About Simbona

From Jimma University to Ethiopian manufacturing.

A MedTech company that began as research at Jimma University Institute of Health, and now designs and manufactures Class I and Class II medical devices for low-resource settings.

Simbona engineers assembling electronics at the component pre-testing bench

The company

Simbona Africa Healthcare's journey began in 2014 as a healthcare technology research and development initiative led by Engr. Habtamu Abafogi at the Jimma University Institute of Health (JUIH).

2014

R&D begins

2015

Company established

2025

EFDA authorisation

The company was officially established in 2015 as a sole proprietorship in Jimma, Ethiopia, following financial support from BMCE Bank of Morocco through the African Entrepreneurship Award.

Since 2016, Simbona has been part of the Villgro Africa Impact Investment Incubation Center based in Nairobi, Kenya.

Simbona is a multi-product MedTech company engaged in the local design and manufacturing of Class I and Class II medical devices in Ethiopia, specifically suited for low-resource environments. All products are developed in compliance with international standards and ethical practices.

Its flagship neonatal devices — Infant Radiant Warmers, Neonatal LED Phototherapy Units, and Conventional Phototherapy Units — are registered and licensed by the Ethiopian Food and Drug Authority. Simbona's UVC disinfection technologies have also received regulatory approval.

The journey

Research, engineering, manufacturing, impact.

012014
Research
Healthcare innovation work begins at Jimma University Institute of Health.
022016
Engineering
The first working, standard circuit boards for medical devices.
032024
Manufacturing
The Jimma medical device manufacturing facility is completed.
042025
Impact
EFDA market authorisation and registration, May 2025.

Timeline

Eleven years from university lab to EFDA authorisation.

Taken from Simbona’s product catalogue — from Healthcare Innovations at Jimma University Medical Center in 2014 to EFDA market authorisation in May 2025.

2014
Healthcare innovations at Jimma
At the invitation and under the supervision of Mr. Kora Tushune, Mr. Habtamu Abafogi began his work on Healthcare Innovations at Jimma University Medical Center.
2015
Company established
Simbona Africa Healthcare was officially established as a sole proprietorship in Jimma, Ethiopia (R&D work had begun in 2014).
2016
First circuit boards
The first working and standard circuit boards for medical devices were created, following many difficulties and lessons learned.
2017/18
International standards adopted
The first two international standards for medical devices were adopted for locally designed items, with assistance from Jimma University, the Ethiopian Standard Agency, AHRI, and the Grand Challenges Ethiopia program.
2019/20
Safety tests and clinical performance
Grand Challenges Ethiopia funded engineering safety tests. Devices independently tested by the Ethiopian Conformity Assessment Enterprise (ECAE). In December 2020, Jimma University hosted Clinical Performance Test activities supported by IDRC and Villgro Africa.
2021/22
Ethical approvals
Clinical study procedures authorised by the University IRB in October 2021. On 15 April 2022 the National Research Ethical Review Committee granted ethical approval; EFDA granted ethical approval in October 2022.
2023
Clinical performance test
14 Oct 2023 – 14 Oct 2024: clinical performance test conducted at Jimma University Medical Center under EFDA supervision.
2024
Manufacturing facility completed
15 January: Jimma Town Administration provided production space. 16 March: the medical device manufacturing facility was completed, backed by Villgro Africa.
2025
EFDA market authorisation
May 2025: Simbona's products received EFDA market authorisation and registration.

The facility

Made in Ethiopia.

Jimma is the manufacturing site and manufacturer of record. Addis Ababa holds an industry-zone presence. The floor below is evidence of local production.

Infant radiant warmers under assembly at Simbona's facility — Radiant warmer assembly

Row of LED phototherapy units on the production floor — Phototherapy production

Stacks of Simbona control boards — Control boards

A Simbona technician sewing at an industrial machine — In-house upholstery

Simbona engineers assembling and testing electronics — Electronics testing

Sheet fabrication equipment in use on Simbona's workshop floor — Fabrication on the workshop floor

Circuit boards and components laid out in Simbona's quality testing area — Quality testing area

Internal wiring of a Simbona UV sterilizer cabinet — UV cabinet assembly

Manufacturing & manufacturer of record
Jimma
Ginjo Guduru Kebele, Jimma Town, Oromia Regional State, Ethiopia
Industry zone presence
Addis Ababa
Kolfe Keraniyo Sub-city, Wereda 04, Industry Zone, Ethiopia

Impact

Local manufacturing, measurable reach.

Hospital-acquired infection burden, Simbona’s UV answer, and the numbers behind deployments across Ethiopia.

Open the impact page

Regulatory & standards

Authorised, tested and built to published standards.

May 2025: Simbona's products received EFDA market authorisation and registration.

EFDA
Ethiopian Food & Drug Authority
ECAE
Ethiopian Conformity Assessment Enterprise
IEC
International Electrotechnical Commission
IES
Institute of Ethiopian Standards
ETA
Ethiopian Technology Authority

Standards applied

IEC 60601-1:2005
IEC 60601-2-21:2009
IEC 60601-1-2:2007
ISO 9001:2007

EFDA Guideline for Registration Requirements of Medical Devices other than In Vitro Diagnostic Devices

Directives

93/42/EEC Medical Devices Directive and amendment 2007/47/EC
Conformity assessment procedure per Article 11.3.a

Manufacturer of record

Simbona Africa Healthcare, Ginjo Guduru, Jimma, Oromia, Ethiopia

Vision

To be a continental leader in transforming paediatric healthcare in Africa by providing innovative, affordable and locally manufactured medical devices that save lives and strengthen resilient, self-reliant health systems.

Mission

To design, manufacture and distribute high-quality, cost-effective paediatric medical devices specifically adapted for low-resource settings across Africa — striving to enhance child health outcomes, reduce neonatal mortality, foster homegrown innovation, and promote sustainable business practices. Through strategic partnerships and technology transfer, to strengthen local manufacturing capacity and decrease dependency on imported medical technologies.

Strategic objectives

01Improve health outcomes
02Foster technology transfer
03Promote import substitution
04Deliver affordable solutions
05Ensure business sustainability
06Reduce neonatal mortality
07Influence policy and ecosystems

The team

The people behind the devices.

Leadership

Hana Berhanu
Chief Executive Officer and Product Designer
Samuel Sisay
Chief Technology Officer
Fikadeab Minase
Technical Manager
Hanna Berhanu
Operational Lead and QMS Team Lead

Engineering and production

Mohammed Jemal
Senior Mechanical Engineer
Fayid Ahmed
Embedded System Designer
Samuel Mathwos
Mechanical Engineer and Ergonomics Expert
Esubalew Belay
Technical Inspection Engineer
Berhanu Hiluf
Product Manufacturing Process Lead
Tirufat Wondimu
Senior Product Researcher

Operations

Mintesinot Eshetu
Sales and Marketing
Mesfin Abebe
Financial Consultant

Advisors

Anela Sahale
Business Advisor
Snider Mugese
Portfolio Advisor
Yibeltal Siraneh (PhD)
Clinical Consultant

A team member is listed only once their exact job title is confirmed. See CONTENT-NEEDED.md §6.

Partners & funders

Institutions standing behind the work.

UNDPInstitutional partner and funder named in the product catalogue.
Grand Challenges CanadaSupported clinical work at Jimma; collaborated on donating 100 phototherapy units to 50 hospitals.
IDRC-CRDI CanadaSupported clinical performance test activities at Jimma University (December 2020).
Ministry of Health EthiopiaCollaborated on donating 100 neonatal phototherapy units to 50 hospitals.
AHRI (Armauer Hansen Research Institute)Assisted with adopting the first international standards for locally designed devices (2017/18).
Villgro AfricaImpact investment incubation centre; Simbona has been part of Villgro Africa since 2016.
MInTMinistry of Innovation and Technology — partner named in the product catalogue.
African Entrepreneurship AwardFinancial support via BMCE Bank of Morocco that enabled Simbona's establishment in Jimma in 2015.
The Tony Elumelu FoundationPartner and funder named in the product catalogue.
ECAPartner and funder named in the product catalogue.

Visit