Strategic Sourcing for the Orthopaedic Industry A Knowledge Enterprises, Inc. Publication

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1 Strategic Sourcing for the Orthopaedic Industry A Knowledge Enterprises, Inc. Publication Product Development and Procurement Professionals Create the Competitive Edge in a Slowing Market John A. Engelhardt, Chief Executive Officer, Knowledge Enterprises, Inc. The growth of the global orthopaedic market has slowed considerably since While this statement no doubt surprises few of you, many have not yet realized what impact this will have on them personally over the next few years. This article aims to clarify just that. You have all undoubtedly already felt the effects of this. Many of you have had budgets cut, projects cancelled, hiring frozen or limits imposed on spending beyond what is considered business critical. First a reminder. The underlying growth in demand is still robust, and will continue well into the century. The growth of the dollar market is slowing, driven mostly by the reconstructive and spine segments. Exhibit 1 illustrates this phenomenon. Page 1 of 6

2 EXHIBIT 1 GLOBAL MARKET GROWTH 1998 TO 2005: SPINE AND ALL ORTHOPAEDICS 30% 25% 20% 15% 10% 5% 0% 1998/ / / / / / /2005 All Ortho Spine Nearly all of this slowdown is due to price and mix. Let s quickly look at what price and mix means. Price refers to what the company is paid by the hospital for a given product. In the last few years hospitals have been balking at price increases for orthopaedic products, because their own profits are lagging. Mix refers to the premium attached to an improved technology, say, a ceramic head as opposed to a metal one, or metal-on-metal as opposed to poly/metal bearing. For the same reasons as above, the market has begun to resist this and is requesting improved technologies at lower prices. What all this means is that companies are not able to raise prices like they used to, and are finding it more and more difficult to sell improved technologies at premium prices. In essence, the companies profit margins begin to erode. To make up for this, the companies will have to drive cost out of the entire commercialization process. Perhaps some of you have not yet considered that you will be asked to make a more direct contribution to the corporate margin objectives, as an increasing share of the responsibility will fall directly on product development engineers, manufacturing/quality control AND procurement/purchasing! Many reading this will say, How can I affect profit margins? That s the job of finance and marketing and sales. Read on. Page 2 of 6

3 Better AND Cheaper AND Faster You will be increasingly asked to streamline the commercialization process from napkin sketch to implantation. Not only will you have to drive cost out of the design, testing, regulatory approval and production processes, but you will be asked to learn how to complete them all more quickly than ever in history, without a single product or system failure! You will become world-class experts in concurrent development, designing for manufacture, zero defect protocols and perhaps a concept strange to you: design for profitability! The most successful companies will be those that are able to optimize the entire commercialization process beginning in the early conceptualization and design phases, and drive out the inefficiencies that have been built up from a decade of margin growth. From a Straight Line to a Circle For the highest performing companies of the future, gone are the days of marketing throwing the specs over the R&D wall and them tossing prints to manufacturing, and somewhere in there getting the QC and regulatory folks involved. This serial, linear commercialization model is rapidly becoming extinct, especially in the light of tighter margins and global competition. Exhibit 2 shows the classical serial process. EXHIBIT 2 SERIAL COMMERCIALIZATION PROCESS Specification/ Analysis Design Prototype Test Gauging/ Tooling, etc. Final Specs IDEA MARKETING R&D QA/MFG ENG PURCHASING/ PRODUCTION PRODUCT Change/ Delay At each subsequent step, changes require the process to essentially begin again, sometimes back to the very beginning. Each time the system restarts, priorities shift and relearning is necessary. Page 3 of 6

4 This restart process is extremely expensive in dollars, of course, but perhaps more important in time, or speed to market so often held by marketing to be the key to commercial dominance. Here s a good illustration. Let s say that the sales plan for a new implant system is $10MM next year. Your team is working on it for a January 1 launch. Let s assume there are 2,080 working hours in a year. Every hour the launch is delayed costs the organization $4, in lost revenues. That s $80.13 every minute! One dollar thirty four cents a second! Now you can see why streamlining the commercialization process is so valuable. It sure puts a new perspective on things, when a design change requires a new regulatory submission that may take as long as six months! This also illustrates the value of getting all departments in the process concurrently, especially procurement. A meltdown in the supply chain can nuke a new product timeline. Although concurrent development has been touted for decades as the new paradigm, few companies have truly embraced it, especially in the medical device markets. In fact, a new term is needed to describe an optimally efficient model of development. For the sake of illustration, let s call it concurrent commercialization. In this new paradigm, all elements of commercialization are engaged simultaneously, beginning at the concept stage. A new set of criteria accompanies the design process from the idea to the patient. At the napkin sketch stage, the following questions are asked and answered, and then continuously re-asked and re-answered until the product is on the shelf. Of what is the part to be made? Do more cost/time effective alternatives exist? How is the part to be manufactured? Is this the most cost/time effective method? How is the part to be dimensionally validated? What is the most cost/time effective method of doing so? Can alternative methods eliminate time and cost without compromising quality or function? What is the earliest and broadest regulatory strategy that can be applied to the part? Can we make design changes to optimize the entire process without compromising quality and function? Have these changes fundamentally affected the commercial features and benefits? The regulatory disposition? How does my make/buy decision affect all of the above? Some of the above can be answered by advanced development tools, such as design and manufacturing simulation packages. Others will need to be the subject of numerous iterations and reduction to prototypes. Page 4 of 6

5 Some product development engineers will look at this list and say, It s not my job to decide the cheapest way to make a part. Some purchasing people may comment, Just give me the final production prints and I ll find the best way to get it manufactured. This new way of looking at life turns the straight line development system back upon itself into a circle in which each element of the process is integrally and continuously involved from nearly square one. Exhibit 3 shows the relationship between the disciplines in the concurrent commercialization model. EXHIBIT 3 CONCURRENT COMMERCIALIZATION PROCESS MANUFACTURING/ ENGINEERING CLINICAL/ REGULATORY R&D/ MARKETING PURCHASING/ PRODUCTION PRODUCT QA You will also note that the concurrent process mandates R&D and marketing together to be central to the management of the process. This is essential in order to create and maintain the original specifications through multiple iterations. Note also that the concurrent process includes direct and simultaneous dialogue with purchasing. This is to provide continuous feedback regarding the most optimal alternatives that might be available to the process. In the concurrent process, delays are noted early and can be anticipated and avoided. By constant communication of design evolution, optimizations can be implemented by all parties involved. The result is better AND cheaper AND faster. Page 5 of 6

6 It has been our observation that the most successful concurrent development programs include clinical evaluations after each critical iteration, as well as a dedicated pilot production process. Changing How You View Technological Improvements Most everyone in the development process is excited about new technology. The reality of today is that the system can no longer abide by technology for technology s sake. To find a stronger or more biocompatible material or a sterilization process that zaps more microorganisms, or a plastic that can withstand more autoclave cycles, are all noble endeavors, but you will heretofore be asked how the system can afford such improvements. The ability of your organization to best its competitors will not so much be measured by driving improved technologies to market, but by doing so under the most favorable metrics. Becoming Business Critical Your value inside your organization is proportional to your contribution to its corporate directives. While research and development and supply chain management have perhaps in the past seen themselves outside of any direct contribution, the future does indeed belong to them. By streamlining the commercialization process, speeding time to market, innovating at increasing cost efficiency (and with zero defects), you will more directly ensure that your company s strategic and financial directives are met, its place in the increasingly competitive market environment assured and your place in the organization secure as critical to its ongoing success. John A. Engelhardt is a former orthopaedic industry executive. He holds 19 patents for orthopaedic devices, including several market-leading products. He has led teams in the commercialization of products for large and small joints, trauma and spine, always under budget and in record time. He can be reached at john@orthoworld.com. Knowledge Enterprises, Inc. 147 Bell Street, Suite 303 Chagrin Falls, Ohio USA (phone) (fax) Page 6 of 6

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