Identifying the right medical manufacturing partner to fulfil your wound care needs requires confidence and knowledge in their ability. How do you go about selecting the correct partner, someone you trust with delivering quality for your customers. During the vetting process, it is highly recommended to be aware of the following:
- Qualifications
- Production space
- Complete process
- Risk
- Wound care experience
Qualifications
Qualification checking is an absolute first place starting point. What qualifications does the company have? Are they ISO 13485 certified and registered with the FDA? Are all their sites registered? Have the quality team got the correct qualifications? These points are critical to ensure that your product will be produced to the right standard, in the correct environment and protect the end user or patient. All these questions can be answered through a remote audit, simple supplier questionnaire form or discussion with the manufacturer. It is essential to ask for evidence of certificates especially during these strange times where an onsite audit is difficult to carry out. Constant communication and transparency between both parties plays a vital role in the success of the partnership and risk management.
Production Space
Once the qualifications have been confirmed the production environment is the next crucial factor to investigate. Are they entirely medical focussed? Do they have correct procedures in place to operate cleanroom facilities? How are raw materials handled and is 5S in place? As your product is a medical device it is highly likely that it will need to be produced in a cleanroom for the patient’s safety, for which there are a huge number of procedures that need to be gone through every day to ensure that a cleanroom is operating to the required standard. Is the company completing their daily checks on air pressure? Are the correct gowning procedures (head to toe) being followed? Are environmental checks taking place to the regularity specified? Again, most of these questions can be answered remotely at this current time and video call audits can work well to ensure that the cleanroom looks clean, is well organised and staff are following the standard operating procedures.
Complete Process
Contract manufacturing companies that can offer the complete package are few and far between. It is a huge benefit to select a partner that can take the product journey right through from design, certification, manufacturing, packing and sterilisation. The positive effects on the environment, cost savings and removal of risk such as transport damage and double if not triple handling are significant.
Risk
Risk is of ever-growing importance in the medical device market and is an essential point in selection if your product is going to be produced entirely by the one partner. Do they have a well-formed and detailed business continuity plan? Do they have multiple sites with the same production equipment on each? What is their geographical position, and could anything put your product at risk of supply in the future? A risk assessment questionnaire is good way to get details and requesting to see the company’s business continuity plan provides good insight into the companies view on risk.
Wound care experience
For a medical manufacturer to install confidence in their clients, they will need to be able to demonstrate expertise and experience, which are common traits for delivering products to meet your requirements. Establishing whether or not they can fulfil your needs is something that needs to be identified before proceeding. This can be achieved through sample based work, having your future manufacturing partner produce evidence highlighting their ability to complete your project. Then clarify if they are able to deliver in full and meet your quantity requirements; deliver on time without delay; minimal to zero product faults; undisturbed raw material supply chains. If there are hinderances to production and distribution, what solutions are in place to combat this.
In summary, identifying your medical manufacturing partner can be a long and drawn out process ensuring you find someone you can trust. Clarity, communication and transparency from your provider is the solution for a good foundation moving forward.