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

Misfits

Team Sisu often finds themselves to be the misfits at most networking events. With a geographically-diverse market neglected by the larger business world, many in the for-profit medical device industry find our aims improbable. At other events, the “do well by doing good” crowds sometimes gasp when we mention our business model; often implying that our monetary goals will always shadow our health impacts. We have found our niche and several have embraced our ability to negotiate the often divided realms of life science businesses and global health.

Yet, we continue to confront lines of questioning that are flavored by the audience. Below are two general examples of conversations that want to put Sisu in a specific category. The first, from a start- up business fellow at a pitch competition, and then, global health expert from a health system strengthening conference.

“In Africa, how do you know there’s money there until you’ve sold something? There are no rules, just sell it.”

One crowd is the US lean startup community- you know them, preachers of constant iteration. Iteration is king in this case and what we believe is truly innovative at Sisu. The lean startup model, however, can be iterative to the point of recklessness- not a quality that a medical device company should really value. The lean startup model also generates the long stream of half-hearted apps that continue to stream out of Silicon Valley- an industry with lots of money that appears to be thrown at underdeveloped projects destined to flop or be acquired. When the latter strategy succeeds, it's great for investors, but inserts the startup (which has been unable to build organization/system beyond an initial product) into the large companies and associated bureaucracy. New ideas are getting put into old structures too soon, often diluting original aims or negating long term system’s change.  

Acquisition can be a boon- but only once a startup has created something that reworks a system; single ideas treated this way will not survive.The original ideas for many apps/products solve big problems, but this cross pollination/acquisition game with the same group of people’s ideas is heading for stagnation.

“How are you delivering product to impoverished countries in the Global South and you’re actually reporting health impacts and making money off of it?”

This question comes in many forms, though most often a touch more subtlety. Yes, we are selling products in countries that have been given one dimension: “developing” and “poverty alleviation”. These words are slathered across them via media. Big Aid organizations and others have insinuated that capable, resourceful and talented local people (our current partners, future employees and customers) cannot live there.

Some large NGO’s and international organizations have made strides toward dissolving this image of foreign aid- but the philosophy is deeply embedded. Many have worked in some of the farthest reaches of the world with immense experience with both successes and many failures in delivering healthcare products and access worldwide. These organizations have a depth of knowledge in these areas, but have left us viewing these areas as primitively stationary in poverty, not as explosively growing economically.

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All teasing aside- both philosophies have incredible value in seeking a solution. Neither can claim to have found the correct process, either, and perhaps it’s because of the philosophy they share of only being able to have one priority.

We disagree. Monetary compensation and human-centered initiatives don’t have to be mutually exclusive. Emerging markets are a strategic choice and are repeatedly reported as having explosive growth. Exploding economic growth, often caused by a growing middle class, also creates greater demand on health systems. These health systems need a way to provide care that impacts patients in their own context, otherwise risking inaccessibility to healthcare for large swaths of their patient populations. 

Sisu has found that by following the threads of both business and impact- we can be most successful. Both philosophies seek to reach scale to solve problems and to sell products. The entire health system is important to both create profits and benefits. As Sisu formally opens its seed round, we find ourselves straddling the middle- socially minded with hard nose business outlook. 

Katie KirschComment
Clinical Humility
OBGYN Residents at the University of Zimbabwe Medical School post-workshop with Sisu Global Health's first device,  Hemafuse. 

OBGYN Residents at the University of Zimbabwe Medical School post-workshop with Sisu Global Health's first device,  Hemafuse. 

If there’s something that sticks in our minds daily, it’s how little the medical community seems to know about the areas in which we work. Sisu is preparing for its first clinical pilot with its portfolio device, Hemafuse, later this year in Zimbabwe. All of our preparations through ISO standards and training regulations have led us to this momentous milestone - putting our intervention into human use.

This device is surgical - meaning that it can intervene during a pivotal moment in an individual’s care. Compared to most moments when autologous blood transfusion occurs, the Hemafuse, as an intervention, will be both more urgent and more evident in terms of results. Its handheld, sleek design reduces both blood flow issues and failure modes from a slippery, gloved hand mid-surgery. In many of the surgical suites that we’ve been in, space is at a premium. Improvements on hospitals and buildings are not keeping up with the increase in patient admittance and population growth, meaning smaller rooms for more people.

This device, as one Tanzanian doctor put it, will eliminate a ‘messy’ and sometimes futile process.  

All opinions from these doctors point to the success of this device, however, the glaring fact that autotransfusion, the recycling of a person’s own blood, has been debated solely in Western countries. Of all the published material concerning African healthcare, only 1-2%  have contributions from the continent’s own physicians. Additionally, these articles and the repository services that attempt to collect thousands of articles are often not internationally indexed to include African medical papers. They come from a continent that has been performing autotransfusion for years, but whose voices have not been given the mechanism to be heard in the medical community.

Doctors, clinicians, and innovators in these countries need to be heard. Many discussions at US-based and European-based forums expound large statistics or frameworks for short-term humanitarian relief. These are quickly shot through with expert comments - this is not single war or disaster, it’s a daily reality in many places. Concrete plans are sputtered out, but sound naïve. We know so little.

Working with our doctors in Zimbabwe and Ghana, our team is humbled by how much there is to learn. Their input is taken with utmost seriousness and integrated in everything we do. Our goal with this clinical pilot is not only initial results on the device’s performance, but to work with the University of Zimbabwe and National Blood Service in Harare to further a graduate student’s education and enable more publications about the issues of blood access. These are learned professionals with distinct sets of expertise that need to have their research heard across the medical community.

From right to left: Gillian Henker, Sisu's Chief Technology Officer; Dr. Tinashe Gede, Doctor of Internal Medicine at the University of Zimbabwe; and Katherine Kirsch, Sisu's Chief Marketing Officer.  

From right to left: Gillian Henker, Sisu's Chief Technology Officer; Dr. Tinashe Gede, Doctor of Internal Medicine at the University of Zimbabwe; and Katherine Kirsch, Sisu's Chief Marketing Officer.  

Katie KirschComment
We're Hiring!

Interested in working for an up and coming startup? Like operations or engineering? Then check out our current openings below. If you like what you see, send a resume and brief cover letter explaining why you'd want to join our team to info@sisuglobalhealth.com

Research and Development-Sisu Global Health is looking for a product development engineer or researcher with technical and quality systems experience to aide in the development of products for emerging markets. This is a 3-month engagement with the potential for full-time. Sisu is seeking a biomedical engineer, mechanical engineer, mechanically-minded electrical engineer, or a biology/biomechanics researcher with mechanical inclinations.

Sound like you? Click here for the full listing.

Business Development- Sisu Global Health has an opening for a business development position to create systems for supply chain management and quality control in Sisu’s products. This is a 3-month engagement with the potential for a permanent position. Part-time/consultancy is negotiable during the 3-month engagement.  Sisu is seeking an individual with a graduate-level business education or systems engineering with an understanding of operations. A background in international business or industrial operational engineering is preferred.  Click here for the full listing. 

Sound like you? Click here for the full listing. 

CEO's Note: Dreaming It in Charm City

The field of blood study and blood-related product development is a small one, and the field of autotransfusion (blood recycling) is even smaller. It often seems like everyone knows everyone else. We've had a lot of great mentors in the blood space from afar, but it hasn't been until we tapped into the inner workings of the Baltimore/DC area that we realized quite how small.

Just six weeks ago, we moved to the Charm City for the DreamIt Health Accelerator program from our medical device manufacturing home in Grand Rapids, Michigan. We were looking for other resources and mentors in both the blood transfusion and global health community to take our company to the next level, and we've found them.

The DreamIt Health office is in the Power Plant Live building, just to the left of this photo. Not a bad view of the harbor, eh?

The DreamIt Health office is in the Power Plant Live building, just to the left of this photo. Not a bad view of the harbor, eh?

One of our new, wonderful mentors in Baltimore, Iris Sherman, runs a company called Kitchology, but her past is in autotransfusion. She invented an autotransfusion device used on Ronald Reagan after the 1981 assassination attempt. His punctured lung and subsequent internal bleeding was salvaged, filtered, and re-transfused promptly; saving the president’s life. We met Dr. Paul Ness and Dr. Steven Frank who have had their work on autotransfusion talked about in the New York times and in the Washington Post, about how autotransfusion is actually safer and better for the patient than using donor blood. Their commentary on autologous blood transfusion in the United States elicits thoughts of how a device such as the Hemafuse could be used in the US, not just developing countries, to save on health outcomes and costs. And the list of influencers continues: Keytech, World Vision, Catholic Relief Services, Jpheigo, Fyodor Biotechnologies are just a few of the organizations that we continue to engage.

These conversations have challenged us to think bigger, sooner. We are thinking how we can strategically get to our long-term vision as soon as possible. We aim to be a medical device company for the developing world: we seek a MNC-like strategy with a developing world focus, instead of and Ideo-like strategy with their focus solely on design. We aim to change the way medical device is designed: 80% of the world’s medical technology should not be designed for only the 10% of the developed world. Simple, elegant, medical device design and implementation can revolutionize healthcare across the globe. A number of organizations designing phenomenal technology including non-profits and universities. The problem is commercializing and scaling this technology. We will continue to develop Hemafuse; however, we are thinking strategically of how we can use the momentum we've already gained to commercialize not only our own devices, but those from other sources as well.

Carolyn Yarina is Sisu Global Health's CEO. You can learn more about her here or drop her a line at info@sisuglobalhealth.com 

Katie KirschComment