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A Medical Ventilator is a device to assist respiration in critically ill patients and those requiring
emergency care. Ventilators are also used while giving anaesthesia to the patient before the surgery.
The demand for the Medical Ventilator is increasing with the increasing number of critically ill
patients.
In response to the COVID-19 pandemic many governments have released calls for high volume
manufacture of ventilators to support the treatment of respiratory distress. Design and Manufacturing
facilities will be responding to commit prototypes and manufacturing process for regulatory approval
by these governments. National Instruments is well positioned to answer the urgent needs for OEM
components, Rapid Prototyping and Production Test for these product lines.
As an estimate the time frame for engagement on these opportunities is:
OEM Integration: Early March to mid-April
Rapid prototyping: Early March to June
Production test: Early March to end of 2020
Companies addressing this need will fit into two types: (1) those that will be designing a new product
and attempting to receive regulatory approval, and (2) those that will be taking an existing design and
ramping production pace.
An example of (1) is Oxford University and King's College London who have designed a radical new
design for ventilators which meet minimum requirements and can be manufactured for under £100 2
and because of simplicity can meet order requirements quickly. These designs have received backing
1
Taken from Insights of “Medical Ventilator Market” by Application – Critical Care, Neonatal Care, Emergency
Care etc. till 2023
2
Coronavirus: Prototype ventilators could be mass-produced to ease NHS pressure
1
Authored by James Voaden
form large manufacturing firms, such as Sony, to turn the prototype into mass produced components.
At time of writing these products are entering human trials.
An example of (2) is existing medical manufactures who have ramped production by 3-4 times to
complete orders. In Italy Siare Engineering International Group have brought in military officers and
temporary staff to increase production throughput from 160 a month, to 500.
Accounts with expertise will be picking up this project, beyond the typical life science companies.
This document provides an engagement and qualification plan for accounts in life science product
design and manufacture. It can be used to identify prospects accounts.
Contents
[Reactive] OEM Integration into ventilator...........................................................................................4
Requirements of OEM Integration.....................................................................................................4
Personas............................................................................................................................................4
NIs Main Value drivers:......................................................................................................................4
Key Discovery areas...........................................................................................................................5
Recommended offering.....................................................................................................................5
Key risks.............................................................................................................................................5
Enablement resources.......................................................................................................................5
Rapid Prototyping & Verification of Ventilators....................................................................................6
Requirements at the prototype stage................................................................................................6
Characterise component performance..........................................................................................6
Confirm component integration....................................................................................................7
Verify hardware and software design............................................................................................7
Ensure durability............................................................................................................................7
Personas............................................................................................................................................7
NIs Main Value drivers:......................................................................................................................7
Key discovery areas...........................................................................................................................7
Recommended offering.....................................................................................................................8
Key Risks............................................................................................................................................8
Enablement resources.......................................................................................................................8
Production Test (Validation) of Ventilators...........................................................................................9
Requirements at the Production stage..............................................................................................9
Deploy new test lines....................................................................................................................9
Product manufacture process Quality control.............................................................................10
Throughput and production flexibility.........................................................................................10
NIs Main Value drivers:....................................................................................................................10
2
Recommended offering...................................................................................................................10
Enablement resources.....................................................................................................................11
Key Risks..........................................................................................................................................11
Appendix A: Example requirements....................................................................................................12
Rapidly manufactured ventilator system specification....................................................................12
Contents..........................................................................................................................................12
Ventilation......................................................................................................................................12
Gas and electricity...........................................................................................................................13
Infection control.............................................................................................................................14
Monitoring and alarms...................................................................................................................15
Monitoring......................................................................................................................................15
Miscellaneous.................................................................................................................................15
Standards........................................................................................................................................16
Unknown issues..............................................................................................................................17
Battery backup............................................................................................................................17
Appendix B – MathWorks reference Medical Ventilator with Lung Model.........................................18
Medical Ventilator with Lung Model...............................................................................................18
3
[Reactive] OEM Integration into ventilator
Requirements of OEM Integration
Note: NI is not typically a source in OEM components and these opportunities should be approached
with caution. Due to regulations NI would have to meet certain requirements which aren’t currently
guaranteed. While NI shouldn’t be proactive in these applications, there have been requests come in
for OEM components.
The basic design of the ventilator requires input of pressurised oxygen to be mixed with filtered air.
This is then pumped at pressure to the patient to assist breathing by detecting the patients
breathing cycle. This operation requires the use of sensors and control to reach a desired oxygen
ratio, pressure and volume. It will require further control to detect several fail-safe scenarios
including the patient stops breathing or failure in the gas/electricity supply.
Example Ventilator schematic showing key components. This example includes an air compressor
where most specification documents call to make use of oxygen pressurised to four bar. 3
The components NI could provide would be DAQ components to interface to sensors and/or
controller boards to embedded decision making on the device.
Personas
Design engineer *note a lot of design teams will be interdisciplinary teams or engineers/scientist
from other backgrounds may try and move into the design engineer role.
3
Taken from The Pandemic Ventilator
4
accelerate design and prototyping stage by integrating COTS ADC or controller will
reduced design complexity: integrated signal conditioning and ADC to USB / known interface
to control boards
Use existing tools: Phyton, C, Matlab
Heightened level of support
Key Discovery areas
What is the expected result by integrating NI components?
o How will they verify this decision?
What component availability will be needed and when?
What is the regulatory approval process?
Recommended offering
Key risks
For medical applications it is necessary to achieve regulatory approval. This process would typically
take years but will be accelerated during this time to 2/3 months. The UK has not eased the
requirement for the approval although in the US Food and Drug Administration (FDA) announced
that it had reduced barriers in the medical device approval process to help speed up the production of
ventilators.
The design process is minimised during this application with some teams taking as little as one day
before submitting a bid. This isn’t an area to be proactive, but we may reactively be engaged with
potential manufactures.
Enablement resources
5
Rapid Prototyping & Verification of Ventilators
Requirements at the prototype stage
Once a design concept has been confirmed it will move to the prototyping stage where performance
will be presented to the regulatory body. Once this has been approved it will move to
manufacturing. This prototyping stage will be revisited to complete modifications for future models
with extra functionality or improved quality.
During the prototyping stage the engineering teams will have three top requirements:
Example Ventilator prototype designed by the University of Oxford and Kings college in response
to the COVID-19 pandemic4
A few components will be designed and manufactured specifically for the design. These components
will need more detailed testing to understand performance. In the figure above the design team has
manufactured a custom bellow to pump the gas mixture. It would be necessary to test the pressure
performance to ensure it can achieve the ranges specified and can do so consistently. Component
test for this would be to monitor the performance over a longer cycle as hardware-in-the-loop
testing.
4
Taken from Oxford and King’s Developing Prototype for Rapidly Deployable Ventilator
6
Most of the sensing elements will be pressure, analogue output for control and digital input/output.
Where possible designers should purchase COTS pressure sensors with integrated signal
conditioning to reduce design complexity. This will mean most of the signal interface will be to 0-10
V or 4-20 mA.
Before regulatory approval can be sought, the device will need to be verified against several
minimum requirements. These teams will likely be working alongside suppliers and production
teams to increase the pace of product release.
Ensure durability
Because of the application a degradation in performance would be unacceptable. The UK
specification requires full functionality for 100% duty cycle over 14 days. The design team will need
to accelerate these tests but will still require significant time for life cycle testing.
The durability tests may be completed for the full device, for component or sub-components.
Personas
Design engineers
Test engineers
Technicians
7
b. Confirm component integration
c. Verify hardware and software design
d. Durability
2. What is the organisations experience conducting test?
3. What must be presented to the regulation body?
4. What is the data management strategy?
5. Who are the suppliers of your test tool chain?
6. Where will production test be conducted?
Recommended offering
Flex logger: Quick sensor configuration and data logging of mixed signals to verify electromechanical
systems, all without programming.
Key Risks
Anyone building a solution will be cautious about picking up new tools as there is reduced tome to
learn and implement. It will be important to utilise existing knowledge base which can be
complimented by consultancy and partners.
Enablement resources
Solutions Brochure: NI's Electrical Functional Test Solution
Case study: Validating Control Algorithms by Rapid Prototyping of the Controller for an Integrated
Starter Generator
Case Study: Using LabVIEW and CompactRIO to Create a Liver Dialysis Prototype Authorized for
Clinical Trials in Germany
8
Production Test (Validation) of Ventilators
Requirements at the Production stage
As the design finalises and gains regulatory approval it will be sent to manufacturing facilities. It will
be their role to design a manufacture and test process. This involves investing in temporary
infrastructure and workforce to ensure throughput can be achieved. From a test perspective the
major requirements are to:
In Italy Siare Engineering International Group has ramped production from 160 per month to 2000
within four months. The Italian army was brought in to supervise and drive production pace. 5
The manufacturing facility will need to quickly build a test system to function for these devices.
These test systems will need to be replicated to match the through put requirements. Training the
test operators to use the test system will also be a high concern.
5
Taken from Army joins the production line as ventilator makers scramble to meet demand
9
Emphasis in designing the test system will be placed on throughput speed, availability of
components and speed to design / redesign. Any saving on test time would reduce the chance of it
being a bottle neck in production.
Some organisation will re-purpose existing test infrastructure to meet this demand. These teams will
benefit from support and consultancy to build a strategy for this migration.
Manual tests will be performed on several units within each batch. This can include deeper analysis
of functionality and may include destructive test. The aim of the data collected here would be to
further inform product design, supplier control and manufacturing process control.
Recommended offering
PXI instrumentation ensures complete and accurate test coverage with a modular
architecture mounted in ultra-reliable PXI chassis.
TestStand and LabVIEW software provide rapid development of complex test steps and
sequences.
PXI systems conserve floorspace because of their small, light form factor. Order them
preassembled and installed using NI ATE Core Configurations.
SystemLink™ software deploys updates and democratizes data insights to optimize
operational efficiency.
10
TestStand for rapidly deployable and usable UI
VirtualBench for manual diagnostic test
Enablement resources
NI's Electrical Functional Test Solution
Key Risks
Anyone building a solution will be cautious about picking up new tools as there is reduced tome to
learn and implement. It will be important to utilise existing knowledge base which can be
complimented by consultancy and partners.
11
Appendix A: Example requirements
Rapidly manufactured ventilator system specification 6
This is a specification of the minimally (and some preferred options) clinically acceptable ventilator
to be used in UK hospitals during the current SARS-CoV2 outbreak. It sets out the clinical
requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of
the anaesthesia and intensive care medicine professionals and medical device regulators.
It is for devices, which are most likely to confer therapeutic benefit on a patient suffering with ARDS
caused by COVID-19, used in the initial care of patients requiring urgent ventilation. A ventilator
with lower specifications than this is likely to provide no clinical benefit and might lead to increased
harm, which would be unacceptable for clinicians and would, therefore, not gain regulatory approval.
It must be borne in mind that intensive care medicine is a whole system of care and ventilators cannot
be safely used on any patient without trained staff and other equipment and medicines. Where these
impinge on the specification they are mentioned below.
It is proposed these ventilators would be for short-term stabilisation for a few hours, but this may be
extended up to 1-day use for a patient in extremis as the bare minimum function. Ideally it would also
be able to function as a broader function ventilator which could support a patient through a number of
days, when more advanced ventilatory support becomes necessary.
Ventilation
must have mandatory ventilation (for the deeply sedated and paralysed). The user can set a
tidal volume and the output is a pressure regulated flow to achieve this volume, for example,
pressure regulated volume control (PRVC), SIMV-PC
optional pressure support mode for those patients breathing to some extent themselves, for
example, BIPAP. The user sets an inspiratory pressure and an expiratory pressure. The ventilator
can sense when a patient starts to breathe in and apply the inspiratory pressure, then sense when
the patient starts to breathe out and apply the expiratory pressure (this pressure is still positive but
lower than the inspiratory pressure)
6
Taken on 24/03/20 from https://www.gov.uk/government/publications/coronavirus-covid-19-ventilator-
supply-specification/rapidly-manufactured-ventilator-system-specification
12
If the patient stops breathing in pressure support mode, it must failsafe automatically onto mandatory
ventilation.
Inspiratory airway pressure, the higher pressure setting that is applied to make the patient breathe in:
Positive End Expiratory Pressure PEEP (usually called EPAP during pressure support mode). The
lower pressure applied to the patients airway to allow them to breathe out, but not too much:
Inspiratory:Expiratory ratio (I:E) (note, confusingly, it is actually E/I time). The proportion of each
breathing cycle that is spent breathing in compared to breathing out:
range 10 to 30 breaths per minute in increments of 2 (only in mandatory mode) can be set by
the user
Tidal Volume (Vt). The volume of gas flowing into the lungs during one inspiratory cycle:
all gas connectors and hoses must use standard non-interchangeable connectors and be colour
coded according to current standards
must connect to wall pipeline oxygen supply via Schrader valve connector (BS 5682, not the
bicycle wheel version). If hose not permanently fixed to machine, then must connect with NIST
(Non-Interchangeable Screw Thread – ISO 10802). Oxygen pipeline pressure is 4 to 5 Bar
13
optionally can incorporate a backup oxygen cylinder connected via either Schrader valve or
Pin Index System
must be able to be operated on any attached cylinders. Oxygen cylinder pressure is either 1 to
137 bar if no regulator is fitted, or 4 bar if the cylinder incorporates a pressure regulator. The
ventilator must be able to work with either. The ventilator must include a pressure regulator to
decrease 137 bar cylinder pressure to 4 bar working pressure. Working pressure inside the
ventilator may be up to 4 bar, but it must be impossible to expose the patient to any pressure above
40 cmH2O
optionally can connect to wall pipeline medical air via Schrader valve (NB ‘medical air’ is 4
bar. Must not connect to ‘surgical air 7 bar’ supply)
optionally can connect to Anaesthetic Gas Scavenging System
optionally can operate using an oxygen concentrator device for input oxygen
Electricity supply:
user must be able to control inspired oxygen proportion (FiO2). The percentage of oxygen in
the gas being breathed in by the patient. Room air is 21% oxygen
at least 50% and 100% options
very preferably ideally variable between 30 and 100% in 10% steps
patient breathing system connections: the ventilator must present 22mm outside diameter
(OD) ‘male’ standard connectors for connection to user supplied 22mm ‘female’ connectors on the
breathing system
All elements in the gas pathway must meet biological safety and oxygen safety standards, especially
to minimise risk of fire or contamination of the patient’s airway.
Infection control
All parts coming into contact with the patient’s breath must be either disposable or decontaminatable
between patients.
All external surfaces must be cleanable in the likely event that they get respiratory secretions or blood
splatter on them. Cleaning would be by healthcare workers manually wiping using an approved
surface wipe with disinfectant or cloths and approved surface cleaning liquid.
There will be a separately sourced HMEF-bacterial-viral filter between the machine and patient which
may impact on resistance within the system, which may need to be accounted for with some designs.
14
The pressure being delivered to the patient is the specified pressure. If the filter has a resistance of,
say 2 cmH2O, the ventilator needs to output 37 cmH2O to achieve a set 35 cmH2O at the patient.
This will need further detailed consideration. Usually HMEF filters have negligible resistance, but the
viral filtering filters may have much higher resistance that may be clinically relevant.
Monitoring
Miscellaneous
Optionally it can be used beyond 14 days, the expected durability must be specified.
Ideally small and light enough to mount on patient bed and orientation-independent functioning.
Should be as robust as possible. For example, it may be dropped from bed height to floor.
15
It must be intuitive to use for qualified medical personnel, but these may not be specialists in
ventilator use:
must not require more than 30 minutes training for a doctor with some experience of
ventilator use
must include instructions for use
ideally instructions for use should be built into the labelling of the ventilator, for example,
with ‘connect this to wall’ etc
must include clear labelling of all critical functions and controls using standard terms,
pictograms and colours that will be readily recognised by UK healthcare staff
Must have transparent design, supply chain, manufacture and testing processes that are of sufficient
quality to enable MHRA officials to deem appropriate for usage in exceptional circumstances.
Must not be excessively cumbersome so that it would impede hospital operations or prevent easy
movement within hospital premises.
Must be made from materials and parts readily available in the UK supply chain (anticipating
increasing global restrictions on freight movement).
Standards
There are many standards that exist in this area. Below is a list of the most relevant ones. They are not
formal regulatory requirements but many are harmonised against regulatory requirements. Consider
them as helpful advisory standards for now. MHRA will lead an exercise to define which can be
‘safely’ relaxed for this emergency situation:
Unknown issues
absolute minimum oxygen requirement is the human consumption of about 250 ml/min.
However, achieving this is only possible if certain breathing system designs are used and ‘driving’
gas is done by air. Specifically, would have to use circle breathing system with active CO2
absorption
16
if consumption in the range 1 to 2 l/min is acceptable, then a wider range of designs is
possible, but some very basic designs are not
if consumption in the range 10l/min is acceptable, then any possible design can be considered
What is the resistance of HMEF-bacterial-viral filters that are to be used with the ventilator? Is it
clinically relevant?
Is there any need to consider running from only low pressure oxygen, for example, from a
concentrator? This makes design more complex.
How plentiful is the supply of syringe drivers and drugs for sedation?
If monitoring can be done by another machine, it could be left out of the ventilator, but essential
parameters must be available to the clinician.
Battery backup
Every current ventilator used inside hospitals has a battery backup, so users will expect it to be there
and will behave as if it is, for example, unplug it from the wall in order to rearrange cables or while
manoeuvring the patient. However, this needs very careful thought to balance the risks. Including this
in the spec means instantly trying to source 30,000 large, heavy batteries. Specifying a DC voltage (ie
12VDC) may well be the most sensible for the machine working voltage. Need the advice of an
electronic engineer with military/resource limited experience before specifying anything here. It needs
to be got right first time.
17
Appendix B – MathWorks reference Medical Ventilator with Lung
Model7
This example models a positive-pressure medical ventilator system. A preset flow rate is supplied to
the patient. The lungs are modeled with the Translational Mechanical Converter (MA), which converts
moist air pressure into translational motion. By setting the Interface cross-sectional area to unity,
displacement in the mechanical translational network becomes a proxy for volume, force becomes a
proxy for pressure, spring constant becomes a proxy for respiratory elastance, and damping
coefficient becomes a proxy for respiratory resistance.
The exchange of oxygen and carbon dioxide in the moist air mixture is not currently modeled.
Model
7
Taken from Medical Ventilator with Lung Model 27/03/2020
18
Check Valve 1 Subsystem
Humidifier Subsystem
19
Simulation Results from Scopes
20
This plot shows the accumulation of condensed water in the expiratory tube, which should be drained
periodically. The water comes from the humidifier and the patient's respiration.
21