The design and manufacture of medical devices has changed dramatically in the last decade. The advent of 3D printing and software applications that enable simulation for testing concepts and prototypes enables organizations in this field to bring safer products to market more quickly than ever before. Versatility and flexibility is also possible; it is physically and financially feasible to design and fit devices that fit perfectly for an individual patient, such as an artificial hand. Many of the engineering software vendors provide invaluable software to make the job easier. Solidworks, a subsidiary of Dassault Systèmes, has developed and built a range of products which are available as a portfolio, that enable and support the medical product value chain from concept through to regulatory approval.
An End-to-End Toolkit
While there are many vendors offering some or most of the software applications needed to produce 3D designs, run simulations and create bills of material, Solidworks claims to be the only company that provides a complete solution, as opposed to point solutions and PLM (product lifecycle management) software. The Solidworks Product Portfolio is a PDM (Product Development Management) solution, and they are confident that its contents will satisfy two critical success factors in medical device development; regulatory requirements and time to market.
Parent company Dassault Systemes are recognised as the world leader in 3D systems, so much so that they call themselves the “3D Experience Company”, abbreviated to “3DS”. While the Portfolio offers every possible 3D engineering aid, from CAD to visualization and preparation for 3D printing, its real strength is in the documentation that it generates. Every step of the journey is recorded and traceable, which is vital if regulatory approval is to be granted.
Factors that Affect Outcomes: Regulation
It is understandable that medical devices require far more rigorous testing and approval than most products, after all, a poor quality shoe may be uncomfortable and give you blisters, a sub-standard stent could kill you. Although the average total cost for bringing a new medical device to market is much less than the $ 1 billion required for a new drug, the cost of regulation can be as high as 77% of the overall cost, especially when you are dealing with the FDA and the device is a Class III device. The FDA’s Class III device is regarded as high risk and is any device that needs to be inserted into the patient’s body, such as a hip replacement or a stent and requires a special and costly PMA (pre-market approval). A 510(k) approval for lower-risk devices takes just a big chunk out of the total product budget as illustrated below in a figure from an article in Medical Product Outsourcing Magazine, discussing a report published in 2010 by Price Waterhouse Coopers.
Illustration of regulatory cost as a component of medical product development in the US
The report examined the impact of regulation on new medical devices in the US and Europe. It was found that US patients would generally have to wait an extra two years after a device was approved in Europe before they would be able to benefit.
One of the challenges in getting a PMA or a 501(k) is the compilation and presentation of all the relevant documentation to the FDA. This is where Solidworks offers a clear advantage, because every detail of the workflow is automatically recorded, from design to final prototype. Without this functionality, the R&D staff is tasked with compiling all the data from disparate systems. The manual overhead adds time to the project and is error-prone. Having all the necessary documentation collated and integrated saves many hours both in the lab and in negotiations with the FDA, bringing down costs as well. Many of these costs are salary related: approximately 1/3 of employees are tasked with quality control and adherence to regulations. Superior documentation should reduce the headcount required as well as reduce hours spent in compliance activities. Improved delivery times are also vital when it comes to competition.
Factors that Affect Outcomes: Competition
Despite the hurdles to be overcome with regulation and compliance, competition is fierce in the medical product world. So speed is of the essence, balanced with uncompromising quality. A single, integrated stream of applications that moves from concept through 3D rendering, iterative testing of the model using simulations such as FEA and CFD, as well as a comprehensive standard parts library, optimizes the time taken to get to approval and into the market. It is also possible to decompose the product into smaller parts and test them independently and then together, accelerating testing by simplifying what has to be tested, rather than deal with the entire product every time. The ability to customise a product for an individual patient is also simplified with the Driveworks application, which takes a pre-existing model and adjusts it according to a set of criteria specified by the engineer.
Any competitor who is using a range of different products will find it difficult to match the speed to market that the Solidworks tools provide.
Some Success Stories
While some medical devices require stainless steel for manufacture, plastic is used wherever possible. Plastic design is specialized and requires a specific toolset to design the plastic part to be manufacture-ready, for instance, when injection molding or 3D printing is required. As Dassault and Solidworks are experts in 3D modelling, they are the first choice for companies producing devices that can be printed on a 3D printer.
- One example of where 3D printing is a lifesaver is in the manufacture of devices that can be inserted in newborns with birth defects. One infant had a very soft windpipe that kept collapsing: a splint was designed and inserted to protect and strengthen the windpipe.
- Tensys Medical Inc attributed the use of Solidworks tools in shortening their design process by 60% when they designed a non-invasive arterial blood pressure management system. This enabled them to get their product out ahead of their competitors.
- Exoskeletons for assisting hemiplegics, paraplegics and quadriplegics to move independently are becoming a major subject of biomechanics. At Solidworks World 2018, Korean professor Kyoungchul Kong revealed 2 exoskeletons designed to assist his fellow-workers, one for paraplegics, called WalkON, and one for hemiplegics and people with walking difficulties called Angelegs.
There are hundreds more examples of designs, ranging from more ergonomic pill bottles to artificial arteries, all of which have been designed using Solidworks tools. The cost of the software is easily recouped, whether it cuts down on regulatory costs, accelerates time to market, cuts down on prototyping via simulation, or all three. Licensing for all products can either be on a subscription or perpetual basis. There is also a 3-month subscription option available for some applications, specially tailored for small companies who need the products for a short-term project. The license management is provided by Flexera, and OpenLM can manage licenses for all all Solidworks products.