Presentation Title to go Here
HeartSine Technologies COMPETITIVE LANDSCAPE ®
AVAILABLE SHOCK BOXES IN EU/ROW
MANUFACTURERS – BRANDS
• • • • • • • • • • • •
• • • •
D D D CH I I I NL TUR NL NL ES
USA USA USA USA
– USA Primedic Spacelabs – Weinmann (Meducore) – Corpuls (C1) – Schiller (Fred) - Progetti (Rescue Sam) - A.M.I (Saver One) - Tecno Gaz (Tecnoheart) - Cardiotech B.V (CardiAid) - Metsis - USA Philips (HSFR series, FRX) - CH Telefunken (Lifeline HR1) - Bexen Cardio („Osatu“)
-
Medtronic/Physio Control (LP Express) US Defib Welch Allyn (AED10) ZOLL – Japan GE (Responder AED) stopped
• • • • • • • • • •
KOR KOR KOR IND IND J J J CN CN
-
CU Medical (I-PAD) (MePAD-OEM) Nanoomtech Mediana Cardiac Science (G Series) LifePLus ZOLL (AED plus series) Nihon Kohden (AED 2100) USA Defibtech (Nihon Kohden) Mindray (Bene Heart) M&B (AED 7000)
• •
BRA BRA
- Instramed (CardioMax) - Cmoss Drake (Life 400)
AED MANUFACTURERS FDA/CE APPROVED ZOLL
Philips PhysioControl
Cardiac Science
Defibtech/ Nihon Koden
Schiller
Welch Allyn/ Zoll
HeartSine
NEW FDA REQUIREMENT SINCE 2015
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431907.htm
FDA vs CE Step 1 Using the FDA classification database, determine the classification of your device by researching “Predicate Devices” already registered in the US market. Pay special attention to the three letter Product Code and seven digit Regulation Number associated with the predicate devices you identify. If no predicate found, use 513(g) or De Novo process. US FDA device classification is made up of Class I, Class II and Class III.
Step 2 Implement Quality Management System (QMS) which meets the FDA Quality System Regulation (QSR) found in 21 CFR Part 820. This is also commonly known as FDA Good Manufacturing Practice (GMP). Step 3 Innovative Class II, and all Class III, devices will likely require clinical studies. Get “Pre-Submission (Pre-Sub)” feedback from the FDA. Step 4 If clinical studies will be required, apply for an Investigational Device Exemption (IDE). Develop clinical trial protocol and conduct studies. * Step 5 For Class II devices, prepare and submit 510(k) Premarket Notification application. Pay 510(k) or PMA submission fee. For Class III devices, prepare* and submit Premarket Approval (PMA) application. Pay PMA submission fee to FDA. Step 6 For Class III, FDA conducts facility inspections of all major suppliers involved in the design and production of your device. All parties must be compliant with FDA QSR. Step 7 For Class III devices, FDA conducts facility inspections of all major suppliers involved in the design and production of your device. All parties must be compliant with FDA QSR.. Step 8 For Class II devices, the FDA issues 510(k) clearance letter and posts it online. For Class III devices, the FDA issues PMA approval letter and posts it online. Step 9 At this time, you must be in full compliance with QSRs. The FDA will not inspect Class I or II device manufacturers for compliance prior to device registration but does conduct random inspections and can issue a Form 483 for non-compliance.. Step 10 If you have no local presence in the US, appoint an FDA US Agent representative as a local point of contact with the FDA.. Step 11 List your device and register your company using FURLS system on the FDA website in accordance with 21 CFR Part 807; contract manufacturers and sterilizers must also register and list. Specify your appointed US Agent. Your FDA Establishment Registration and Listing must be renewed on a yearly basis. Step 12 You are now able to sell your device in the US. The FDA listing on their website will serve as your authorization to commercialize your device in the US. This authorization does not expire as long as certain types of changes are not made, e.g., design, intended use..
FDA vs “CE” APPROVAL Rules underlying CE marking Responsibility for CE marking lies with whoever puts the product on the market in the EU, i.e. an EU-based manufacturer, the importer or distributor of a product made outside the EU, or an EU-based office of a non-EU manufacturer. The manufacturer of a product affixes the CE marking to it but has to take certain obligatory steps before the product can bear CE marking. The manufacturer must carry out a conformity assessment, set up a technical file and sign a Declaration stipulated by the leading legislation for the product. The documentation has to be made available to authorities on request. If importers or distributors market the products under their own name, they take over the manufacturer's responsibilities. In this case they must have sufficient information on the design and production of the product, as they will be assuming the legal responsibility when they affix the CE marking. There are certain rules underlying the procedure to affix the marking: Products subject to certain EU directives or EU regulations providing for CE marking have to be affixed with the CE marking before they can be placed on the market. Manufacturers have to check, on their sole responsibility, which EU legislation they need to apply for their products. The product may be placed on the market only if it complies with the provisions of all applicable directives and regulations and if the conformity assessment procedure has been carried out accordingly.
The manufacturer draws up an EC (or EU) declaration of conformity or a Declaration of performance (for Construction Products) and affixes the CE marking on the product. If stipulated in the directive(s) or regulation(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure or in setting up a production quality system. If the CE marking is affixed on a product, it can bear additional markings only if they are of different significance, do not overlap with the CE marking and are not confusing and do not impair the legibility and visibility of the CE marking. Since achieving compliance can be very complex, CE-marking conformity assessment, provided by a Notified Body, is of great importance throughout the entire CE-marking process, from Design Verification, and set up of Technical File to the EC Declaration of Conformity. [6] Self-certification Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who decides whether the product meets all the CE marking requirements. If a product has minimal risk, it can be self-certified by a manufacturer making a Declaration of Conformity and affixing the CE marking to their own product. In order to self-certify, the Manufacturer must do several things: 1. Decide whether the product needs to have a CE marking and if the product applies to more than one directive it needs to comply with all of them. 2. Choose the conformity assessment procedure from the modules called out by the directive for the product. There are several modules available for the Conformity Assessment Procedures as listed below: Module A – Internal production control. Module B – EC type-examination. Module C – Conformity to type. Module D – Production quality assurance. Module E – Product quality assurance. Module F – Product verification. Module G – Unit verification. Module H – Full quality assurance.
OTHER WORLDWIDE APPROVALS
FDA
Northern America
CE
EU
CFDA
Chinese FDA
KFDA
Korean FDA
UL
Canada
TGA
Australia
ANVISA
Brazil
PMDA
Japan
HeartSine‘s “SHOCK BOX“ USPs
10
0,9 kg
Combined battery AND electrode cartridge
1,1 kg
1 – shelf life, 1 – disposable 1 – price, 1 – test date
longest guarantee lowest cost of ownership
IP56 Highest IP Rate
LINK to IP Rate Chart http://www.dsmt.com/resources/ip-rating-chart
Competition vs WEIGHT
Schiller Easy Port 0,35 kg > 2.000 EUR
SAM 300/500 Series 1.1 kg < 1.300 EUR
Competition vs ELECTRODE LIFETIME > 2 YEARS
4 years 5 years
5 years
Competition vs GUARANTEE > 7 YEARS
7 years standard 10 if required 7 years standard 10 if required
SAM Series 10 years
Competition vs IP56 RATE
SAM Series IP 56
HeartSine‘s SHOCK BOX USP‘S
USE USPs!
Decreased weight provides increased savings for
aircraft use!
0,9 kg
o
1.1lb of weight equals an average of 20.9 gallons of fuel savings per year per aircraft.
o
100 aircraft X 20.9 gallons= 2,090 gallons of fuel.
o Jet-A @ $4.69/ gal x 2,090 = $9,802.10 in fuel savings alone.
1,1 kg
USE USPs!
Combination of electrodes and battery with ONE shelf life for: o
Lowest service and maintenance costs
o
Always new and fresh battery after use
o Lowest costs for batteries and electrodes
Combined battery AND electrode cartridge 1 – shelf life, 1 – disposable 1 – price, 1 – test date
Example:
140 EUR for PAD PAK cartridge shelf life 4 years 140/4 = 35 EUR/year
35/12 =
2,92 EUR/month
USE USPs!
10 year guarantee =
10
o
10 year usability
o
10 years of updates
o
10 year safety
Example:
1.200 EUR for SAM 300 series with 10 years guarantee 1200/10 = 120 EUR/year
longest guarantee lowest cost of ownership
120/12 = Example:
10 EUR/month
1.000 EUR for HeartStart HS1 with 8 year guarantee 1000/8 =
125/12 =
125 EUR/year
10,41 EUR/month
USE USPs!
IP56 is ONE factor for 10 year guarantee
IP56 Highest IP Rate
o
Use in “all“ environments
o
Use under difficult conditions
o
UNIQUE feature!
COMPARE “APPLES to APPLES“!!
Brand
Type
IP Rate
ASP
Guarantee
Costs per Electrode year shelf life
Battery shelf life
Electrode costs
Total costs during the guarantee
Battery costs
Philips
HS1
21
1099
8
137.38
2
65
x
3
=
195
4
169 x
1
=
169
1463
Telefunken
AED HR1
55
995
6
165.83
3
65
x
1
=
65
3
55
x
1
=
55
1115
CU Medical
IPad SP1
55
980
5
196.00
2
49.30
x
2
=
98.60
4
236 x
1
=
236
1314.60
Medtrax
Heartsafe One
55
1550
2
775.00
3
39
x
0
=
0
3
Battery and Electorde Package
1550
Zoll
AED Plus
55
1749
7
249.86
5
49
x
1
=
49
5
64
x
1
=
64
1862
METSIS
Lifepoint Pro
54
799
5
159.80
2.5
69
x
1
=
69
5
139 x
0
=
0
868
Defibtech
Lifeline AED
54
1295
8
161.88
2
43
x
3
=
129
7
255 x
1
=
255
1679
Cardiac Science
G5
54
1500
7
214.29
2
55
x
3
=
165
4
270 x
1
=
270
1935
44
1150
8
143.75
2.5
85
x
3
=
255
2.5
Battery and Electorde Package
1405
56
945
10
94.50
4
95
x
2
=
190
4
Pad-Pak
1135
PhysioControl Lifepak CR Plus HeartSine
SAM 350P SAM 360P
Data available as of 13 May 2015
AVAILABLE SHOCK BOXES IN EU/ROW
MANUFACTURERS – BRANDS
• • • • • • • • • • • •
• • • •
D D D CH I I I NL TUR NL NL ES
USA USA USA USA
– USA Primedic Spacelabs – Weinmann (Meducore) – Corpuls (C1) – Schiller (Fred) - Progetti (Rescue Sam) - A.M.I (Saver One) - Tecno Gaz (Tecnoheart) - Cardiotech B.V (CardiAid) - Metsis - USA Philips (HSFR series, FRX) - CH Telefunken (Lifeline HR1) - Bexen Cardio („Osatu“)
-
Medtronic/Physio Control (LP Express) US Defib Welch Allyn (AED10) ZOLL – Japan GE (Responder AED) stopped
• • • • • • • • • •
KOR KOR KOR IND IND J J J CN CN
-
CU Medical (I-PAD) (MePAD-OEM) Nanoomtech Mediana Cardiac Science (G Series) LifePLus ZOLL (AED plus series) Nihon Kohden (AED 2100) USA Defibtech (Nihon Kohden) Mindray (Bene Heart) M&B (AED 7000)
• •
BRA BRA
- Instramed (CardioMax) - Cmoss Drake (Life 400)
AED MANUFACTURERS FDA/CE APPROVED ZOLL
Philips PhysioControl
Cardiac Science
Defibtech/ Nihon Koden
Schiller
Welch Allyn/ Zoll
HeartSine
NEW FDA REQUIREMENT SINCE 2015
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431907.htm
FDA vs CE Step 1 Using the FDA classification database, determine the classification of your device by researching “Predicate Devices” already registered in the US market. Pay special attention to the three letter Product Code and seven digit Regulation Number associated with the predicate devices you identify. If no predicate found, use 513(g) or De Novo process. US FDA device classification is made up of Class I, Class II and Class III.
Step 2 Implement Quality Management System (QMS) which meets the FDA Quality System Regulation (QSR) found in 21 CFR Part 820. This is also commonly known as FDA Good Manufacturing Practice (GMP). Step 3 Innovative Class II, and all Class III, devices will likely require clinical studies. Get “Pre-Submission (Pre-Sub)” feedback from the FDA. Step 4 If clinical studies will be required, apply for an Investigational Device Exemption (IDE). Develop clinical trial protocol and conduct studies. * Step 5 For Class II devices, prepare and submit 510(k) Premarket Notification application. Pay 510(k) or PMA submission fee. For Class III devices, prepare* and submit Premarket Approval (PMA) application. Pay PMA submission fee to FDA. Step 6 For Class III, FDA conducts facility inspections of all major suppliers involved in the design and production of your device. All parties must be compliant with FDA QSR. Step 7 For Class III devices, FDA conducts facility inspections of all major suppliers involved in the design and production of your device. All parties must be compliant with FDA QSR.. Step 8 For Class II devices, the FDA issues 510(k) clearance letter and posts it online. For Class III devices, the FDA issues PMA approval letter and posts it online. Step 9 At this time, you must be in full compliance with QSRs. The FDA will not inspect Class I or II device manufacturers for compliance prior to device registration but does conduct random inspections and can issue a Form 483 for non-compliance.. Step 10 If you have no local presence in the US, appoint an FDA US Agent representative as a local point of contact with the FDA.. Step 11 List your device and register your company using FURLS system on the FDA website in accordance with 21 CFR Part 807; contract manufacturers and sterilizers must also register and list. Specify your appointed US Agent. Your FDA Establishment Registration and Listing must be renewed on a yearly basis. Step 12 You are now able to sell your device in the US. The FDA listing on their website will serve as your authorization to commercialize your device in the US. This authorization does not expire as long as certain types of changes are not made, e.g., design, intended use..
FDA vs “CE” APPROVAL Rules underlying CE marking Responsibility for CE marking lies with whoever puts the product on the market in the EU, i.e. an EU-based manufacturer, the importer or distributor of a product made outside the EU, or an EU-based office of a non-EU manufacturer. The manufacturer of a product affixes the CE marking to it but has to take certain obligatory steps before the product can bear CE marking. The manufacturer must carry out a conformity assessment, set up a technical file and sign a Declaration stipulated by the leading legislation for the product. The documentation has to be made available to authorities on request. If importers or distributors market the products under their own name, they take over the manufacturer's responsibilities. In this case they must have sufficient information on the design and production of the product, as they will be assuming the legal responsibility when they affix the CE marking. There are certain rules underlying the procedure to affix the marking: Products subject to certain EU directives or EU regulations providing for CE marking have to be affixed with the CE marking before they can be placed on the market. Manufacturers have to check, on their sole responsibility, which EU legislation they need to apply for their products. The product may be placed on the market only if it complies with the provisions of all applicable directives and regulations and if the conformity assessment procedure has been carried out accordingly.
The manufacturer draws up an EC (or EU) declaration of conformity or a Declaration of performance (for Construction Products) and affixes the CE marking on the product. If stipulated in the directive(s) or regulation(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure or in setting up a production quality system. If the CE marking is affixed on a product, it can bear additional markings only if they are of different significance, do not overlap with the CE marking and are not confusing and do not impair the legibility and visibility of the CE marking. Since achieving compliance can be very complex, CE-marking conformity assessment, provided by a Notified Body, is of great importance throughout the entire CE-marking process, from Design Verification, and set up of Technical File to the EC Declaration of Conformity. [6] Self-certification Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who decides whether the product meets all the CE marking requirements. If a product has minimal risk, it can be self-certified by a manufacturer making a Declaration of Conformity and affixing the CE marking to their own product. In order to self-certify, the Manufacturer must do several things: 1. Decide whether the product needs to have a CE marking and if the product applies to more than one directive it needs to comply with all of them. 2. Choose the conformity assessment procedure from the modules called out by the directive for the product. There are several modules available for the Conformity Assessment Procedures as listed below: Module A – Internal production control. Module B – EC type-examination. Module C – Conformity to type. Module D – Production quality assurance. Module E – Product quality assurance. Module F – Product verification. Module G – Unit verification. Module H – Full quality assurance.
OTHER WORLDWIDE APPROVALS
FDA
Northern America
CE
EU
CFDA
Chinese FDA
KFDA
Korean FDA
UL
Canada
TGA
Australia
ANVISA
Brazil
PMDA
Japan
HeartSine‘s “SHOCK BOX“ USPs
10
0,9 kg
Combined battery AND electrode cartridge
1,1 kg
1 – shelf life, 1 – disposable 1 – price, 1 – test date
longest guarantee lowest cost of ownership
IP56 Highest IP Rate
LINK to IP Rate Chart http://www.dsmt.com/resources/ip-rating-chart
Competition vs WEIGHT
Schiller Easy Port 0,35 kg > 2.000 EUR
SAM 300/500 Series 1.1 kg < 1.300 EUR
Competition vs ELECTRODE LIFETIME > 2 YEARS
4 years 5 years
5 years
Competition vs GUARANTEE > 7 YEARS
7 years standard 10 if required 7 years standard 10 if required
SAM Series 10 years
Competition vs IP56 RATE
SAM Series IP 56
HeartSine‘s SHOCK BOX USP‘S
USE USPs!
Decreased weight provides increased savings for
aircraft use!
0,9 kg
o
1.1lb of weight equals an average of 20.9 gallons of fuel savings per year per aircraft.
o
100 aircraft X 20.9 gallons= 2,090 gallons of fuel.
o Jet-A @ $4.69/ gal x 2,090 = $9,802.10 in fuel savings alone.
1,1 kg
USE USPs!
Combination of electrodes and battery with ONE shelf life for: o
Lowest service and maintenance costs
o
Always new and fresh battery after use
o Lowest costs for batteries and electrodes
Combined battery AND electrode cartridge 1 – shelf life, 1 – disposable 1 – price, 1 – test date
Example:
140 EUR for PAD PAK cartridge shelf life 4 years 140/4 = 35 EUR/year
35/12 =
2,92 EUR/month
USE USPs!
10 year guarantee =
10
o
10 year usability
o
10 years of updates
o
10 year safety
Example:
1.200 EUR for SAM 300 series with 10 years guarantee 1200/10 = 120 EUR/year
longest guarantee lowest cost of ownership
120/12 = Example:
10 EUR/month
1.000 EUR for HeartStart HS1 with 8 year guarantee 1000/8 =
125/12 =
125 EUR/year
10,41 EUR/month
USE USPs!
IP56 is ONE factor for 10 year guarantee
IP56 Highest IP Rate
o
Use in “all“ environments
o
Use under difficult conditions
o
UNIQUE feature!
COMPARE “APPLES to APPLES“!!
Brand
Type
IP Rate
ASP
Guarantee
Costs per Electrode year shelf life
Battery shelf life
Electrode costs
Total costs during the guarantee
Battery costs
Philips
HS1
21
1099
8
137.38
2
65
x
3
=
195
4
169 x
1
=
169
1463
Telefunken
AED HR1
55
995
6
165.83
3
65
x
1
=
65
3
55
x
1
=
55
1115
CU Medical
IPad SP1
55
980
5
196.00
2
49.30
x
2
=
98.60
4
236 x
1
=
236
1314.60
Medtrax
Heartsafe One
55
1550
2
775.00
3
39
x
0
=
0
3
Battery and Electorde Package
1550
Zoll
AED Plus
55
1749
7
249.86
5
49
x
1
=
49
5
64
x
1
=
64
1862
METSIS
Lifepoint Pro
54
799
5
159.80
2.5
69
x
1
=
69
5
139 x
0
=
0
868
Defibtech
Lifeline AED
54
1295
8
161.88
2
43
x
3
=
129
7
255 x
1
=
255
1679
Cardiac Science
G5
54
1500
7
214.29
2
55
x
3
=
165
4
270 x
1
=
270
1935
44
1150
8
143.75
2.5
85
x
3
=
255
2.5
Battery and Electorde Package
1405
56
945
10
94.50
4
95
x
2
=
190
4
Pad-Pak
1135
PhysioControl Lifepak CR Plus HeartSine
SAM 350P SAM 360P
Data available as of 13 May 2015
