Product Development

A good Product  Development process starts way before a product design is available.  The Voice of Customer (VOC) needs to be listened, historical data needs to be analysed, business requirements needs to be collected, international applicable standards and regulations and last but not least the market that the company is in needs to be understood properly. With all that in hand as input some good design alternatives can be created and the few selected concepts can be tested and developed  further to make sure the product is robust enough to mass manufacture and meet with the patients. 

Just like any other regulated environment, structural approach is the key in developing a product. In such complex projects where there are multiple affecting factors , it is highly likely that companies can get lost in details or found themselves moving in circles and not moving to the planned direction. Hence, a wholistic and a structural approach is vital.

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During the planning phase, all the inputs gathered in the concept feasibility and research activities must be collected as input. This is where the major planning protocols are also put in place. to name a few: Risk Management Plan (according to ISO:14971:2019), Human Factors Engineering Plan (IEC 62366-1:2015), Design Validation Plan.  Also, the project team should consider, global regulatory approach, whether the product needs a clinical study or it contains software. 

PMforMedTech helps you to create your product development planning tailored to your needs to make a flawless development process. 

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At this stage, it is expected that all the above mentioned factors are used to create related risk management files (uFMEA, dFMEA, pFMEA, sFMEA), product and process related specifications are clarified and the design documentations(product specifications, labelling and packaging specifications, process specifications) are prepared to continue with the verification and validation activities. 

Majority of the work is done at this stage. It is expected that all the testing to show compliance to applicable standards and regulations, compliance to specifications and evidence shoving that the product contains acceptable risk and all the mitigation activities are performed properly are collected at the verification and validation stage. 

This is also where start closing the product development deliverables like, validation reports, Usability Engineering Reports, Cybersecurity reports to name a few.

A good product can only be developed with a robust  process. Hence, before the design transfer all elements related to product manufacturing needs to be developed and put in place. A Device Master Record (DMR) needs to be developed. All the related work instructions, quality inspection procedures needs to be in place and all the related process validation activities (IQ / OQ / PQ) must be closed. The production readiness should be done based on the volume/sales  estimations of the in scope product. Once the Design History File (DHF) is complete, the handshake between R&D and Manufacturing department can be done. 

This is of course not the end. The manufacturing department can only release the products once the related approvals from the authorities are secured. 

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It is said that in MedTech, in all product development activities there are actually two products. One is the medical device itself and the other one is the documentation that is generated during the product development phases. 

Missing one important element can cost months of additional efforts to the company and hence delay the product launch. PMforMedTech will help you in reviewing/building the product development process by considering all necessary input elements and putting them in a gate phase approach so that we focus on the right thing at the right time. Building technical documentation according to the most recent EU MDR (2017/745) , reviewing your submission package for CE Marking and FDA 510k submission is one of the way that we can contribute to your organisation.