Investing in Impact

Thank you for listening to Villgro Africa. Today, we hosted Wambui Gachiengo, an innovation leader in the medical device industry with experience in both North America and East Africa and Dr. Robert Karanja, a renowned medical researcher with over 15 years of experience and the Chief Innovations Officer & Co-founder of Villgro Africa. The show was hosted by Wilfred Njagi, CEO & Co-founder Villgro Africa and Dr. Arun Venkatesan, CEO & Co-founder Villgro USA. This podcast is produced by Villgro Africa.

What are some of the steps you need to go through from prototyping a medical device innovation to commercialization?

Wambui: 

- Always start with the user and keep the end user front and central in the entire process. 

- Observe and have lots of conversations with people who would be using the device. Once you understand that space then you need to do a lot of homework on the clinical and technology space as well as understanding competitive devices. 

- Once you do the development you have to go through the regulatory process and you have to do a lot of testing. That includes user feedback so that you iterate until you get to a device that the market wants and that can be approved from a regulatory stand point and that can also be commercially successful.

Can these steps can be packaged in a replicable & transferrable manner compared to what you have seen in the West and what you have seen in East Africa? 

Wambui: Absolutely. I know there are people who say things like invention and innovation are things that cannot be taught but I believe that if you have these tools and you understand them well you can implement them in any environment. If you have teams of people who really understand their subject matter expertise you can use these tools and teach them and guide people to keep the end users in mind and continue the innovation process. It may be the case that we may have to tweak some of the process and structures a bit to fit the environment we may need to work on building enabling environment like having access to rapid prototyping and the end ISO Certified manufacturing facilities but I believe we are already moving and will be able to adjust as we move forward.

What are the areas where Villgro Africa adds most value?

Robert

- The value we add is funding it is usually very small funding but it helps innovators to get a stamps of approval, some recognition and validation to potential funders or investors that typically would want to sit on the fence until they see that the venture is more of a sure thing.

- Being able to provide a learning by doing type of mechanism that allows an innovator or young startup to actually go through those five steps unlike learning in theory, working with the benefit of the experience within the Villgro Africa team. This helps de-risk the commercialization process in a very significant way.

- We are also an honest broker. Regulators may not want to have a direct line of communication to the people they are regulating but it is possible for them to have discussions with enablers like us. That way we are able to have the feedback loop between the regulators and those who are being regulated. This is important especially for us in the ecosystem because our regulators are also learning how to regulate home grown innovations.

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This is the first episode of a three-part series on Medical Device Regulation: Navigating the FDA/CE mark regulatory process. 

In this episode, we host Sona Shah, Founder & CEO of Neopenda. Neopenda is a medical device company focused on designing and implementing use base technologies for emerging markets. Their remote vital signs monitor reduces the burden of clinicians and helps them monitor more patients efficiently while reducing the risks of infection.

Sona Shah gives us insights into how they navigated the regulatory process for their medical devices in the USA and East Africa, the challenges they faced, and how MedTech devices can go about getting regulatory approvals for their products. 

"By no means should you compromise safety qualities because you are developing products for a different market...investing the time and money into developing a robust process early on is something that is required for all medical device companies." ~ Sona Shah

Should companies prioritize Regulatory Approvals and at what stage?

- Quality is essential - setting up a robust quality management system early on will give you an understanding of how to approach document controls and revision history. Investing in it early on and understanding the standards you will have to adhere to from a regulatory perspective is also important.

- Getting feedback from your users during your iterations and understanding how to document that is key during the early stage. You may want to go through the regulatory approvals once you have a more defined product.

How can companies minimize expenses while maximizing regulatory outcomes?

- Consultants - Regulatory consultants are essential because they understand the nuances of the documentation of the regulatory process. It is important to establish the QMS with them and once you have that set up you follow the laid down process. As you are starting to finalize your product I would recommend bringing on a consultant as it will save you the time and money you may have o spend redoing your product.

-Even if you are applying for local regulation I would recommend you understand the FDA/CE Mark process well because it can be a lot of work to go from local registration to stringent authorities like FDA/CE Mark. Design for submission to FDA/CE Mark during your process as this is typically sufficient for local registration.

This is the second episode of a three-part series on Fundraising: Demystifying the local vs expat founder funding gap. In the previous episode we learnt that one of the proof points investors are looking for is a strong team armed with passion and diverse skill sets.

In this episode we host James Copple, Founder of Strategic Applications International (SAI) also known as Servant Forge and Chrispinus Onyancha, founder of a Ugandan-based startup called clinicPesa - on the role of team dynamics in fundraising.

Part I - Investment Readiness

Over the past few months, there has been increased discussion around the funding gap between expat and locally founded companies. To explore this further, this is the first episode of a three-part series on fundraising with a specific focus on demystifying this gap.

In this episode, we talk about what makes expat founders more investment ready and how local founders can attract more funding with Joshua Kibera, a local founder of The Pathology Network, and Emilian Popa an expat founder of Ilara Health. 

Key Takeaways

- Connections and relationships are important in fundraising. Companies with strong relationships with funders have a higher chance of raising more funds compared to companies with fewer connections. 

- Relationships are built from visibility and access to information. Most foreign founders have a background in business schools like Harvard and MIT where information is accessible and relationships are easier to make compared to a founder sitting in Mombasa trying to raise funding from the same pool of funders.

-  Income disparity - Expat founders have the advantage of getting the very early stage seed money (bootstrap capital) from friends and family who are more culturally inclined to invest in ideas. They are also able to attend more competitions and conferences across the world to meet investors.

- Information is however becoming more accessible with more virtual competitions and pitches taking place. Investors have also become more accessible compared to the past when one had to travel to pitch or meet them.

- Socio-cultural factors - culture is also a major factor, ex-pat founders are more articulate in communicating their Big Hairy Audacious Goal while local founders tend to downplay their achievements.

What Investors look for in an Innovator

- The team - the quality of people, their motivation, and their skillset.

- The market dynamics - the size of the market, the need, potential expansion, and whether the product can be replaced.

- Communication - Are they able to communicate their Big Hairy Audacious Goal well?

Thank you for joining us today for this episode on bridging the funding gap between local and expat founded companies. In the next episode, we will discuss the role of team dynamics in fundraising.

We invite your suggestions or comments. Feel free to go to our website at www.villgrokenya.or.ke and share your thoughts or offer suggestions for future podcasts.  This podcast is produced by Villgro Kenya and Rob Beyer and Wilfred Njagi were your hosts. See you in the next episode.

Key Takeaways:

Med-tech innovations are picking up the pace in East Africa in a bid to provide homegrown solutions to healthcare challenges. Being a nascent field there are fewer mentors who have gone before them within the ecosystem to help them scale their innovations. There is a need for more mentors to help guide these innovators to not only develop impactful innovations but also thrive as enterprises.

Mentorship helps innovators (Mentee):

• Gain access to funding – mentors help innovators in fundraising and putting together compelling proposals for their projects so that they are able to compete on a global front.

• Fill the skillset gap – Enterprises gain access to mentors who have years of expertise that complement their team and help them move forward fast with fewer mistakes.

• Access to networks – Mentors can help unlock partnerships with key people who can benefit the enterprise.

Mentees need to 

• Really understand their device, process, service of what they are developing, do extensive research on the market to see if it is scalable. 

• Think through the business aspect during the product development stage. Don’t look at them too late when so much has been done.

• Evaluate whether they should focus on the R&D later on in their journey or whether they can outsource it so that they can focus on marketing and distribution. 

• Mentees also need to reach out to mentors, make the most out of it, and utilize the expertise available to them. Seek out other mentors and do your best to seek the specific guidance you need.

At Villgro Kenya we run a mentorship program for our portfolio companies, in a bid to expose them the much-needed guidance in business development and product development. Feel free to view our mentors here .