Development of a Low-Cost Insulin Infusion Pump: Lessons Learned from an
Industry Case
Luiz E. G. Martins, Hanniere de Faria, Lucas
Vecchete, Tatiana Cunha and Tiago de Oliveira
Institute of Science and Technology
Federal University of São Paulo
São José dos Campos, Brazil
{legmartins, hanniere.faria, lucas.vecchete, ts.cunha,
tiago.oliveira}@unifesp.br
Abstract—In the last 30 years there have been great advances
in technology for diabetes treatment, which facilitated the
management of the disease and its complications. Among the
advances we can mention the development of insulin infusion
pump. However, diabetes treatment using the insulin pump
still remains expansive in Brazil, especially because the device
and its accessories are imported. The aim of this paper is to
report a prototype development of a low-cost insulin infusion
pump aimed to benefit Brazilian people suffering with Diabetes
Mellitus type 1. The prototype development is a result from a
cooperation between Brazilian academy and industry. We
comment the development of such a prototype and the lessons
learned obtained from it.
Keywords-insulin infusion pump; diabetes mellitus;
embedded systems; safety requirements.
I. INTRODUCTION
International Diabetes Federation´s (IDF) most recent
study estimates that 8.3% of adults - 382 million people -
have Diabetes Mellitus and by 2035 this will rise to 592
million, posing the disease as one of the most challenging
health problems of the 21st century. Yet, with 175 million
of cases currently undiagnosed, a vast amount of people
with diabetes are progressing towards complications
unawares [9]. Different regions are being affected to widely
differing degrees, and according to IDF it is estimated that
number of people with Diabetes Mellitus in Brazil, between
20-79 years, is around 11.9 million. The most common
forms of the disease are classified as type 1 and 2. The type
1 Diabetes Mellitus (DM1) is characterized by severe
deficiency in insulin secretion caused by the destruction of
beta cells in the pancreas, that are responsible for the
hormone secretion, generated by autoimmune process or
unknown cause. The type 2 Diabetes Mellitus is
characterized by insulin resistance combined with
inadequate secretion, it is the most common type of disease,
occurring in 90% of the cases in developed countries [1].
A Brazilian nationwide multicenter study recently
revealed worrying data about the situation of DM1 in Brazil.
It has followed 3,591 patients of 20 different Brazilian
cities, in five regions, and only 15% of diabetics have their
blood glucose under control. Also according to the study
most of the patients, 71.5% were diagnosed before the age
Dulce E. Casarini and Juliana Almada Colucci
Paulista Medical School
Federal University of São Paulo
São Paulo, Brazil
{dulce, colucci}@nefro.epm.br
of 15, and approximately 20% before the age of 5. This
means that these people will live with the disease for most
of their life, increasing the risk of development of chronic
complications due to a poor glycemic control. Therefore, the
cost to public health system and the society tends to increase
in coming years, unless the public policy provides the
possibility to suitable glycemic control for the population
[1, 2]. It is known that the patient with diabetes requires a
strict monitoring and control. Currently, the Brazilian
Information System for Basic Care (SIAB) performs
monitoring of about 1.2 million patients, especially the
patients with DM1 due to disease severity. It is important to
say that poor glycemic control in the first five years of
evolution of diabetes seems to play an important role in the
development of vascular complications [3]. Diabetes
Control and Complications Trial (DCCT) demonstrated that
the intensive treatment using insulin, applying daily
multiple doses or by using continuous subcutaneous
infusion pump, when compared to the conventional
treatment, provided a significant reduction in the incidence
and progression of microvascular complications [4, 5].
From the late 20th century there have been great
advances in technology for diabetes treatment, which
facilitated the management of the disease and its
complications. Among the advances we can mention the
development of insulin infusion pump. Although this device
is largely used in the United States since 1970, in Brazil
only fifteen years ago treatment using insulin infusion pump
started to be prescribed more frequently. The goal of such a
therapy is to simulate what happens in the body of healthy
individuals by keeping the delivery of insulin constant for
24 hours, therefore maintaining normal blood glucose
concentration between meals and in feeding times.
Currently there are in the market few portable insulin
pumps, controlled by embedded computer systems, however
these insulin pumps have a high cost of acquisition in Brazil
since all available models are imported. Considering costs
of about US$ 4,500 the acquisition of the insulin pumps is
prohibitive for most of the Brazilian people.
The aim of this paper is to report a prototype
development of a low-cost insulin infusion pump aimed to
benefit Brazilian people suffering from DM1. The prototype
development is a result from a partnership between
 Brazilian academia and industry. The remainder of this
paper is organized as follows. In Section 2, we present
background and comment related works. In Section 3, we
present an overview of the prototype that is under
development in cooperation with Brazilian industry.
Lessons learned from the industry case study is discussed in
Section 4. In Section 5, we present the conclusions and
further works.
II. BACKGROUND AND RELATED WORKS
Insulin infusion pumps are useful automated instruments
for treatment of diabetic patients, specifically for the
management of DM1. This kind of automated pump has the
proposal to perform as the human pancreas does, delivering
insulin according to the metabolism needs, maintaining
blood glucose in normal range. Furthermore, insulin pumps
help diabetic people simplify their routine that relies on
manual control of blood glucose levels and a manual insulin
application with a syringe, substituting the conventional
treatment by a device that can be adapted to different
lifestyles, avoiding inconveniences and ensuring greater
flexibility.
Based on a field research conducted in the preliminary
step of this research, observing different pumps from the
market, it was noticed that the insulin pumps follow a
pattern of operation, which can be described as a generic
model of insulin infusion pump. In Yi Zhang et al. [6] a
generic model for insulin infusion pump is presented. The
generic model consists of an user interface using input and
output devices to communicate with the patients, such as
LCDs, buttons, sound alerts; a battery that powers the whole
system; a unit responsible for all data processing, wherein
that unit is the entire circuit composed mainly by a
microcontroller or microprocessor, and it is responsible for
all infusion calculations, as well as the storage of user-
entered infusion data; an infusion mechanism, composed by
a motor, syringe and plunger, catheter and insulin reservoir.
According to the American Diabetes Association,
currently the insulin pumps cost from $ 4,000 to $ 8,000
with just few manufacturers ruling the market around the
world. Prices in Brazil become more expensive due to
import taxes, and combined with currency conversion, the
value of an infusion pump can reach more than 22 Brazilian
minimum wages. The advantages of each pump and its
manufacturer vary in proportion to the price. For example,
while there is a pump with a removable battery and reduced
interface quality, there are pumps with the latest interface
with support for USB battery charging with much higher
price.
PAREI III. INDUSTRY CASE: PROTOTYPE OF A LOW-COST
INSULIN INFUSION PUMP
A. Context
The industry case study reported in this paper was
conducted during the initial phase of a project to develop a
prototype of a low cost insulin infusion pump. That project
has been developed in cooperation with the Brazilian
companies DeltaLife (http://www.deltalife.com.br) and CNA
Desenvolvimento (http://www.cnadesenvolvimento.com.br),
which are companies in the area of electronic medical
devices and mechanical design, respectively. It was
identified a gap in Brazilian market that have motivated
industry and academia to join forces for such a
development.
Participated in that phase of the project six people: one
mechanical engineer – with more than 5 years of industry
experience; one electronic engineer – with more than 10
years of industry experience; one requirements engineer –
with more than 10 years of experience in industry and
academia; two software engineers with two years of
industry experience; and one doctor with more than five
years of experience in diabetes treatment using insulin
infusion pump. Both mechanical and electronic engineers
had high experience in embedded systems development.
The requirements engineers and software engineers had few
experience in embedded systems.
B. Prototype Requirements
In the following subsections we present the results from
requirements engineering performed to the proposed
prototype. The requirements were divided into hardware,
functional and safety requirements.
1) Hardware Requirements
The pump must have a power supply, which is a non-
rechargeable battery easy to change. The insulin reservoir is
a common syringe found in the regular market, and the
whole case of the prototype was designed to fit such
syringe, considering that we are developing a low-cost
insulin pump. A stepper motor with sufficient precision to
ensure the reliability of the infusion process, connected to a
mechanical system with an axis that will move the syringe
plunger. To get the accurate control of the stepper motor a
driver is required. The communication between system and
user is done via a Liquid Crystal Display (LCD), four
buttons, and a buzzer. All functionalities of the system are
controlled by a low power consumption microcontroller
from the MSP430 family [7].
2) Functional Requirements
The main functional requirements defined to the
prototype are described as follows:
• Information Exhibition: the pump must expose on its
LCD approximate battery levels, insulin amount, time,
malfunction alarm, and description of motor usage
status (see Figure 2).
• Check numeric data of battery levels and insulin: user
has the option to check the status of the battery and
insulin on a separate screen for more precise analysis.
• Configure and enable infusion profiles: user can setup
five different basal infusion profiles for each 24 hours.
Any time user may redefine the stored profiles.
• Configure and enable quick infusion (bolus infusion):
the user can setup the amount of insulin that he/she
wants to infuse at the moment.
• Enable the insulin reservoir exchange: the user will
have a step by step explanation on the screen of how to
change the insulin reservoir.
• Critical alerts: for each problem, such as lack of
battery or lack of insulin, the pump must use audible
and visible alerts.
3) Safety Requirements
Considering that a insulin infusion pump is a safety-
critical system, additional care was taken to ensure safety
requirements, which were organized into the following
hazard categories [6]: operational, hardware and software
hazards. The hazard categories are described as follows.
a) Operational Hazards
Failures related to operational hazards may occur while
users are operating the pump due to lack of attention or poor
information to the user. The failures in this category are:
• Air in the catheter: presence of air in the catheter
decreases the amount of infused insulin, and may
cause under dose situation.
• Catheter disconnected or perforated: catheter
improperly connected or punctured may cause
decreasing of the expected amount of infused insulin
causing under dose situation.
• Reversed insulin flow: this situation may cause under
dose situation.
• Excessive requests of bolus: excessive infusions may
cause overdose.
• Configuration of very high values for infusion (basal
rate or bolus) may cause overdose.
• Configuration of very low values for infusion (basal
rate or bolus) may cause under dose.
• Empty insulin reservoir: with empty reservoir, the
infusion is not performed and may case under dose.
b) Hardware Hazards
Failures related to hardware hazards can be caused by
defects during the pump manufacturing, or handling of the
pump by the user. The main failures identified in this
category are the following:
• Fault in microcontroller: as the microcontroller is the
"heart" of the pump it is mandatory to ensure a good
protection of the chip against external environment.
• Failure in nonvolatile memory: one possible way to
avoid this failure is to create a parallel storage module.
• Failure in volatile memory: once volatile memory is
present on the microcontroller, protecting the chip is
necessary to avoid such a failure.
• Motor does not operate as instructed: as most
mechanical systems, if the calculations are not
performed analyzing slack and tolerances, the engine
can be damaged.
• Motor does not stop when a fault occurs: if the engine
does not stop, a mechanical key moved by induction
may reduce the problem once there is still power
supply running.
• Fatigue or breach of mechanical parts of the motor;
• Buzzer with unusual behavior: another difficult
problem to be avoided, the most conventional way is
shielding physical shocks, only allowing the passage of
sound.
• Jammed button: the button issues implies in their
mechanical precision, so one way to avoid this is to
implement a button damping system.
• Key bounce: a good circuit design and a correct
installation of the buttons may prevent this kind of
failure.
• Failure of the battery sensor: a battery sensor is
included in the microcontroller, if not, it can be
implemented on programming based on empirical
cases, providing safety with the battery life time.
• Real-Time Clock (RTC) late or early.
• Failure in the communication channels of electronic
components: to avoid this defect, a refined circuit
design should be made and tested in different
environments.
• Insulin reservoir broken, cracked or punctured: as the
reservoir is exchangeable, it will be subject to defects,
but their exchange is performed easily, thus becoming
more an operational problem. Greater investment in
material used could be done.
c) Software Hazards
Failures related to software hazards can be caused by
defects introduced during embedded software development.
The main failures in this category are: sending incorrect
messages to the user; incorrect step calculation for the
infusion (basal rate or bolus); wrong size variables; data
concurrency; infinite looping; incorrect navigation between
option menus; threshold of ill-defined sensors; incorrect
conversion of the sensor values; reading incorrect values of
buttons. In order to increase the system safety, all these
hazardous situations must be avoided and they were taken
into account during the prototype development.
C. Hardware Design
The whole structure was designed from a marketable
syringe, which is an important issue in the development of
such a low cost system. The case of the prototype is
109.3mm long, 73mm wide and 25mm thick, tailored to a
syringe 3mL. Figure 1 shows three views of the developed
prototype taking into account the adopted syringe.

Figure 1. Overview of the prototype; (b) Case and insulin reservoir; (c)
Electronic schematics with control buttons and LCD.
The mobility of the syringe plunger is made from a
threaded spindle which will move because of the stepper
motor, which is connected to the spindle through a gear
transmission. Another aspect of hardware that needed to be
thought, that had more importance in the aspect of HCI, was
the graphical user interface. The prototype graphical
interface is based on a custom LCD 21mm in height and
40mm in width. Thus, the information shown on the LCD,
for each pre-defined behavior of the pump, would be
controlled through a combination of outputs using the
properly segments.
Figure 2. Layout of the LCD.
The design of the LCD had to attend the hardware
requirements of the microcontroller used, which was the
MSP430FG439. This microcontroller with a 16-bit RISC
architecture has an ultralow-power consumption, consuming
300 µA in active mode and 1.1µA in standby mode. It also
has several features (see datasheet supplied by Texas
Instruments), including an integrated LCD driver with
support for 128 segments. Therefore, the LCD is designed
to have up to 128 segments, the layout of the LCD proposed
for the prototype is presented in Figure 2. The stepper motor
chosen to the initial tests was the Portescap P010-064, with
typical holding torque of 1.8 mNm, step angle of 15 , 10
mm in diameter, and weight 9.0g.
D. Software Architecture
The software of the infusion pump is structured
modularly, allowing functions to be easily modified and
improved. Basically, the software architecture was divided
into 6 modules: motor, business, timer, display, state_view
and main.
1) Main Module
The main module is responsible for initializing all the
required parameters, preparing the infusion pump to start its
normal operation. Firstly, this module sets the ports that will
be used, active the LCD, initialize the variables and start the
first state of the infusion pump, that is the initial view to the
user. After that, this module load from the flash memory the
basal and bolus profiles already saved by the user, the
information about the quantity of insulin infused and the
number of steps that the motor performed. Therefore, the
system is able to calculate the insulin remaining on the
reservoir and the position of the syringe plunger. If there is
an active profile, the module configures it to the current
hour and finally starts the timer.
Figure 3. Overview of the software architecture.
MSP430FG439 has two segments (A and B) in flash
memory, one with 128 bytes of space where the information
will be preserved to avoid any problem in case of power loss
of the infusion pump, and every time that some information
is updated it will be kept at one of the segments.
2) Timer Module
The timer module is designed to count hours, minutes and
seconds andit is also responsible for calling the function that
sets the infusion amounts in the current hour, and the
function that checks if it is necessary to infuse insulin in
every second. The timer is started when the function
“configure_timerA” is called by the Main Module and uses
the TimerA interruption to fires every ½ second.
3) Business Module
The business module contains the functions and rules that
enable the infusion according to the basal and bolus profile,
it manages the rules to save information into flash memory.
This module is also responsible for updating the information
of the infused amount and quantity remaining in the
reservoir. The functions of this module are explained as
follows. The function configure_current_hour() is called to
configure the intervals between the infusions using a
preconfigured quantity of insulin (0.5 unit), in each hour
that the Timer Module counts. This function uses the
quantity of the insulin configured to current hour based on
the following equation:
qtd_infusion_hr = rem_insulin/qtd_min_infusion (1)
interval_infusion_hr = rem_seconds_hr/qtd_infusion_hr (2)
Example: let's assume that the infusion pump was turned
on in 5:15:30 am, in other words, 2.670 seconds remaining
to complete the hour. In addition let it be considered that it
had already infused 5 units from the originally 20 units
configured previously to this hour.
qtd_infusion_hr = 15/0.5 = 30 (30 infusions of the 0.5 units has to
occur up the remaining hour)
interval_infusion_hr = 2670/30 = 89 (every 1 minute and 29
seconds an infusion of 0.5 units has to occur up the remaining
hour)
Thus, the counter is set to count up to 89 seconds, where
the function verify_infusion() checks every second whether
or not the counter has reached 89 seconds and, if so, sets the
flag_basal_infusion() and resets the count to the next
infusion. The function activate_infusion() is called in an
infinite loop once this function could be a long operation
and can’t be called by an interruption. This function checks
if the flag_basal_infusion() and flag_bolus_infusion()
profile was fired. If so, the function adds the amount of
basal and/or bolus infusion to be infused, updating in the
flash memory the information about insulin of the reservoir
and the infused current hour.
4) Motor Module
Responsible to send commands to the stepper motor, the
motor module contains the functions that apply the right
voltage sequences according to the stepper quantity and
frequency required. This module also contains the
parameters of the stepper motor, such as the relation
between steps and rotation degree, the frequency for the
application of steps, the sequence of steps, and the rotation
degree corresponding to deliver a minimal quantity of
insulin (0.1 insulin unit).
5) Display Module
The display module is a library designed to control the LCD
present in Figure 3. We created functions to hide the
complexity to control the display; the programmers just
write on the display, call the corresponding functions
according to what is necessary to show. The functions that
control the display are explained as follows:
• upper_number_float(float num): this function receives
a float number to display in the upper_segment;
• units(bool mode): enables symbol “U”;
• hours (bool mode): enables symbol “H”;
• percent (bool mode): enables symbol “¨%”;
• basal(bool mode): enables “graphics” symbol to
indicate basal infusion;
• bolus(bool mode): enables “thunder” symbol to
indicate bolus infusion;
• lower_cout(char string[]): this function writes a string
on the text display;
• clock(bool mode): enables “clock” symbol;
• battery_display(int amount): this function displays 1/3,
2/3, 3/3, according to the battery charge;
• reservoir_display(int amount): this function displays
1/4, 2/4, 3/4, 4/4, according to the reservoir capacity;
• stop(bool mode): enables “stop” symbol;
• malfunction(bool mode): enables “malfunction”
symbol;
• alarm(bool mode): enables “alarm” symbol”.
6) State View Module
The state_view module takes the control of the states that
the infusion pump can achieve, in other words, it is the
representation of the state that GUI and the internal
processing can assume. Depending on the user action, the
infusion pump can give a different action to a button to
allow the user to interact with different functions of the
pump. The states that the infusion pump can achieve are
modelled in UML’s states diagram, as presented in Figure 4.
Figure 4. Insulin pump states controlled by software.
IV. LESSONS LEARNED
In this section we describe three lessons learned from the
development of the low-cost insulin infusion pump
prototype.
A. Insulin Reservoir
Issue: Low cost is a very important requirement in this
project. During the prototype development we kept in mind
the necessity to develop a low-cost insulin infusion pump,
both considering the components and the maintenance of the
final product. During the insulin pump based DM1
treatment patients need to change insulin reservoir each two
days on average. Therefore, the reservoir cost has a strong
impact for the patients.
Adopted solution: Considering the strong impact that
insulin reservoir has over the maintenance cost of the insulin
pump, we decided that the reservoir should be a regular
syringe found in the market. This decision drove the whole
hardware design, impacting the definitions about the pump’s
case and the LCD dimensions, the stepper motor to push the
plunger, the power supply necessities, the size of the
electronic schematics and so on. The adopted syringe was
the model BD PosiFlush™ 3mL. Such solution seems
adequate because this syringe adopts the same diameter of
the standard syringe 10 mL, which keeps it short enough for
pump’s case design and demands low torque to push the
plunger. At the moment, the unit cost of this syringe is
about US$ 0.50 into the Brazilian market. Taking into
account the safety issues, we are considering to offer pre-
filled syringes, however we are still analysing the involved
costs.
B. Calculation of the Insulin Dilution to the Basal Profile
Issue: For such issue we had to consider two main
functionalities: calculation of the interval between basal
infusions and calculation of the steps for the motor
execution. The calculation of the interval has the
responsibility to dilute the amount of insulin configured in
the corresponding basal profile according to the current
time. A series of twenty tests was performed, each one with
duration of one hour and an amount of insulin required (the
minimum amount of insulin configured in the system is 0.1
unit). With the test results it was verified that when the
calculated interval was not an integer value, the number of
infusions returned was greater than it should be. The reason
for that is the way the required insulin is diluted through one
hour, since the dilution method attempted to reach the best
dilution possible.
Adopted Solution: when the calculated interval is a
float value (resulting in more infusions in some cases) we
could just consider the integer part from the calculated
infusion interval. When the integer part of calculated
interval is considered, the interval is smaller than it should
be (which leads to more infusions), which actually is not an
issue, only by limiting the amount of insulin infused into the
period considered.
C. LCD Design
Issue: For the development of the prototype during the
early steps, an initial model implemented on a robust
development kit was built, using a graphic liquid crystal
display (GLCD). GLCD is flexible to program since it is
based on an array of pixels. When we started the LCD
design for the prototype, a problem related to the hardware
emerged, which was the number of segments supported by
the LCD driver (128 segments). It was necessary to design a
display interface that should be able to respond to the users
in the same way it was meant using GLCD, but with a
saving of images and symbols to meet the LCD number of
segments.
Adopted Solution: Initially the display was set to offer
time and date display, the support symbols, the numbers
display, and the text display having 12 characters. This
setting exceeded the microcontroller pins, which pushed us
to do some modifications. The date display was removed,
and the time would be displayed at the text display. The text
display would be formed with up to 5 letters, (positions in
the LCD), and phrases and words shown in the pump
display would become abbreviations, as explained in the
user manual. In fact, together with the insulin values, the
support symbols are the most important elements to be
shown into the pump display. With this modification it was
possible to design the layout of the LCD using 128 pins (as
shown in Figure 2).
V. CONCLUSION
We presented in this paper the results from a real project
of prototype development of a low-cost insulin infusion
pump. The prototype is currently at the test stage, we are
testing the user interface and the precision of the insulin
delivery by the stepper motor. We also are analyzing the
certification requirements established by ANVISA
(Brazilian agency of health surveillance). The accuracy of
insulin pumps is of great concern, especially in cases with
low infusion rates, where they can limit glycemic variability
and unexplained hypo- or hyperglycemic events unawares
[8]. So, the next step of the prototype development will start
with in vitro studies, using a continuous microweighing
method to measure water delivery, and evaluate the
accuracy of our prototype. Based on the results of laboratory
accuracy study, we will move for the next step, the in vivo
study to evaluate the reliability of the device. To do so, we
intend to use the most common animal model of human
diabetes, streptozotocin-induced diabetes in the rat. This
will be an useful model to test the efficacy and the precision
of our system for control of blood glucose and amelioration
of diabetic complications.
ACKNOWLEDGMENT
This work was funded by FAPESP (process number
2010/511904-9).
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