Plastics offer many advantages, from flexibility and simplicity to cost-effective manufacturing. However, device makers do encounter design and manufacturing challenges that can create roadblocks.
Shantanu Shivdekar believes that plastic materials have a bright future when it comes to being used as a primary material for the design and manufacture of medical devices—especially if today’s device makers can begin to address some of the most common challenges. Currently product development engineer at Ethicon, a Johnson & Johnson company, Shivdekar has garnered more than 15 years’ worth of experience in the medical device industry, focusing his career on the process of manufacturing and product development. He also completed his master’s in plastics engineering and has an intimate understanding of the challenges associated with designing medical device technologies using plastic materials.
He’ll be speaking about these challenges at the MD&M Minneapolis conference on October 31st, in “Plastics Related Challenges in Medical Device Design and Manufacturing.”
MD+DI asked Shivdekar to discuss how manufacturers can address many of these challenges so that plastic materials are valuable to device makers for next-gen medical device technologies.
MD+DI: For starters, can you talk about some of the most common challenges that device makers are facing with plastic materials during the design and development phases? How can these developers adequately identify and overcome these challenges?
Shivdekar: Some of the most common challenges developers are facing fall within the loosely defined medical device design requirements. This often results in several iterations of part design over a period, and a lack of information on end use of device and components, plastic material selection, processing methods, etc. These factors can be addressed by gathering information from market research, customer input, competitive research, and other similar or predecessor devices. In addition, prototyping plastic development can significantly reduce timeline and cost, while providing early feedback from end users. These tools and techniques can help development engineers in decision-making positions to avoid potential mistakes down the line.
MD+DI: Can any of these challenges be avoided through the process of 3D printing plastic materials, or does 3D printing present its own unique set of challenges?
Shivdekar: 3D-printed plastics provide great benefits that allow us to evaluate engineering builds and pilot builds so that we can flush out ideas and assess potential changes that may be needed in the design and development of plastic parts. It certainly reduces overall development timelines, especially when research and design wants to try out various design versions without impacting the overall project timeline. On the downside, 3D-printed plastic parts have limitations on dimensional tolerances, mechanical performance, and assembly process. Now, with further advances in additive manufacturing, there is the potential to overcome some of these challenges.
MD+DI: Can you talk a little about plastic material supplier challenges and the impact they can have on the manufacturing process?
Shivdekar: Plastic material suppliers are consolidating and rationalizing resin material grades. As a result, it is difficult for development engineers to evaluate future impact due to supplier changes or the obsolescence of resin grades. Plastic material supplier changes results [in a] supply chain impact on business. It also leads to design change and revalidation of manufacturing processes. On many occasions, these changes can take over a year. As a result, careful considerations in supplier selection, dual resin grade qualification, and use of healthcare resin grades can provide risk mitigation to medical device makers.
MD+DI: What can you tell us about understanding sensitivities and how device makers can plan accordingly up front?
Shivdekar: On many occasions, design and development can undermine the fact of common process variation due to raw material input, manufacturing processes, assembly processes, secondary operations, environment, and the handling of devices. These changes can result in failures during the end use of [a] device. Some of these factors can be addressed in the early stage by incorporating robust approaches such as testing multiple lots of materials, capturing edge of failures during design validations and process validations, as well as incorporating manufacturing and process variations on critical process inputs.
MD+DI: What could you tell us about some of the factors that arise during the manufacturing process, conversion of material, storage, and end use?
Shivdekar: Manufacturing processes for plastic raw materials and conversion affects the end use of plastic. This could be tied to plastic material properties such as molecular weight, or the polymerization process on raw material. And time, temperature, and pressure effects during conversion (injection molding, extrusion) can cause significant changes in the performance of plastics. Thus, it is imperative to understand raw material specifications and how that can translate into design requirements. Also, manufacturing process validation needs to capture all potential factors in process characterization in order to minimize impact during ongoing manufacturing. Material storage and end use need to be evaluated using the shelf life of plastics. Excessive exposure to humidity, UV radiation, and temperature variation at a storage facility can trigger the degradation mechanism of plastics and may go unnoticed. Evaluation of storage conditions and end use can be assessed using polymer properties, and its performance, to establish the shelf life of plastics.
MD+DI: Finally, given your extensive background with both product development and plastics, do you think that plastics still have a bright future in the realm of medical device design—despite all of the challenges we’ve discussed? Do you think the material advantages outweigh the challenges? What types of devices do you think could benefit the most from plastic design and manufacturing?
Shivdekar: I truly believe that the advancement in chemistry of plastic materials and conversion technology and 3D printing and additive manufacturing processes are helping expand applications of plastics. Still to date, plastics offer robust and cost-effective solutions to a wide range of medical devices including endoscopic, urology, cardiovascular, and neuromodulation applications. There are certainly challenges in implantable and dissolvable biomaterials, but overall the diverse offering of plastic grades and the ever-growing high-tech manufacturing qualities are helping medical device makers to provide exciting and innovative solutions.
Don't miss “Plastics Related Challenges in Medical Device Design and Manufacturing” on October 31 at MD&M Minneapolis.