Configuration Management and Product Configuration in the Medical Device Industry

1. Configuration Management and Product Configuration in the Medical Device Industry The word configuration comes into mind we immediately think of few orderly items associated with one main item. When we talk of configuration management for any product say medical device then, it is the process approach of establishing product’s performance, functional and physical attributes, with its requirements which is best gained through its design and operational information till lifetime of product. In case of medical device compliance level must be excellent. Configuration management helps maintaining and creating, required attributes, functional characteristic and specification not only for the product but also for manufacturing process. Configuration you offer must be very user friendly. It allows user to select what user needs but it should not confuse users means that user selection should worry for interdependency of selection and what is opted out. Clarification at the selection stage make user understands what is being selected and whether it will meet its purpose. Let us say example is infusion pump for administering drug to patient and patient is infant means now user selection should show the different configuration for normal other patient and infant where pump design is there to variability to a dose infant patient and not scalable up to elder than infant. Similarly, the other pump made for non-infant is not scalable down to adjust lower dose for infant so both configurations will be different and shall be made clear at configuration level for user to understand well. This was one simple example but when company makes several products and configuration for user to select “make to order,” Configure to order, assemble to order. It becomes challenge for the company to serve and user to order however initial work on such configuration serves lot of issues for company and one of the biggest is inventory management. Such challenges can be managed through detailed customer support team. This will also enhance customer satisfaction. Various other systems SAP running in the company must be configured to such ordering system which should automatically indicate user about delivery date on his configuration selection. Company may have some apparent disadvantage or challenges for its functioning like engineering design team must devote more time in ensuring that offered configuration works flawless, thus they are less available for more innovation. Sometime customer makes mistakes in ordering which needs to be corrected before supply or else product may fail in performance and result into complaint. Company must ensure additional resources to take care of such issues which may impact its profitability. This brings the importance of configuration management.

2. Some major steps may help better configuration management, 1.All resources and processes must be integrated to configure the product process then to just produce product itself. 2.Eliminate a wrongly configured order expert must ensure that certain configuration are pre- validated by system itself before the order is accepted. 3.User level system should also be flexible enough to choose multiple configuration and user is allowed to choose as many parameters as possible. 4.Cost of software system and other paraphernalia may cost more initially and may be a license cost too but such initial investment may be essential and prove profitable in long run. Enhance the efficacy of your configuration system and its management, 1.Define and document all configuration rules on paper with team and with thorough risk assessment, build a best model of configuration for user to use. Once validated then incorporate into system. 2.Define standards and conventions related to features, options and rules to have better uniformity and consistency. 3.Test early and often with even smallest change to ensure its bug free. May be use your sales team member as customer to evaluate it independently. Followings are benefits of configuration management. 1.Normally user is not allowed to configure a product who does not know on compliance requirement. This helps customer and build up his satisfaction level. 2.Customer while doing its selection learns about constraints and limitations and gets guidance on best selection through system.

3. 3.It is also possible to demonstrate the pictures and videos of functioning of its selected configuration which also enhances customer happiness. 4.Not to mention about customer to have handy information on pricing, delivery, use of multiple languages. There are several benefits to device manufacturing company too. 1.Reduces manufacturing lead time, order error proofing reduces cost of complaint handling, product replacements. 2.Other benefits like inventory management, replenishment, BOM product structuring. 3.Reduces considerable time on information going through engineers thus reducing lead time on information from engineers to factory floor. 4.User history created in system helps for future in many ways. 5.It is needless to mention as there are several general benefits of systems which are associated with system. Success of this exercise will depend on the expert and experienced input and that is possible through an experienced consultants like Iziel healthcare who has versatile products experience and problems associated with this and success factors. When we are talking of IT system-based project, backup system must be strong. Master data management, change control (Design control, engineering changes, customer requested changes, New improved configuration with changes). Review of changes and its impact on production, coordinate changes and risk assessment are essential. Expertise in these areas are very essential and if not available inhouse then go for outsourcing. Do not forget compliance requirement.