Navigating Regulatory Process for Medical Devices Part II

Guests – Wambui Gachiengo & Dr. Robert Karanja

Hosts – Wilfred Njagi & Dr. Arun Venkatesan

Wilfred: Having led innovation team in the western market and patented your own device, we don’t see people coming back often. What inspired you to come back and what are your plans for building the local invention ecosystem

Wambui: It has always been my intention to come back and to use the knowledge and skills I acquired in the US to make an impact on people’s lives on the African continent. While there are more resources in the US, I believe that the opportunity to make a difference is greater in Africa

Kenya also seems to be at the tipping point ‘with very highly trained professionals and the ability to move tech development manufacturing and specifically healthcare technology forward and enable Africa to be an actual industrial power that can be reckoned at a global level.

I am hoping to work with strong players in the incubation and acceleration field to empower these professionals to use powerful tools like design thinking and other tools in the development field to structure the innovation process so that we can produce social and economically impactful innovations.

Wilfred: At a very high level 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. The first thing to do is to 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 all of that is understood then you can really nail down your requirements and really understand what the device is that you are going to develop. Taking that you then start the development with a very clear understanding of what the user needs. 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.

Wilfred: Do you think some of these steps can be packaged in a very replicable transferrable manner compared to what you have seen in the West and what you have seen in East Africa? Do you think these are transferrable processes?

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.

Wilfred: Can you speak to documentation. I know if you are preparing to go through regulatory then all these steps you mentioned need to be documented as you make iterations in your design history.

Wambui: For especially many engineers and some human being in general the documentation is often that thing which is not fun. We want to be developing and building stuff. But if we think of the documentation as part of the development that will enable us to develop a device that is useful, approvable and even commercially successful, the documentation becomes less painful. Documentation would be first of the user requirements. You document those very clearly so that you are very clear about what it is you need to be developing as well as things about the regulatory process. What class of device are you developing? then you have to keep a good record of the flow down of those user requirements to technical requirements then going even further to the testing and the validation of your device. You have to keep a really good and complete design history file and what that means is that any time you make a design change, that has to be documented. When you do your risk analysis and testing, all these have to be very well documented so that you have a good package for your regulatory approval process

Arun: Wambui, you have brought up a very important point about the interlink between the regulatory process and the process of medical device development. Let me take you one step back to the manufacturing process certification (ISO 13485) then the product approval, can you explain these a little bit further and shed some light on the development process and how this is impacted by the regulatory approval process. How can developers tune themselves to this so that they have maximum success?

Wambui: While I am not a regulatory expert I can talk at a very high level about this. As I mention earlier, medical devices need to be manufactured in certified manufacturing facilities. You mentioned the ISO 13485, this certification takes into account a certain level of quality controls as well as documentation practices that is in the manufacturing process so that the products that are going through the certified facility are repeatedly high quality. A developer needs to keep that in mind that the product they are developing is going to be transferred into that kind of a facility.

On the other hand, for product approval processes whether it is a FDA, CE Mark or locally KEBS or PPB approval, these provide frameworks to ensure the medical devices that hit the market are safe and efficacious. Depending on the risk level of the device under development, that approval process can be fairly simple or a clearance process that is based on similarity to previous devices or it can entail a very long process that includes a clinical trial.

So the first thing to do is to identify what process a device will go through so that you understand what the requirements will be from a regulatory perspective and get those done in a timely manner. Also having a quality management system is key to make sure that the things like a design history file, risk analysis are completed in a timely and structured way.

I’d like to add that one of the things some engineers as they are innovating and inventing do not think about is bringing in a strong manufacturing expert before they freeze their technology development so that there is that seamless transfer of your approved device to an ISO certified facility.

Arun: You are uniquely placed with your experience from both worlds. You understand the Kenyan ecosystem and the US. Based on what you have learnt, what can startups do to minimize their expenses while maximizing on regulatory outcomes?

Wambui: I think if I say documentation again I may start sounding like a broken record but I think it is mandatory. The amount of stress, time and money you can save yourself by having very good documentation cannot be overstated. Many of the times when we are innovating or inventing we want to get to the device that works, but the process along the way, engineers just want to do the engineering work but that documentation that shows you have done your due diligence, that the changes that you have made and the things you have put in place have been thought through.

Every part and component in the device has been looked at whether it is from a compatibility standpoint or any other thing, due diligence needed to be done from an engineering perspective has been done. I also recommend that you do research on the space that you are working in thoroughly so that you understand it from a clinical, competitive, landscape and technology perspective. Doing your homework before you bring in a consultant will save you time and money.

Arun: All this discussion sometimes runs the risk of making it sound very complicated but I just wanted to stress that it is just detail orientation. The process of documenting and analyzing risks is fairly straightforward. How complicated do you think this is for the internal work?

It is fairly straightforward especially once you have done it before and if you have support. The support is available in the regulatory requirements, ISO Standards and the EM Standards, it is very well laid out, what you need to do from a risk management perspective, from the need for a design history file and so on. It is very straightforward.

Wilfred: Robert it is good that you mentioned ecosystem challenges earlier, in your last five years of experience working with inventors in east Africa, what are the common challenges that you have come across

Robert:  One of the big one is that most of the inventors we have worked with are very strong in the sciences and what I have found is that especially in Kenya and East Africa there is a lot of capacity in the life sciences. There is a bigger gap when it comes to the engineering side of things so whether you are talking about a medical device, a drug what you realize is that the capacity, training and domain expertise during the early stages of the discovery phase is quite straight forward. When you start to figure out how to do mass production and manufacturing for the market, whether it is chemical engineering or electronics, there is a challenge in that regard. So that is the first, translation from science to technology.

The second is being able to make the technology a commodity and launching it in the market place. We have a major knowledge gap in terms of finance, business and on top of that there has been a massive challenge in the ecosystem in terms of the way intellectual property is understood. We have seen a lot more lock in as a result of creating awareness about Intellectual Property among the research, academia communities. It has created more harm than good. We know that no one organization can have all of the skillsets you need to take an innovation from idea to scale. We do need to build entrepreneurial teams and the information asymmetry is such that people are fearful of opening up and inviting complementary skillsets to partner with them then whole innovation comes to a stop. So that is in terms of capacity and lack of a team work approach to innovation.

The valley of death. In the tech space it is possible to come up with an idea, code and within a few months you launch it to the market and test it with actual customers because there is no manufacturing that comes into play. However, when we talk about a hardware invention based innovation then for this you need to figure out the manufacturing piece. In heath there is a massive regulatory angle to it. It is not just enough to understand where you can build your product but you also have to understand if the manufacturing is compliant and whether it is being done within the good manufacturing practice. Is it able to meet the regulatory demands in order to achieve market approval whether it is locally or in other markets you intend to commercialize your invention?

So that again is a massive gap. I think for Africa, engineering is probably the weakest link when it comes to STEM. On top of that adding the QMS, standards and support services whether it is consultancy or otherwise. Being able to build QMS that are world class, those kind of things requires one to glean on people who can help design those QMS and roll them out. A lot of challenges also on the soft skills beyond the hard skills of engineering and then on top of that you realize that all these things cost money. Where do you get te funding to be able to do this?

Fortunately, we have seen a lot in the form of research and innovation grants that can be able to help innovators to overcome some of those initial hurdles but then again it is not always easy. One may be good at writing grants to bring in the funding but how do you also come across the funding to the business aspect of your innovation or one that provide patents. We therefore need build an ecosystem that can provide complementary private capital that can do what the typical grants cannot do. It is very difficult to get grants that will help you set up a sales team, do patenting so those kind of things require private capital so we need to start building capacity for angel investments and smaller ticket size investments that can complement these sectors.

Wilfred: As you move from translational research to innovation to market and market to scale-up it is like there is a new learning curve in each step. 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. A lot of it is based on our ability to do rigorous due diligence which ultimately gives a vote of confidence to other follow-on investors.

The way we provide 360 support. Looking at the Villgro model we invest heavily in talent. If you look at myself, I’m a scientist, Wambui is an engineer and within the team we have members who are able to provide a lot of expertise on the business side. 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, the small mistakes’ that can trip a first time innovator do not end up becoming the waterloo of these innovations because the Villgro Africa expertise and experience is part and parcel of the development and the roadmap. That know how coming in to a first time innovator and entrepreneur makes a difference.

Being able to have these conversations whereby we are able to engage investors downstream so that even as we are making progress with our incubatees we are already getting to understand what the investment landscape and regulatory landscape looks like and how that informs the manufacturing, product development and commercialization strategy.

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.

Wilfred: What would you tell an aspiring inventor listening to us today

Robert: It is amazing the capacity that is readily available to innovators today compared to five years ago when we started out. Right now when you talk to our regulatory authorities they understand that there is a gap and a lot of work to be done in terms of homegrown innovations. Investors are already looking at the track record of companies that have really done the heavy lifting in terms of being the trail blazers so it is an easier path it’s not as an unbeaten path as before.

The biggest thing to highlight to innovators is that you do not have to walk that path alone. You should be able to work with trusted proven partners like Villgro to help you cross that valley of death and help address the skill set gap that might be there.

Wilfred: Wambui what would you tell an aspiring inventor? How can they stay motivated and stay true to the cause?

Wambui: Medical device development is not for the faint of heart for sure. You have got to have some commitment. What has always kept me going is the fact that at the end of there will be a device that will potentially save people’s lives or at least improve the quality of their lives. So to think of it in that way that you are making an impact to actual human lives and affecting the way that people live, that is what keeps me going and keeps a lot of medical device engineers going.

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.

Wambui Gachiengo, is an innovation leader in the medical device industry with experience in both North America and East Africa. She shared her insights withe Wilfred Njagi on the process of taking a device from idea to market.

Wilfred: At a very high level 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. The first thing to do is to 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 all of that is understood then you can really nail down your requirements and really understand what the device is that you are going to develop. Taking that you then start the development with a very clear understanding of what the user needs. 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.

In summary :

1. Start with the User in Mind
2. Research on the clinical & technology space and understand competitive devices
3. Nail down the requirements for the development of your device
4. Start developing with the user needs in mind
5. Do a lot of testing, incorporate user feedback and iterate until you have a marketable device
6. Go through the regulatory process

Wilfred: Can you speak to documentation. I know if you are preparing to go through regulatory then all these steps you mentioned need to be documented as you make iterations in your design history.

Wambui: For especially many engineers and some human being in general the documentation is often that thing which is not fun. We want to be developing and building stuff. But if we think of the documentation as part of the development that will enable us to develop a device that is useful, approvable and even commercially successful, the documentation becomes less painful. Documentation would be first of the user requirements. You document those very clearly so that you are very clear about what it is you need to be developing as well as things about the regulatory process. What class of device are you developing? then you have to keep a good record of the flow down of those user requirements to technical requirements then going even further to the testing and the validation of your device. You have to keep a really good and complete design history file and what that means is that any time you make a design change, that has to be documented. When you do your risk analysis and testing, all these have to be very well documented so that you have a good package for your regulatory approval process

Listen to more of Wambui’s advice to developers here

Dr Robert chats about his experience in starting Villgro Africa, his game changing and defining experience in a one-month training program on innovation in Sweden. One of the major partners of the program is Sweden’s government agency for development cooperation, that works through a multifaceted collaborative partnership model enabling social change and impact within the sustainable development sector in emerging markets. His experience at the training session changed the perspective on the innovation sector with a feel-good understanding on drivers guiding a knowledge focussed economy.

The discussion delves into how technological innovation can transform Africa from an extractive driven model of natural resources to an innovation focussed mobile platform enabled economy. Example Microfinance, Fintech, Telemedicine etc. Villgro Africa has made a deep impact on the lives of the underprivileged in Africa, impacting more than 1 million lives, with investment of over $800K across 24 startup’s. One very interesting startup is Rescue, the largest network of first Kenya’s best first responders. Wheels for Life enables expectant mothers to reach the hospital during curfew hours. The inventiveness is a significant success during the pandemic as all mothers who have used this service have survived.

The major part of the discussion is on healthcare sector. According to Alt Network, in Africa, fewer than 50% have access to modern healthcare facilities but 25% of the global disease burden. With health coverage ~ 4% in Africa and government expenditure less than 10% of their GDP, the region faces major acute healthcare crisis. According to the Africa Business Community, 11% of Africans experience catastrophic spending for health care every year, 38% delay or forgo healthcare because of high costs. Dr Robert shares an excellent perspective on this aspect. Africa has only a 3 to 4 percent share of global pharmaceutical industry and 2 to 3 percent share of global medical devices. Yet many countries with Africa are ahead of the curve in fighting the pandemic. Another troublesome statistic is African DNA is only 2.3 percent of the global genome database.

Robert proposes a universal healthcare plan for the citizens in Kenya and a universal tax to sponsor the initiative. Listen to the in-depth interview to understand the African development ecosystem especially Kenya.