Researchers from the CARE Fertility center are about to begin trials of a silicone womb that is designed to better mimic a woman’s body. The group beleives the system will reduce the number of eggs needed to be havested, and result in better quality embryos.
The device was created by Anecova. It works developing embryos in a perforated silicon container, that is inserted into the woman’s own womb. After several days, the container is removed and viable embryos are selected for implantation. In standard IVF, eggs harvested from a woman are fertilised in the lab and allowed to develop in an incubator for 2 to 5 days. The healthiest embryos are chosen to be transferred into the uterus.
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A new market report and a new book, dealing specifically with the biomaterials industry, are available from Research and Markets. One deals with dental biomaterials and can be found here: www.researchandmarkets.com/reports/c83736
The book covers metal materials used in implants. It talks about surface characterization techniques and is found here: www.researchandmarkets.com/reports/c83558
From the sticky fingers that brought you tape and other adhesives, comes internal bandages for use in surgical operations. The ability of geckos to use their adhere to various locations is due to a principle called Van Der Waals. Simply put, Van Der Waals posits that little bumps and valleys on an object creates more surface area and therefore enables better adhesion. The principle has for several years now been studied and adapted to create medical adhesives. However, those uses have primarily been for dry environments. The latest research from MIT results a biodegradable bandage that can be used internally during surgeries in wet environments.
An implantable film enables control over drug delivery. MIT researchers created the film that disintegrates when voltage is applied across its surface. The film could be used to coat an implantable powered device that would release medication on command. Applying a small voltage from the device to the film causes it to break down and release its drug. Turning the voltage off again stops the film dissolving. The researchers used nanoparticles of a pigment called Prussian blue—an inorganic iron hexacyanoferrate compound—to make the film and a chemical called dextran sulphate to represent the drug in their prototype.
During MD&M West, consultant Phil Triolo discussed the challenges of coated devices and combination products. Specifically he covered meeting both technical and regulatory requirements for these types of products.
Triolo had several pieces of advice for achieving such goals. For example, he explained that it is usually better to adapt or use an existing test method instead of trying to develop one from scratch. Validation takes longer with a new method.
When it comes to testing, make critical assumptions. For example, always anticipate that a coating will come off the device it is modifying. “Assume worst case scenarios,” he said. “And then prove that the outcome is still safe.”
One of the most interesting moments in the conference was when Triolo discussed biocompatibility of materials. He explained that IAO 10993-1 recommendations, as modified by FDA memo G95-1 can be used, depending on intended patient contact and duration of use. However, for neural tissue contact, there are different rules. To start, device makers can use 10993-4 for blood-contacting devices, but they should be used as a starting point only because FDA does not recognize this as a consensus standard.
Ultimately, Triolo’s advice is to test, retest, and test again. “Sometimes it is easier to provide test data [to FDA] than rationale.”
Right now, the body is no place for bio-based polymers. But that doesn’t mean the industry should ignore starch-based polymer systems. That is the conclusion I reached after attending a lecture during MD&M West. There are myriad opportunities to incorporate polymers with a smaller ecological footprint.
Shriram Bagrodia of Cereplast gave the lecture. He spoke about using starch-based polymers in single-use devices and in devices that are used outside the body. Particularly he discussed the development of hybrid plastics, such as his company’s proprietary biopropylene.
Much like hybrid cars, these plastics have the desired characteristics of regular plastics, but they also have aspects that make them more efficient. For example, the biopropylene is a blend of polypropylene, starch, what Bagrodia terms a compatibilizer for the starch and PP, and a blend of plasticizers. More than 50% of the product is derived from natural and renewable sources. This means that the plastic has a more stable price than polypropylene, and it also has higher durability than starch-only materials.
It is a step in the right direction. The next hurdle: Getting companies to switch out their existing polymers for these biopolymers where appropriate. I think the best way to start is to encourage companies to design new products with these materials in mind. It will be a less-burdensome route (at this point) than trying to replace the materials in existing products.
One interesting factoid: replacing traditional plastics with starch based polymers means reducing the carbon cycle from 10 million years to only 90–180 days. No contest.
Today I met with Solvay Advanced Polymers. The company reps came to our offices in Los Angeles to discuss the company’s newest biomaterials (click here for the press release describing the materials).
Although I’m always interested to learn about new technologies, I was struck by the firms processes for moving into the biomaterials sector. To make it easier for device makers to adopt products, the company has instituted a quality system based on ISO 13485. According to global medical market manager, Shawn Shorrok, Solvay is in compliance with all relevant aspects of ISO 1348. Of course, as suppliers, they can’t get that “ISO” title, because the system is specific to manufacturers of medical devices.
I do like the idea, however, that Solvay is actively discussing how to address OEM concerns for quality management. (Incidently, Solvay pursued ISO 13485 compliance as a direct result of its desire to break into the biomaterials market).
Its not a bad idea to demand that suppliers meet relevant standards. Of course you all know that because a supplier says it has a system doesn’t mean you have to take their word. Audits are a great way to confirm that a supplier is keeping its word on quality systems.
NAMSA’s Davide E. Albert recently spoke at MD&M West. Among other topics, Albert discussed the importance of characterizing materials for medical devices. Characterization is the process that describes the nature of the materials. It includes chemical, toxicology, physical, mechanical, morphological, and electrical aspects of all materials used in devices. The process should be done, he expalined, not only as a matter of safety, but to optimize performance and reduce risks. In addition, proper characterization satisfies regulatory considerations and the data can be used throughout the product life cycle for problem solving.
Using EN ISO 10993-1 and ISO 14971 can help developers gain an understanding of the characterization needs, he said.
