What is Scaled Manufacturing?

Scaled manufacturing takes a medical device idea or concept from prototype to production in quantities required to meet customer demand with absolute consistency and reliability. Because of the competitive advantage scaled manufacturing offers, product designers can expand or retract supply with minimal effort, cost, or infrastructure—creating an efficient response to unpredictable industry and customer demands.

What Can Go Wrong?

To realize the true value of scaled manufacturing, it is essential to approach each project carefully and strategically. If the transition from prototype to full scaled production is not fully planned, the entire project may suffer a number of pitfalls. These pitfalls include: not getting the product to the market on schedule, suffering from product quality concerns, and costly regulatory action. These manufacturing disruptions in turn are likely to lead to customer dissatisfaction and costly rework.

For medical device innovation companies, effective scaled manufacturing is especially valuable. The medical device industry is tightly monitored by a number of regulatory bodies including the Food and Drug Administration (FDA) and the Quality System (QS) Regulation/Current Good Manufacturing Practices (CGMP). In order to fulfill safe and compliant products without the resources available to meet growing demand, many companies turn to a manufacturing partner with expertise in this area. These valuable partners can assist product design companies with the time-consuming nuances of regulation requirements, enabling them to focus on their core business.

While the risks of scaled manufacturing seem large, they are easily avoided with foresight and planning. The key to avoiding pitfalls in the process is to understand the potential challenges and to change the process accordingly.

The Impact of the Original Design

Designers who consider scaled manufacturing during the initial design phase will ease the product production transition and will realize cost benefits while minimizing regulatory, cost, and quality issues. Exploring the considerations and benefits of Design for Manufacturability (DFM) and scaled manufacturing early in the design is important for a new product to get to market on time to meet customer demand and market opportunity.

One of the main issues to consider when implementing DFM is to keep the manufacturer’s capabilities in mind. For example, engineers should consider designing the product with commercial, readily available parts as this reduces costs and limits part obsolescence exposure. This will help the supply chain remain viable throughout the product life cycle.

DFM emphasizes the concept of design for ease of assembly—reducing assembly time and lowering manual labor costs. Engineers should also use DFM to mistake-proof the product and assembly process as much as possible. For instance, an engineer may design a product whose parts must be assembled in one simple, correct way. By automating assembly steps and making the assembly process precise and free from tribal knowledge, the designer helps reduce quality issues and manage costs.

Planning for a Successful Transition

The transition between prototype and large-scale manufacturing takes time and careful consideration. An important step in the transition is to identify holes in documentation and testing procedures.

According to the Quality System (QS) regulation, manufacturers are required to prepare and implement detailed documents, referred to as Standard Operating Procedures (SOP), outlining steps and actions of the process. Manufacturers must adhere to their SOP without any deviation or modification to guarantee each final product matches the product designer’s expectations. This QS regulation also requires manufacturers to create and maintain documents such as design history files, device master records, device history records, and training records.

Failure to follow documentation requirements may cost time, production, engineering resources, and may cause unnecessary rework. To smoothly transition from engineering to production, tribal knowledge must be detailed in the SOP in a way that can be easily understood. To highlight potential issues, it is a good idea to have an objective third party, unaffiliated with the product, implement the documentation in a controlled environment.

Additionally, it is an FDA requirement to adequately evaluate devices before they are released for distribution to ensure that the device is safe and effective. This evaluation must be completed by the product designer who must decide aspects of the device to test and/or inspect and create written supporting documentation to limit the potential for errors.

In addition to identifying and filling holes in documentation and testing procedures, it is also a good idea for the device designer and the manufacturer to create a validation build. According to FDA requirements, a company must objectively prove that its manufacturing processes consistently result in a product that meets predetermined specifications. Besides meeting requirements, a validation build of a new product can uncover quality issues not previously found in the design, highlight mistakes and ambiguity in manufacturing documents and allows latent problems to be solved before the product is released.

The Importance of the Partnership

A written agreement between product designers and outsourced manufacturers is required by the FDA, and is an essential step in the entire process. The agreement should address expectations of each party and clearly define their respective roles and responsibilities. To ensure the agreement complies with all applicable laws, it must undergo legal review. Although quality and regulatory responsibilities are sometimes drafted in a separate quality agreement, this approach is not ideal because of the potential for delays and being forgotten.

For many medical devices, the relationship between product designers and manufacturers is the greatest indication of successful scaled manufacturing. In order to have a successful relationship, it is a good idea to have a detailed written agreement, an understanding of the supply chain, and protection for the device and designers.

A medical device designer should not underestimate the importance of supplier quality controls because the materials and components from suppliers determine the overall quality of a final product. It is important to understand and identify the associated risks of supplied material or services on the quality of the product during the design phase to ensure the manufacturer implements the proper degree of supplier control when the product goes into production. Poor quality control over suppliers can have far reaching consequences from customer dissatisfaction to costly regulatory action.

Additionally, both the FDA and the QS regulation state that manufacturers must ensure received product and services conform to specified requirements. Supplier controls can consist of external audits to a supplier’s facility or internal quality checks such as receiving incoming inspection (RII), ensuring supplies are intact and meet specifications for production. Another good supplier control is supplier certifications, such as certification to an ISO standard, which are good indications of quality control, but should not be the exclusive evaluation of a potential supplier.


For many medical device companies fulfilling a safe and compliant product can be demanding—and increasing the production level can lead to more headaches. To scale a product to increased levels of production, designers should carefully consider each step of the process. Keeping the tips and warnings offered in this article in mind before you enter into a project with a contract manufacturer will help to create a safe, efficient, cost-effective and pleasant outsourcing experience.

Lianne Coppinger is the Director of Compliance and Regulatory at Coghlin Companies