Memorandum

To: Re: PURPOSE: The purpose of this memorandum is to request approval to evaluate research on a biomedical replacement meniscus for the human knee. The evaluation will be based on the following criteria: durability, biocompatibility, strength, and estimated cost of the biomedics. The goal of this project is to submit to you a documented and illustrated report that examines the strengths and weaknesses of various types of biomedical meniscus replacements in order for you to make well-informed decisions about future production of your products. SUMMARY: SaluMedica is an innovative organization that leads in the fields of biomedical device development and manufacturing. SaluMedica currently produces Salubria, which is an effective organic polymer that is known to be highly biocompatible. This product may have the potential to be used in a replacement meniscus. The meniscus acts as a buffer between the femur and tibia. Once the meniscus is torn, it must often be removed. Without a meniscus, humans can expect to develop arthritis as early as their thirties. Currently no replacement options for a torn meniscus exist. I propose to compare the feasibility of using Salubria as a replacement meniscus to other materials. I will base the comparison through biocompatibility, strength, durability, hydrophilicy, biostability, and compliancy. BACKGROUND: Director of Product Development Replacement meniscus ..

SaluMedica strives to provide the state-of-the-art biomaterials. SaluMedicas main product, Salubria, marks a breakthrough in the development of medical products to replace soft tissue in the human body. Salubria can stand up to millions of loading cycles, yet it is soft enough to match natural tissue. It contains water in similar proportions. It is biocompatible, strong, made mostly of water (like human tissue), and has a low coefficient of friction. Salubria is expected to be instrumental in the development of orthopedics, neurosurgery, and cardiovascular surgery. Consequently SaluMedica may be interested in knowing whether a market exists for using this product as a replacement for the meniscus. The meniscus acts as a buffer between the femur and tibia. It also disperses weight and reduces friction while the knee is moved. Once the meniscus is torn, part or all of it must simply be cut out of the knee. In the best case, the meniscus can be sutured back together and hopefully will heal. However, the surgery has a low success rate along with a long and painful healing process. Repetitive loadings in the human knee without a meniscus cause quick and detrimental damage. This damage can lead to arthritis to people in their thirties. However, within the past few years, the development of a replacement meniscus has become a topic of extensive research. Nonetheless, the development of replacement cartilage presents many problems. First and foremost, loads taken by the human knee make finding a suitable replacement difficult. Few synthetic polymers are durable enough to withstand these repetitive loads. Second, the material must be biocompatible. Finding a material that is both compatible and durable is even more challenging. The immune system does not want outside things put in it. It is very selective and resists many materials. Human tissue is about 99% water; therefore, the biomaterial must be of approximate proportions. However, a biomaterial made mostly of water tends to lack in strength and durability. Finally, the material must be slippery, so that it acts as a lubricant in the knee. I plan to compare Salubria to other potential meniscus replacement materials. I will then produce a documented and illustrated report that will attempt to answer the following questions: How biocompatible is each replacement cartilage? How strong are the different materials? How durable is each replacement material? What products are already FDA approved? What miscellaneous limitations does each product have? How much work is left in refining each product?

RESEARCH PLAN: I will perform the following tasks in order to complete the research:

Task 1: Identify up-to-date and related technical literature Descriptions of the databases are as follows: Compendex: Is the computerized version of the Engineering Index, an index of engineering materials started in 1884 Contains over 9 million records and over 5,000 references from journals, conferences and trade publications Has nearly 500,000 new records added annually Contains over 190 disciplines and specialties within engineering PubMed: Is a search engine that accesses MEDLINE, a database of life sciences and biomedical information Contains more than 18 million records from over 5,000 publications Contains citations to all articles Task 2: Obtain relevant technical literature I will obtain my literature in the following ways: Access and download articles from the online databases Gather electronic or print copies through the interlibrary loan service

Task 3: Search the Internet I will use the following websites to assist me in gaining additional information. Salumedica.com Twease.org Medscape.com

Qualifications:

I am based to perform my research based on the following qualifications: Coursework involving fatigue limits Three personal meniscus surgeries