Design for Medical Device Manufacturing
Three mission-critical questions for medical device manufacturing:
- How much value is in speed to market?
- Are you losing critical development time on designs that must be revised in order to be manufactured at scale?
- Are inefficient design, prototyping and testing cycles leading to R&D cost overruns?
Companies who engage an engineering team with deep expertise in designing for manufacturability can achieve quicker speed to market with fewer cost and timeline overruns as compared to companies who design new technologies using only inhouse and contract resources.
Early Engagement with Contract Manufacturer
Our client, a privately held medical device start-up company, came to us as they were embarking on the development of a pioneering technology in the treatment of a common medical condition. Their expertise was in the technological developments and they needed a partner with deep experience in medical device manufacturing. With the possibility of multiple competitors working on the same problem, our client knew speed to market would be a critical factor in the commercial success of their technology. They quickly identified that an early engagement with a contract manufacturer who could participate in the design would be key to achieving speed. This ‘design for manufacturability’ mindset guided the team as they developed the technology.
Design for Manufacturability
Engaging the engineers of a contract manufacturer prior to design freeze makes prototyping cycles more efficient, lowers development costs and improves development leadtime. This results in quicker speed to market for new technologies.
Other companies often struggle with adopting an early engagement process to design for medical device manufacturing. It can be a genuine blind spot in the R&D process of many companies. By driving development of new technologies solely with inhouse or contract engineering resources, these companies inadvertently create unnecessary cycles of prototyping which slows the speed to market and adds to development costs. Engaging the contract manufacturer’s engineering resources prior to design freeze adds value to the R&D process.
Our client’s forward-thinking engineering team avoided those problems because they understood the value of an early relationship with a contract manufacturer. That understanding led to a decision to embed our engineers within their team for interactive research and development around the connectivity challenges in the design. This embedded team of engineers proved so valuable to the process, the full higher level device build progressed smoothly. Our team provided quick-turn prototyping, testing and manufacturing of the full technology being developed. The client quickly realized the value of our embedded team to achieve an efficient and timely transition to manufacturing, resulting in the necessary speed to market.
Our client achieved the speed to market they needed to create a commercial success with their product. Within 36 months of developing the product, our client’s technology had successfully treated more than 17,000 patients in the U.S. and Europe and had significant data proving the effectiveness of the treatment. Following the conclusion of that study, the client received FDA approval to market the product. As a result of their success as a commercially viable and medically effective treatment, the client soon entered into an agreement to sell to a major global medical technology leader for more than $400 million. The technology developed is a commercial and medical success and today is widely considered to be the preferred treatment in its category.