Contraceptive implant removal device target product profile Ibrahim Mohedas 1 , Zerihun Abebe 2 , Delayehu Bekelu 2 , Tina Al-Khersan 1 , Amy Kamdem 1 , Caitlin Choi 1 , and Kathleen Sienko 1 1 University of Michigan, Ann Arbor, MI, USA; 2 St. Paul’s Hospital Millennium Medical College, Addis Ababa, Ethiopia Contact: Ibrahim Mohedas, [email protected] Background Data Collection Design ethnography methods performed between May 29 th and July 22 nd 2016 at St. Paul’s Hospital Millennium Medical College in the Killinkii Michuu Family Planning Clinic, Selam Health Center, Addis Ketema Health Center, and Kolfe Health Center Participants were collected through a snowball sampling methodology, and a semi-structured interview protocol guided the questions This study was considered exempt by the University of Michigan International Review Board Requirements were developed using a range of information sources including benchmarking, academic literature, medical texts, internet, and in-country observations and interviews. Observations Specific to implant removal, attention was directed towards complications during the procedure Researchers took note of resources available for HCPs, variations in facilities, and different methods employed for removal Interviews 28 interviews were conducted with a variety of stakeholders including: physicians, health officers, midwives, nurses, and medical residents HCP was asked to complete a freehand removal with each prototype to better understand the removal process and to observe how a device could improve the procedure Results & Discussion • The target product profile developed through extensive interviews with prototypes and observations is shown below. • We found the most important points to facilitate during the procedure included: • 1) Implant stabilization prior to lidocaine administration • 2) Facilitating lidocaine administration in both amount and location • 3) Assisting in the incision during removal • Other key features include: • Low-cost to fit into the supply/funding constrained global contraceptive environment • Ergonomics: of key importance due to the small nature of the implants and need to ensure implants don’t break Data Collection Target Product Profile Conclusions Subdermal Implants 99.5% effective in delaying first pregnancies, spacing births, or ending childbearing [28]. Does not require user compliance Preferred method of contraception by both government and nongovernmental organizations. Removal Procedure Must be performed by mid-to-high level HCPs, limiting access for women in rural and urban areas. Procedures completed by low-to-mid level providers are lengthy and painful. Guiding Research Question: What are the requirements of a task-shifting device to aid in the removal of contraceptive implants to enable frontline healthcare providers to safely and effectively remove implants? • Further interviews are required to fully understand certain requirements, particularly: • 1) Palpability: defining the distance required to raise the implant under the skin • 2) Cost: defining the willingness to pay for an assistive device and understanding the tradeoff between effectiveness and cost • 3) Ergonomics: further interviewing with prototypes to define what aspects of the device are most important to ergonomic fit Future Work • Prototypes based upon TPP are currently being developed and tested on simulator to determine effectiveness • Multiple implant stabilization methods being explored and automated incision Ref-ID: A185-3 Figure 3: Prototype A Figure 2: Prototype B Figure 1: physician demonstrating removal Prototypes • Prototype A stabilizes the implant by impeding backwards movement. The pressure applied on the proximal end of the implant raises the distal end, which aids the HCP in incision location. • Prototype B offered an alternate solution by raising the implant and lessening the need to reach into the incision. The prototype requires the HCP to squeeze together the legs of the device in order to secure the distal end of the implant. Then, the two “feet” on the legs of the prototype will roll and push the implant out of the incision. • Prototype C combines both aspects of A & B by stabilizing the implant using a circular cuff, applying pressure, and squeezing the skin around the implant to push the implant out of the incision. [1] Levine, J. P., Sinofsky, F. E., Christ, M. F., & Implanon™ US Study Group. (2008). Assessment of Implanon™ insertion and removal.Contraception, 78(5), 409-417. [6] Asnake, M., Cole, C. B., Oliveras, E., & Tilahun, Y. (2011). Scale-up of task-shifting for community-based provision of Implanon. 2009-2011 technical summary. [8] Federal Ministry of Health, (2013). Module 3: Long Acting Family Planning Methods. Facilitation Guide, 12-24. [28] Implanon Side Effects - Birth Control Implant. (n.d.). Retrieved August 18, 2016, from https://www.plannedparenthood.org/learn/birth-control/birth-control- implant-implanon Funding References
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Contraceptive implant removal device target product profile Ibrahim Mohedas1, Zerihun Abebe2, Delayehu Bekelu2, Tina Al-Khersan1,
Amy Kamdem1, Caitlin Choi1, and Kathleen Sienko1 1University of Michigan, Ann Arbor, MI, USA; 2St. Paul’s Hospital Millennium Medical College, Addis Ababa, Ethiopia
Contact: Ibrahim Mohedas, [email protected]
Background Data Collection
Design ethnography methods performed between May 29th and July 22nd 2016 at St. Paul’s Hospital Millennium Medical College in the Killinkii Michuu Family Planning Clinic, Selam Health Center, Addis Ketema Health Center, and Kolfe Health Center Participants were collected through a snowball sampling methodology, and a semi-structured interview protocol guided the questions This study was considered exempt by the University of Michigan International Review Board Requirements were developed using a range of information sources including benchmarking, academic literature, medical texts, internet, and in-country observations and interviews.
Observations Specific to implant removal, attention was directed towards complications during the procedure Researchers took note of resources available for HCPs, variations in facilities, and different methods employed for removal
Interviews 28 interviews were conducted with a variety of stakeholders including: physicians, health officers, midwives, nurses, and medical residents HCP was asked to complete a freehand removal with each prototype to better understand the removal process and to observe how a device could improve the procedure
Results & Discussion • The target product profile developed through extensive interviews with prototypes and observations is shown
below. • We found the most important points to facilitate during the procedure included:
• 1) Implant stabilization prior to lidocaine administration • 2) Facilitating lidocaine administration in both amount and location • 3) Assisting in the incision during removal
• Other key features include: • Low-cost to fit into the supply/funding constrained global contraceptive environment • Ergonomics: of key importance due to the small nature of the implants and need to ensure implants
don’t break
Data Collection
Target Product Profile Conclusions
Subdermal Implants 99.5% effective in delaying first pregnancies, spacing births, or ending childbearing [28]. Does not require user compliance Preferred method of contraception by both government and nongovernmental organizations. Removal Procedure Must be performed by mid-to-high level HCPs, limiting access for women in rural and urban areas. Procedures completed by low-to-mid level providers are lengthy and painful.
Guiding Research Question: What are the requirements of a task-shifting device to aid in the removal of contraceptive implants to enable frontline healthcare providers to safely and effectively remove implants?
• Further interviews are required to fully
understand certain requirements,
particularly:
• 1) Palpability: defining the distance
required to raise the implant under the
skin
• 2) Cost: defining the willingness to pay
for an assistive device and
understanding the tradeoff between
effectiveness and cost
• 3) Ergonomics: further interviewing with
prototypes to define what aspects of the
device are most important to ergonomic
fit
Future Work
• Prototypes based upon TPP are currently
being developed and tested on
simulator to determine effectiveness
• Multiple implant stabilization methods
being explored and automated incision
Ref-ID: A185-3
Figure 3: Prototype A
Figure 2: Prototype B Figure 1: physician demonstrating removal
Prototypes • Prototype A stabilizes the implant by impeding backwards movement.
The pressure applied on the proximal end of the implant raises the distal end, which aids the HCP in incision location.
• Prototype B offered an alternate solution by raising the implant and lessening the need to reach into the incision. The prototype requires the HCP to squeeze together the legs of the device in order to secure the distal end of the implant. Then, the two “feet” on the legs of the prototype will roll and push the implant out of the incision.
• Prototype C combines both aspects of A & B by stabilizing the implant using a circular cuff, applying pressure, and squeezing the skin around the implant to push the implant out of the incision.
[1] Levine, J. P., Sinofsky, F. E., Christ, M. F., & Implanon™ US Study Group. (2008). Assessment of Implanon™ insertion and removal.Contraception, 78(5), 409-417. [6] Asnake, M., Cole, C. B., Oliveras, E., & Tilahun, Y. (2011). Scale-up of task-shifting for community-based provision of Implanon. 2009-2011 technical summary. [8] Federal Ministry of Health, (2013). Module 3: Long Acting Family Planning Methods. Facilitation Guide, 12-24. [28] Implanon Side Effects - Birth Control Implant. (n.d.). Retrieved August 18, 2016, from https://www.plannedparenthood.org/learn/birth-control/birth-control-implant-implanon
Funding References
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