Navigating through the process of obtaining product clearance or approvals can be challenging. From early start-up to well-established Fortune 500 companies, the engineering and business requirements typically requires a high-level of technical competency and experience specific to project technical requirements.
In 1998 Design Solutions was established to partner and collaborate with its customers to provide--from concept generation to manufacturing—an unmatched technical skill set that implements proven medical device design and product development methodologies, along with a flexible business platform, while maintaining the highest level of quality assurance throughout the process.
In 1998 Design Solutions was established to partner and collaborate with its customers to provide--from concept generation to manufacturing—an unmatched technical skill set that implements proven medical device design and product development methodologies, along with a flexible business platform, while maintaining the highest level of quality assurance throughout the process.
MEDICAL DEVICE DESIGN TECHNICAL SKILL SET
Proof-of-concept and feasibility design
An important element in early proof-of-concept and feasibility design is risk. Design Solutions places a high degree of importance in its work product to assist its customers in reducing, removing, and managing risk, especially as it relates to the hazards and safety of a device. Additionally, Design Solutions works to establish an early and thorough understanding of the customer requirements for a specific medical device. Whether it be scientific or technical risk, a proof-of-concept device can be developed to be evaluated on the bench, in vitro or in vivo quickly and effectively to address these hurdles. Early proof-of-concept and/or feasibility prototypes provide valuable input in establishing solid medical product specification and requirements.
Creation of medical product specifications and requirements
Design Solutions takes a great deal of pride in its project planning methodologies. From electrical and mechanical engineering, software, and firmware development, to usability design and testing, Design Solutions incorporates over 22 years of medtech design and development experience and expertise to properly establish planning protocols to ensure an effective project plan. As part of the project planning phase, Design Solutions, looks at a high-level hazard analysis in order to effectively plan safety features for your device.
Medical device prototype builds for clinical trials and design verification efforts
Now more than ever, obtaining clinical data is instrumental in all aspects of the medical product development and business processes. Design Solutions understands this and places emphasis on designing and building prototypes for design verification and clinical trials to ensure intended results. Design Solution’s personal can come along side your team to effectively look at how the device performs during in vivo testing and ensure the device is tested against the regulatory standards required for first in human trials.
Generation of manufacturing transfer documentation
Alongside the generation of the various documents within a Design History File (DHF), Design Solutions prepares and provides the required documentation for a seamless manufacturing transfer to the selected manufacturing partner. Design Solutions will work with your chosen manufacturer to ensure a seamless transition of the design and be there to verify the first article devices coming off the line are made to your specifications.
Such a pleasure to work with the Design Solutions team…they get the job done on time and beyond expectations! Yes, the deliverable fulfills its core function of safety and efficacy, while reducing our COGS. But moreover—and uncommon to the med device space—the deliverable reached a level of aesthetic completeness, both in ID and graphical usability, that in a word: delights. Across the board, everyone at Design Solutions are always professional and accessible. I would work with DSI again in a second." |
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