August Update: Regulatory Clearance, GSBI Fellowship and SL@B

Key Milestone Achieved: Regulatory Approval in Ghana

Exactly one month after we received our regulatory approval in Kenya, we received our regulatory approval in Ghana. These regulatory approvals are a testament to Hemafuse and the hard and diligent work of our team.

With two regulatory approvals achieved, we  now have the opportunity to secure purchase orders in two key markets. Ghana is the launching point for the West African market while Kenya is the launching point for the East African market. Once we secure our next round of funding we will be well positioned to enter these two markets and then scale rapidly!

Winners of $250k Saving Lives at Birth Grant

We are proud to be the an awardee for the Saving Lives at Birth Validation Grant. This is the second stage of a grant we had been awarded 3 years ago and will fund a multi-country evaluation of Hemafuse. We will also hear in the next couple of months if we qualify for additional funds in addition to the $250k award so keep your ears tuned for even better news!

Sisu was one of just 15 submissions selected out of 550 applicants from around the globe for the prestigious grant from the U.S. Agency for International Development (USAID), the Bill & Melinda Gates Foundation, Grand Challenges Canada (funded by the Government of Canada), the Norwegian Agency for Development Cooperation (Norad), the U.K’s Department for International Development (DFID) and the Korea International Cooperation Agency (KOICA). 

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CAMTech First Mile Innovation
 
Carolyn Yarina, Sisu's CEO, pictured at the World Health Assembly this past June. 

Carolyn Yarina, Sisu's CEO, pictured at the World Health Assembly this past June. 

Sisu Global Health recently won the First Mile Innovation Challenge from  the Consortium of Affordable Medical Technologies (CAMTech), GE Sustainable Healthcare Solutions and Massachusetts General Hospital's Global Health program. This competition sought applications from around the world that address health hardships in low and middle income countries. Sisu was the sole winner of a $25,000 grant and access to GE’s five.eight accelerator network. Over 80 projects competed from companies across the world. GE Healthcare also featured Sisu in Geneva at the 2017 World Health Assembly for this award in June. Check out our photo diary featured via CAMTech here

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New Office(s)

Sisu is still moving and shaking! More on the former, as Sisu now has a new office in Baltimore. We are now located on 2720 Sisson Street in the Remington neighborhood. We welcome visitors interested to learn more about medical devices in emerging markets, partnership opportunities and those interested in trying our products. 

Our Chief Marketing Officer, Katie Kirsch, is on the African continent for a majority of this year. She will be primarily based in Accra, but has plans to engage markets in Eastern and Southern Africa. She plans to set up direct channels for Hemafuse sales over the coming months. 

Blood Bag Hands
Expanding Our Scope

Sisu continues to expand application of Hemafuse, its first portfolio product, by approaching new clinical sites across the southern hemisphere. 

Hiccups happen.

In the past, we made the assumption that as a small team, we need a laser focus to push forward. This has been ingrained in us from the teachings of a US infrastructure with a clear path to market. The steps may be bureaucratic and long, but they are also consistent, documented, and well understood. Input produces an output. But we don’t work in the US, we work in Africa with a fluid landscape where the incentives are different.

This requires a new multi-approach to kicking off our initial pilot study for Hemafuse. Originally, our laser focus approach involved coordinating with a single clinical site in Sub-Saharan Africa. The partnership seemed to have the capability/titles/clinical experience to get Hemafuse in the hands that want to use it. Finding the hands wasn’t difficult. The trick is also finding clinicians with the time and support to truly scrutinize a medical device’s first time in surgery.

Systematic, research-focused protocols (like it sounds) are a lot of work. Feel free to ask any specialist in academia; their jobs are not easy. And without major incentives for publication, often a tool for career advancement, the cost/benefit of doing a small pilot study is not always available to all of our African partners.

Lucky for us, not all. It was time to seek a second opinion. And we were overwhelmed with the response.

Through several of our Baltimore-based partners, the Gates Foundation network and some cold calls, we discovered that these doctors are calling to do the research. We just needed to present them with the option. The quantity and quality of the responses has been massive; and our confidence in coordinating this study abroad has been restored.  And led to some significant realizations on our approach.

The research support and new leads generated by expanding our geographic scope for this initial pilot has not only enabled our clinical strategy, but begun to anecdotally increase demand. Unlike clinicians and researchers in other contexts, our current partners repeatedly ask questions on supply chain management and how they can build purchase capacity in their institution. Their intent is beyond the initial research study. They are excited by the possibility of such an innovation becoming a valuable tool in their practice, once it’s been proven.

Our original, narrow focus on a single country for smaller studies was a short-sighted assumption around speed through regulatory and first sales.  By looking beyond that single variable, we’ve reminded ourselves that we are building a system and rediscovered our mission: incentivizing stakeholders along the entire value chain. This engagement continues to be scarce as evidenced by our clinician’s entrepreneurial and multi-lateral concerns. Their hospitals, and the distributors that supply them, will eventually be our customers. Their investments in the innovation of Hemafuse at this early stage will influence our B2B relationships well into the future.

Want to hear more about Sisu's mission? Come see CMO, Katie Kirsch, talk at Light City's Health Innovation Conference

Katie Kirsch Comment
Made in the USA

If you tune into news about the economy, you’ve heard a lot of talk about the decline of US manufacturing. When I first arrived at Michigan in 2007, the Great Recession was hitting the region hard, as most everyone I met had a connection to automotive manufacturing . Every conversation I had was a personal tale of how their job was in jeopardy of offshoring.  

The past couple of years are in stark contrast to 2007. Due to soaring labor costs in China, US manufacturing is projected to be increasingly competitive in terms of costs. This has already caused a number of manufacturing jobs to be “reshored” back to the US and is projected to increase. While the manufacturing environment in the US is improving, the one thing that hasn’t changed is the strength of relationships between companies and their suppliers.  

Sisu Global Health has chosen manufacturing partnerships in the US because of these strong partners here at home. As a small company starting out, good suppliers are key to making it through the transition from idea to marketable product. Medical devices specifically require independent research, testing and regulated manufacturing, and tracking quality assurance. 

In dealing with US regulations, we have been able to find these partners that intimately know our difficulties and lend their expertise. We can meet in person and make adjustment utilizing their expertise in smaller batches of devices.

Because of our outstanding suppliers, our first production parts have come off the line and we are eager to start bio-compatibility and sterilization testing. This first lot of devices are planned for our first human patient clinical study. Our team has learned a lot from the process of choosing and collaborating with contract manufacturers. Many companies know the failure of bad partnerships. We have confidence them and they make our company stronger.

Written by CTO, Gillian Henker, and guest blogger, Kevin Lee. If you are interested in learning more about re-shoring, check out this articlethis other one, and the cities leading the charge