When it comes to implantable devices, the material makeup of the technology is not only critical to the success of the device, but it also has a significant impact on the cost. Often times implantables need to be able to survive some of the harshest conditions in the body, where any kind of unexpected breakdown in materials can have critical adverse effects if they aren’t safely designed. This, of course, leaves many device makers with a very short list of potential materials.
Len Czuba is president of Czuba Enterprises, a Chicago, IL-based medical device development consultancy that specializes in helping manufacturers take products from concept to market. His primary focus is in the selection and processing of plastics and biomedical polymers used in medical devices, specifically implantables. Czuba will speak at the MD&M Minneapolis conference on “Sourcing and Qualifying the Best Material(s) for Your Implantable Device” on Wednesday, Nov. 8.
Czuba recently talked to MD+DI Qmed about the challenges of developing cost-effective devices that require costly biocompatible materials, and some of the alternatives manufacturers can use to help control production costs, in order to deliver technologies to the market at a reasonable price.
Qmed: The market for medical devices and technologies is becoming increasingly lucrative as emerging innovations often come at a very high price. What are some of the biggest challenges of developing innovative technologies that can still reach consumers at a reasonable cost?
Czuba: The cost of developing new technologies and innovative medical devices can be likened to an iceberg. By the time the product gets to the marketplace, the consumer is most often not aware of the incredible investment in time and fortunes that were required to bring that product to them. They see the product, often a small device with just a small amount of polymeric components that seemingly cost a few cents or dollars to make — but the cost to the consumer is hundreds of dollars. They only see the “tip of the iceberg” and think the product should be inexpensive. They don’t see or realize that often these products take millions of dollars and man-hours to bring them to the marketplace, which could be considered the underwater mass of the iceberg.
The most frequent examples of high-priced medical devices are implantable devices, which are often composed of plastics or polymers that are priced by suppliers in what many consider to be an outrageous price range. So how do we control, if not reduce, the cost of implantable materials? To start, we need to begin to identify the best materials for specific applications, then seek any alternative materials and suppliers that can match the requirements for the application. By having more than one material and more than one source for the material, it assures there will be no supply problems, as well as provides leverage for in negotiating things like delivery dates, inventory requirements, and purchasing arrangements. Ultimately, developers must use the best material for the job that can be obtained at the lowest reasonable cost.
Qmed: Often times the most innovative implantable devices are comprised of costly biocompatible materials that can drive the market price of the medical device up to what many may consider exorbitant levels. How can developers begin to bridge this gap so that novel devices can be developed without sacrificing innovation and performance?
Czuba: We need to start by agreeing on what is an exorbitant cost for the material. If the material is for a relatively inconsequential product, such as a flower pot tray used to carry seedling plants from a supplier to a user, then a wide variety of materials can meet the requirements of that tray. On the other hand, if the product is for a heart valve designed to replace a malfunctioning human valve, then the application is very critical and the material selected to meet the requirements must be very carefully qualified, tested, and consistent in quality.
What price for this heart valve would be considered exorbitant? If that patient had no other option other than the replacement valve made with the implantable biomaterial selected, then almost any price would not be too much when the materials are used in a device that keeps a patient alive.
On the other hand, if the device were to need a selection of several materials necessary to make the functioning device safe and effective, it might be worthwhile to consider a redesign that could isolate the separate components within another acceptable body tissue contacting material; that way the only material exposed to tissue contact would be the qualified material. This would ultimately help save money for the manufacturer as they would only need to qualify one material for long-term implantable use — helping them bridge that cost gap without sacrificing quality.
Qmed: What would you say are a few examples of some cost-effective materials that can drive innovation forward while still allowing developers to maintain control over the cost of their device or technology?
Czuba: Although there is no one list of so-called “FDA approved” materials, most product design engineers in the industry understand that when designing a new long-term implantable device, the materials available make a short list. Astute engineers will select materials that have been shown to be acceptable in similar applications, rather than trying to select and then qualify an entirely new material. Some of the materials that are being used successfully for implantable products recently are polyether ether ketone (PEEK), UHMWPE, polysulfone, polytetrafluroro ethylene (PTFE), silicone, polyurethanes, and a variety of bioresorbables such as PLA, PGLA, and polycaprolactone.
In some cases, a new product will require material properties not available in the familiar families of materials. Then the design engineers will need to work with test labs to come up with a testing program that will help them qualify a new material for the application. It will sometimes take longer and be more expensive than using known materials, but if the application justifies it, then it is certainly possible to qualify a new material for the technology.
Qmed: Can you talk a little about the importance of iterative design and the process of redesign? What effect do you think it could have on material-related costs and the process of development for manufacturers?
Czuba: Designing or redesigning a product from concept to product without using an earlier design or product to help guide your own process of design can lead to unforeseen complications with cost, time, and effort. A redesign of a product that has already been shown to be effective can have advantages in allowing the designer of the newer version to incorporate some design elements that have already been proven to be effective.
The current trend which uses rapid prototyping methods to convert a concept or an engineering drawing to an actual part can significantly help reduce both the time and costs associated with developing the final product. Often minor design elements can be modified and improved after seeing and trying the original design concept reduced to a functioning part. For systems that are capable of using the intended material in the prototype part, it can offer the design team a chance to see if the dimensions of the final product can withstand the stresses of use and abuse.
In some cases, the design can even be improved by removing unnecessary support structures or by reducing the original thicknesses because the material properties can withstand the requisite forces being used with it. In the life of the product, savings like these can be a significant part of a long-term savings program.
Qmed: What role can materials suppliers and processors have in the equation, and how can they help developers keep costs down?
Czuba: I have not heard any supplier offer materials that are equivalent to the biomaterial, but do not carry the designation and the shocking price of the biomaterial originally intended for use. For example, one supplier told me that they offer two grades of the same polysulfone; one for industrial and consumer goods, and the other for the long-term implantable device market. The difference in price per pound on the implantable material is sometimes 50 times the cost of the non-implantable grade.
How can suppliers help keep costs down? Suppliers could easily offer the industrial grade of a biomaterial as a preliminary material to be used to help test the concept and the design before the design is finalized, and testing the functionality with the final implantable biomaterial. As long as the user knew and understood that all the required testing needed to qualify the final product was to be done with the selected biomaterial, then I believe that much experience and design optimization can be done with the lower cost industrial equivalent material.
Suppliers can also serve to help guide the design engineers who may not be as familiar with the selection of biomaterials available for use, as well as which material may be best suited for their product requirements. Suppliers willing to help in this selection process can add value to any design team.
Qmed: What are some of the trends that you’ve seen, or expect to see, as the industry begins to adapt to the rising costs of implantable devices?
Czuba: I would like to turn this question around and suggest that it is the medical device industry that will need to adjust to the changing medical device market in light of the newest technologies now available. Take for example an implantable blood glucose sensor that is directly linked to a wearable insulin pump. How will those affected by diabetes, both patients and physicians treating the disease, adapt to change in care from multiple needle sticks a day to obtain a blood sample to determine blood glucose levels, to an innovative new sensor technology and an insulin delivery system?
The implantable sensor device communicated with the pump automatically and the insulin delivery can be done seamlessly, requiring no patient intervention. I’d say that is quite a bit to adapt to, and not in an undesirable way. The adaptation here will be for the patient to be willing to undergo the placement of the sensor, the training necessary to monitor and support this new method of treatment, and to pay for the anticipated higher initial cost to begin the treatment. In the long run, the savings will result from not needing to test blood glucose levels in the same way that was necessary before the new technology. The quality of life and patient outcomes will, without a doubt, be dramatically improved.
Qmed: Finally, what would you say is the most important thing for developers to remember when it comes to controlling materials-related costs for implantable devices? Is there anything that could be on the horizon that developers need to prepare for or keep an eye on?
Czuba: All polymeric, metal, or even ceramic devices put into the body are foreign bodies. The body does not recognize these as native or natural materials or surfaces. When foreign bodies are sensed within the body by the bloodstream, the system automatically reacts to try to change and insulate or isolate the foreign body from the system. I believe that our industry will find ways to overcome this typical foreign body rejection reaction and begin to design materials that can coexist within the body without ever triggering the foreign body response.
Once this is shown safe and effective, new products can be developed which rely on these tissue compatible surfaces. Even better, and dare I say more expensive (but cost effective), implantable devices will be developed which can deliver even better therapies and treatments to the human patient. This technology is virtually here, keep watching!