Development of Orthopedic Implants

Design & Development of Orthopedic Implants

Today, the number of orthopedic manufacturers are growing over the world. Mechanical or material engineers in cooperation with medical clinicians are establishing the new companies to fabricate orthopedic implants according to their understanding and evaluations on the current similar products which have been developed by well-established companies such as Depuy-Synthes, Zimmer-Biomet, Stryker, Smith&Nephew, Wright, etc. Such grown companies try to follow the design concepts of well-developed implants to localize the implant in their countries. In general, orthopedic implants might be appeared as some components that could be easily fabricated by normal available manufacturing processes such as machining, casting, forging, or moulding. However, there would be multiple challenges in manufacturing, material, testing, analyzing, validation, verification, per-market clinical evaluation, and post-market clinical investigation. Even with fabrication of implant with similar design and from the same material, the production and post-production processes and treatment could significantly put the implant in high level of risk or failure. 

In this page, design and development of the orthopedic implants, from design conception to post-market clinical investigation is documented. Based on my deep knowledge on development of the orthopedic implants in view of biomechanical, material, biological, and clinical aspects (as published in my book "Trauma Plating Systems") and my rigorous experience in R&D engineering and project management in orthopedic implant industry, I have decided to prepare some usable and straight-forward documents for whoever has concerns for effective development of the orthopedic implants. I would announce the written documents in this page once prepared in a very reasonable price to be reachable for relevant audience. Whoever is interested to the provided documents, could contact me at orthoimplant.develop@gmail.com.

هموطنان ایرانی که علاقمند به مستندات تهیه شده می باشند، می توانند از طریق ایمیل ذکر شده در بالا برای پرداخت از طریق کارت به کارت شتابی، مکاتبه نمایند

Risk Management Report

A template for organizing the Risk Management Report has been written and is ready to deliver to whoever is interested. This template is almost ready for use for Notified Body review for issuing the safety and effectiveness license for the implant system.  Although the contents is usable for all orthopedic implants, however, it is greatly suitable and fully ready for trauma fixation system and spinal fusion stabilization. If your product is total joint replacement or non-fusion spinal stabilization, you can contact me at orthoimplant.develop@gmail.com to revise this document accordingly. 

 

Document details:

Document No.: 101

No. Pages: 17

Format: **.docx

Language: English

Price: USD30

Free Preview: Yes

*Free consultation after purchase

Cleanliness Evaluation Protocol

This protocol would express how to evaluate and validate the cleanliness of orthopedic implants after cleaning process. Implant might be contaminated on its surface during raw material production, material storage, implant production, implant post-production by organic carbons, oil and coolant, DNA, bacterial microorganism, and endotoxin. Existence of these contaminants on the implant surface even after cleaning process would reduce the effectiveness of the implant safety when implanted into the body. It is therefore, some evaluation tests are beneficial to evaluate the level of implant cleanliness. In this documents, these evaluation tests are described and the relevant acceptance limits for each test is determined. 

 

Document details:

Document No.: 201

No. Pages: 11

Format: **.docx, **.pdf

Language: English

Price: USD16

Free Preview: Yes

*Free consultation after purchase