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?
- Is inefficient design, prototyping and testing cycles leading to R&D cost overruns?
Companies who engage an engineering team with deep expertise in design for manufacturability can achieve quicker speed to market. It will result in 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 when they started the development of a pioneering technology in the treatment of a common medical condition. Their expertise was in 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 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. It also lowers development costs and improves development lead time. 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. But by driving development of new technologies solely with inhouse or contract engineering resources, these companies inadvertently create unnecessary cycles of prototyping. This misstep slows the speed to market and adds to development costs. Engaging the contract manufacturer’s engineering resources prior to a 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 medical 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. They achieved an efficient and timely transition to medical device manufacturing, resulting in the necessary speed to market.
Project Results
Our client achieved the speed to market they needed to create a commercial success with their product. Within 36 months of developing the medical device, our client’s technology had successfully treated more than 17,000 patients in the U.S. and Europe with significant data proving the effectiveness of the treatment. Following the conclusion of that study, our 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. Today it’s widely considered to be the preferred treatment in its category.
Learn more about Nortech’s medical device manufacturing expertise.
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Our medical device manufacturing experts will meet with you to evaluate your process to design for manufacturability and to provide guidance for ways we can help you improve the process.
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