Q and A with FactorsNY's Paul Mulhauser

Paul Mulhauser is the president of FactorsNY, a firm that specializes in the design and development of medical products “with a focus on resolving the factors that create excitement through customer satisfaction,” he said. Mulhauser recently took the time to answer some questions about his perspective on product R&D trends. Following is an excerpt of the interview.

MPO: Given that we know more OEMs are outsourcing R&D, take a moment to reflect on the 'why' factor. What are some practical as well as unique reasons you believe the trend is taking hold? In other words, what do you believe are some of the 'motivating factors' for OEMs to outsource their R&D?

Paul Mulhauser: Profit (or conversely survival) is an enormous 'motivating factor' to outsource. In today's results-driven economy, R&D must continually feed the hungry and efficient machines...or we see the machines get sold. And if R&D can't keep up with the demand, that can be outsourced as well!   
Small startups as well as large, previously vertically integrated entities, see the efficiency of simply using other available resources—expertise, equipment, experience—to meet their corporate objectives. They appreciate better margins more quickly with less overhead...when it's ultimately the product—not the process—that they're selling.

MPO: What types of practices have you put into place to meet varying needs of customers?

Paul Mulhauser: While our customers come to us with their own core technologies, we've built our core competency around identifying the human and other factors that contribute to our design and development of products that excite customers through the implementation of such technologies.

MPO: What benefits do OEMs stand to gain from outsourcing their R&D functions?

Paul Mulhauser: A less parochial vantage, looking beyond one's conventional realm, can reveal exciting new opportunities. Small emerging and large corporate entities alike appreciate the advantages of achieving rapid growth through the outsourcing of well focused SWAT teams with specialized expertise and prior experience. An insightful edge and accelerated R&D efforts are achievable without the burden of organizing or maintaining internal infrastructure and associated overhead.

MPO: How far do you think this trend has come over the past couple of years? Where do you see it headed?

Paul Mulhauser: Outsourcing is economy driven. Today growth is a mandate. Public companies are determined to achieve ever-increasing quarterly returns just to survive. Level income is not acceptable. To bolster the bottom line many large OEMs have been management driven to consolidate, merge and refocus corporate objectives.  

Through a decade of market-driven management practices, reorganization (as well as attrition) has resulted in losses to accrued R&D knowledge base. Such large dismantled companies and, of course, smaller start-ups as well as companies expanding into new areas particularly enjoy the ability of outsourcing large portions of the R&D process.     

MPO: Do you believe medical device OEMs will ever be truly comfortable with handing over a large portion of the process? Why or why not?   

Paul Mulhauser: Yes, comfort is achieved through completion of successful programs! While companies maintain an intimate vested interest in building, understanding and exploiting their evolving core IP technologies, peripheral aspects of development are readily outsourced.  

MPO: How is the time crunch to get a new product conceived & finished affecting your ability to get a product to come to fruition? Have timelines shifted in any way?

Paul Mulhauser: New technologies accelerate deadline expectations—just as fax was outmoded by e-mail, the 9:30 pm FedEx drop replaced mail, CAD visualization tools, 3D modeling and rapid prototyping have accelerated the entire process.   

Today boundaries are dismissed; they’re merely lines on maps, as gigabytes of data are instantly volleyed between continents. Use of offshore vs domestic resources is no longer a question of practicality but merely politics.  

MPO: How are you accommodating tighter deadlines from your clients?
Paul Mulhauser: We surround ourselves with expertise, trust our depth of experience, reach out to appreciate new technologies and maintain and build a network of capable suppliers.

I find the accelerated pace and quick realization of results exhilarating and addictive.  And I enjoy working with those who share that satisfaction.

Effective upfront strategy becomes ever more important to assure that the hungry efficient machines are fed with the right new products—or better yet, new categories of products—to meet and exceed corporate growth expectations.  

MPO: What kinds of features or attributes of newer products are you seeing emerging? In what ways do unique characteristics in a new product design make your job more challenging, and how are you meeting those challenges?

Paul Mulhauser: I see a proliferation of “high-tech solutions emerging for low tech problems.”  Technology proliferation has facilitated use of previously unattainable sophisticated intelligent systems—that is, to improve value through integration of performance adding sensors, feedback loops, computer controls, etc.  

Straight cuts, long ago a manufacturing practicality, aren't a consideration as intelligent machines are indifferent to the complexity of their programmed paths. The toys of our profession are totally cool! The products we can create are awesome. Life is too short for mediocrity.  
 
MPO: What are some of the steps you take during the research and development phases?

Paul Mulhauser: Not so surprising—though our technological tools have changed—our methodical approach remains sound, just a lot more efficient!  

Immersion in achieving a thorough understanding of user needs inarguably is precedent to the exploration of alternative solutions... before identifying and locking-in upon optimal directions worthy of development...and subsequently taken through production implementation. Evolving solutions must be challenged, evaluated and tested throughout the process. Leaving out a step jeopardizes success. Experience complements technology to expedite the decision and development processes.
 
MPO: How would you characterize the typical customer’s (OEM’s) involvement?

Paul Mulhauser: The client must be involved in the R&D process to ensure that resulting products meet the client's needs as well as the customers'. It's also important that in-house teams, ultimately responsible for ongoing product support, understand and appreciate the basis for developmental decisions for the products in their pipeline, lest the design intent be lost in translation or over time.  

For example, a very successful surgical stapling instrument we'd once designed had over time gone through so many evolutionary incremental improvements by a succession of in-house engineers that a basic understanding of the device's functional performance eventually was lost.  It no longer performed reliably. Like a recipe, the formula was lost—"It wasn't chocolate cake anymore... it had evolved into something different!" We went back to the basic principles of the invention to restore performance.  

MPO: What do you feel is essential in terms of making the OEM/vendor relationship work, as well as making the product as optimal as possible?  

Paul Mulhauser: While 'design by committee' can be daunting, it's important that all significant stakeholders—marketing, manufacturing, customer, management—communicate throughout the processes...or risk the resulting birth of an orphan child.  

Through the years I've found the strongest consultant relationships, earned respect and loyalties are formed between teams and individuals... not necessarily between companies. I continue to enjoy working closely with numerous clients returning from a succession of different companies. Healthy relationships endure time and generally don't shift unless there's a corporate changing of stakeholders. (I suppose not dissimilar to political term shifts or sport team trades).  

MPO: What criteria should an OEM use to help evaluate the best candidate for an R&D phase?

Paul Mulhauser: I believe selection most often comes down to the comfort level of the individual and team gatekeepers, relative to their personal trust in the resource's capabilities, experience, ability to deliver and—perhaps most significantly—the ability to establish a working relationship…that is, both parties are thinking, “How cool it would be to work with these guys!”

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