Application of Human-Centered Design in the Production of Medical Devices and in Development of Vaccines, Drugs, and Diagnostics

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Abstract

This paper describes the concept of Human Centred Design (HCD) and its applications in the health sector. Inculcating the five core principles of HCD can provide a more effective and efficient approach in the processing and production of medical devices, vaccines, diagnostics, and drug development. The application of HCD principles is of importance in developing a patient centric focus in developed health care systems but arguably is far more important in areas of the world where factors mitigate against the development of sophisticated health care options.  HCD approaches will be discussed in this context, using working examples from the area of diagnostics, vaccines, medical devices and drug development and their application in underdeveloped countries.  Comparisons will be made between the HCD approach and traditional approaches to medical innovation.

Introduction

What is Human-Centred Design (HCD)?

HCD is an approach to interactive systems development that is used to make systems usable and useful by focusing on the users, their needs, and requirements. [3] By applying human factors/ergonomics concepts and usability knowledge and techniques, HCD enhances effectiveness and efficiency and in turn improves human well-being, user satisfaction, accessibility, and sustainability. Using this method during production could also possibly counteract adverse effects of use of some systems on human health, safety, and performance.

The concept was first introduced by Mike Cooley during a professional transition to computer-aided design with an aim to improve user experience. [3] HCD was previously known as participatory design and was birthed in ancient Athens. As time passed This concept soon began to slither its way the world and flourished there under names such as Design Science, Universal(inclusive) design, transformation design, service design and user- centred design.

Principles of Human-Centered Design:

1. Empathize: Learn about the target audience for the product. This is done through surveys, questionnaires, immersion into the audience, meetings, self-documentation, user experience interviews, etc.
2. Define: Establish key questions based on the audience requirements and the product. Identifying the theme, interpreting findings, sorting through the findings, framing opportunities, and setting a ‘Design Challenge’ are involved in this process.
3. Ideate: Brainstorm and create solutions. The problems may involve including factors such as visual, tactile, experiential aspects of the product. 
4. Prototyping: Build the representations of one or more ideas to introduce to users record their response. 
5. Test: The user feedback from the created prototypes is used to improve the product to ensure complete user satisfaction. 

HCD principles have proven to be useful in a number of settings, especially in the health industry.

One of the most prominent examples that demonstrates this is Project Firefly. Details of this project will be highlighted in the section below.

Why is such an approach necessary in the health sector?

Communication between the health industry and the public is not satisfactory, and since patient autonomy and communication is one of the main pillars of medical ethics this is vitally important.  which may mislead people or leave them in the dark when it comes to their own healthcare. This may be because the quality of education in various parts of the world (especially underdeveloped countries) does not always allow everyone to gain a good understanding of the scientific processes that guide our healthcare system. 

The industry being science driven is essentially top-down managed focussing resources on wealthy markets and always with a view to profit margin.  In a world where healthcare is of utmost importance in places such as third world countries, this approach does not bode well for attaining acceptable global health. [1]

Figure 2 shows a global map of countries that produce and sell drugs whereas Figure 3 displays the distribution of where these drugs are being purchased. It is clearly observed that the global health market is mostly confined to first world countries or countries where wealth is abundant. Big pharmaceutical companies are gradually starting to realise that there is a massive market in underdeveloped countries. This should seem abundantly clear especially as we are paving our way through a global pandemic. Moreover, disease outbreaks more often than not, tend to take place in underdeveloped countries.

There are some other factors that generally may not be considered during the production of healthcare equipment and drugs. Some communities may have religious beliefs that may go against some treatments or drugs. Poverty is one of the main concerns that stand in the way of global health. Incorporating HCD principles during development can definitely help break through some of these barriers. Moreover, the global health market is mainly centered in first world countries or countries where wealth is abundant. Big pharmaceutical companies are starting to realise that there is a massive market in third world countries, especially since the onset of pandemics, disease outbreaks, etc., tend to happen in underdeveloped countries. The same can be said about countries where cultural and political factors play a big role in the acceptance of certain forms of healthcare. There may not be a very potent market in such areas as the healthcare provided to them in the form of drugs, vaccines or even certain medical devices may not be acceptable. This is where HCD can really dive into production and really find out the specific requirements of such communities which will in turn give rise to new markets and essentially benefit all those involved.

Applications of HCD in the Production of Medical Devices

Even with the presence of such a vast variety of lifesaving technology, only few of these benefit communities with minimal resources. To begin with the high purchasing price is an obvious issue, on the other hand the World Health Organization found that nearly three quarters of devices provided by industrialized countries are not used when they reach low resource communities. There are many possible reasons as to why this occurs:

• Power fluctuations in such areas can cause most of the medical and diagnostic devices to fail.
• High temperatures, high humidity, dust, insect infiltration, poor availability of spare parts and low staff-to-patient ratio can lead to unsatisfactory treatment for the patients.

To produce efficient and well-designed products that are functional in locations with minimal resources, medical devices need to be developed in such a way that they cover the requirements of the local patients, clinics, hospitals, and communities.

Applying this concept during the process of development of medical devices will have the following advantages:

• It will highlight the essential requirements of the stakeholders that are involved in the success of the medical technology and will in turn bring about a positive change in global health.
• The chances of producing more creative solutions will increase
• The information generated using this concept will help in the quick evaluation of similar devices completely avoiding months of monotonous testing.
• Laying out the basic targets to hit will help come up with a solution that satisfies all the essential needs of the patients and the stakeholders.

A case study that highlights all these key features is discussed below.

Case Study: FIREFLY PROJECT [2]

Jaundice affects a large population of new-born babies all around the world every year, 100,000 cases of which become fatal and leaving at least 50,000 babies disables. This problem most commonly occurred in Africa and South Asia. To treat this condition, new-borns require a treatment known as phototherapy which is a minimally invasive treatment the shines blue light on the skin of the affected new-borns. This allowed the new-borns to pass the excess bilirubin out of their bodies through urine or stool, so it does not cross the blood-brain barrier. Design that matters (Dtm), Medical Technology Transfer and Services (MTTS) and East meets West foundation combined their resources and knowledge and became instrumental in the production of better tools to treat new-born jaundice in low- resource hospitals.

The following steps took place:

1. First thing that was done was defining the team, identifying the appropriate team members, users, stakeholders and scanning through the available technologies and existing approaches
2. The identified stakeholders, users were interviewed, and every single requirement is listed and defined.
3. Consolidation of the data and beginning of the ideation process. From the information gathered, the aim was to create a device that would meet the following requirements:

• Effective- device must provide intense phototherapy and also look like it is providing intense phototherapy. The perception of efficiency is important to drive stakeholder adoption
• Comforting- aiming to make a ‘high-tech bird’s nest’; comfortable for the new-born and aiming to achieve more area of light shown on the skin
• Maintainable- should be easy to clean with high grade alcohol or disinfectants to prevent the risk of infection. It should also be durable to ensure long life and reduce cost long term. This was done by ensuring the absence of moving parts to prevent wear and tear.
• User friendly- People with low community level education and skillset should be able to use this device hassle-free.

4. Ideation and prototyping began using the abilities of the high power- long lasting- LEDs that function low consumption of electricity, to their advantage. The shape of the device was in the form basket that could fit in small places in crowded hospitals hence allowing them to accommodate more new-borns.

5. When undergoing testing, user and stakeholder feedback was taken and incorporated into the final prototype. One interesting point that was noticed is that when one of the nurses covered the shade of the basket with a cloth, the exposure to the blue light was prolonged and more intense and hence, was more effective. It soon became mandatory to cover the basket with a sheet. Such a simple change would have not been left unnoticed if it were not for this all-rounded approach

Conclusion: This approach to Project Firefly created a medical device that rid local hospitals of the requirement and maintenance of high-cost equipment, excessive overcrowding, low performance, or failure to conduct treatment due to power fluctuations or complicated operation.

Application of HCD in the Development of Vaccines

The development of any kind of vaccine involves several steps: exploration, multiple phases of clinical development, registration, and launch. Application of the principles of HCD may result in a shorter production period of vaccines. By doing so, the durations of clinical development may decrease leading to the faster administration of the vaccine. [1]

Even during a crisis as big as the current one known as covid-19; the development of the vaccine was undertaken in a span of few months whereas normal vaccines take years to get approval. This leads the population to doubt the viability and efficacy of the vaccine itself. Moreover, the quality and future consequences of the vaccine may be put in doubt due the top- down managed companies that are racing to develop a vaccine for COVID-19 and get approval without going through all the stages of its clinical development.

Given that HCD principles are to be incorporated in vaccination programme, the following steps are to be followed:

1. Study of disease epidemiology: Getting a deep understanding of the frequency, risk factors, causes and the general target population though HCD
2. Collecting and defining: Using this information to create a vaccine that meets all safety and efficacy requirements
3. Accessibility: The vaccine needs to be accessible to the target population through reliable delivery facilities. They may also need to be stored in controlled environments, and if this is the case for third world countries, a detailed plan must be laid out to ensure the safe transport and storage of the vaccine. This is where an HCD approach may benefit the system.
4. Cultural and political acceptance: Communication is an essential factor here to ensure maximum participation in the vaccination programme.
5. Cost effectiveness: This can be ensured through local human centric approaches and local delivery.

Application of HCD in Drug Development

As seen in the above figure, third world countries have a very minimal share and participation in the global pharmaceutical market. [5] This is unfortunate as it is very evident that pharmaceutical companies have a big opportunity for a market here given, they follow an HCD approach during drug development. Like vaccines, drugs also require about 10-12 years to go through all the phases of production (drug discovery, preclinical development, clinical development, approval and then to the market) making the final product extremely expensive. This leads big pharmaceutical companies to target bigger and more reliable markets making the availability and cost of these drugs in third world countries questionable. Using an HCD approach during drug development and administration will benefit both- pharmaceutical companies and the people in need of medication.

Drug Repurposing:

This is one such HCD approach used during drug and administration. Drug repurposing is the concept of re-using previously existing drugs for new therapeutic uses. [6]

For example: Chloroquine is a drug that is generally used to treat or prevent malaria. However, after studying the mechanism and working of the drug, it was found that chloroquine may also be used to treat symptoms of Covid-19. [7]As the drug is being repurposed and not developed from scratch and all the existing side-effects are known, it in turn boosts availability and affordability of the drug. Covid-19 has now spread to every continent and having affordable medication to treat its symptoms is essential.

Applications of HCD in Diagnostics

One important aspect to cover during the development of diagnostic devices is the concept of surveillance which is also one of the foundation principles of HCD.

What is surveillance? 

The systematic, on-going collection, collation, and analysis of data for public health purposes to assess and respond as necessary- it is the continuous collection of information to inform action.

Surveillance performs the following tasks:

• Understanding trends and developments quickly at the site of action.
• The large amount of data that is collected from surveillance can be used for research purposes.
• Helps to identify the pattern and prevalence of the disease.

Why do we need surveillance?

• Helps in detecting outbreaks and intervening in affected areas
• To monitor ongoing threats
• To evaluate public health care policies
• To ensure that all necessary information is acquired based on which limited resources may be used efficiently

Affordable and reliable diagnostic equipment is a rarity in third world countries. This is where an HCD approach along with surveillance can help create satisfactory diagnostic equipment.

What to expect from such diagnostic equipment?

• Needs to be affordable for low-income populations.
• Easy to use and interpret.
• Must stay viable during storage in their respective environmental conditions.
• Must be reliable and accurate.
• Must be suitable in communities with cultural and religious principles.
• Some equipment may require a certain level of privacy.

An example of a diagnostic equipment that was designed using an HCD approach has been explained in the case study below by the University of Washington. [8] This is a perfect example to illustrate the importance of surveillance and the drastic changes in diagnosis and treatment it can bring about.

Case Study: 

In this study, the entire continent of Africa was broken down into blocks of 9.6 square mile area. Each block was assigned a local group of people to monitor the prevalence of HIV which produced a detailed image of where this disease was mostly prevalent in Africa. It was found that HIV affected more areas in South Africa and the epidemic was found to be non-existent in the majority of the content. Such a fine-grained image of the distribution of this disease would not have been discovered if this surveillance had been done at a national or province level. This information that was collected had a huge impact in the diagnosis, treatment, and prevention of HIV in Africa.

The problem that the officials faced now was that due to the population’s mobility, the infection was spreading faster and administration of treatment for the infection proved to be difficult as each individual was asked to pick up their own prescriptions. This led to many patients missing several doses. Consequently, a new policy was introduced that allowed members of the local HIV-positive peer support groups to pick up and distribute each other’s medications. It is clearly visible here that an HCD approach to treating this infection provided a simple solution that had a drastic impact on the population’s health.

This study led to the discovery of self-testing HIV kits that met all the requirements of diagnostic equipment as listed above and proved to be extremely useful in preventing the spread of HIV. [9] 

It provided the following benefits:

• Diagnose HIV status.
• Diagnose whether HIV medication has been taken (irregular administration of medications leads to aids).
• Negates the need to travel to a clinic.
• Test can be taken in privacy eradicating the fear of the heavy stigma that hovers around this disease

Conclusion

HCD has proved to have a lot of promise in the health care industry. These are only a few areas where it can be applied. There is much scope for its principles in the future of healthcare and we are only beginning to tamper with its possibilities. It can be concluded that using this concept and appropriate resources, any given project can be created and function at its maximum potential. HCD principles serve as the necessary guidelines to do so.

References

1. WHO global strategy on people-centered and integrated health care services
2. Neonatal Phototherapy and Vitals Monitoring Device- Team 49| Parul Agarwal, Marty Puru and Hiba Shahid| ECE 445 Design Review Document|2/22/18
3. Alexandra Nemeth. https://blog.movingworlds.org/an-introduction-to-human-centered-design/
4. Michelle L Henninger  1 , Carmit K Mcmullen  2 , Alison J Firemark  3 , Allison L Naleway  4 ,  Nora B Henrikson  5 , Joseph A Turcotte. Perm J. 2017;21:16-191.
5. Matej Mikulic, Sep 4, 2020. /www.statista.com/statistics/309425/prescription-drugs- market-shares-by-top-companies-globally/
6. Sergey A. Shiryaev1, Pinar Mesci2, Antonella Pinto1, Isabella Fernandes2, Nicholas Sheets3,
   Sujan Shresta3, Chen Farhy1, Chun-Teng Huang1, Alex Y. Strongin1, Alysson R. Muotri2 &
   Alexey V. Terskikh1 Scientific Reports | 7: 15771 | DOI:10.1038/s41598-017-15467-6
7. Drug repurposing: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5758385/
8. Laura Dwyer-Lindgren etal. (2019) Nature, 570, 189-193. Mapping HIV prevalence in Sub-Saharan Africa between 2000-2017.
9. WHO prequalification reports. Mylan test kits lateral flow for HIV. www.who.int/diagnostics_laboratory/evaluations/pq-list/190708_pqdx_0320_090_00_pqpr_mylan_hiv_self_test.pdf

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