Addressing market complaints through learning launch for Autoinjector device.

Introduction

I am a pharmaceutical supply chain management professional focused on external manufacturing  supplies and operational excellence related to the same. I was assigned a task to reduce the market  complaints for an injectable device for US market. This device has plastic based components with a  prefilled syringe made of high quality glass and autoinjector system that will be used to deliver the  dose to patients suffering from migraine. As the product design suggest it is intended for use directly  by the patients, i.e whenever the migraine attack happens the patient can use the device immediately  without any assistance from medical professional. Giving the patients convenience to use the product  and portability to carry made the product successful and of high value. However as the product sales  increased the market complaints also increased and majority of the complaints when classified  categorically as device malfunctioning.

The Challenge:

This Autoinjector device product was unique and novel in design hence the device assembly machine  was also custom made to order to fit the requirement. Since this product was already in the market  for several years now and given the highly regulated environment of US market it was imminent to  address the issue.

Thorough evaluation of the nature of market complaints revealed several possibilities of the device  not working. Hence rather unconventional it was decided to quickly address these issues through  learning launch process.

Learning launch 1:

As the device was new and unique and very different in design than the innovator product it was  essential to educate the customers the right way to use it. Several educational sessions and webinars  were conducted with prominent pharmacist and medical practitioner as well as field force on how to  use the device properly. Step wise diagrams on proper usage of device were also introduced in the  patient information leaflets which helped a lot at first. We observed reduction in the complaints but  that was not significant and with the addition of new user, the trend line were maintained.

Learning launch 2:

Although it was important to educate the front end on correct usage and ensuring new user were also  able to use the device correctly, it didn’t yield significant result, learning launch 2 phase was designed  to check and control the release of faulty device. There were systematic procedure for product release  and until the device passed those test will not get released to market. Although these test were  significant to batch release and the sample size just enough to justify the same, It didn’t offer anything  on the prediction of failure. After several brainstorming session with the team it was decided to put a  camera system that will check and reject the device at the source itself. This was working although  not in its best way but significant enough to get accepted. At the same time our product yield was also  compromised as the camera system and was attributed to the camera system rejecting the good  devices too.

Learning launch 3:

Across learning launch 1 and 2 our entire focus was on either educating the customer and ways to  reject the faulty device, both these learning launches proved to be important and paved the way for  the third phase of the process. For learning launch 3 we directed our focus on understanding what  made the device to malfunction in the first place. This helped us to look at the design of Assembly  machine itself since changing the design of autoinjector device product was a long process given to  regulatory environment. Once again the team assembled for brainstorming but this time I brought in  the Assembly machine manufacturer to capture their insight.

Further detailed investigation into the design function of device and its compatibility with the  assembly machine revealed some surprizing but significant fact. We discovered more or less the issue  to be with the breakages of more than one components of Autoinjector device components  internally  which was not visible to the camera system that led to device malfunction. These breakages were  accounted to the incompatibility of the plastic and Glass components of the Autoinjector device and  the robotic pneumatic arm of the assembly machine. This robotic arm was hydraulic powered with no  control on the force it exerted on the device component while it fixes the Glass syringe in the bottom  assembly of the device. This was eureka moment for us as we were significantly close to remedy the  issue. Immediately we worked on changing the Pneumatic robotic arm of the assembly machine from  hydraulic to servo powered. This servo powered arm will provide the exact amount of force that is  required to fix the glass syringe in the bottom assembly of the device without breaking any of the  components. With the help of experts we exacted on the force that need for the device to be  assembled without damaging. We implemented this and are expecting significantly reduction in  market complaint in upcoming 3 to 4 months’ time.

Conclusion:

We did address the actual root cause and expecting to see some major improvement as far as market  complaints are concerned. We are also expecting yield improvement by improving the design. Across  the three learning launches there were several realization about the device manufacturing process  and the challenges it can pose to the end user as well as the manufacturer. We learned one significant  aspect about device manufacturing that less the number of components the lesser will be the chance  of error or malfunction.

This use of learning launch to quickly test the theory and implement the solution and then iterating  the process till we achieve the best possible solution has proven significantly on how issues can be  addressed, a rather unconventional way to put this tool to use but it immensely helped in arriving to  the best possible solution.


Addressing market complaints through learning launch for Autoinjector device . Introduction I am a pharmaceutical supply chain management professional focused on external manufacturing supplies and operational excellence related to the same . I was assigned a task to reduce the market complaints for an injectable device for US market . This device has plastic based components with a prefilled syringe made of high quality glass and autoinjector system that will be used to deliver the dose to patients suffering from migraine . As the product design suggest it is intended for use directly by the patients , i.e whenever the migraine attack happens the patient can use the device immediately without any assistance from medical professional . Giving the patients convenience to use the product and portability to carry made the product successful and of high value . However as the product sales increased the market complaints also increased and majority of the complaints when classified categorically as device malfunctioning . The Challenge : This Autoinjector device product was unique and novel in design hence the device assembly machine was also custom made to order to fit the requirement . Since this product was already in the market for several years now and given the highly regulated environment of US market it was imminent to address the issue . Thorough evaluation of the nature of market complaints revealed several possibilities of the device not working . Hence rather unconventional it was decided to quickly address these issues through learning launch process . Learning launch 1 : As the device was new and unique and very different in design than the innovator product it was essential to educate the customers the right way to use it . Several educational sessions and webinars were conducted with prominent pharmacist and medical practitioner as well as field force on how to use the device properly . Step wise diagrams on proper usage of device were also introduced in the patient information leaflets which helped a lot at first . We observed reduction in the complaints but that was not significant and with the addition of new user , the trend line were maintained . Learning launch 2 : Although it was important to educate the front end on correct usage and ensuring new user were also able to use the device correctly , it did n’t yield significant result , learning launch 2 phase was designed to check and control the release of faulty device . There were systematic procedure for product release and until the device passed those test will not get released to market . Although these test were significant to batch release and the sample size just enough to justify the same , It did n’t offer anything on the prediction of failure . After several brainstorming session with the team it was decided to put a camera system that will check and reject the device at the source itself . This was working although not in its best way but significant enough to get accepted . At the same time our product yield was also compromised as the camera system and was attributed to the camera system rejecting the good devices too . Learning launch 3 : Across learning launch 1 and 2 our entire focus was on either educating the customer and ways to reject the faulty device , both these learning launches proved to be important and paved the way for the third phase of the process . For learning launch 3 we directed our focus on understanding what made the device to malfunction in the first place . This helped us to look at the design of Assembly machine itself since changing the design of autoinjector device product was a long process given to regulatory environment . Once again the team assembled for brainstorming but this time I brought in the Assembly machine manufacturer to capture their insight . Further detailed investigation into the design function of device and its compatibility with the assembly machine revealed some surprizing but significant fact . We discovered more or less the issue to be with the breakages of more than one components of Autoinjector device components internally which was not visible to the camera system that led to device malfunction . These breakages were accounted to the incompatibility of the plastic and Glass components of the Autoinjector device and the robotic pneumatic arm of the assembly machine . This robotic arm was hydraulic powered with no control on the force it exerted on the device component while it fixes the Glass syringe in the bottom assembly of the device . This was eureka moment for us as we were significantly close to remedy the issue . Immediately we worked on changing the Pneumatic robotic arm of the assembly machine from hydraulic to servo powered . This servo powered arm will provide the exact amount of force that is required to fix the glass syringe in the bottom assembly of the device without breaking any of the components . With the help of experts we exacted on the force that need for the device to be assembled without damaging . We implemented this and are expecting significantly reduction in market complaint in upcoming 3 to 4 months ’ time . Conclusion : We did address the actual root cause and expecting to see some major improvement as far as market complaints are concerned . We are also expecting yield improvement by improving the design . Across the three learning launches there were several realization about the device manufacturing process and the challenges it can pose to the end user as well as the manufacturer . We learned one significant aspect about device manufacturing that less the number of components the lesser will be the chance of error or malfunction . This use of learning launch to quickly test the theory and implement the solution and then iterating the process till we achieve the best possible solution has proven significantly on how issues can be addressed , a rather unconventional way to put this tool to use but it immensely helped in arriving to the best possible solution .