MASTER IN PRODUCT DESIGN AND

DEVELOPMENT

PROJECT PLAN

DESIGN AND DEVELOPMENT OF A MEDICAL

ROBOTIC DEVICE FOR ASSISTED SURGICAL
PROCEDURES FOR BREAST CANCER PATIENTS

ROLANDS STROZS,
Nº20264
ABSTRACT

With the current society aging new challenges arise, with one of them being cancer. One in eight women
will develop breast cancer, during their lifetime. One of the best methods of prevention of cancer is early
diagnosis – using several methods of imaging like mammography and magnetic resonance imaging (MRI).
Ultrasound is also a common and affordable method of detection and offers real-time feedback to the
performing doctor, ultrasound can also be used to guide a biopsy needle for sample collection. However, this
process is challenging and takes decades to master.
Based on this problematic IPCA’s 2AI scholarship program project called OncoNavigator (NORTE-01-
0145-FEDER-000059) was created. This project proposes a navigation framework that combines the
information from real-time ultrasound imaging and magnetic breast lesion tracker with a collaborative
medical robotic to improve the precision of current breast cancer procedures, offering safer, faster, and easier
treatment for breast cancer patients. The task for this project is the creation of a case/shell encasing the
technology that will be attached to a KUKA medical robot.
With the main objectives of OncoNavigator and my role defined, the focus of this project will be split
between the patient and doctor needs and requirements. For improvement of the patient experience a user
centred design approach will be implemented, creating surveys and conducting interviews for the reflection
of the design proposal. At the same time ongoing rapid prototyping method will be used and usability tests
performed by colleagues of the project. Once a more refined design concept will be created a usability test
will be performed by a doctor for refinement of the project proposal.

Key words:
Industrial Design, Medical device design, User centred design, Usability, Breast cancer

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TABLE OF CONTENTS

ABSTRACT.............................................................................................................................................2
TABLE OF CONTENTS.........................................................................................................................3
LIST OF FIGURES.................................................................................................................................4
PROVISIONAL INDEX.........................................................................................................................5
THEMATIC FRAMEWORK..................................................................................................................7
PROBLEMATIC.....................................................................................................................................9
RESEARCH QUESTIONS...................................................................................................................10
HYPOTHESIS.......................................................................................................................................10
GENERAL OBJECTIVES....................................................................................................................10
1.1 ONCONAVIGATOR OBJECTIVES....................................................................................................................10
1.2 PROJECT OBJECTIVES....................................................................................................................................12

METHODOLOGY................................................................................................................................12
WORK PLAN........................................................................................................................................15
TIMETABLE.........................................................................................................................................16
BIBLIOGRAPHY..................................................................................................................................17
ASSOCIATED PROFESSORS.............................................................................................................20

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LIST OF FIGURES

Figure 1 Core biopsy needle.............................................................................................................7

Figure 2 Verza needle guide 1..........................................................................................................8
Figure 3 Verza needle guide 2..........................................................................................................8
Figure 4 Mamography of a breast with magnetic seed.....................................................................8
Figure 5 The KUKA medical arm...................................................................................................11
Figure 6 The Murab Project............................................................................................................11
Figure 7 Research Methods for Product Design.............................................................................13
Figure 8 Iterative cycle....................................................................................................................13
Figure 9 Iterative cycles in timeline................................................................................................14
Figure 10 Work Plan Timetable......................................................................................................16

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PROVISIONAL INDEX

Abstract
Acronyms
Table of Contents
List of Figures
List of Tables

Chapter I – Introduction
1.1 Thematic Framework
1.2 Problematic
1.3 Research Questions
1.4 Hypothesis
1.5 General Objectives
1.5.1 OncoNavigator Objectives
1.5.2 Project Objectives
1.6 Methodology
1.7 Work Plan
1.8 Timetable

Chapter II – Concept
2.1 Introduction
2.2 Survey
2.2.1 Survey aims
2.2.2 Target audience
2.2.3. Results
2.3 Concept Design
2.3.1. Initial Work
2.3.2 Design Proposals
2.3.3 Final Results
2.4 Prototyping
2.4.1 Setup and aims
2.4.2 Results
2.4 Usability
2.4.1 Target Group and setup

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 2.4.2 Metrics
2.4.3 Final Results

Chapter III – Refinement

3.1 Introduction
3.2 Interviews
3.2.1 Target group
3.2.2 Questions
3.2.3 Results
3.3 Refined Design and Prototyping
3.3.1 Introduction
3.3.2 Design Evolution
3.3.2 Refined Design Proposal
3.3.3 Final Results
3.4 Usability Tests by a Specialist
3.4.1 Metrics and Setup
3.4.2 Results

Chapter IV – Finalization
4.1 Introduction
4.2 Combined Result Summary
4.3 Product Development detail
4.4 Final Results

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THEMATIC FRAMEWORK

The life expectancy continues to increase with the global average now being 72.81 years and it is predicted to
be continuously increasing (World Life Expectancy 1950-2021, n.d.). Successfully solving the infectious
diseases, that killed people in early life have created new challenges – aging is a growing trend and with it
comes new challenges. One of the major ones is cancer – the leading cause of death worldwide, accounting
for nearly 10 million deaths in 2020 (Cancer, n.d.). The most common cancer in the world currently is breast
cancer (Cancer, n.d.). It is estimated that about 1 in 8 or 13% of women will develop an invasive breast
cancer during their lifespans (U.S. Breast Cancer Statistics, 2021). It is also considered to be on the top five
of deadliest cancers with 685 000 deaths from breast cancer in 2020 (Cancer, n.d.). However, the mortality
rate is low within the diagnosed cases as it is in fifth position in the survival rate from all cancers and 86.3%
of women live after treatment (Cancer Survival Rates, 2018).

The major role in the survivability of this cancer is early detection, diagnosis and treatment (Sun et al., 2017).
There are several detection methods – regular and digital mammography, digital breast tomosynthesis (3d
mammography) and magnetic resonance imaging (MRI) (Mammography Technique and Types, 2020). There
are as well new methods of imaging called microwave tomography that show promising results (Aldhaeebi et
al., 2020). Ultrasound can be used as well as detection method, however the physician needs to be skilful
enough to understand the imagery and detect potentially harmful lesions (Mammography Technique and
Types, 2020).
If a potentially suspicious lesion is detected a preoperative diagnosis, called biopsy, is performed (Bick et al.,
2020). There are several biopsy variants - fine-needle aspiration, core needle biopsy and vacuum-assisted
biopsy. A one-time use biopsy needle made by IZI Medical can be seen in figure 1. This needle is spring
loaded to retrieve the sample fast. To perform the biopsy the physician is inserting the needle in the body
part guiding it to the area of interest with the help of ultrasound imaging. Once the lesion is punctured, the
doctor can extract a sample with the help of the biopsy needle for pathology analysis a posteriori (Bick et al.,
2020).

Figure 1 Core biopsy needle

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 Source: (Quick-Core Auto Biopsy Needles, n.d.)

To aid with the performance of the procedure, there can be attachments added to the ultrasound probe. It is
common to add needle guides to have a more controlled performance during the procedure (Van Geffen et
al., 2008). There are several versions available as they are made to fit specific ultrasound probe models. In
figure 2 and 3 can be seen Verza needle guide by Civco.

Figure 2 Verza needle guide 1 Figure 3 Verza needle guide 2

TM
Source: (CIVCO - Verza Needle Guidance
TM
System for VerzaLink Transducers, n.d.) Source: (VerzaInteractiveBrochure, n.d.)

If a surgical procedure is required, to assist the doctor during the surgery the target area is localized (seeded)
(Bick et al., 2020). There are several types of seeding methods available, which are chosen based on the
circumstances, like budget, governmental regulations, or the doctor’s preference. However, the type of
marking method of this project is focusing on is called magnetic seed localization. Magnetic seeding is a
relatively new technique where a cylinder of 1x5 mm is inserted using similar needle, needle guide and
orientating with ultrasound in real time to see the lesion and the needle (Franceschini et al., 2021). The
operating surgeon can navigate to the area of interest using this method. In figure 4 can be seen a
mammography with already seeded lesions.

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 Figure 4 Mamography of a breast with magnetic seed
Source: (Zacharioudakis et al., 2019)

PROBLEMATIC

To perform the biopsy, the physician is inserting the needle in the body part, guiding it to the tumour with the
help of ultrasound imaging. This process requires high precision and skill to puncture the tumour with the
needle - potentially errors can occur and the patient can get injured (Themes, 2019). The process is carried
out by aligning the ultrasound probe on the same axis plane as the needle. This is done due to fact that
ultrasound shows a 2-dimensional image (a single segment) of a body part (How Does an Ultrasound Work?
| Mayfair Diagnostics, n.d.).
Once the lesion and needle are visible on screen, the needle is positioned parallel to the probe and the chest.
This done to prevent the needle damaging the patient’s chest wall (Radiographics.18.4.Pdf, n.d.).
This procedure can be difficult to perform as it is easy to lose the needle and the lesion on the screen, besides
that there is also the possibility to miss the lesion once the needle is fired (Radiographics.18.4.Pdf, n.d.)

If the performance has not been successful, the doctor needs to repeat the procedure until a sample is
collected. Human error has a substantial influence over the results as there is a 10 to 15% better rate of a
correct diagnosis, if two physicians look at the case instead of one (Mammography Technique and Types,
2020).
Finally, to obtain the profession in radiology is a very long process – before a radiologist is able to start
practicing, there are 13 years of learning required (Torres, n.d.). Even after that, there is still a learning curve
to master the technique (FACR, n.d.). The needle guides attached to the ultrasound probe keep the needle
parallel to the probe at all times, however it is limiting the angle of the needle, which sometimes needs to be
parallel to the chest wall and probe to avoid injuries (FACR, n.d.).

On the other end of the spectrum there is the patient. More than half of cancer patients suffer from clinically
high levels of anxiety before consultations and 37% of the patients remains in that state after the consultation
(Bronner et al., 2018). On top of that, diagnostic consultations often involve invasive procedures and the use
of biopsy needles. While it is more common within children to have fear of needles, 16% of adults still avoid

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annual influenza vaccination due to fear of needles (McLenon & Rogers, 2019). The needle size for
vaccination is 25 – 23 gauge which is 0.515 - 0.642 mm (Vaccine Administration: Needle Gauge and Length,
n.d.), however the regular biopsy needle in comparison is much larger – 14 gauge or 2.1 mm and varies in
length depending on the breast size and depth of the lesion (Needle Gauge Chart | Syringe Needle Gauge
Chart | Hamilton, n.d.).(Bick et al., 2020).

The complexity of the breast cancer treatment procedures for the doctor in combination of pre-consultation
anxiety, fear of needles and invasive procedures for the patient is a daily struggle in the medical field.
Besides that, the mentioned attachments to the ultrasound probe are single use items. That means that after
the procedure the needle guide is discarded adding more to plastic waste. The aim of the project is to address
the main mentioned issues as well as aim to address the issue of the single use items or as Cameron
Tonkinwise suggests design away or undesign these attachments. (Yelavich & Adams, 2014).
RESEARCH QUESTIONS

From the identification of the main problems, research questions were formulated based on user-centred
design approach for the patients and ergonomic/usability test driven design process for the performing
doctors.

 Can user centred design approach positively impact patient’s experience – reduce anxiety and fear during
the breast cancer related procedures?
 Will this process improve the experience of the performing doctor as well?
 Can ergonomic and usability tests be the leading design process for creation of a medical device for
health specialists?

HYPOTHESIS

The user centred design approach will aid in creation of better experience for patient during breast cancer
procedures and improve the performance of the doctor by implantation of usability tests.

GENERAL OBJECTIVES

The objectives of this project were set based on the pre-defined set of goals by the OncoNavigator project
which are elaborated bellow.

1.1 ONCONAVIGATOR OBJECTIVES

The first phase of the project will be an extensive study of state-of-the-art breast oncological procedures.
With the acquired information, individual modules of the OncoNavigator proposal will be created.

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 AI will be implemented for the automatic detection of breast lesions from ultrasound and magnetic
resonance imaging data. An important aspect of the oncological procedures is to precisely target the lesion,
for that a magnetic localization system for breast tumour mapping will be created. This will be incorporated
within an end-effector of the KUKA robotic medical arm, which is certified for use in medical procedures
(KUKA LBR Med Lightweight Robot, n.d.). The end-effector will be programmed to operate smoothly and
reduce user-dependency during the magnetic seeding, biopsy, and ultrasound screening.

For the control of the device a user-friendly interface will be developed for easy control of the
OncoNavigator during all the procedures. All these elements will be combined in a functional prototype
attached to the KUKA medical arm seen in figure 5 bellow.

Figure 5 The KUKA medical arm

Source: (KUKA LBR Med Lightweight Robot, n.d.)

1. To better illustrate the end goal of the OncoNavigator project, a good example is a project called
MURAB that is currently in development as well. It is using the KUKA medical robotic arm and has
incorporated an automated needle guide/needle in the end-effector that can be seen in figure 6. This
project focuses on breast cancer treatment as well, but with different methods of imaging and
guidance (About MURAB · MURAB, n.d.).

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 Figure 6 The Murab Project
Source: (‘Updates on the MURAB Project’, n.d.)

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1.2 PROJECT OBJECTIVES

The task of the scholarship is the creation of a case/shell encasing the technology that will be attached to the
KUKA robot. Within this task a set of objectives are established:

 Research and gathering information relevant to the chosen topic including the state of the art.
 Based on the acquired information, formulation of the problematic and hypothesis is defined.
 Creation of a questionnaire for the general public to see the reactions to medical equipment that is
intended to be used in the project.
 Initial design concept generation
 Rapid prototyping and performance of usability tests to guide the design process.
 Creation of survey to former/existing cancer patients to reflect on the prototype proposal.
 A more refined design proposal creation and prototype creation for performance of usability tests by a
practicing specialist.
 Based on acquired information a finalization of the design.

METHODOLOGY

The project realization will be based on principles of design thinking by Tim Brown (CEO of the IDEO) with
focus on user centred design approach that will include both the doctor and the patient experiences. As T.
Brown states “Although I would love to provide a simple, easy-to-follow recipe that would ensure that every
project ends as successful as this one, the nature of design thinking makes that impossible.” (Brown, 2009).
This reflects as well in the IDEO’s own website which has quoted 10 different definitions of what exactly is
design thinking (Design Thinking Frequently Asked Questions (FAQ), n.d.). For this particular reason there is
no specific method used. The design thinking process is employed conceptually and interpreted for this
project by creating a customed workplan, that is elaborated in the work plan chapter, focusing on the creative
problem solving of both parties – patients and doctors.

Parts of the creation of the work plan was based on The Research Methods for Product Design by Alex
Milton & Paul Rodgers. The authors provide a set of tools, which does not necessarily have particular rules
of order as they state “the design process is more cyclical than linear” (Milton & Rodgers, 2013). In figure 7
it can be seen the provided research methods from which some were chosen for this project, underlined in
red. Some methods of designing like sketching, brainstorming and 3d modelling will be used, however there
will also be emphasis on photo and video diaries, questionnaires and surveys, interviews, rapid prototyping,
product usability and mock-up making.

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 Figure 7 Research Methods for Product Design
Source: adapted from (Milton & Rodgers, 2013, pp. 16-17)

These chosen research methods have been organized in 5 stages which can be seen on the Timetable chapter
(figure 10). The first stage is predefined by the OncoNavigator project. However, as A. Milton & P. Rodgers
argue: “Each iterative cycle includes four distinct stages, which are usually passed through before either
repeating the cycle to gather additional research data, or satisfied with the research undertaken moving on to
the next stage of the design process and the next cycle of design research and development.” (Milton &
Rodgers, 2013). The illustration of the iterative cycles can be seen in figure 8.

Figure 8 Iterative cycle

Source: (Milton & Rodgers, 2013, p 15)

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Then this cycle or in the case of this project each cycle is a stage of the project. Then this cycle is inserted in
the timeline or design process that can be seen in figure 9.

Figure 9 Iterative cycles in timeline

Source: (Milton & Rodgers, 2013, p. 15)

This means that stages from 2-5 (cycles) of the project plan can be analysed, reviewed, then adjusted if
needed to move forward in the design process and the cycles repeated until the finalization of the project. A.
Milton & P. Rodgers elaborate and provide more information on each method. Based on their suggestions,
also a set of surveys and interviews will be created and carried out.

Finally, the realization of usability tests will be based on the Measuring the User Experience by Tom Tullis
and Bill Albert (Tullis & Albert, n.d.). The first round of tests will be carried out by a small group size – the
researchers of the 2AI department to receive general feedback about the prototype. Then, provided by the
OncoNavigator project, there will be an opportunity to perform usability test by a doctor. Based on the
authors work, metrics will be carefully selected and defined, all steps of the tests will be documented by
taking pictures and filming the process.

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WORK PLAN

The work plan of the project is organized in several stages and an organizational diagram/timetable is
created to better illustrate the steps and phases of the proposed work plan (Figure 10). The organizational
diagram/timetable can be seen in the next chapter.

Stage I: The objectives of the OncoNavigator are established and will not be altered. Based on these
objectives set as the foundation of the project, my own research within the project is identified and defined -
medicine and medical procedures involve both patients and performing doctors. These two groups will be the
main focus of this research.

Stage II: Gathering information about procedures and related information surrounding the breast cancer
treatment will play a crucial part to establish framework of this area. Exploring the state of the art will be a
critical factor for the project as it gives a good foundation for design process and identification of present
problems.

Stage III: From the identification of the main problems, research questions are formulated based on user-
centred design approach for the patients and ergonomic/usability test driven design process for the
performing doctors. These will be the main methods for realization of the project.

Stage IV: surveys will be conducted to guide the design process in a user-oriented manner in order to
understand the patient’s perspective and needs. At the same time continuous rapid fabrication will be used to
create prototypes by 3d printing to perform usability tests for improvement of the current experience with the
medical equipment for the doctors.

Stage V: For the next stage of design proposal, another survey will be conducted, aimed at former and
existing patients and final usability tests performed by a practicing specialist. The goal is to create an
anonymous survey aimed at people who had/has breast cancer. This reflection on the prototype will help
refine the final model in a user(patient)-oriented manner. It is planned by the OncoNavigator project to
collaborate with specialists from hospitals who perform breast cancer related procedures daily. This will be
the opportunity to perform usability tests with actual specialist for the creation of the final proposal.

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TIMETABLE

Figure 10 Work Plan Timetable

Source: Author’s work

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ASSOCIATED PROFESSORS

Prof. Demétrio Matos

Instituto Politécnico do Cávado e do Ave (dmatos@ipca.pt)

Prof. Miguel Terroso

Instituto Politécnico do Cávado e do Ave (mterroso@ipca.pt)

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