ANALYSIS OF EXISTING POLICIES ON MANUFACTURE OF MEDICAL DEVICES IN KENYA 119 views0 applications


Concern Worldwide is an international non-governmental humanitarian organization dedicated to the reduction of suffering and working towards the ultimate elimination of extreme poverty in the world’s poorest countries

Concern Worldwide invites Expressions of Interest for the provision of the following consultancy services:

ANALYSIS OF EXISTING POLICIES ON MANUFACTURE OF MEDICAL DEVICES IN KENYA

1. Background/ Context

Concern Worldwide is an international humanitarian NGO dedicated to ending extreme hunger and transforming the lives of the world’s poorest people. To achieve this mission Concern seeks to address the root causes of poverty by engaging in long term development work and response to emergency situations in both urban and rural contexts.

The Sustainable Development Goal 9 (SDG) envisions the building of a “resilient infrastructure, promoting inclusive and sustainable industrialization and fostering innovation.” Specifically, target 9b advocates for “domestic technology development, research and innovation in developing countries,” which includes a focus on fostering an enabling policy environment. Across Africa, including in Kenya, there is a vibrant culture of designers, engineers, and entrepreneurs creating products intended to improve people’s lives. A strong foundation for widespread innovation exists, but is highly constrained by a lack of skills and training and poor access to quality tools and materials. As a result, many manufactured products in the Kenyan market are not designed locally and may fail to meet local needs. While Kenya has committed to industrialize and eventually manufacture products locally in the Government’s ‘Vision 2030,” the reality is that little progress has been made in the development of infrastructure to allow for in-country manufacture of health promoting devices. An assessment of 40 health facilities in Nairobi, Kenya indicates that none of them had all essential equipment available. A large majority of medical supplies in Kenya are imported (over 90%) from abroad. Very little equipment is locally procured and this is limited to non-complex equipment such as beds and trolleys. To catalyze local transfer of technology in the development and manufacture of health promoting prototypes, UNICEF Kenya in partnership with Concern Worldwide through the ‘maker project’ collaborates with the Government of Kenya as well as a diverse range of local partners and stakeholders to develop and nurture innovation platforms that design, prototype and produce lifesaving and health promoting devices predominantly for use in under-resourced maternity hospitals and health facilities throughout the region. The joint mission of the collaboration is to develop innovative, low-cost, locally designed and built health-promoting devices and other health solutions that contribute to improved, more equitable access to quality care for women, new-borns and children. To advocate for scale up and contribute to policy on innovative medical devices, the project needs to assess existing policies at the national level and identify gaps, particularly for the manufacture of medical devices, consumer lifestyle goods and other health care solutions as well as the engagement of the private sector where appropriate.

2. Objective/Purpose of the Consultancy

The purpose of this consultancy is to;

· Assess existing policies at the national level on manufacture of medical devices. Specifically this will include identification of existing policy frameworks, identification of key institutions and their role in regulating the manufacture of medical devices and an analysis of the gaps in the policy environment ( technical, human resource, financial, research and development, infrastructure, supply chain )

· Identify and assess the existing policies for enhanced private sector engagement in local manufacture of medical devices.

· Develop external stakeholders’ engagement framework with clear timelines and milestones based on the gaps identified.

3. Methodology

The main methodologies that will be employed include:

· Desk review –secondary data review

· Key informant interviews to identify additional data sources (i.e. unpublished data or grey literature). This will include interviews with; Ministry of Health (MOH)-Reproductive Maternal Health services , Kenyatta National Hospital (KNH) (Bio Medical Engineering, Obstetric Gynaecology units) , University of Nairobi (UON) and other research institutions, manufacturers and distributors of medical devices, Pharmacy and Poisons Board, Kenya Beuro of Statistics (KEBS), Kenya Medical Supplies Agency (KEMSA), KEMRI, Vision 2030 Secretariat, Ministry of Trade and Industrialization , PPP Unit in the Treasury

· Analysis and development of a policy brief on the legal and policy environment for local manufacture of medical devices

4. Deliverables/Outputs

· Inception report that includes brief data review, sampling procedures, methodology and a clear activity work plan

· Raw data from secondary and primary data sources

· A well written report on the existing policy environment and gaps. Structure of the report will be provided

· A policy brief with key messages and recommendations for reform.

· External stakeholders engagement framework and clear timelines and milestones

5. Proposed Timelines

This task will be undertaken in 2018. The Consultant should include a proposal of the number of days the assignment will take.

6. Remuneration

The Consultant is expected to provide a financial proposal for the whole assignment. Agreed rates will be based on prevailing market competitive rates and value for money.

Payment will be made upon verification of the final work by Concern Worldwide’s Programmes Director.

7. Expertise and Skills Required

At least Master Degree in Public Policy and administration or Masters in Public Health with proven track record of similar work is relevant

Understanding on policy framework for health technology and medical device regulations is important

How to apply:

Interested candidates who meet the above requirements must submit the following;

· A technical proposal (Max. 10 pages) including;

o Proposed methodology

o Work plan including the activity schedule with the total number of days and earliest date of availability to undertake assignment

o Demonstration of Capability i.e. CV of the lead consultant and, if quoting for an organization, attach the CV of any other personnel to be involved in the assignment

o A list of previous work done (Work Completion Certificates)

o Telephone and email contacts of at least three (3) professional referees who can validate technical expertise

· A financial proposal quoted in Kenya Shillings for the whole assignment

All submissions, addressed to the HR & Administration Coordinator, Concern Worldwide, Nairobi, must be sent to the following email addresses: [email protected] and [email protected] with the subject of the email as ‘Analysis of Existing Policies on Manufacture of Medical Devices’. The closing date for submissions is Sunday, 25th November 2018.

Concern has a Code of Conduct and a Programme Participant Protection Policy to ensure the maximum protection of programme participants from abuse and exploitation.

CONCERN WORLDWIDE IS AN EQUAL OPPORTUNITIES EMPLOYER

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Concern Worldwide works with the world's poorest people to transform their lives.

We are an international humanitarian organisation dedicated to tackling poverty and suffering in the world’s poorest countries.

We work in partnership with the very poorest people in these countries, directly enabling them to improve their lives, as well as using our knowledge and experience to influence decisions made at a local, national and international level that can significantly reduce extreme poverty. In 2015, we positively impacted the lives of 22.5 million people.

For more than 45 years, Concern has been dedicated to reducing suffering and fighting hunger and poverty. Today, Concern’s work is needed more than ever.

concern40th_john_oloughlin_kennedy_president_mcaleese_058.jpg

John and Kay O'Loughlin with President Mary McAleese on the 40th anniversary of Concern's foundation.

Concern was founded by John and Kay O’Loughlin-Kennedy in 1968, as a response to the famine in the Nigerian province of Biafra. The famine was largely precipitated by the conflict that followed Biafra’s attempt to secede from Nigeria.

John’s brother, Father Raymond Kennedy, a Holy Ghost Priest, had returned to Ireland from Nigeria with news about the plight of people in Biafra where widespread famine was becoming a reality due to the Nigerian blockade of food, medicines, fuel and basic necessities.

John, Kay and Raymond held a press conference in the Shelbourne Hotel to raise awareness and funds. This allowed them send the first ‘mercy flight’ to Biafra.

But much more was needed,  some weeks later a larger meeting was called in the home of John and Kay, Africa Concern was formed and the fundraising continued.

Send One Ship

Africa Concern with the Knights of Columbanus launched an appeal in June 1968 for the famine in Biafra with the slogan "Send One Ship".

Becoming Concern

On 29 September, a 600 tonne ship named the Columcille arrived at Sao Tome, a Portuguese island off the coast of Biafra, filled with vital supplies of powdered food, medicines, and batteries. In 1970, a huge cyclone hit East Pakistan (now Bangladesh) and the public were asked to respond. Africa Concern simply became Concern.

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0 USD Nairobi CF 3201 Abc road Full Time , 40 hours per week Concern Worldwide

Concern Worldwide is an international non-governmental humanitarian organization dedicated to the reduction of suffering and working towards the ultimate elimination of extreme poverty in the world’s poorest countries

Concern Worldwide invites Expressions of Interest for the provision of the following consultancy services:

ANALYSIS OF EXISTING POLICIES ON MANUFACTURE OF MEDICAL DEVICES IN KENYA

1. Background/ Context

Concern Worldwide is an international humanitarian NGO dedicated to ending extreme hunger and transforming the lives of the world’s poorest people. To achieve this mission Concern seeks to address the root causes of poverty by engaging in long term development work and response to emergency situations in both urban and rural contexts.

The Sustainable Development Goal 9 (SDG) envisions the building of a “resilient infrastructure, promoting inclusive and sustainable industrialization and fostering innovation.” Specifically, target 9b advocates for “domestic technology development, research and innovation in developing countries,” which includes a focus on fostering an enabling policy environment. Across Africa, including in Kenya, there is a vibrant culture of designers, engineers, and entrepreneurs creating products intended to improve people’s lives. A strong foundation for widespread innovation exists, but is highly constrained by a lack of skills and training and poor access to quality tools and materials. As a result, many manufactured products in the Kenyan market are not designed locally and may fail to meet local needs. While Kenya has committed to industrialize and eventually manufacture products locally in the Government’s ‘Vision 2030,” the reality is that little progress has been made in the development of infrastructure to allow for in-country manufacture of health promoting devices. An assessment of 40 health facilities in Nairobi, Kenya indicates that none of them had all essential equipment available. A large majority of medical supplies in Kenya are imported (over 90%) from abroad. Very little equipment is locally procured and this is limited to non-complex equipment such as beds and trolleys. To catalyze local transfer of technology in the development and manufacture of health promoting prototypes, UNICEF Kenya in partnership with Concern Worldwide through the ‘maker project’ collaborates with the Government of Kenya as well as a diverse range of local partners and stakeholders to develop and nurture innovation platforms that design, prototype and produce lifesaving and health promoting devices predominantly for use in under-resourced maternity hospitals and health facilities throughout the region. The joint mission of the collaboration is to develop innovative, low-cost, locally designed and built health-promoting devices and other health solutions that contribute to improved, more equitable access to quality care for women, new-borns and children. To advocate for scale up and contribute to policy on innovative medical devices, the project needs to assess existing policies at the national level and identify gaps, particularly for the manufacture of medical devices, consumer lifestyle goods and other health care solutions as well as the engagement of the private sector where appropriate.

2. Objective/Purpose of the Consultancy

The purpose of this consultancy is to;

· Assess existing policies at the national level on manufacture of medical devices. Specifically this will include identification of existing policy frameworks, identification of key institutions and their role in regulating the manufacture of medical devices and an analysis of the gaps in the policy environment ( technical, human resource, financial, research and development, infrastructure, supply chain )

· Identify and assess the existing policies for enhanced private sector engagement in local manufacture of medical devices.

· Develop external stakeholders’ engagement framework with clear timelines and milestones based on the gaps identified.

3. Methodology

The main methodologies that will be employed include:

· Desk review –secondary data review

· Key informant interviews to identify additional data sources (i.e. unpublished data or grey literature). This will include interviews with; Ministry of Health (MOH)-Reproductive Maternal Health services , Kenyatta National Hospital (KNH) (Bio Medical Engineering, Obstetric Gynaecology units) , University of Nairobi (UON) and other research institutions, manufacturers and distributors of medical devices, Pharmacy and Poisons Board, Kenya Beuro of Statistics (KEBS), Kenya Medical Supplies Agency (KEMSA), KEMRI, Vision 2030 Secretariat, Ministry of Trade and Industrialization , PPP Unit in the Treasury

· Analysis and development of a policy brief on the legal and policy environment for local manufacture of medical devices

4. Deliverables/Outputs

· Inception report that includes brief data review, sampling procedures, methodology and a clear activity work plan

· Raw data from secondary and primary data sources

· A well written report on the existing policy environment and gaps. Structure of the report will be provided

· A policy brief with key messages and recommendations for reform.

· External stakeholders engagement framework and clear timelines and milestones

5. Proposed Timelines

This task will be undertaken in 2018. The Consultant should include a proposal of the number of days the assignment will take.

6. Remuneration

The Consultant is expected to provide a financial proposal for the whole assignment. Agreed rates will be based on prevailing market competitive rates and value for money.

Payment will be made upon verification of the final work by Concern Worldwide’s Programmes Director.

7. Expertise and Skills Required

At least Master Degree in Public Policy and administration or Masters in Public Health with proven track record of similar work is relevant

Understanding on policy framework for health technology and medical device regulations is important

How to apply:

Interested candidates who meet the above requirements must submit the following;

· A technical proposal (Max. 10 pages) including;

o Proposed methodology

o Work plan including the activity schedule with the total number of days and earliest date of availability to undertake assignment

o Demonstration of Capability i.e. CV of the lead consultant and, if quoting for an organization, attach the CV of any other personnel to be involved in the assignment

o A list of previous work done (Work Completion Certificates)

o Telephone and email contacts of at least three (3) professional referees who can validate technical expertise

· A financial proposal quoted in Kenya Shillings for the whole assignment

All submissions, addressed to the HR & Administration Coordinator, Concern Worldwide, Nairobi, must be sent to the following email addresses: [email protected] and [email protected] with the subject of the email as ‘Analysis of Existing Policies on Manufacture of Medical Devices’. The closing date for submissions is Sunday, 25th November 2018.

Concern has a Code of Conduct and a Programme Participant Protection Policy to ensure the maximum protection of programme participants from abuse and exploitation.

CONCERN WORLDWIDE IS AN EQUAL OPPORTUNITIES EMPLOYER

2018-11-26

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