Literature Review: Open Source Auto-Injector
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Background Information[edit | edit source]
Like any other sector development in the medical sector is taking place at a fast rate. Auto-Injector is one of the devices which is used by many healthcare practitioners, patients, parents (for children under 12) around the globe for the purpose of injecting insulin into the body on there. This comes in handy during a life-saving emergency situation like for Miagrane and anaphylaxis patients. The number of versions is available in the market which varies in designs, volume capacity, sizes, and degree of autonomy.
Market Survey[edit | edit source]
Following are the different versions available in the market with varying functionality, ergonomically designed features and capacity:
1) SmartPilot for YpsoMate which is having features like Bluetooth connectivity, advance patient guidance, user-centered industrial design, and real-time tracking
2) PenInject 2.25: SHL’s 1st injector project is another model in this device family which is easy to use, button activated and reusable
3) Allflex 20ml Automatic Syringe autoinjector device which has a design which provides UV protection and dose adjustable facility from (1-20 ml)
4) Electronical Syringe EVOL, 500 µl without needle this device is unique features like a programmable, universal charger facility, Electronic syringe assembly, etc.,
5) Socorex® 5cc Twin Self-Refilling Syringe is a costlier one but has some remarkable feature abilities like ergonomically designed, individually adjustable two barrels.
6) Nj Phillips 50 mL Semi-Automatic Repeater Syringe - Plastic available in market for price range of $50 - $60 with features like built-in needle magazine, choice of 5 fixed-dose settings, reliable and cost-effective.
References[edit | edit source]
Performance characterization of spring actuated autoinjector devices for Emgality and Aimovig [edit | edit source]
Dou, Z., Eshraghi, J., Guo, T., Veilleux, J. C., Duffy, K. H., Shi, G. H., & Vlachos, P. P. (2020). Performance characterization of spring actuated autoinjector devices for Emgality and Aimovig. Current Medical Research and Opinion, 36(8), 1343-1354.
- The study is based on the performance comparison of two single spring-actuated auto-injectors (AI), Aimovig, and Emgality AI devices at specific test conditions, room temperature, and storage temperature.
- Several quantitative comparisons have been performed out of which 14 quantitative comparisons had statistically consequential variations.
- The study finds several performance differences between the two auto-injectors (AI) devices despite having the same principle. However, more clinical trials are
needed to verify several different risks subjected to premature device removal and intramuscular injection.
Türk, M., Türk, G., Koç, A., Karabıyık, Ö., & Yilmaz, I. (2020). What Should the Optimal Adrenaline Auto-Injector Needle Length Be?. Asthma Allergy Immunology, 18(2).
- The article is all about the needle length of adrenaline auto-injector and its injection failure risk in adults.
- The methodology in the research dealt with the determining of injection risks by taking various needle length and the optimal length of needle is determined by considering the least risk.
- The results show that the risk is higher in women especially with higher BMI. Also, the outcome can be improved if the needle length is determined according to BMI.
Usability of mepolizumab single-use prefilled autoinjector for patient self-administration [edit | edit source]
Bernstein, D., Pavord, I. D., Chapman, K. R., Follows, R., Bentley, J. H., Pouliquen, I., & Bradford, E. (2019). Usability of mepolizumab single-use prefilled autoinjector for patient self-administration. Journal of Asthma, 1-12.
- Based on the examination of an antibody “mepolizumab” for the treatment of asthma using single-use prefilled auto-injector (AI).
- The observation was carried out in the phase of 4 weeks.
- The study finds all the patients safely self-assessed the antibody using an autoinjector both at home and clinic without any additional safety concerns.
Kessler, C., Edwards, E., Dissinger, E., Sye, S., Visich, T., & Grant, E. (2019). Usability and preference of epinephrine auto-injectors: Auvi-Q and EpiPen Jr. Annals of Allergy, Asthma & Immunology, 123(3), 256-262.
- Study revolves around the comparison between two epinephrine injectors which have different designs
- Comparison is based on ability to device injection instructions, most common use-errors, time for completing key injection task, and user compatibility.
- From study inference can be made that Auvi-Q is designed in a better way which finds its way to use in life-threatening situations as compared to EpiPen Jr.
Development and usability of a new subcutaneous auto-injector device to administer hydroxyprogesterone caproate to reduce the risk of recurrent preterm birth [edit | edit source]
Travanty, M. N., Calawa, B., Shalaby, W. S., Jozwiakowski, M. J., & Haraldsen, K. B. (2018). Development and usability of a new subcutaneous auto-injector device to administer hydroxyprogesterone caproate to reduce the risk of recurrent preterm birth. Medical Devices (Auckland, NZ), 11, 241.
- The article is based on the development of an auto-injector for HPC to minimize the likelihood of chronic premature births.
- A single-use disposable auto-injector having prefilled and fixed-dose is developed and evaluated in multiple formative and validation studies followed by design iterations and validation testing.
- An auto-injector is successfully developed to administer the HPC to minimize the likelihood of chronic premature births.
Rodriguez, E. A., Arnold, M. L., & Wilkerson, M. G. (2018). A Review of Auto-Injector Pen Safety and Preventative Strategies. SKIN The Journal of Cutaneous Medicine, 2(5).
- Presented the case study of incidences which led to auto-injector device injuries.
- Discussed the concerns regarding the safety issues and its preventative strategies to minimize the injuries despite having manufacturer's guidelines.
Improving the safety of disposable auto-injection devices: a systematic review of use errors [edit | edit source]
Weinhold, T., Del Zotto, M., Rochat, J., Schiro, J., Pelayo, S., & Marcilly, R. (2018). Improving the safety of disposable auto-injection devices: a systematic review of use errors. AAPS Open, 4(1), 7.
- The paper presents the identification of the potential errors and to improve the safety concerns of a disposable auto-injector.
- A quantitative analysis to identify the errors has been done with the help of data extraction and analysis which can be very helpful for the future design of the disposable auto-injector devices.
Design and Verification of a Reloadable Adrenaline Auto-Injector for Intramuscular Injections [edit | edit source]
Nair, G., Levin, M., & Sivarasu, S. (2018). Design and Verification of a Reloadable Adrenaline Auto-Injector for Intramuscular Injections. In Frontiers in Biomedical Devices (Vol. 40789, p. V001T11A011). American Society of Mechanical Engineers.
- The research is based on the design modeling of a reloadable adrenaline auto-injector (AAI) which is used for the intramuscular injections.
- The design is primarily MATLAB based CFD model which used Hagel-Poiseuille equations and later tested on the porcine blocks using 3D printed AAI to observe the results.
- This design can be lead to cost reduction of the AAI which generally costs $300 per device on the average.
Thueer, T., Birkhaeuer, L., & Reilly, D. (2018). Development of an advanced injection time model for an autoinjector. Medical Devices (Auckland, NZ), 11, 215.
- Based on the mathematical modeling for predicting the injection time for an auto-injector (AI).
- The study involved MC simulations and sensitivity analysis for finding injection time for disposable autoinjector.
- The validation concluded the model as a highly accurate model with less than 12% modeling error.
Contemporary issues in anaphylaxis and the evolution of epinephrine autoinjectors. What will the future bring? [edit | edit source]
Greenberger, P. A., Wallace, D. V., Lieberman, P. L., & Gregory, S. M. (2017). Contemporary issues in anaphylaxis and the evolution of epinephrine autoinjectors: What will the future bring?. Annals of Allergy, Asthma & Immunology, 119(4), 333-338.
- Article discusses an increase in anaphylaxis patients with an alarming rate along with its cause and possible solutions, modification required in autoinjector devices.
- Detailed report of a patient who has been affected due to improper treatment within a limited timespan is discussed
- Length of the needle should be designed as per age group to avoid the risk of bone injection
Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients [edit | edit source]
Brand-Schieber, E., Munjal, S., Kumar, R., Andre, A. D., Valladao, W., & Ramirez, M. (2016). Human factors validation study of 3 mg sumatriptan autoinjector, for migraine patients. Medical Devices (Auckland, NZ), 9, 131.
- Experiments with detail study and reviews were performed with migraine patients with a newly developed auto-injector
- DFN-11 found to be a highly efficient device among all patient irrespective of their familiarity with the device
Development of devices for self-injection: using tribological analysis to optimize injection force [edit | edit source]
Lange, J., Urbanek, L., & Burren, S. (2016). Development of devices for self-injection: using the tribological analysis to optimize injection force. Medical Devices (Auckland, NZ), 9, 93.
- Frictional effects generating inside the autoinjector are studied through experiments and possible lubrication methods are discussed.
- Experiments are performed which includes a device which has a combination of additives, polymers, and lubricants, and results are plotted
- It is observed that silicon-based external lubricants give the best performance over PTFE based lubrication
Comparison of drug delivery with autoinjector versus manual prefilled syringe and between three different autoinjector devices administered in pig thigh [edit | edit source]
Hill, R. L., Wilmot, J. G., Belluscio, B. A., Cleary, K., Lindisch, D., Tucker, R., ... & Shukla, R. B. (2016). Comparison of drug delivery with autoinjector versus manual prefilled syringe and between three different autoinjector devices administered in pig thigh. Medical devices (Auckland, NZ), 9, 257.
- The study is the comparison of autoinjector with a manual pre-filled syringe in case of drug delivery.
- There were two studies conducted First is AI vs manual syringe and the second is AI with different mechanical properties.
- Many parameters were considered including gauge and length, needle size, etc.
- The study can be useful in future research of injection technologies.
Drug-device combination products in the twenty-first century: epinephrine auto-injector development using human factors engineering [edit | edit source]
Edwards, E. S., Edwards, E. T., Simons, F. E. R., & North, R. (2015). Drug-device combination products in the twenty-first century: epinephrine auto-injector development using human factors engineering. Expert opinion on drug delivery, 12(5), 751-762.
- Wide scope of age group might need to use epinephrine auto-injectors and for that its design should be most efficient. Designing equipment by human factors consideration is an important part of the discussion.
- User-specific problems might include lack of portability, failure to carry them consistently and safely, etc.,
- Emphasis is given on training of patients, Parents (in case if the patient is a child), and healthcare professionals
- User-specific designs, considering various factors like safety, durability, portability, user-interface has been discussed and validated with experiments.
Patient Satisfaction with the New Interferon Beta-1b Autoinjector (BETACONNECT™) [edit | edit source]
Ziemssen, T., Sylvester, L., Rametta, M., & Ross, A. P. (2015). Patient satisfaction with the new interferon beta-1b autoinjector (BETACONNECT™). Neurology and therapy, 4(2), 125-136.
- The study aimed at the review of patient satisfaction and preference for BETACONNECT™ (beta 1b auto-injector).
- The study was conducted by the 15-min online survey which was participated by many patients in Germany.
- Out of 118 patients, BETACONNECT™ is preferred over the previous injection method by 90% of patients.
- Some of the features which satisfied most of the patients are less pain, smoother injections, adjustable speed and depth of the injection, ease of use, etc.
- Use of BETACONNECT™ (AI) gave high satisfaction to the patients which resulted in a reliable recourse to improve the injection experience for the patients.
Sheehan, T. C. (2015). Design of a Double-Dose Epinephrine Auto-injector Using 3D-Printing.
- The research is based on the designing and 3D printing of a double dose epinephrine auto-injector (AI).
- Work includes the trigger and hold the springs and after the first and second doses to protect the needle which is quite the challenging part.
- The manufacturing of the device has been done using 3D printing based on the extrusion techniques.
Comparison of adrenaline auto‐injector devices: Ease of use and ability to recall use [edit | edit source]
Robinson, M. N., Dharmage, S. C., & Tang, M. L. K. (2014). Comparison of adrenaline auto‐injector devices: Ease of use and ability to recall use. Pediatric Allergy and Immunology, 25(5), 462-467.
- The article is based on the comparison of AAI devices, Anapen and EpiPen and the data collected in the comparison is from Australia.
Song, T. T., Worm, M., & Lieberman, P. (2014). Anaphylaxis treatment: current barriers to adrenaline auto‐injector use. Allergy, 69(8), 983-991
- Besides the importance of autoinjector devices for anaphylaxis patients, there is a considerable increase in the number of patients.
- Research found that there is limited awareness among healthcare professional, lack of availability if AAI in public spaces, high cost of injectors, failure to use this device are some of the barriers
- Study also reveals that there should be a balance between the healthcare industry, policymakers, and government of respective country for proper availability of AAI devices
Dennerlein, J. T. (2014). Anaphylaxis treatment: ergonomics of epinephrine autoinjector design. The American Journal of Medicine, 127(1), S12-S16.
- Article bolster the fact that most important factors while designing the autoinjectors are patient characteristics, such as age, physical capabilities like strength. Other factors discussed in this include designing with a safety and portability point of view.
- Ergonomic factors like shape, grip, color, and size are discussed.
- Detailed study has been done on the gripping of the handle along with its intended functions and the appropriate amount of force.
Design validation and labeling comprehension study for a new epinephrine autoinjector [edit | edit source]
Edwards, E. S., Edwards, E. T., Gunn, R., Patterson, P., & North, R. (2013). Design validation and labeling comprehension study for a new epinephrine autoinjector. Annals of Allergy, Asthma & Immunology, 110(3), 189-193.
- Author addresses the problems associated with currently available auto-injectors in the market for which assessment was performed on a specific number of peoples.
- Newly designed product found effective after experiments which include brief written instructions(leaflet), voice instructions, and overall design.
Money, A. G., Barnett, J., Kuljis, J., & Lucas, J. (2013). Patient perceptions of epinephrine auto‐injectors: exploring barriers to use. Scandinavian Journal of Caring Sciences, 27(2), 335-344.
- In this article importance of medical self-care and management through proper education, training, improved equipment design which are used by patients, general public, and most importantly healthcare professionals.
- Fifteen user experiences have been recorded through interviews and primary conclusions were made based on this data.
- Possible solutions including personal training to patients and healthcare professionals are suggested. It is also inferred that there should be mandatory changes in design that help patients and other locals around to worry less about the possible danger from the end-user.
Friedrichs, A., Bohnet, J., Korger, V., Adler, S., Schubert-Zsilavecz, M., & Abdel-Tawab, M. (2013). Dose accuracy and injection force of different insulin glargine pens. Journal of diabetes science and technology, 7(5), 1346-1353.
- Five commercially available autoinjectors with three dose values are studied and compared on basis of force required, the time needed, accuracy
- Decisions are made based on tolerance limit, average deviation, and coefficient of variation.
- Low injection force required for insulin - Lantus pens as compared to reusable insulin pens.
Topal, E., Bakirtas, A., Yilmaz, O., Ertoy, I. H., Arga, M., Demirsoy, M. S., & Turktas, I. (2013). A real-life study on acquired skills from using an adrenaline autoinjector. International archives of allergy and immunology, 160(3), 301-306.
- Experiments were performed with Sixty-four patients including children who are infected with anaphylaxis
- Logistic regression model was used to perform the design of experiments (to find out factors affecting the usability of the auto-injector device
- Proper training to caregivers/patients is required through periodic follow-up to minimize some barriers in using the device appropriately.
Wilkins, J., & Simpson, I. (2012). Mathematical modeling for faster autoinjector design. Drug Dev Deliv, 12(6), 41-45.
- Effect of different design parameters (injection time and force, shear stress) on the physical behavior of autoinjector is studied using mathematical modeling
- Mathematical model (Ordinary Differential Equation) for each component is fed into the MATLAB and Simulink and graphs are generated from which design parameters can be fixed
- Advantage of using MATLAB over physical experimentation is justified through manufacturing tolerance case study
Injection Force of Reusable Insulin Pens: Novopen 4, Lilly Luxura, Berlipen, and ClikSTAR [edit | edit source]
Friedrichs, A., Korger, V., & Adler, S. (2011). Injection force of reusable insulin pens: Novopen 4, Lilly Luxura, Berlipen, and ClikSTAR. Journal of Diabetes Science and Technology, 5(5), 1185-1190.
- Articles describe the study of injection force required by four reusable auto-injector pens and test is conducted with two varying test methods
- The study also reveals that CS (ClickSTAR) pen require lower injection force which is beneficial for diabetic patients