Digital hospitals market report sweden_20151215

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!


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 AppendixBy Robert Harju-Jeanty

www.medicallead.se


Contents





5. Market Access




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


Contents





5. Market Access




9. Contact Persons

10. References


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.


Contents





5. Market Access




9. Contact Persons

10. References


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

MunicipalitiesLandstingen

(Regions)

Organizer

HospitalsHealth centers

Dentists

Elderly care

Child care

Social care

Public management

Regions Municipalities

ProcurementFree choice system

Private companies

3rd sector

Responsible for 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 Inhabitants11 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 RegionsEach 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 - ProcurementStockholm 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/

Kronoberghttp://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

http://www.sll.se/om-landstinget/upphandling/

http://www.vgregion.se/inkop

http://www.skane.se/organisation-politik/Att-gora-affarer/upphandling/

http://www.regionostergotland.se/Om-regionen/Att-gora-affarer-med-oss/Aktuella-upphandlingar/

http://www.lul.se/sv/Landsting--politik/Utveckling-och-ansvar/Upphandling/

http://www.rjl.se/Om-regionen/verksamheter/ledning-och-stodverksamheter/verksamhetsstod-och-service1/inkop/

http://www.regionhalland.se/om-region-halland/organisation/aktuella-upphandlingar/

http://www.regionorebrolan.se/sv/Om-regionorebrolan/Detta-ar-landstinget/Lednings--och-verksamhetsstod/Upphandling/

http://www.7-klövern.se/

http://www.opic.com/upphandlingar/gavleborgs-lan/?gclid=CJ7-3tLErskCFebhcgod6GQNAg

http://www.ltdalarna.se/Om-landstinget/Ovrig-landstingsverksamhet/Upphandling/

http://www.landstingetsormland.se/Utveckling-forskning/Miljo/Testsida-Miljo/Upphandling/

https://www.e-avrop.com/liv/e-Upphandling/Default.aspx

http://www.vll.se/default.aspx?id=64535&refid=3009

http://www.ltv.se/Om-landstinget/Ekonomi/Upphandlingsenheten/Var-verksamhet/

https://www.nllplus.se/For-foretag/Upphandling/

http://www.lvn.se/Om-landstinget/Landstingets-organisation/Landstingsservice/Upphandlingsenheten/

http://www.ltkalmar.se/om-landstinget/detta-gor-landstinget/upphandling/

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

http://ltblekinge.se/Om-landstinget/Upphandling-och-avtal/

http://www.regionjh.se/omoss/upphandling.4.4dc3b946126df75d1b38000188.html

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 whichabout 60 perform surgery.


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)

https://www.google.se/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjN9r2k4K7JAhXE3SwKHbVqC6gQjRwIBw&url=https://twitter.com/schlossklinik&psig=AFQjCNF6TSmf-NGMeKlsscoT5aApQpQPGQ&ust=1448650095006152

https://www.google.se/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjN9r2k4K7JAhXE3SwKHbVqC6gQjRwIBw&url=https://twitter.com/schlossklinik&psig=AFQjCNF6TSmf-NGMeKlsscoT5aApQpQPGQ&ust=1448650095006152


Contents





5. Market Access




9. Contact Persons

10. References


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)


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 thesame 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/

http://www.offentligaupphandlingar.se/sv/konto/oversikt/


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.


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”, manytimes 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 mayleave 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.


Example: Västra Götalandsregionen (ref 6)

• Purchasing of Medtech devided into twomain 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 fromdifferent 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?


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 earlierinto 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. Largerinvestment decisions are political decisions with separate protocols, whichmeans the information of a future project can be public long in advance.

• Smaller investments below 5 MSEK can be decided by local healthcareadministration, and these are done continuously.

• From a Medtech point of view, the hospital project in Helsingborg will be themost extensive.


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: [email protected]


Example: Medtech at Norrlands Läns Landsting (ref 19)

• The most Northern county of Sweden makes 10-20 public tenders annually withannouncements. Below the current tender frame agreements.

• Additionally, NLL makeshundreds of smaller, direct purchases, somewith a competitive dialogue.

• Future needs:

– Expansion of SunderbyHospital, Luleå.Emergency room,Diagnostic imaging,Operating rooms.

• Contact person:Niklas Ranneberg, DirectorPublic 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 investedto meet higher demandsfrom growing population.

• Innovation procurementNew Karolinska + Philips,concerning medicalimaging: value 1,9 bn SEK.

– Process start 2011, Master CalibrationAgreement in 2014.

– Agreement signed for14 + 6 years.



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. Independentprocesses from other parts of Capio.

• Established suppliers at SLL (StockholmCounty Council) are also used at S:t Görans, and the hospital has the right to joinin 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.


Contents





5. Market Access




9. Contact Persons

10. References


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- ochläkemedelsförmånsverket), 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-pouchesthat 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 specificarea, 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.


Contents





5. Market Access




9. Contact Persons

10. References


Business Challenges in Sweden

Understand the process

• “Samat haasteet kuin suomalaisessakin julkisessa sektorissa: hankintalainpuitteissa 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, jossakaupalliset asiat hoituvat huomattavasti nopeammin.”

• “Ruotsissa on vahva kotimarkkina sairaalasektorilla ja totuttu käyttämäänkotimaisia 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 voivatsaada merkittävää kilpailuetua jo tarjousvaiheessa käyttämällä prosessi- ja logistiikkasiantuntijoita.”

• “Kypsä markkina. Suomen toimijalle ei ole tilaa.”

(ref 5)


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10. References


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 medicaldevices there are still a lot to be purchased (ref 15).

• In specialized care the hospital itself has needs in cancer and cardiac care, acutetrauma and childrens’ healthcare.

• Additionally, SLL will before 2020 renew all operating rooms and intensive careunits at Huddinge, Danderyd and Södertälje hospitals (ref 15).


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 completerenewal of the hospital ICT-system, and one part of it will involve all medicaldevices connected to it.” Carin Sjösten Nilsson, Västra Götalandsregionen (ref 9)

The Swedish Digital Hospital!


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 haveimportant market opportunities is some regions.

– In Norrbotten (northernmost Sweden) is a project involving electronic stetoscopes andvideo conference (ref 19).


Region Östergötland and Linköping’sUniversity 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: [email protected]

• 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.


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 hospitalprojects ongoing or prospected in Sweden:

• Helsingborg wants to create the most modernacute hospital in Sweden with a total budgetof 4,8 bn SEK. The project time is 2013-2023.See picture to the right. (ref 25, 27)

• Skåne University Hospital in Malmö will investover 6 bn SEK in renewals and expansion.In the first phase, in 2016, new buildings forinternal 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 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 VlachosHead of Strategic Innovation

Karolinska Universitetssjukhuset


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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 nextare 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 toopen up your own office. Local presence always makes business easier. A big partner,such as an international company with Nordicheadquarters in Sweden, or one of the big healthcarelogisitics 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. RememberHenry 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, becausethere 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 thanelsewhere and all coworkers may influence a decision. Therefore,it may be important to remember to have presentations andway of influencing all layers in an organisation. Remember thattender documents are in Swedish, and even though most Swedesunderstand and speak English, communication in Swedish willmake business processes smoother.

*commercial service providers include Visma and Offentligaupphandlingar

http://www.opic.com/

http://www.offentligaupphandlingar.se/


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Contact Persons

Eero ToivainenGrowth Program [email protected]+358 40 343 3357

Finpro

www.finpro.fi

Robert Harju-JeantyCEO

Medical [email protected]

+46 702 662 999

Leena PesuSenior Consultant

[email protected]

+358 45 105 7950

Finnish Trade Organisation Fintra OyTammasaarenkatu 5

00180 Helsinkiwww.fintra.fi


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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-huset27. Charlott Wictor, Strategisk inköpare, Enheten för läkemedel och medicinsk teknik, Region Skåne, 20151207


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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=

A human healthcare productthat is not a medicine or a vaccine.


• 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.


• 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.


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.


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)


The three largest export segments are medical technical instruments, in vitrodiagnostics and orthopedic implants (ref 2).

Health & Medicine

Digital hospitals market report sweden_20151215