An experienced, recommended, custom furniture professional came over to my house to bid on building a low-profile cabinet for a flat-screen TV with shelves, off the ground to save space in a small family room. I had a clear vision of what the finished product would look like. The vendor listened thoughtfully, looked around the room, and said “I don’t want to talk myself out of a job but why don’t you mount the TV above the mantle, run the cables through the ceiling to your components in the pantry and use a RF remote to control everything.” I felt stupid initially but was really pleased with the outcome I never would have come up with on my own.
Time to Market
To speed time to market with highly differentiated, competitive products, there are several critical elements to consider during the input-output matrix phase of your project.
R&D should participate with the customer/medical advisory board interview process because each person will hear something different from customer feedback and the resulting performance characteristics should be a blend of what multiple experts heard them say.
Upstream Marketing needs to be disciplined and specific about what they want the new product to do, listing key prioritized performance characteristics. The “Opportunity Algorithm” is an excellent exercise conducted with customers to achieve a robust, prioritized list. An example for a high-pressure low compliance balloon catheter, currently key features in the percutaneous transluminal angioplasty (PTA) market, might be “effective displacement of occlusive vessel lesion without balloon “dog-boning” or rupturing of the vessel.” “Solutions” are not a part of the input side of the input-output matrix.
R&D engineers should be encouraged to explore internal and external technical resources, with appropriate confidentiality in place, to identify the right output pieces of the input-output matrix. How could an engineer experienced in interventional neuro know the key performance characteristics of balloon catheters used below the knee?
Realization of a new product project from preliminary design definition to commercialization is considering innovation developed for long-term production. Often, manufacturability is not considered until late in the device development process. This is especially true for start-up companies that may not have manufacturing facilities or specialized experience to understand the true scope of the device development project. Outsourcing multiple phases of production to multiple partners can result in disparate processes and product evaluation standards slowing the time to market, scaling to volume manufacturing, and future manufacturing efficiencies to reduce cost later in the product’s life cycle.
Working with well integrated, yet specialized contract manufacturers offers medical device designers access to very experienced project management teams that facilitate implementation level decisions for those who are closest to day-to-day work. When matters like quality management, design transfer, process control, and validation are developed early alongside manufacturing partners, time to market can dramatically improve. For example, typical new balloon catheter projects including necessary design changes and verification and validation (V&V) should take months to complete, not years. (See Figure 1)
Device engineers must understand development and manufacturing costs early in the design and development phase of complex medical devices. Senior leadership will look at the forecast for many projects and ask the following questions that new products project teams need to be prepared to answer.
What is the competitive advantage of this product and how will the company sustain that competitive advantage? Are there design changes planned to stay competitive: Lower profile, improved functionality, time savings?
What is the plan to reduce cost over the next three years when the product faces increased competition? No senior leader wants to hear the company is locked into a supplier without options, or that volume is the only path to control cost. Successful project teams that win internal approval research and develop downstream solutions when they are considering contract manufacturers to respond: “The contract manufacturer we’re working with can develop our product, manufacture it for us with volume discounts, and transfer manufacturing to us if/when we want to bring manufacturing in-house.”
Commercialization of a successful medical device begins by evidencing clear product safety and effectiveness with dramatic results addressing disease states within healthy, uncrowded markets. A simple model includes either a product that outperforms the market leader for approximately the same average selling price or performs as good as the market leader for significantly less cost to the hospital. “Ease of Use” has an entirely new meaning in modern healthcare that has widespread implications to the system:
- Can the procedure be simplified enough to move from the hospital to a surgery center or clinician’s office?
- Are the clinician time savings measurable? A 10-minute procedure time savings for a doctor in private practice, at 200 cases per year, is greater than 4 days of savings that could be devoted to additional revenue generation for the practice, time spent with family, or a mix of both.
- Does the product reduce post-operative complications enough to reduce the nursing acuity required to manage them? Moving the patient from the ICU to “The Floor” saves the hospital thousands.
In essence, timing is everything and bringing engineering experts to the table early enough to develop a process that is validated with the intent of long-term manufacturing while the prototype is still being developed facilitates mutual on-demand access to the people, processes, and manufacturing technologies needed to be successful. With mutual mindshare and respect, medical device engineers and manufacturing engineers enter into a well-orchestrated blend of competencies, a nurtured relationship with collaboration as an essential component for comprehensive R&D throughout the product’s life cycle.
Optimizing Outcomes from a Risk Perspective
Many successful companies are formed with a robust quality management system (QMS) system as the foundation. Fortunately, many contract manufacturers have taken the lead and mirrored their quality systems to those of the most stringent medical device original equipment manufacturers (OEMs). A top score in an audit or annual scorecard from a large, established OEM will not only win new business from that existing division but will likely expand to other relevant divisions within that corporation. Nobody wants to re-invent the wheel when it comes to selecting a contract manufacturer and working with a company with a sub-standard QMS is setting yourself up for failure. Even if you decide to file the 510(k) through your company there’s a great deal of benefit of working with a contract manufacturing organization (CMO) Quality team that has experience filing 510(k)s because they can craft the V&V activity accordingly. (See Figure 2)
Supply Chain is another function to nail down. Smart OEMs link their supply chain managers with those of prospective contract manufacturing partners to identify risk. Here are some key questions every CMO should be able to answer.
- What is your company’s level of vertical integration and how much do you rely on outside suppliers to manufacture your core products?
- What percent capacity are you currently operating at, and what changes, if any, would be required to meet our forecast? At your current growth rate, when do you reach capacity?
- At what run-rate would you dedicate equipment to us? Will we need to purchase any equipment to reside at your facility to supply our products?
- What are your current lead times for products like ours, and what happens when a customer needs expedited delivery?
- Do you have any recent supplier scorecards you would be willing to share the data from?
Product Line Life-Cycle Planning
In many companies, the project concludes at launch with some brief post-launch monitoring and the development team dispersing shortly after to move on to their next project. The activity almost completely shifts to Marketing, Supply Chain, and Quality. Before the project becomes a distant memory, the project team should identify what the next-generation product should look like based on the post-launch surveillance conducted by Marketing and customer feedback.
Only the engineers who met the challenges developing the new product can effectively comment on them as they relate to any future design change proposal. Most great new product sales will eventually plateau after all the low-hanging fruit has been picked. In addition, end-users will want to see that the OEM they are working with will continue to make improvements to the product to address unmet medical needs. OEM project teams should work together with their CMO to create a list of potential upgrades to the existing design, with a clear description and estimated budget, so that the OEM can communicate effectively with new and existing end-users and “flip the switch” when senior leadership gives the approval to improve the product. (See Figure 3)
In the balloon catheter space, the trend has been larger diameter, longer length, higher burst pressure, and smaller sheath compatibility. This trend is expected to continue. The right CMO will work with their OEM to nail down future design possibilities or actively anticipate them, pre-developing the next iteration to earn the right to win the next project with speed to market.
Twenty-first century OEMs are looking beyond traditional CMOs in search of long-term partnerships where the CMO can become an extension of their R&D Department. Trust, alongside a solid non-disclosure agreement (NDA), is earned, and critical in the exchange of performance characteristics that lead to highly differentiated, successful product launches. Trade secrets are important but if you’ve ever heard a CMO say “If you can tell us a little more about what you’re trying to accomplish with your product, we’d have a better chance of helping you,” there’s a good chance you’re setting your new product up for failure.
Supply Chain, Quality, and Operations of the CMO should meet at least quarterly with the OEM to review the forecast and make suggestions about ordering patterns to maximize lead times and deliver pro-active cost reductions. For example, balloon catheter costs are driven by lot size and inspection. The most expensive part of a balloon catheter is the balloon and the most expensive part of the balloon is the inspection. It is not uncommon for CMO Supply Chain managers to suggest different lot sizes to balance cost, lead time, and forecast as well as share best practices with less-experienced OEMs. It’s their job and a great way to build relationships.
This article was written by Mark Geiger, VP Sales and Marketing, Interface Catheter Solutions, Laguna Niguel, CA. For more information, Click Here . MD&M East, Booth 2210