By Dr. Kate Stephenson, Dyad Engineering

There is a world of difference between making one unit versus 100,000 units of a product, especially if what you are developing and manufacturing is a medical device. Moving into manufacturing is not just about design readiness, it serves as the defining point in an organization’s maturity. In medical devices, it is the terrifying leap from producing a few carefully-crafted clinical units, to the thousands of units that will go into the hands of strangers. Because of this, your “manufacturing readiness” needs to be assessed across multiple key areas.

Is Your Design Ready

Most of the elements needed to manufacture parts effectively are part of the tried-and-true field of design for manufacturability. Do you have draft and minimal wall thicknesses on your molded parts? Have you dialed in your dimensional tolerances where necessary, and loosened them where this is not needed? In this era of rapid prototyping methods with reduced geometric restrictions, classic blunders like undercuts and impossible tool paths may remain undiscovered right up until the transition to higher volume manufacturing methods. Off-the-shelf parts have their own risks in the jump to production. Have you vetted suppliers and made sure they can the supply your components with the certifications you need? Runs to the nearby hardware store are no longer an option. In medical devices, late-stage design changes to address these challenges can not only mean extra cost and delay, but potential invalidation of testing completed using the previous design.

Is Your Process Ready

There are no parts so perfect that they cannot be assembled in the wrong way. Because early units are frequently assembled by engineers or senior techs, “obvious” knowledge can be lost when the processes are transferred over to a manufacturing team. Whether it is assembling a tricky gear train, applying just the right amount of glue, or inspecting finished units for defects, all the previous intangible knowledge must be made explicit and documented. Scaling production drastically changes how parts are moved through an assembly line, how quality checks are completed and how documentation is filled out. Some of these challenges are met with process and documentation, while others require the design and manufacture of custom jigs and fixtures. Once those processes and tools are created, they must be documented via training materials and drilled into the workforce. Out-of-date process documentation and missing training records are the most common offenses highlighted by regulatory audits.

Is Your Business Ready

While there are loads of books on designing and developing products on a shoestring, manufacturing is the hard line when most major investments are made. Whether it is buying capital equipment, leasing storage space, or the massive surge in personnel needed to make and sell your product, expenses skyrocket with production. This mean the company’s finances need to be ready when the design is. Do you have cash deposits on hand for your custom tooling? Do you have sufficient funds for payroll? Do you have your sales and invoicing system in place to take payments? In addition to the finances, your logistics chain, both downstream to your raw materials, and upstream to deliver to your customers, needs to be complete. Your goal is to make sure that the gap between writing the major checks and seeing revenue is crossed as efficiently as possible.

Are You Risk Ready

The start of manufacturing also brings an explosion of liability. This should seem logical since regulatory bodies regulate medical device manufacturers; not prototype houses, not research labs, but manufacturers of the final product. Manufacturing is when a company’s impact on the general population comes home, for better or worse. While we like to think of the positive aspects (happy doctors, healed patients, and healthy profits) you must remain vigilant of potential risks. Improper use by doctors, faulty parts, over-eager sales teams going off-message are all common issues faced by companies with product on the market. Mitigations for dealing with these must be ready when the product is. These include a carefully maintained quality system, processes to deal with adverse events reported to the FDA, and the ability to pass surprise audits at any time.

Ready Your Manufacturing Plan for Success

While all these considerations may seem overwhelming, they are critical to examine and keep front-of-mind when developing your manufacturing plan. By putting the right strategies, processes, people and quality checks in place, you can make the transition from medical device prototype to large-scale manufacturing, a successful one.

Dr. Kate Stephenson is an engineer, researcher, public speaker and writer with over 20 years and 60+ products of technical experience. Her consulting firm, Dyad Engineering, focuses on technical and educational strategies for implementing disruptive technologies in the health field. Her clients include startups, investment firms, academic institutions and Fortune 100 companies. Kate has a PhD in Mechanical Engineering from Stanford University and has developed and taught multiple classes and workshops in new medical product innovation.She is particularly passionate about the ways new technologies have allowed for innovation in under-served populations, primarily by disrupting the resources necessary to bring such products to the market.