It is increasingly possible to set up a medical device startup as a “virtual” company. With the ubiquity of high speed internet connections and inexpensive, even free, web conferencing applications along with cloud-based file sharing sites, savvy entrepreneurs focused on commercializing quickly and with minimum expense can use outsourced services, contractors and consultants for just about everything.
There are contract design houses, contract clinical research organizations, “rent-a-CFO” firms, freelance sites for graphic designers and all sorts of marketing experts, manufacturer’s representative sales organizations, outsourced customer service and support organizations, logistics companies to warehouse and distribute your products, websites that will display your product and process customer orders, and (the subject of this article) contract manufacturing organizations (CMO).
This article from MDDI explains in detail how to design in anticipation of using a contract manufacturing organization. The logic and elements should be easily understood by anyone with ISO9000 experience, as the process is to “plan the work and work the plan.” The first step is to create a Design Transfer Toolbox. In the toolbox are a number of specifications, documents, and plans. From the article:
- User requirements specification (URS). What must the process do?
- Sequence of events (SOE) chart. When will each assembly step occur?
- Functional requirements specification (FRS). How will the process operate? How will the functionality be tested?
- Design specification (DS). How will the configuration of the process with detailed drawings and databases be defined?
- Trace matrix. How is each design requirement tested and verified? This directly relates each requirement to test functionality.
- Process failure modes and effects analysis (pFMEA). How will the CMO prove it has built the right product in the right way? Input document is the product design failure mode and effects analysis (dFMEA).
It’s important to understand that this is a collaborative process between the medical device company and the CMO. The various specifications and processes must be detailed and agreed to by both parties before a contract is signed and work commences. The consequences of not following rigorous documentation and not having copious communications will be delays, quality problems, and regulatory infractions. On the other hand, investing time and effort before doing the design transfer can result in a high quality, cost-competitive manufacturing process and a successful long-term relationship between the medical device company and the CMO.
Takeaways: Not only are virtual medical device companies possible, there are high quality, reasonably priced companies and individuals operating as contractors, consultants, and freelancers that are eager for your business. If you are a medical device startup CEO with an urgent need to get to market, you should consider outsourcing areas outside of your core competencies. You will save money and time.