Medical devices, designed and manufactured for healthcare technology, have a remarkably important role in patient care. The key element in the sector is that there cannot be any compromises with the safety and effectiveness of the devices – the device needs to be perfectly suitable for its intended use to ensure the safety of patients. Meanwhile, the requirements of different parties have grown over the years – today’s innovations need to be easy to use and cost-efficient and the latest technologies need to be utilized.
“The medical staff, decision makers and companies in the field are increasingly cost-critical, and comparison between devices as well as the service providers is been made continuously. Agile design and product development comes to prominence in a situation where the device and its features need to meet the specific requirements of the customer, combined with cost-effective manufacturing, utilization of the latest technology and a rapid product launching schedule”, says Innokas Medical’s Project Manager Lauri Westling.
The decision makers benefit for example from the evaluation of the availability, usability, efficiency and cost-effectiveness of the latest technologies, which enables the hospitals to put their effort on essential key functions and prioritize their resources. The requirements and needs of end-users reflect directly to companies selling their products and devices to hospitals – and thus to companies taking care of the design and manufacturing of those products and devices.
“The need of developing the product development processes to be agile enough, combined with the rapid design transfer and cost-effective manufacturing, without compromising the high quality of the product will be an increasingly important issue in the future. In addition, we need to remember that all decisions that are made during the product development process will straightly have an effect on the manufacturing of the product; like on the production processes and materials that are used. However, especially in smaller companies there are usually a bit limited knowledge and knowhow of how to take all the necessary manufacturability issues into account. This may easily lead to manufacturing been carried out using inefficient and unfavorable methods”, Westling continues.
Cost-efficiency and manufacturability as competitive factors
However, the trend is quite clear. In addition to the development of design and product development processes and utilization of the newest technologies, the cost-efficient manufacturability may be seen as one of the increasingly important competitive factors within the medical device business. The manufacturing is easily outsourced to a professional manufacturing partner, but if there isn’t any needed manufacturability related skills and knowhow in-house and the manufacturing is outsourced to a partner with limited capabilities, the inconvenient methods and solutions may be transferred from first product to another product generations in the future, also.
“Bigger corporates are typically able to take the necessary issues into account already in the very early product development phase when talking about product’s manufacturability. However, there are plenty of smaller companies working in the field who doesn’t necessarily have the kind of knowledge and resources in-house to take care of these issues. Roughly generalized, about 20 % of the product parts cause approximately 80 % of the product’s manufacturing costs. That’s why these parts are precisely one key thing that engineers should pay attention to regards of manufacturability and the reasonable price of the final product”, Robert Ashorn, Innokas Medical’s Mechanical Engineer says.
The importance of the design and development phase of the product cannot be stressed out too much. The high-quality product development process should be based on wide knowledge and skills of taking all the necessary issues into account; like the objectives and limitations of product’s lifecycle and the different stages of it, and the various factors affecting on the manufacturability of the product. Through this, remarkable savings both in material and production costs can be achieved, which will obviously affect directly to the total costs of the final product.
“The needs and requirements for product features naturally drive the concept stage of the product development. But later, the smaller companies’ engineering teams may find it challenging to combine these needs and requirements with cost-efficient manufacturability rules. As we partner with our customers in both product development and manufacturing phases, we have specialized also on different methods of DfX to ensure our customers’ objectives can be achieved. By utilizing the different methods of DfX, the entire process, from idea to finished product, forms a cost-effective process as a whole, as the product design, manufacturability and an effective manufacturing processes are developed at the same time. The process is implemented alongside with the R&D project where the design can be optimized for the cost-efficient production process”, Westling tells.
“For example, with the Design for Cost –analysis, which we can be implemented during the product development process, we will make an analysis, which allows us to critically look at the structure of the product to identify the most potential matters for cost savings. This can lead in most cases directly to lower manufacturing costs without compromising the quality of the product”, he continues.
The high quality combined with cost savings requires deep knowledge and capabilities
In addition to the specialization in medical device design and manufacturing, one of Innokas’ advantages is the company’s full service capability: the product development process is not carried out only in close cooperation with customer’s and Innokas’ engineering teams, but Innokas NPI team will also be involved in the project. During the various stages of the project, all the other necessary resources from different functions will be included in the project, too; from component engineers to sourcing, manufacturing and logistics experts. Using the necessary experts enables the team to create e.g. a comprehensive manufacturability analysis, which Innokas aims to make in an early stage of the product development process. The best results are typically achieved through this model, as the device structure can be still modified if the analysis has been made early enough.
“In the analysis phase of Design for Assembly, we analyze the structure of our customer’s product and consider the alternative production methods to enable an appropriate and cost-efficient system assembly. Smooth assembly as well as more optimal amount of parts naturally speeds the assembly time and lowers the manufacturing costs of the product. Easier assembly typically reduces errors and improves the quality of first pass yield while lowering the quality costs. We also utilize our professional, qualified network of suppliers, for example with material and component selection. As an example, when we have done this to one of our customers, we were able to reduce the material and labor costs of up to 29 %, which shows that the savings can be significant”, tells Mikko Kangas, who works as an Account Director at Innokas. He has also a long history in leading different kinds of product development projects.
Feedback and analyzes of the component selection as well as the agile proto series before transferring the product to the actual manufacturing are also essential parts of the process verifying the solutions and decisions that have been made earlier.
“During the design transfer, Innokas’ NPI team gives the manufacturability feedback about the product design, component selection and manufacturability. All the process methods combined with the required documentation reviews as quality control tool we’re able to prevent obvious errors to be transferred to manufacturing phase, thereby improving the quality and the total costs of the product while speeding up the launching time to the market”, Kangas says.
Striving to more optimal, lower manufacturing costs without compromising the high quality of the product is therefore possible – it requires deep knowledge, wide capabilities and critical analytics taken into practice. In future, this kind of knowledge may be seen to have even more important role in the field due to the existing trends. Due to digitalization and the development of new technologies, the product lifecycles become shorter and the pressure for re-designing the existing products or for agile product development of new, cost-effective products will be increasingly important from the perspective of competitiveness.
“The economically successful product is generated by ensuring the high quality of the product while optimizing its manufacturing costs. During the different kinds of customer projects Innokas’ capabilities as well as knowledge within this has grown even further, that will surely benefit our other customers in the future, too. We have the full service knowhow in-house, so we’re able to form a very talented team of design, manufacturing, quality and sourcing experts to successfully implement the projects – taking care of the manufacturability, cost-effectiveness, lifecycle management as well as the quality issues, too. The added value, which the professional partner can create to the client in such cases, may in terms of time-to-market, but especially financially, be very significant”, Westling concludes.