Background 1

Background 2

Solution 1

Solution 2

Developed an analytical pneumatic model for the deforming liner and designed a product integration with a low number of injection molded parts that used a single oscillating vacuum source enabling use with OTS pump sources.

model 1

model 2

I went through several prototyping rounds early on as we developed the design parameters. In order to make functional prototypes I worked out a method to fabricate skin-safe silicone parts using materials from the special effects industry and 3d-printed molds.

One advantage we had was that there were pumping mothers in our immediate families. This allowed us to do informal user testing outside of restrictions usually placed on human research. We built a quantification platform that could monitor milk expressed, cup pressure, and liner pressure throughout a pumping session and couple our prototypes with a programmable hospital-grade pump source. This allowed us to carry out DOEs to explore the influence of different parameters on milk expression efficiency and comfort. While we were able to identify operating window limits and validate the comfort and effectiveness of our device, there were a lot of external influences to account for when analyzing the data and making decisions. We were very excited to build on the initial trials at a larger scale with production units but did not get the chance to do that.

prototyping

testing mass

testing pressure

I brought in an industrial designer that I have partnered with extensively over the past 17 years to support our ID and brand language development. Together we converged on a device design that was practical, manufacturable, easy to assemble and clean, had tolerant functional interfaces, and a refined look and feel.

One particularly challenging component was the breast sheild with a deformable liner. I developed an approach consisting of a PPS rigid frame over molded with liquid silicone rubber and consulted with different molders to validate the shutoff and ejection scheme. We were able to build samples for evaluation with machined frames over molded with cast silicone in stainless steel molds.

Drawing package

Production 1

Production 2

Production 3

Molds

Breast pumps are considering to be low risk, class 2 medical devices by the FDA which means that they must be produced within a qualified supply chain under a ISO13485 quality management system, and must go through an FDA 510K review process to establish safety and equivalency to reference devices.
We engaged consultants and advisors to help us navigate this and committed to mastering the concepts and workflows, many of which I was familiar with from previous projects and a course I took on medical device regulation.

One aspect of the compliance effort that was particularly formative for me was the need to execute and document a formalized design control matrix that demonstrates the end design effectively serves the user needs by mapping the path through user needs, requirements, specifications, verification, and validation efforts. I built an understanding of the requirements as established in the FDA CFR’s as well as an understanding of how they are usually executed by consulting with a range of personal and professional contacts. One thing that became very apparent to me was that the intention and rationale behind a formalized design control framework exists across every product development effort, albeit in often times different languages and levels of detail. This has become foundational in how I think about developing product features, designs, and manufacturing efforts.

Most of our parts for the pump kit product were injection molded plastic which needed to be produced in an ISO 9001-ceritfied facility, while final assembly and packout needed to be done in an ISO13485 facility. I built a list of over 100 potential manufacturing partners which I then cropped down to 5 options based on interest in working with us and suitability to the product. The path we went with was an assembly house, Coastline, in Tijuana Mexico that produced a variety of consumer-medical disposables and was cost effective and flexible. Attached to this assembly house was a local San Diego injection molder called ROA Pacific. The founders of ROA pacific have built a unique business where they invest in high quality, full electric presses with automation accessories and produce parts with very low man power. By automating and simplifying onsite operations and working closely with a toolmaker in China to develop tools and processing parameters, they are able to provide incredibly competitive pricing on parts made in the states. The experience of working with them on this project led to a longstanding working relationship in which I often am called on to provide CAD support to their customers when models need to be adjusted for moldability or geometry needs to have partings lines, draft, etc. needs to be added. And I can consult with them early on to discuss tool construction and design approaches early in projects.

The lean operational structure meant that the inspection efforts had to be efficiently implemented so that they did not require complex setups or advanced equipment. This helped to solidify my sensitivity to design parts with thoughtful datums and inspection SOPs that achieve the required design intent while minimizing overhead.

Supply Chain

We wanted to commercialize a dedicated pump device as well as quantification device and app to provide a cohesive product experience with advanced functionality. I studied reference pumps across price points to understand potential topologies and dependencies. I then took an effective and available design and customized it for our specific needs using an integrated analytical model. I then worked out a electromechanical layout based on a selected form factor before collaborating with my ID partner to refine a detailed design. We also hired a freelance embedded system designer to develop a prototype electrical design before engaging medical device EMS CMs to quote an ODM commercialization effort. User feedback on the pump design was that it was OK, but not any different from current devices when it came to usability and practicality. This drove us to undertake another round of ME and ID design integration in order to explore a cylindrical form factor which was easier for moms to handle and use. As well as a set of soft-goods accessories which helped enable a better end to end experience.

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