9 Mistakes Start-ups Make Choosing A Contract Manufacturing Partner
How do you choose the best contract manufacturing partner for you? All contract manufacturing companies (such as a contract manufacturing partner for medical devices) operate differently. Thus, there are strengths and weaknesses to working with various contract manufacturing companies when you are a start up or small company looking to outsource your regulatory testing. In order to avoid new business start up mistakes and start up manufacturing risks, these are 9 considerations to take into account while finding a contract manufacturing company that meets your needs. See our article on contract manufacturing for outsourcing pharmaceutical production HERE.
#1 Access to free, timely guidance for first time regulatory testing for small companies
If you are performing regulatory testing for the first time, expert consultation is necessary to hit all of the regulatory milestones for your specific product and avoid new business start up mistakes. Start ups and small companies are early in their product journey. Thus, they are often working with tight deadlines and limited budgets. Many contract manufacturing companies are unable to provide free, timely guidance for first time regulatory testing. We recommend ensuring that the company you choose is capable of providing free guidance within the turnaround time you need.
#2 Availability of short turnaround times for batch release testing following sterilization
As mentioned above, start ups and small companies have the added pressure of tight deadlines and limited budgets. Deadline and budget constraints inherently create start up manufacturing risks. Long turnaround times in batch release testing following sterilization, result in high inventory costs. In order to keep your inventory costs low, we recommend seeking out a contract manufacturing partner for medical products capable of working with you and facilitating short turnaround times for batch release testing following sterilization.
#3 Experience with regulatory and biocompatibility testing services for unique product families
Medical device start ups and small companies are often aiming to kick-start a niche product that will reinvent their industry, knock-the-socks off their competitors, or cater to a specific audience in need. Thus, it is important to work with a contract manufacturing parter for medical products that is flexible and capable of tailoring their services to support the needs of a unique product family. Many contract manufacturers are good with known products. However, few contract manufacturers have regulatory and biocompatibility testing expertise in supporting unique product families. If you are supporting a unique product, we recommend finding a contract manufacturing partner that has regulatory and biocompatibility testing expertise with unique product families. Do not make a common new business start up mistake and go for cheaper options over quality options that save you time and money in the long run.
#4 Availability of reasonable prices for simple routine testing
Unfortunately, it is common practice for contract manufacturing companies to charge unreasonably high prices for simple routine testing. Keeping this in mind, check to make sure the prices for routine testing you are receiving (or will receive) are in proportion to other testing options. Choose a contract manufacturing partner that dictates their pricing structure not just on time but on the difficulty of the testing being performed to reduct start up manufacturing risks. Check to see if you can receive discounts on frequent routine testing so that you can get quality services with a pricing structure that works within your budget.
#5 Limited to no additional Contract manufacturing partner consulting fees for standardized testing services
Nobody wants to pay more than necessary for quality services. Many companies have unnecessary consulting fees for standardized testing services that require little to no process modification between clients. Before selecting a contract manufacturing partner, check-in on consulting fees for the standardized testing services you require to avoid new business start up mistakes like paying unnecessary consulting fees.
#6 Prompt communication regarding test status, release of results notifications, etc.
When it comes to regulatory tests critical to your product pipeline, nobody wants to be left waiting. Long waits increase start up manufacturing risks. Make sure that your contract manufacturing partner provides regular and prompt communication of test statuses, release of results notifications, and the like so that you know what is happening with your device’s regulatory testing without having to chase someone down.
#7 Ability to speak with a study director when needed
Communication is important in any relationship. The relationship between your company and your contract manufacturing partner isn’t any different. Many contract manufacturing companies do not have the bandwidth to work intimately with their partners and provide the ability to speak with a study director on-demand when needed. When selecting a contract manufacturing partner make sure that you will be provided with the level of communication you need to support your internal milestones and testing needs.
#8 Capability to seamlessly coordinate between sterilization partner and testing laboratory
Especially when it comes to regulatory testing, coordination between the sterilization partner and testing laboratory is crucial. Using EO residual testing as an example, you want EO residuals testing to be performed as soon as possible following sterilization and for the packaged devices to be shipped and stored under manufacturer-specified conditions. Lack of coordination could jeopardize the accuracy of EO residual test results and lead to delays in product testing. Thus, choose a contract manufacturing partner with an established relationship with their sterilization partner. Make sure that your contract manufacturing partner is capable of seamless coordination between their sterilization partner to prevent errors and delays in product regulatory testing. For companies creating nonsterile products, see our article on top nonsterile manufacturing processes.
#9 Ability to support additional information requests from the FDA on prior testing performed without charging significant consulting fees
FDA testing requirements are constantly evolving, and you never know when an unexpected additional information request will be made. In order to keep any delays out of your product pipeline, it is important to choose a contract manufacturing partner that has the flexibility to accommodate additional testing that addresses any information requests that you receive from the FDA on prior testing that has been performed. It is equally important to choose a company capable of supporting all your testing needs without gouging your budget with consulting fees or fees for expedited services. You are trusting the contract manufacturing company you work with to support your product success. Your testing partner should be in a position to work with you to overcome expected challenges, not focused on squeezing as much money out of you for additional testing as possible. Thus, evaluate the ability of your contract manufacturer to support additional information requests from the FDA on prior testing performed without charging unnecessary consulting fees.
MycoScience is a contract manufacturing organization specializing in sterile syringe and vial filling. MycoScience also offers Preservative Efficacy Testing, Sterilization Validations, Bioburden Testing, Cleaning Validations, Microbial Aerosol Challenge Testing, Accelerated Aging, Microbiology Testing, Cytotoxicity Testing, Bacterial Endotoxin Testing, EO Residual Testing, Package Integrity Testing & Environmental Monitoring services medical devices and allied industries. MycoScience is an ISO 13485 certified facility.
References
Michael J. Akers. Sterile Drug Products Formulation, Packaging, Manufacture, and Quality. Drugs and the Pharmaceutical Sciences. Informa Healthcare. 2010.
