is growing, and is an opportunity, especially in primary care and some medical specialities. This target group might have lower entry barrier, due to shorter decision processes compared to public tenders. Executive Summary
  • 6. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix
  • 7. Background and Aim Digital Hospitals Program • The Digital Hospitals export program is designed for Finnish companies working with technology that improves the quality of care. • The export program is focused on the Nordic countries, due to the massive hospital constriction and refurbishment projects ongoing and planned in the region. • The companies participating in the program can enter international markets as a larger group with the help of the program. This document • The purpose of this market study was to give an overall picture of the Swedish healthcare market, with focus on healthcare technology and the opportunities for Finnish companies operating in this sector. • The results will be used to plan further activities in the export program. • The market study was prepared by Fintra and Medical Lead.
  • 8. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix
  • 9. Public and Private Healthcare • Public healthcare is far regionalized in Sweden. 70% is financed by local taxes. • Just like in all Nordic countries, 100% of the population is covered by public healthcare. • Public healthcare covers 80% of the total healthcare costs in Sweden. (ref 9) Responsible for care Organizer Public companies Taxes Municipalities Landstingen (Regions) Organizer Hospitals Health centers Dentists Elderly care Child care Social care Public management Regions Municipalities Procurement Free choice system Private companies 3rd sector Responsible for healthcare
  • 10. Public and Private Healthcare Public Buyers • 20 counties (Swe: landsting) or regions (#21 on the map is formally a municipality). • 290 municipalities. • The Swedish state. • Sometimes the counties/regions make tenders together, for instance ”7-klövern” or ”5-klövern”. County/Region Inhabitants 11 Stockholm 2 200 000 12 Västra Götaland 1 600 000 20 Skåne 1 300 000 14 Östergötland 440 000 10 Uppsala 350 000 13 Jönköping 340 000 16 Halland 310 000 8 Örebro 290 000 6 Gävleborg 280 000 5 Dalarna 280 000 15 Sörmland 280 000 7 Värmland 270 000 2 Västerbotten 260 000 9 Västmanland 260 000 1 Norrbotten 250 000 4 Västernorrland 240 000 19 Kalmar 240 000 17 Kronoberg 190 000 18 Blekinge 150 000 3 Jämtland 130 000 21 Gotland 57 000 ”7-klövern” > 2 million inhabitants
  • 11. Counties and Regions Each region publishes their own tenders, often via their own systems. (There is no national tender site such as Hilma in Finland). Below are links to the regions’ procurement departments, with up to date information on contact persons and procurement plans. County/Region Homepage - Procurement Stockholm http://www.sll.se/om-landstinget/upphandling/ Västra Götaland http://www.vgregion.se/inkop Skåne http://www.skane.se/organisation-politik/Att-gora-affarer/upphandling/ Östergötland http://www.regionostergotland.se/Om-regionen/Att-gora-affarer-med-oss/Aktuella-upphandlingar/ Uppsala http://www.lul.se/sv/Landsting--politik/Utveckling-och-ansvar/Upphandling/ Jönköping http://www.rjl.se/Om-regionen/verksamheter/ledning-och-stodverksamheter/verksamhetsstod-och-service1/inkop/ Halland http://www.regionhalland.se/om-region-halland/organisation/aktuella-upphandlingar/ Örebro http://www.regionorebrolan.se/sv/Om-regionorebrolan/Detta-ar-landstinget/Lednings--och-verksamhetsstod/Upphandling/ 7-klövern www.7-klövern.se Gävleborg http://www.opic.com/upphandlingar/gavleborgs-lan/?gclid=CJ7-3tLErskCFebhcgod6GQNAg Dalarna http://www.ltdalarna.se/Om-landstinget/Ovrig-landstingsverksamhet/Upphandling/ Sörmland http://www.landstingetsormland.se/Utveckling-forskning/Miljo/Testsida-Miljo/Upphandling/ Värmland https://www.e-avrop.com/liv/e-Upphandling/Default.aspx Västerbotten http://www.vll.se/default.aspx?id=64535&refid=3009 Västmanland http://www.ltv.se/Om-landstinget/Ekonomi/Upphandlingsenheten/Var-verksamhet/ Norrbotten https://www.nllplus.se/For-foretag/Upphandling/ Västernorrland http://www.lvn.se/Om-landstinget/Landstingets-organisation/Landstingsservice/Upphandlingsenheten/ Kalmar http://www.ltkalmar.se/om-landstinget/detta-gor-landstinget/upphandling/ Kronoberg http://www5.ltkronoberg.se/Om- landstinget/Arbomr/Upphandling/?_t_id=1B2M2Y8AsgTpgAmY7PhCfg%3d%3d&_t_q=upphandling&_t_tags=&_t_ip=78.67.218.177&_ t_hit.id=EPiServer_Find_Framework_BestBets_ExternalUrlBestBet/TOFWGvk5TvyXpC5Cd5_bmA&_t_hit.pos=1 Blekinge http://ltblekinge.se/Om-landstinget/Upphandling-och-avtal/ Jämtland http://www.regionjh.se/omoss/upphandling.4.4dc3b946126df75d1b38000188.html Gotland http://www.gotland.se/upphandling
  • 12. Hospitals in Sweden Ranking of the 7 university hospitals: 1. Universitetssjukhuset i Linköping 2. Norrlands universitetssjukhus 3. Universitetssjukhuset Örebro 4. Akademiska sjukhuset i Uppsala 5. Skånes universitetssjukhus 6. Sahlgrenska universitetssjukhuset 7. Karolinska universitetssjukhuset Ranking of 36 middle-sized hospitals: 1. Länssjukhuset Ryhov, Jönköping 2. Vrinnevisjukhuset, Norrköping 3. Visby lasarett 4. Värnamo sjukhus 5. Blekingesjukhuset, Karlshamn 6. Örnsköldsviks sjukhus 7. Länssjukhuset i Kalmar 8. Lasarettet i Ystad 9. Sunderby sjukhus, Luleå 10. Västmanlands sjukhus, Västerås 11. Centralsjukhuset, Kristianstad 12. Södra Älvsborgs sjukhus, Borås Ranking 2014, by Dagens Medicin (ref 23) Depending on how a hospital is defined, there are around 100 hospitals in Sweden of which about 60 perform surgery.
  • 13. Public and Private Healthcare Private Buyers • In 2014, the local units, counties or regions bought ca 13% of the healthcare services from private companies. Additionally, the counties and regions buy services from other public healthcare units. (ref 10) • In Stockholm the privatization trend has gone further than in many other places, and over 30% of the healthcare belongs to private companies, but the public healthcare, Stockholms Läns Landsting, is anyhow the biggest purchaser. – The primary care of the metropolitan area of the capital of Sweden is to the majority privatized. However, primary care makes up only 17% of the whole healthcare cost for the region. • The biggest private companies are (ref 22): – Capio (13 bn SEK in turnover 2014), that for instance run • Capio St Görans sjukhus in Stockholm (1,7 bn SEK 2014). – Praktikertjänst (10 bn SEK 2014) – Attendo (Attendo Sverige AB 3,6 bn SEK 2014) – Aleris (Aleris AB 1,7 bn SEK 2014)
  • 14. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix
  • 15. Purchasing Processes Public Tenders • Public tenders (Swe: offentliga upphandlingar) follow the law ”LOU” (Swe: Lagen om offentlig upphandling, 2007:1091), corresponding to Finnish JYSE. • The aim of the law is to stimulate a better use of the society’s resources. This means the tenders have to have professional and neutral demands, in a way that the outcome (the winning offer) can not be predicted. They have to be announced in special publishing places connected to the caregiver. Note that Sweden does not have a national publishing site, such as HILMA in Finland. • The monetary thresholds follow the EU-regulations, currently 1,8 MSEK or 0,2 MEUR requires a full public tender procedure. A simplified procedure can be done with tenders of value between 1,8 and 0,5 million SEK. These public tenders have to be announced in TED, Tenders Electronic Daily, the European online version of European public procurement. Direct purchase has the threshold 505 800 SEK. Purchase below this value do not have to be announced, but there is still requirement of professional procurement processes. (ref 3, 13)
  • 16. Purchasing Processes Public Tenders • Like elsewhere in the EU, CPV-codes are used to identify the products. • Year 2014 there was a total of 856 tender ads in Sweden of the CPV-group 33, medical equipment, drugs and hygiene articles (ref 4). – Medical equipment (Swe: Medicinsk utrustning) has code: 33 10 00 00. Note that some Medtech may fall under a different code, for instance laboratory equipment belongs to CPV-group 38. – The distribution of all 94 open tenders of CPV-group 331 in Sweden, week 47, 2015 (ref 3): • Tenders below 0,5M: 17% • Tenders between 0,5M-1,8M: 26% • Tenders above 1,8M: 57% • The proportion is roughly the same throughout the year. 17 % >0,5 M 26 % 0,5-1,8 M 57 % >1,8 M
  • 17. Examples of tenders open now Year 2015, week 47, all Swedish current tenders of CPV-group 331 (ref 3) Urologiska hjälpmedel Medicinska förbrukningsartiklar Tvätteritjänster Mobila röntgensystem med digitala trådlösa detektorer Drogtester Bröstproteser X-Ray Equipment for mice Miscellaneous medical devices and products Produkter för Urinvägar, mag-tarm inkl inkontinensprodukter Desinfektionsutrustning Materielförsörjning Apparatur för röntgenbehandling Läkemedelsförsörjning Medicinska förbrukningsartiklar Invasiv tryckmätning Medicinsk utrustning, läkemedel och hygienartiklar APAP Utrustning för medicinsk bildbehandling med ultraljud och doppler Upphandling av två stycken kabinettdiskdesinfektorer Medicinsk utrustning Cellfördelare Sårbehandling special 2016 del 2, SLL572 Operationsmikroskop för mikrokirurgiska ingrepp 201-420 A och 301-420B Lustgasdestruktion Eksjö och Värnamo Upphandling av en kompakt röntgendiffraktionsspektrometer, även kallad en benchtop XRD Medicinsk utrustning Användarstöd i samband med distribution och konsumtion av taltidningar Patientövervakningssystem Smådjursklinikutrustning Bröstimplantat Röntgenapparatur Röntgenapparatur Medicinsk utrustning, läkemedel och hygienartiklar Diverse medicinktekniska produkter Medicinsk utrustning Utrustning för sterilisering, desinfektion och hygien Synhjälpmedel Medicinsk utrustning, läkemedel och hygienartiklar Medicinsk utrustning, läkemedel och hygienartiklar Medicinsk utrustning, läkemedel och hygienartiklar Extern remiss avseende personburen strålskyddsutrustning Medicinsk utrustning, läkemedel och hygienartiklar Insulinpumpar och tillbehör Medicinsk utrustning, läkemedel och hygienartiklar Medicinsk utrustning Medicinsk utrustning Oftalmologisk utrustning Stel Endoskopi/ Artroskopi 3D Medicinsk utrustning Bildsystem för ultraljudsbilder Gånghjälpmedel Endoskopiutrustning Apparatur och instrument för transfusion och infusion Patientövervakningsutrustning Utrustning och instrument för tandvård och underspecialiteter A High Content Imaging System Allergiinstrument Injektion och infusion Punkthjälpmedel och programvaror Medicinsk utrustning Lågdosrat brachyterapi: utrustning och förbrukning samt frön Kontrastinjektorer för CT regiongemensam 2015 Uppgradering MR utrustning och MRgFUS-utrustning Hjälpmedel för funktionshindrade personer Injektion/Infusion del 2 Spoldesinfektorer och diskdesinfektorer Medicinsk utrustning RFI avseende antibakteriella suturer Delar och tillbehör till hörapparater Hearing avseende material för patientnära analyser Hörapparater Utrustning för immunfärgning 2015 Delar och tillbehör till hörapparater Ventilatorer SÄS och NU-sjukvården Hörapparater DBS System Röntgenapparatur Inplanterbara läkemedelspumpar för neurologiska behandlingar Laparoskopistaplar MILOU Centralövervakningsystem med lagring för CTG Infusionsutrustning Transportventilatorer IVA 2015 Hörapparater för personer med lätt till grav hörselnedsättning Elastografiutrustning 2015 Hörapparater m.m. Utrustning för tillverkning av Technegas 2015 Hörapparater för barn inklusive tillbehör och reservdelar Operationshandskar, SLL471 Patientövervakningssystem Instrument och sjukvårdsartiklar, SLL480 Hörapparater för personer med grav till uttalad hörselnedsättning Koloskopi- och gastroskopiutrustning, Lasarettet i Enköping Medicinsk utrustning, läkemedel och hygienartiklar Kassettmärkare
  • 18. Example of an open tender http://www.offentligaupphandlingar.se/sv/konto/oversikt/
  • 19. Purchasing Processes Public Tender – National Medtech Guidelines • There are no binding national requirements for Medtech, but below is the closest to national guidelines (ref 1). – Additionally to all basic requirements (by law) that are valid for public procurement, the specifications for a medical device shall contain: • Requirement the product has a CE-mark, • Other specific requirements the user or the operation have on the product, • Product review requirement, • Requirements on specific functions, • Performance requirements, • Documentation requirements, • Requirement of reference to suitable standards, • Requirements the supplier has sufficient abilities to fulfill the contract.
  • 20. Purchasing Processes Continued, Public Tender – National Medtech Guidelines – The following questions must also be taken into account in the specifications (ref 1): • Is the product suitable for the intended use? • What desinfectants can the product withstand? • May the equipment be used with current or planned equipment? • What training for users and medtech personnel is existing or planned? • What are the resources for preventive service and acute service? • Has all concerned personnel been able to say their opinion? • Does the product fulfill all potentially relevant requirements? • What is the judgement of the supplier/s? Is there a long-term commitment? • Is the function control automatic and easy to perform?
  • 21. Purchasing Processes - Example Example: Stockholms Läns Landsting (ref 15, 18) • Purchasing of healthcare can be divided into three groups: – Vårdens varor och tjänster (consumables and drugs), Jan Mattson – Medicinteknisk utrustning (Medtech), Petra Hållander (new person Jan 2016) – Enhet för sjukvård, special cases • Almost all purchases are over >0,5 MSEK, and hence public tenders: – Analysis and specifications are done according to needs of the ”client”, many times in collaboration with suppliers: • Request for Information, RFI, is a proactive request towards suppliers to provide info of solutions that may be used for making specifications. • Hearing is a competitive dialogue with suppliers. • “Extern remiss” (Eng: external referral) is when potential suppliers may leave their opinions on a preliminary specification. – RFIs, hearings, tenders and current contracts are published on http://www.sll.se/om-landstinget/upphandling/, and bigger ones in TED.
  • 22. Purchasing Processes - Example Example: Västra Götalandsregionen (ref 6) • Purchasing of Medtech devided into two main units and 32 subareas (see picture): – Medicinsk och kirurgisk sjukvård – Indirekt material och tjänster • Process for all public tenders >0,5 MSEK: – Analysis and specifications are done in project groups with representatives from different healthcare units. – The purchasing department compiles the documents and announces the tender in TendSign (Visma) database and TED (Tenders Electronic Daily). – The supplier is chosen, signing of contract, and the result becomes public. • Also purchasing below 100 000,- SEK has to follow certain criteria: – Does the product/service fulfill the needs and specifications? – Are there alternatives, other suppliers with similar product/service?
  • 23. Purchasing Processes - Example Example: Region Skåne (ref 27) • The annual investments of Medtech + related IT is around 0,5 bn SEK. Everything is not published, because some are upgrades. • Procurement trends are ”circular business models” (involves recycling), ”innovation procurement”, and generally speaking the supplier is invited earlier into a dialogue than before. No longer will stand-alone products be bought, a partnering will lead to contracts including a whole functionality. • Region Skåne uses TendSign for announcements of public tenders. Larger investment decisions are political decisions with separate protocols, which means the information of a future project can be public long in advance. • Smaller investments below 5 MSEK can be decided by local healthcare administration, and these are done continuously. • From a Medtech point of view, the hospital project in Helsingborg will be the most extensive.
  • 24. Purchasing Processes - Example Example: Region Örebro County • The University Hospital of Örebro is constructing the so called “H-Huset” offering e.g. highly specialized otorhinolaryngology-care, ready by 2020. (ref 26) • The cost for the 27 500 m2 construction project is estimated at 1 bn SEK. • The Medtech procurement, such as surgical equipment, laser, post operative monitoring equipment and anesthesia will start in 2018/2019. • Karlskoga lasarett, also located in Örebro county is currently procuring for the reconstruction of their surgery unit. • Besides these current hospital projects the county council of Örebro purchases Medtech for 100-110 MSEK annually. Purchases exceeding 0,5 MSEK are announced in Visma Opic. • 1/3 of all purchased are < 0,5 MSEK, wherefore direct marketing of products to relevant Medtech units is advisable. • Requests and further information: mt.upphandling@regionorebrolan.se
  • 25. Purchasing Processes - Example Example: Medtech at Norrlands Läns Landsting (ref 19) • The most Northern county of Sweden makes 10-20 public tenders annually with announcements. Below the current tender frame agreements. • Additionally, NLL makes hundreds of smaller, direct purchases, some with a competitive dialogue. • Future needs: – Expansion of Sunderby Hospital, Luleå. Emergency room, Diagnostic imaging, Operating rooms. • Contact person: Niklas Ranneberg, Director Public Procurement, NLL Public Tender Frame Agreement (Ramavtal) Start End Option Dentalutrustning 2012-09-01 2016-08-31 2016-08-31 Centrifuger 2013-09-23 2016-08-31 2017-08-17 Blodtrycksmätare 2012-04-01 2015-11-30 2015-11-30 Undersökningsutrustning för mottagning 2012-01-01 2015-11-30 2015-11-30 Fysioterapiutrustning 2013-04-17 2016-04-16 2017-04-16 Endoskopiutrustning 2014-05-01 2017-02-28 2018-02-28 Infusionspumpar 2013-07-09 2016-07-09 2017-07-09 Dialysmaskiner 2011-11-02 2016-05-31 2016-05-31 Diagnostiskt ultraljud 2012-02-01 2016-01-31 2017-01-31 Digital diktering 2012-03-01 2016-02-28 2016-02-28 Infusionspumpar 2013-08-21 2016-08-21 2017-08-21 Avancerat ultraljud kardiologi 2013-04-15 2016-01-31 2017-01-31 Spoldesinfektorer 2014-01-24 2017-01-24 2018-01-24 Fysioterapiutrustning 2013-08-01 2016-04-16 2017-04-16 Defibrillatorer 2013-06-24 2016-05-31 2017-05-31 Diskdesinfektor mindre verksamhet 2014-01-31 2017-01-31 2018-01-31 Diatermiapparater 2013-10-01 2016-09-30 2017-09-30 Diskdesinfektorer 2013-11-11 2016-11-11 2017-11-11
  • 26. Example: Stockholms Läns Landsting – Innovation Procurement • Total county healthcare budget 2016: 54 bn SEK • During next 10 years, extra 42 bn SEK invested to meet higher demands from growing population. • Innovation procurement New Karolinska + Philips, concerning medical imaging: value 1,9 bn SEK. – Process start 2011, Master Calibration Agreement in 2014. – Agreement signed for 14 + 6 years. Purchasing Processes - Example
  • 27. Purchasing Processes - Example Example of a private hospital, S:t Görans Sjukhus, Stockholm (ref 18): • Capio S:t Görans is the only privately owned emergency hospital in Sweden. – 77 000 yearly visits at the ECU (2012) – 31 medical specialities • Total procurement 3-400 MSEK / year. • Hospital makes proactive procurement, and no announcements. Independent processes from other parts of Capio. • Established suppliers at SLL (Stockholm County Council) are also used at S:t Görans, and the hospital has the right to join in public tenders at SLL. • Needs within 1-2 years: operating rooms, ultrasound, and automatic check-in systems. • Contact person: Purchasing Director Henrik Andersson, tel +46 8 587 01 000.
  • 28. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix
  • 29. Market Access in Sweden The export of medical technology to Sweden is easy from a regulatory point-of- view from another country belonging to the EU, such as Finland. • The CE mark is valid within the whole EU, and therefore the formal requirements are automatically fulfilled. The majority of Medtech in hospitals is covered by department budgets. • The Dental and Pharmaceutical Benefits Agency, TLV (Swe: Tandvårds- och läkemedelsförmånsverket), is a central government agency whose remit is to determine whether a pharmaceutical product or dental care procedure shall be subsidized by the state. 30% of the healthcare in Sweden is paid by the state. • TLV has been commissioned by the Swedish Government to conduct health technology assessments of medical devices. The aim is to produce assessments that can support the organizations responsible for healthcare in deciding whether to introduce new methods and in procurement processes. • Therefore, certain Medtech products, such as dental care and ostomy-pouches that are given to patients against prescription, are approved by TLV in a separate process where health economical aspects are crucial. (ref 14)
  • 30. Market Players in Sweden Entering the market can be considerably more efficient with the right partner. • Many international healthcare companies have their Nordic headoffice in Sweden, such as Novartis, Bayer Healthcare, Philips Healthcare and Alere. • Sweden is also the home of some major global players like Getinge, Elekta, Astra Zeneca and Thermo Fisher Scientific Phadia. • The big logistic companies and wholesalers within healthcare, such as Tamro, OneMed and Mediq, can also influence the success of their partners. • Consider partnering with smaller and mid-sized distributors within your specific area, for instance Trio Lab, ACC Nordic, Mediplast, Instrumenta and Stille. • Trade associations may contribute with support in business and partnering. – Swedish Medtech is the Association for Medical Technology in Sweden, with 170 member companies, representing ca 90 % of the national turnover. – Sweden Bio has about 200 Life Science companies as members. – Swedish Labtech is mostly focused on diagnostics and analysis. – LIF is the trade association for the research-based pharmaceutical industry.
  • 31. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix
  • 32. Business Challenges in Sweden  Understand the process • “Samat haasteet kuin suomalaisessakin julkisessa sektorissa: hankintalain puitteissa on toimittava ja julkiset hankinnat ovat hitaita etenemään.” • “…päätöksenteon aikajänne, hankintojen "perinteisyys" tai vanhat ratkaisut…”  Understand the business culture • “Ruotsissa ei tehdä päätöksiä, ns, keskusteleva kulttuuri.” • “Kumppani oltava ruotsalainen, jolloin kulttuurillisesti tulee tilanne, jossa kaupalliset asiat hoituvat huomattavasti nopeammin.” • “Ruotsissa on vahva kotimarkkina sairaalasektorilla ja totuttu käyttämään kotimaisia toimijoita.” (ref 5)
  • 33. Business Challenges in Sweden  Have the right contacts or partner • ”Osaavien tahojen löytäminen paikallisella tasolla on kuitenkin haasteellista.” • “Oikean kumppanin löytäminen.”  Choose strategy • “Kokemuksemme mukaan suunnitteluryhmät ja projektinjohtourakoitsijat voivat saada merkittävää kilpailuetua jo tarjousvaiheessa käyttämällä prosessi- ja logistiikkasiantuntijoita.” • “Kypsä markkina. Suomen toimijalle ei ole tilaa.” (ref 5)
  • 34. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix
  • 35. Future Opportunities Stockholms Läns Landsting (ref 15, 16) • Nya Karolinska Hospital is one of the biggest hospital projects in Europe, with a total investment of 33,7 bn SEK 2015–2019. 730 new hospital beds, 36 operating rooms and 2 helipads are built. • Many of the procurement processes are already done, but concerning medical devices there are still a lot to be purchased (ref 15). • In specialized care the hospital itself has needs in cancer and cardiac care, acute trauma and childrens’ healthcare. • Additionally, SLL will before 2020 renew all operating rooms and intensive care units at Huddinge, Danderyd and Södertälje hospitals (ref 15).
  • 36. Future Opportunities Stockholm, Göteborg and Skåne in collaboration (ref 8) • Program 3R Framtidens vårdinformationsmiljö (3R Fvm) is going on until 2019 and should lead to: – Increased safety in patient care, i.e. a common medical record system, – Improved conditions for development of healthcare processes, – Possibilities for patient involvement in his/her own care, – Possibilities for more effective working procedures. • ”FVM is by far the most comprehensive project right now. It includes a complete renewal of the hospital ICT-system, and one part of it will involve all medical devices connected to it.” Carin Sjösten Nilsson, Västra Götalandsregionen (ref 9) The Swedish Digital Hospital!
  • 37. Future Opportunities Gävleborg, Västmanland, Norrbotten and Västerbotten: • Today Sweden has about 4800 specialized doctors in primary care, and this is 1400 too few from the goal of 1500 inhabitants/doctor (ref 11). This means all methods that can improve the efficiency of the primary care physicians could potentially have a high demand in those geographical areas with biggest need of doctors. Stockholm area has the smallest need. • Telemedicine and digital health solutions to decrease patient time per doctor will have important market opportunities is some regions. – In Norrbotten (northernmost Sweden) is a project involving electronic stetoscopes and video conference (ref 19).
  • 38. Future Opportunities Region Östergötland and Linköping’s University Hospital (ref 21): • The biggest project in the region is ”Framtidens Universitetssjukhus” in Linköping (4 bn SEK). See picture right. The more important parts are: – Urgent and intensive care, – Diagnostic imaging, – Clinical chemistry. – It has come far already, but some Medtech will still be purchased. – Procurement uses often RFI’s and these and the tenders are published in Visma TendSign. E-mail: upphandling@regionostergotland.se • Another hospital project in the region is ”Vision 2020 – Framtidens Vrinnevisjukhus” in Norrköping. Among other things, energy-saving solutions are in focus, for instance in ventilation and Medtech.
  • 39. Future Opportunities Landstinget i Uppland and Uppsala University Hospital: • The biggest project in the county is ”Framtidens Akademiska Sjukhus” in Uppsala (6,2 bn SEK). The project is ongoing and will be ready in 2022. • In Medtech there will be need for operating room equipment, infusion pumps and diagnostic imaging. • Tenders are published in Visma TendSign. Tel: +46 18 611 0000.
  • 40. Other Hospital Projects Of those not mentioned before, other hospital projects ongoing or prospected in Sweden: • Helsingborg wants to create the most modern acute hospital in Sweden with a total budget of 4,8 bn SEK. The project time is 2013-2023. See picture to the right. (ref 25, 27) • Skåne University Hospital in Malmö will invest over 6 bn SEK in renewals and expansion. In the first phase, in 2016, new buildings for internal medicine, endocrinology, surgery, opthalmology, and respiratory medicine. (ref 25) • Skåne University Hospital in Lund will renew laboratory medicine. (ref 25) • The University Hospital in Umeå is constructing a new psychiatric unit, “Psykiatrisjukhuset” in Umeå. Construction costs of the project is estimated at 600 MSEK and to be finalised earliest in 2018/2019.
  • 41. Hospital Projects Sunderby Sjukhus Framtidens Akademiska Sjukhus Södertälje Sjukhus Huddinge Sjukhus Nya Karolinska Sjukhuset Framtidens Vrinnevisjukhus Framtidens Universitetssjukhus Psykiatrisjukhuset Danderyds Sjukhus H-huset, Örebro Helsingborg Malmö
  • 42. Future Opportunities Future trend in healthcare procurement (ref 20): • “Healthcare is costing too much. The society can’t accept higher costs in comparision to other expenses. We have reached the roof with current 10-15 % of GNP.” • ”Nya Karolinska has procured function, this means we have a long-term commitment (decades) and our partners are resposnibel for the function. However, for example, this doesn’t mean that all MR-equipment will come from Philips, even though they have the contract.” • ”We buy a result, just like Rolls Royce gets paid by flying hour of their motors.” • ”In the future we procure healthier citizens!” Stefan Vlachos Head of Strategic Innovation Karolinska Universitetssjukhuset
  • 43. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix
  • 44. Market Entry Recommendations What business model will work for you? Some tips: • Analyse your market. Look at old public tender results. Find out when the next are coming. Contact procurement managers on your prime market and be proactive to find out how your product and/or service fit the clinical needs. – Who are the competitors? – What are the entry barriers? – Are there important subtitutes? – Is your product reimbursed in Sweden? • Decide about your market access strategy. Use a consultant to help out with partnering. Choose a distributor/partner or decide to open up your own office. Local presence always makes business easier. A big partner, such as an international company with Nordic headquarters in Sweden, or one of the big healthcare logisitics companies may leverage the business in a substantial way. Michael Porter: The Five Forces
  • 45. Market Entry Recommendations What business model will work for you? Some tips: • Consider influencing local opinion leaders. If you have a disruptive technology, this might be the best way to introduce it to the healthcare system. Remember Henry Ford’s quote: ”If I had asked people what they wanted, they would have said faster horses.” Create your own market! Influence in hearings and RTIs! • Following Swedish public tenders is more demanding than in Finland, because there is no national database like HILMA. Consider buying tender surveillance*. Note that procurement below 57 000 € do do not have to be publicly available. • Sweden is the home of consensus. The hierarchy is flatter than elsewhere and all coworkers may influence a decision. Therefore, it may be important to remember to have presentations and way of influencing all layers in an organisation. Remember that tender documents are in Swedish, and even though most Swedes understand and speak English, communication in Swedish will make business processes smoother. *commercial service providers include Visma and Offentligaupphandlingar
  • 46. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix
  • 47. Contact Persons Eero Toivainen Growth Program Director Finpro eero.toivainen@finpro.fi +358 40 343 3357 Finpro www.finpro.fi Robert Harju-Jeanty CEO Medical Lead robert@medicallead.se +46 702 662 999 Leena Pesu Senior Consultant Fintra leena.pesu@fintra.fi +358 45 105 7950 Finnish Trade Organisation Fintra Oy Tammasaarenkatu 5 00180 Helsinki www.fintra.fi
  • 48. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix
  • 49. References 1. Vårdhandboken, 2015. www.vardhandboken.se/Texter/Medicintekniska-produkter/Upphandling/ 2. Swedish Medtech, October 2015. 3. Christian Riddarlo, Offentliga Upphandlingar AB, 20151116. 4. Konkurrensverket & Upphandlingsmyndigheten, Rapport 2015:9. 5. Questionnaire to participating companies in Digital Hospitals, 2015. 6. Ingemar Sesevic, Västra Götalandsregionen, 20151119. 7. Statistiska centralbyrån, 2014. 8. http://3rfvm.se/ 9. Carin Sjösten Nilsson, Västra Götalandsregionen, 20151119. 10. Ekonomifakta, 2014. www.ekonomifakta.se/sv/Fakta/Valfarden-i-privat-regi/Vard-och-omsorg-i-privat-regi/. 11. Läkartidningen, 2013. www.lakartidningen.se/Functions/OldArticleView.aspx?articled=19378. 12. Patrik Puhony, Karolinska Hospital, 20151117. 13. www.upphandlingsmyndiheten.se 14. www.tlv.se/In-English/in-english/ 15. Gunnar Goblirsch, Stockholms Läns Landsting, Upphandlingsenheten, 20151124. 16. www.sll.se/verksamhet/halsa-och-vard/framtidsplanen/ 17. www.sll.se/om-landstinget/upphandling/ 18. Henrik Andersson, Inköpschef, Capio S:t Görans Sjukhus, 20151125. 19. Göran Eriksson, Medicinteknisk strateg, Norrlands landsting, 20151125. 20. Stefan Vlachos, Head of Innovation, Nya Karolinska Hospital, 20151120. 21. Örjan Lehnberg, Gruppchef, Upphandlingscentrum, Region Östergötland, 20151125. 22. www.allabolag.se 23. http://www.dagensmedicin.se/artiklar/2015/01/14/har-ar-hela-listan-over-basta-sjukhusen1/ 24. Patrik Lindmark, Project Leader, Framtidens Akademiska Sjukhus, LUL, 20151126 25. http://www.skane.se/framtid-och-utveckling/framtidens-sjukhus/ 26. http://www.regionorebrolan.se/h-huset 27. Charlott Wictor, Strategisk inköpare, Enheten för läkemedel och medicinsk teknik, Region Skåne, 20151207
  • 50. Digital Hospitals - Sweden Contents 1. Executive Summary 2. Background and Aim 3. Public and Private Healthcare 4. Purchasing Processes with Examples 5. Market Access 6. Business Challenges 7. Future Opportunities 8. Market Entry Recommendations 9. Contact Persons 10. References 11. Medtech Appendix
  • 51. Medtech Appendix 1/7 • Medical Devices or Medtech is regulated in the EU Directive 2007/47/EC, and in Sweden it is harmonized with the Swedish law SFS 1993:584: “Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: – diagnosis, prevention, monitoring, treatment or alleviation of disease, – diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, – investigation, replacement, or modification of the anatomy or of a physiological process, – control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.”
  • 52. Medtech Appendix 2/7 Medtech = A human healthcare product that is not a medicine or a vaccine.
  • 53. Medtech Appendix 3/7 • Medtech products can therefore be a wide variety of products, ranging from simple single-use products, such as band aid, to complex active implantable devices, such as pacemakers. From April 2010, also information technology products and programs dealing with patient data are included (ref 1). • If the product’s principal intended action is in or on the human body by pharmacological, immunological, or metabolic means, the use is defined in other laws and by other regulations.
  • 54. Medtech Appendix 4/7 • The documentation of medtech products is very important. It has to contain all information for safe use by patients, care takers and healthcare professionals. • The documentation has also to include information about installation, service and maintenance, so the personnel taking care of the products can deal with them for optimal use. • The documentation has to include (ref 1): – User’s (patient’s) guide in Swedish, – Instructions for use in Swedish, – Instructions for cleaning and care in Swedish, – Full technical documentation in Swedish or English.
  • 55. Medtech Appendix 5/7 Export, import and net export of Medtech in Sweden, bn SEK (ref 2). Of 17 billion SEK in Medtech import, ca 3% is imported from Finland.
  • 56. Medtech Appendix 6/7 The Swedish Medtech industry • 620 Medtech companies with at least 5 employees and turnover over 1 MSEK. In 2013, around 180 also did research and development. Additionally, there are a lot of smaller companies (1-4 employees). • 23 000 employees in the Swedish Medtech industry in total. (ref 2)
  • 57. Medtech Appendix 7/7 The three largest export segments are medical technical instruments, in vitro diagnostics and orthopedic implants (ref 2).