Outside product development is fundamentally changing how innovation happens in orthopedics.
Every day in orthopedics, there is a secret, behind-the-scenes force creating new products. Strangely, nobody is talking about this stealth movement because both the orthopedic companies and the surgeons want to take full credit for the innovation themselves. However, like clockwork every day, innovative new products are being developed for orthopedic companies and surgeons by Outside Product Developers under strict Confidentiality Agreements.
Who are the Outside Product Developers?
Outside Product Developers (OPDs) are not what you think. They are not the big medical contract companies like Teleflex. On the contrary, the OPDs are small startup teams who know how to convert a napkin sketch idea into a commercially viable product. They are small firms like Arch Day Designand Binder Biomedical. Who? Exactly.
These nimble little teams provide turnkey product development for a fee. OPDs are seasoned entrepreneurs who have learned their trade at the best orthopedic companies. Being small is not a problem, it’s an advantage. The OPDs have access to all the resources that the Big Orthos have (the best engineers, CAD, 3D printing, test equipment, regulatory processes, etc.). The OPDs don’t have any of the red tape that burdens the Big Orthos (slow decision making, politics, layers, compliance oversight, IP committees, regulatory committees). Read the full list of OPDshere.
Why use an OPD?
Three groups secretly use OPDs today, and all three groups have unique needs.
The Big Orthos
1) The Big Orthos need innovation.
The Big Orthos have forgotten how to innovate. Their product development teams are saddled with supporting legacy products. They have become so risk averse that innovation has been bred out of their culture. So, when the Big Orthos decide to pursue “out of the box” innovation, they call an OPD. Outsourcing innovation creates a safety barrier between disruptive innovation and the core business protecting existing product portfolios.
Also, ODPs enable the Big Orthos to purchase a new “ready-for-market” product without dealing with the messy and uncomfortable surgeon consulting issues. It turns out that the Big Orthos are willing to pay handsomely for commercially viable products when much of the risk has been removed (technical risk, market risk, and regulatory risk).
2) Startups need resources.
Startups have great innovative ideas but little cash and few engineers. Startups need to quickly progress from concept to prototype to testing. Speed helps to conserve their cash. Some OPDs are willing to be compensated in partial equity which can help preserve precious startup cash. For this reason, startups often call an OPD for new product development.
3) Surgeon Inventors need direct access to the development process and more control.
The relationship between Surgeon and the Big Orthos has become strained in recent years by regulations and bureaucracy (slow decision making, layers, compliance oversight, IP committees, regulatory committees). Surgeon Inventors need a better vehicle to develop their ideas.
Surgeons are the end users of new products,.yet they are not familiar with the development process. Surgeons need guidance and “hands on” design experience to help convert their fuzzy product ideas into actual working products.
A side-benefit for the Surgeon is that the OPD process is usually faster and more engaging than working with a Big Ortho. Also, the Surgeon who engages an OPD can maintain ownership by retaining IP, licensing rights and future royalties. So, for these reasons, smart Surgeons often reach out to an OPD first.
What specific services do the OPDs provide?
OPDs provide a comprehensive menu of product development services. They can take a product idea as far, or as short, as the customer wants. The customer can just choose off the menu of how deep they want to take the project. Just choose from the menu and pay as you go. Need a CAD model only, no problem. Need a validated product and a regulatory clearance, no problem.
Here is a typical menu of services offered by OPDs from early product concept to commercially ready product.
product planning and definition
concept generation (CAD)
Product animations and presentations
Final product design (manufacturing drawings)
working implant prototypes
Complete instrument set development
feasibility testing, including cadaver labs
final product design
regulatory submission and clearances
Marketing materials (technique guides and advertisements)
design transfer (ready for manufacturing)
sterile inventory on the shelf
logistics, inventory and supply chain facilitation