Medical Device Outsourced R&D – A Disruptive Innovation (for OrthoStreams, by David Skinlo, Marker Medical www.markermedical.com)
Clayton Christensen coined the term Disruptive Innovation to describe a process by which a product or service takes root initially in simple applications at the bottom of a market and then relentlessly moves up market, eventually displacing established competitors.
As we look at the medical device industry; it is clear that the pace of new technology has slowed. One major factor is, in part, due to the way new products are brought to market – in years past, surgeons and inventors who had ideas for new medical products simply reached out to large medical device companies to develop their product ideas. This business arrangement was often in the form of licensing deals or outright technology purchases. These deals were a well-spring of many of today’s medical technologies. However, in today’s environment with increased regulatory oversight, scrutiny of surgeon and manufacturer relationships, increased competition and a need to introduce new products to market quickly, a new approach – no, a disruptive innovation – is required. One trend that is quickly gaining popularity to meet the challenges of today’s market is to “outsource” medical device development to third parties – or what is simply referred to as “Outsourced R&D”. There are several companies in the market today that specialize in these services, one example is Marker Medical.
Marker Medical, established in 2011 by a handful of industry professionals, was created to leverage the small, flexible, responsive and industry-focused structure of today’s industry environment to help companies quickly and cost-efficiently commercialize next generation products. Marker Medical has created a niche’ between large OEM’s and various technology sources (whether that be research universities, surgeons, early stage ventures, or technology experts). Outsourced R&D companies like Marker Medical fill a necessary void which is a critical link in the supply chain of ideas that help fill the product pipeline for the future.
Outsourced R&D companies fill a wide variety of roles in the chain – such as prototype services, design and development services and even full product support. To demonstrate the value of outsourced R&D firms like Marker Medical, let’s look at a case study:
Figure8 Surgical (www.figure8surgical.com)
Background: Figure8 Surgical has developed a revolutionary Flatwire® Sternal Closure technology and was in need of some simple quick-turn prototype support. Watch Animation HERE.
The Figure8 Sternal Closure system utilizes the patented Flatwire technology to close the sternum instead of traditional twisted stainless steel wire. The Figure8 system consists of the Flatwire implants and a tensioning instrument that is used to tension and secure the implants.
Challenge: Figure8 originally contacted Marker Medical for help with redesigning the tensioning instrument. It quickly became apparent that the initial instrument prototypes, though functional, needed further refinement to allow the instrument to match the elegance and simplicity of the Flatwire implant system.
Figure 1 1st Generation Tensioning Instrument
Solution: With their in-house prototyping capabilities and ability to iterate through changes quickly, Marker Medical was able to converge rapidly on a solution that not only improved the function of the device but also improved the final device appearance. This close cooperation with the inventing surgeon and team from Figure8 Surgical allowed for user needs to be addressed in real time, yielding, in the end, a superior design to more traditional approaches.
Based on the success of the instrument re-design, additional aspects of the Figure8 project slowly migrated over until the entire project was transitioned to Marker Medical. This additional effort included implant and package redesign, testing, high volume manufacturing support along with supporting all quality and regulatory activities. This ability to provide á la carte services is precisely the type of support companies like Marker Medical can provide to both individual inventors, small companies, like Figure8 Surgical, and even established companies looking to add additional product lines.
Figure 2 Updated Tensioning Instrument Design- Figure 8 Surgical
Figure8 Surgical was able to leverage the benefits of working with Marker Medical which reduced development cost, time, and improved quality which are of primal importance to a small organization with limited resources. Whether you are an individual inventor, small or large organization looking for á la carte services or full product development activities, it may be worth your time to contact an R&D outsourcer to see how they may be able to help assist with your needs.
Marker Medical (www.markermedical.com)