22 June 2018
Like Minds: What to Consider When Choosing a Software Partner
In the exclusive byline for MedTech Engine, Vladimir Timashov, Delivery Manager in the Healthcare & Life Sciences Practice at DataArt, discusses the qualities that medical device manufacturers should look for in a technology partner.
"The supplier should be flexible and able to adapt to your product development life cycle. Each individual medical device has specific risk factors and intended uses, alongside compliance with the company’s standard procedures. Therefore, you may not necessarily need a black-box software solution, but rather a service to make it possible to implement a software component for your medical devices in close collaboration with your company’s guidelines, as a step-by-step approach. A supplier should be capable of developing and adjusting their procedures and fit to the manufacturer’s QMS needs."
"The supplier should be experienced in medical device software development. Being a highly regulated industry, medical device development requires thorough approaches when it comes to design controls. Partnering with a technology provider that has all the required knowledge and experience in place makes it possible for the software development lifecycle to be built properly from the very start of the journey and ensures that no important steps are missed."
"The supplier should be capable of helping to plan and set up quality controls. You will walk hand-in-hand through planning, solution design, risk assessment, development and validation with the supplier you select… Bringing the technology experts in at the early stages of the planning will help identify and mitigate possible risks related to technology and outline your technology strategy."
"The supplier should fit your culture. It’s helpful to keep in mind that shared values, operational routines and management styles make it possible to avoid conflicts, help align priorities easily and significantly speed up the overall process."
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