Tips for “Voice of the Customer” Medical Device Research in Low- and Middle-Income Countries

Voice of the Customer Medical Device Research
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Tips for “Voice of the Customer” Medical Device Research in Low- and Middle-Income Countries

Authors: Mark Ware

Voice of Customer Medical Device research is an integral component in the user-centric design and development of medical devices. It is increasingly an expectation of regulatory bodies to ensure devices meet the needs and expectations of healthcare workers and patients.

VoC investigation by contextual research in the field is essential for identifying and characterizing key product stakeholders, defining the use environment(s) and use case(s), mapping potential product workflow(s), and exposing technology limitations and shortcomings.

In my 10+ years focused on the development of diagnostic products for Low- and Middle- Income Countries (LMICs), I have made numerous trips to large urban centres and far-flung rural outposts across Africa and Asia. I have also learned firsthand many tips and tricks for conducting successful Voice of Customer Medical Device research in LMICs. This blog explains the importance of conducting VoC research in LMICs and offers 7 of my best tips to help make your VoC research in LMICs more enjoyable and successful.

Voice of Customer Medical Device research in LMICs

Most modern medical devices are designed for use predominantly in High Income Countries (HICs) in North America, Europe and elsewhere. However, many of these products eventually filter down to Low- and Middle- Income Countries (LMICs) where their performance may be lackluster due to the many unique challenges and needs found in LMICs.

The Global Health community acknowledges that medical devices and diagnostic products designed specifically for the challenging environments and needs of LMICs are vital to improve access to care around the globe.

To develop the right products to fill these needs, it is important that VoC research be conducted in LMICs, engaging their peoples, exploring their environments and understanding their needs. There is no substitute for seeing firsthand the many challenges medical devices face in LMICs, the fine dust on every surface, the stifling heat and humidity, the difficulties in reaching remote outposts on difficult roads, or experiencing the inconveniences of frequent power-outages and limited infrastructure. Now on to my 7 tips to help make your VoC research in LMICs more enjoyable and successful.

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Tip #1 – Not all LMICs are created equal

There are 128 countries on the most recent list of LMICs and this list includes large and growing economies as China, India, and Brazil as well as many smaller, less developed economies in sub-Saharan Africa and the Caribbean. So, where do you start your VoC research? First, you need to determine the who and where of your product’s key target market(s).

These should be determined by disease incidence, prevalence, or other available data. Armed with this knowledge, you can then select a small number of locations that are representative of those target markets. This is where you should focus your VoC research. You will never capture all the nuances between different countries, but the similarities will be significant and valuable to research all the same.

Tip #2 – Find the right local partners

So, you know where you want to conduct your research, but lack connections on the ground to organize site visits with key stakeholders?  Visiting an unfamiliar place with its own unique customs and processes can be daunting. You will need to find local partners who understand the lay of the land and know how to open the right doors.

Academics or non-governmental organisations working in your area of interest are excellent places to start. They might be based close to your home base but have local partners or operations with local staff in the locations you are interested in visiting.

Once you make one good contact, your network will often start to grow quickly. International conferences can be another great place to make contacts in countries or regions of interest. Be up front about the purpose of your research, goals and interests. Nothing can replace the knowledge and experience of local support, so plan to spend some time building your networks.

Tip #3 – Do your homework

Nothing beats field research when conducting VoC research. Speaking with end-users, program managers, etc. and visiting their workplaces is irreplicable when trying to understand the challenges and opportunities of developing a novel medical device. However, before packing your bags and hopping on that flight, do some research at your desk, as there might be a windfall of valuable learnings out there to help focus your field research activities.

The World Health Organization, international agencies and non-governmental organizations like the Gates Foundation often publish guidelines, standard operating procedures, and much more on their websites. Many governments have publicly available strategic plans, guidelines and other helpful material to get your research off to a flying start before you ever leave the office.  Academic research on many Global Health topics is plentiful and those academics can be part of your networking strategy.

Tip #4 – Hire a local driver and vehicle

Public forms of transport are either non-existent or extremely limited in many LMICs. And if they exist, availability and reliability can be erratic. Taxi services can be unpredictable and access to rental vehicles very limited. Roads are likely to be poorly maintained in most rural areas and existing maps may be outdated and inaccurate. Finding sources of fuel can also be challenging.

I strongly recommend arranging a full-time driver with access to a sturdy vehicle, preferably a four-wheel drive SUV. For comfort, I advise a vehicle with air conditioning to combat relentlessly dusty roads and warmer climates. Your new local contact can often help organize transport and might even offer their organization’s driver to assist you. And be sure to tip your driver well. They will have earned it driving on those rough roads for many long hours.

Tip #5 – Be ready for the unexpected

I can confidently say that I don’t think I’ve ever had a field research trip go as planned, despite many weeks or months of planning. Be prepared for anything. I have had vehicles break down with punctured tires, malfunctioning engines, and broken suspensions. I have arrived for meetings to suddenly discover the person I am visiting is out of town or unavailable, I have had weather wash out bridges and roads, and much more. Staying flexible and being open to opportunities that present themselves will serve you well.

Build in lots of flexible time in your schedules for unexpected visits to local dignitaries or invites to dine with your local contacts. Getting to know them on a personal level is all part of building trust with your partners. Trust and respect are essential if your research is to get off the ground.

Tip #6 – Plan ahead, obtaining approvals can take time

Gaining permission to visit healthcare facilities and meet with healthcare workers and other stakeholders can be challenging in the best of circumstances and amplified when working in many LMICs. Cultural and language barriers abound. Developing contacts in organizations and building a relationship of trust can be a slow process, even if you are introduced by a trusted local partner. Take your time and be persistent without being pushy or demanding. Share the goals of your work and explain how the research will be used to develop products that could benefit them. I can almost guarantee you will be the first researcher who has come to them and asked their opinions on what sort of products they would like to use and why.

After all your planning, do not be surprised if you are refused entry on the day of your planned visit. It happens. Wires get crossed, security guards might not be informed of your arrival, your contact’s plans might change. Remember Tip #5 and remain flexible. Ask your local contact or driver if there is another site nearby that you might visit instead. Or take them out for a nice snack or a cool drink. They have probably earned the break.

Tip #7 – Interview managers and staff separately

Once you are on-site and are engaging with research subjects you might start to notice a strong culture of hierarchy in the organization. In my experience this can be more common in some regions or cultures. Staff members may be reluctant want to engage with you in the presence of their managers or superiors.

If possible, ask if you can interview the staff privately, even if it is just finding a quiet corner of the lab or office to ask a few quick questions. But remember, many staff may not want to risk disagreeing with their manager’s opinions, so make it clear that any thoughts or information they share with you will remain confidential.

Mark Ware is a StarFish Medical Senior Human Factors Engineer, Molecular Diagnostics Scientist, Human Factors Specialist and Global Health Advocate. Over a 20+ year career in the biotechnology and in vitro diagnostics (IVD) sectors, Mark has worked in both private and not-for-profit organizations, developing a comprehensive understanding of the molecular diagnostic (MDx) market and wider biotechnology landscapes, key large and small industry players, and regulatory frameworks in strategically important global markets.

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