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5/6/2015 | 3 MINUTE READ

20 Questions for Medical Molders

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Before you ask medical device manufacturing advisor Mark Bonifacio any questions, he has a few for you—20 to be exact.

“I call it the 20 questions, and I want to know the answers before I’m even going to give you one iota of advice,” Mark Bonifacio, principal of Bonifacio Consulting Services says with a laugh, although he’s not entirely kidding.


Equipped with a degree in plastics engineering from the University of Massachusetts Lowell, Bonifacio began what has been two-decades-plus in medical plastics manufacturing in 1993 at device OEM, Baxter Healthcare.


In the intervening years, he cofounded medical injection molder and contract manufacturer, APEC, which was sold and became Helix Medical in 2004. In January 2007, he founded Bonifacio Consulting Services, where he he’s currently using his 22 years of experience and those 20 questions to help companies launch new devices, offering expert advice on the technical and business aspects of medical manufacturing.


On June 16, Bonifacio will deliver the keynote address at Molding 2015, celebrating its 25th year and organized by Plastics Technology magazine (for the full agenda, click here).


So what are some of the questions you should be ready to answer for Bonifacio?


  • Where are you going to sell the product?
  • Is it a really big product or a small product?
  • Does it have a lot of assembly?
  • Does it have a lot of materials?
  • Does it have a lot of IP?
  • Is it complicated?
  • What are the tolerances?
  • Has it been done before?
  • Does it involve complex processes?

“Every one of those questions you ask, you get a different answer in your matrix,” Bonifacio says, “and you’re going to see that there are a lot of factors in play here.”


The Big Mistake
Bonifacio’s time in the industry has been spent tackling technical and business questions from both sides of the supply chain (OEMs and contract molders) and for all manner of devices, including artificial heart components, IV systems, syringes, implantables and safety products, in disciplines as diverse as respiratory, anesthesia, ophthalmological, neurology, cardiac, and more.


Using that broad and deep reservoir of experience, Bonifacio has consistently seen one mistake made in the launch of devices. “The biggest thing that I see is everyone wants to use one example or something that they’ve done as the blueprint for everything that follows, and I tell people we’re way beyond that,” Bonifacio says. “The supply chain—especially when you talk globally—has become so sophisticated and so complicated that there is no one kind of cookie-cutter solution.”


Past success most definitely does not guarantee future returns, according to Bonifacio. “We have people say, ‘Hey, when we built that IV catheter, we did this,’ and then they move on to either another company or a totally different device, and they want to treat it the same way. I really caution people about doing that because the supply chains are very different; the capabilities of your suppliers are different; the ordering patterns are different; so you really have to look at everything holistically.”


Keep An Eye on 3D Printing and Robotics
In a wide-ranging presentation at Molding 2015, Bonifacio will also highlight how technology advances are impacting the device industry. Asked about which technologies he’s most interested in, Bonifacio answered quickly: 3D printing and robotics.


“Certainly the proliferation in the advancements in 3D printing,” Bonifacio said, pointing out that  developments seemingly come out every day. “That is changing how we think about things; how we’re developing products; and how we’re launching things. No doubt about that.”


Robotics impact on the healthcare industry is multipronged, according to Bonifacio, ranging from automation in manufacturing at suppliers to home health to the operating room. “The other area is robotics,” Bonifacio says, “and I think that automation and robotics are continuing to advance at such a rapid pace.”


Learn more about Molding 2015 here, including the full agenda. (Photo courtesy Bayer MaterialScience).



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