Development Process

MicroPen Technologies has a track record of working collaboratively with our customers to bring breakthrough products from concept to market entry and commercial success. Our application engineers and materials experts are able to quickly evaluate both the technical and economic viability of MicroPenning® for the desired end product and application. We recommend or select a material system. We design a pattern to achieve the desired functionality. We develop a process for fabrication. We assign an Application Engineer and a MicroPen Engineer to each project. Each application brings its own set of challenges, and we’ve found that bringing together the complimentary capabilities of our team with those of our customer greatly enhances the likelihood of commercial success. Here are the 6 Steps in Micropen Medical’s Development Process.

Step 1: Concept

The earlier we engage with a prospective customer, the more value we bring to the development process. In the CONCEPT phase, it is important to understand the desired functional characteristics of the product. This is the WHERE, WHEN and HOW phase. If specifications or sketches are available, they are fully vetted. Time to market, targeted product volume, targeted price point and other market/economic factors are also important factors at this stage. Once we understand the concept from the prospective customer’s point of view, we conduct a DESIGN REVIEW with our product development team. This is an objective and candid assessment of whether we can do what is asked and/or bring the value that is required. These considerations are always assessed in the context of manufacturability. There are times when we may recommend a design alternative or we may recommend an alternative technology.

Step 2: Quote

If the CONCEPT passes the Design Review, we will quote the Development Process. Our objective is to get your product to market. We recognize that customers may still be making technology choices at this point. While we recognize the implications of that, we believe the prospective customer should get out best commercialization effort at this point. Customers always get our best technology effort.

Step 3: Proof of Concept

Our INSTANT EXPERTISE involves Printed Electronics – the world of inks, substrates and patterns. We acquire the selected substrates and ink(s) and design a basic pattern to determine first-level feasibility. Next, we evaluate the marriage of the materials to the substrate, the behavior of the materials at the point of deposition, and any rheology changes associated with curing or firing. Adhesion of the materials to the surface is fully explored and analyzed at this stage. For many devices, conductivity testing also occurs here in order to assess proximity to desired functionality. For radiopaque device applications, fluoroscopy comparison and analysis is performed. Will the device work? This is the stage where we find out

Step 4: Prototypes

Our prototype lab “prints” small runs, a product development engineer authors a prototype report and delivers both to the customer for inclusion in the customer’s test protocol. Results are shared and necessary adjustments and changes are made.  This is where the value of Micropenning® becomes apparent in that instantaneous adjustments and changes can be made. No long lead time for new masks, and no long queues. Additional prototypes are utilized for animal testing, clinical trials, and regulatory tests.

Step 5: Process Development

Oftentimes, in concert with Step 4, a manufacturing process is developed. During this stage, our product development team works with both the customer and our own manufacturing team. Test data, clinical trial results, and all field related information is analyzed for product and application refinement. The MicroPen manufacturing process is validated and pre-production runs commence.

Step 6: Manufacturing

This is the step where technology gives way to economics. A manufacturing plan is drawn with schedules, unit price, and other factors associated with the delivery of a highly reliable medical device.