The following report has been prepared based upon an assignment given by the company, Ortopedic Care Scandinavia AB. The paper is an exam on basic level, 15 credit points at higher level education within product development. Ortopedic Care Scandinavia AB is working with product development of medical technology products. What makes the corporate unique is the fact that the development is based upon problems encountered by surgeons in their daily work. Suggestions for improvement in technology are given directly by the end users. This paper is based upon such problems. Product development was made on the medical instrument called, suture passer. The instrument is used in endoscopic surgery of the rotator cuff. The cuff is a group of four muscles (and their respective tendons) that stabilize the shoulder. In case of an accident, mostly sport related, these muscles can loosen from the bone. In surgery a suture passer is then used to penetrate the injured tendon with a needle with an attached suture. The passer creates a loop of suture that can be used to attach the damaged tendon. The report is based upon the following problem formulations: The needle has an inconvenient edge that can damage the muscle. The strength of the suture thread is deteriorated by the design of the needle. The suture thread has been known to snap when the surgeon apply to much pressure when tying. If the patient is suffering from subacromial impingement the jaw of the instrument can appear to be clumsy and hard to open. The jaw has sharp teeth which have been known to get stuck in the tendon. The surgeon must then perform an uncontrolled movement which might damage the tendon. The jaw limits the surgeons’ choice of thickness of the suture thread. The thickness of the needle used in the suture passer is limited to one size.  The purpose of the project is to develop a new concept that minimizes the risk for the patient and at the same time the concept should facilitate the work of the surgeon. The concept should meet the set requirements and be presented in the form of renderings of CAD-models and drawings. To achieve this process the instrument uses four different components. The needle, the jaw, the handle and an attachment between the needle and the handle.  Under heading 5, the generating process, each component presents to together with arguments of its design. The instrument consist of 25 components that are all developed from the ground up. The result should be viewed as a thorough concept that can be used for further development. It is recommended that the next step should be an investigation about material choice. When the material is specified a prototype should be manufacture and then used for testing.

ABSTRACT The following report is a part of a thesis project for product development at an undergraduate level. The originator of the project is Orthopedic Care Scandinavia AB that is located in Stockholm and is focused on medical technology. The thesis comprises 15 credits and is carried out the spring semester of 2015 by the two authoring mechanical engineering students at Mälardalen University. The mission includes a product development concept of a surgical instrument detail used in endoscopic surgery. The detail is a suture anchor that is especially adapted to attach sutures for arthroscopic surgery, mostly for hip and shoulder repairs. The product development project has been conducted after an extensive study in medical technology and the regulations that are relevant for working in this subject area. The originator Ortopedic Care Scandinavia AB ordered the project with the hope of getting a concept that they would be able to patent, manufacture and produce for resale. The originator wanted a suture anchor with a simple mounting method, and with smaller dimensions than the suture anchors they are currently using. The product development study was based on the following problem formulation: • Does the product simplify the technical procedure for attachment of the suture when working with arthroscopy? • What is the most e fficient way to optimize the tension in the thread while putting the suture anchor into place? • What kind of changes of existing technical solutions is required for a new suture anchors to achieve a sufficient inventive step to be patentable? To achieve the goal of creating a new type of suture anchors the product development group made a comprehensive theoretical framework that includes both medical technology and product development. In order to scientifically establish its result a number of product development tools were used, including a competitive analysis of existing products in the market which analyze different types of fastening techniques and validate various properties of suture anchors. The result of the project work became the suture anchor Enkel Infästning that is presented in rendered CAD images and a description of the intended fastening technology. Arguments for height of the technical solution and what makes this invention patentable is presented in the results. Manufacturing method and strength strain is presented using computer-aided design tools where the simulation of injection molding is made and FEM analysis demonstrates that the construction of the product will contain for the intended purpose.