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COMPAMED.de spoke with Jörg Stockhardt, who brings developers and manufacturing companies from the medical technology industry sector together and accompanies them during the time it takes to bring their products onto the market.
COMPAMED.de: Mr. Stockhardt, what individual steps have to be considered for complete contract manufacturing in the medical technology industry sector?
Jörg Stockhardt: Initially, the product developer has to write an end product specification in which the exact requirements for the prospective contract manufacturer are determined. During the second step, as a customer consultant I would research possible manufacturers who meet the respective requirements. Then you have to ask yourself in which markets the developer wants to offer his/her product. After all, if applicable the contract manufacturers have to be authorized for a specific market.
After a qualified manufacturer has been found, the partners sign the contracts and pilot production can begin. This is followed by product validation, where the partners assess the suitability of the product for the market application. This is the last step, which decides whether the collaboration bears fruit or not.
COMPAMED.de: In what aspects does contract manufacturing for medical technology differ from other industry sectors?
Stockhardt: It primarily differs in terms of quality assurance agreement. The exact timeframes are defined and clear individual liabilities determined. Responsibility for the storage of particular documentation is also specified in this agreement.
After the developer has found a qualified manufacturer, pilot production can begin; © panthermedia.net/Baloncici
In addition, after product lunch, both partners observe the market – this is not the case for all industry sectors. Apart from that, qualification plays a big role in medical technology. Not just the manufacturing company and its employees, but also the manufacturing spaces and tools must meet the respective ISO standards.
COMPAMED.de: How long can the entire contract manufacturing process take?
Stockhardt: Since the requirements for contract manufacturers are clearly higher than in other industry sectors, you have no choice but to enter into long-term partnerships. Just finding the right partners, arranging the contract conditions and implementing all process qualifications for product validation generally takes at least half a year.
COMPAMED.de: What problems turn up most frequently?
Stockhardt: Difficulties often arise if the partners do not exactly adhere to the specifications – for instance if the manufacturing companies do not abide by the specifications of the developer and do not inform him/her about it. This can later result in huge losses. Even if you do not develop the product or its components from the start but gear it towards a product that is already available on the market, there are often complications because you do not know the exact specifications of the item. There are often problems if the partners do not determine from the beginning, who is responsible for market observation as well as for making corrections or taking care of complaints.
A successful bringing a product onto the market requires a good cooperation of the partners; © panthermedia.net/liv friis-larsen
COMPAMED.de: You have many years of experience in consulting and accompanying manufacturers and medical device companies. Can you remember a case that particularly stands out to you?
Stockhardt: I remember a large misunderstanding that occurred between two partners. The legal manufacturer – meaning the one that later wanted to distribute the product – purchased a finished product from a non-European market and wanted its manufacturing partner to copy it precisely. The manufacturer had the original piece, was able to measure it, take it apart and compare it. In doing so, eventually the device could no longer be used. The manufacturer correspondingly had to newly develop and build the product from scratch. The expectations of the ordering customer in terms of time and costs were thus significantly exceeded. This is an example of what a partnership between an ordering customer and manufacturer should not look like.
The interview was conducted by Michalina Chrzamowska and translated by Elena O'Meara.