Bradshaw Medical – World Class Design and Manufacturing

Bradshaw Medical – World Class Design and Manufacturing

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Written by Mark Bakula, Director of R&D

 

In 1986 at Snap-on Tools Company, by far the largest designer and manufacturer of automotive tools in the world, decided to enter the Medical Tools market. One of Snap-on Tools’ industrial salesmen called on one of the largest orthopedic companies, Howmedica, and discussed the possibility of Snap-on Tools manufacturing a complete orthopedic instrument system of 40 instruments including a roll around tool box with a custom violet paint job. Howmedica tested the abilities of Snap-on Tools by asking them to develop a number of prototypes, some from complete drawings and some from sketches. Because of this relationship, Snap-on Tools started a division to manufacture medical instruments called the Medical Products Division (MPD). With my background in hand tools engineering, I was chosen by Snap-on to lead this new division.  The salesman also discussed and eventually sold Howmedica an automotive ratcheting screwdriver design that was converted to medical specifications. This event was significant, as it was the first time MPD were able to modify an existing automotive tool, convert it to a medical instrument and sell it to the medical industry. To do this, all of the metals were changed from standard automotive steels to stainless steel; the nylon handles were converted to Ultem. Since Snap-on Tools had considerable design understanding of the ratcheting screwdriver design, it was relatively easy to make the conversion. On the other hand the tool storage division in Algona, IA, faced a much more difficult task. This plant produced over 5,000 tool storage units a year, but all of them were painted Snap-on Tools red. Now MPD was asking the plant with production equipment geared to paint only the Snap-on red to paint a custom color. In some ways it might have been easier to go to the moon than to convince the plant to attempt a new color. The plant was forced to modify non-production equipment to paint the Howmedica violet paint. Over time this was successfully completed.

 

Once Snap-on Tools Medical Products Division was able to launch the Howmedica system, numerous other implant manufactures asked us to assist them in developing new instruments. We converted a deflection beam torque wrench, a standard in the automotive industry for over 50 years, to medical materials. We converted a carburetor adjustment tool (for you youngsters, a carburetor was what we had before fuel injection (ask your mom or dad) to an instrument that facilitated the installation of spinal screws for a Johnson & Johnson.

 

We decided that the market place was ready for a kit consisting of a ratcheting screwdriver, hex shafts, torx shafts and flexible extensions. To enhance the kit we took the standard hex and torque drivers and added a twist to them so that they would hold the bone screws on the driver and not fall out. Later, MPD developed the Winquist system. We developed a hand held torque wrench that was accurate to +\- 10% of the torque setting. The set also featured a “T” shaped handle that was completely manufactured from aluminum. MPD had entered an area of huge growth possibilities, for we were able to draw on the entire infrastructure that Snap-On Tools had.  From design resources, CAD support system, metallurgical expertise, test labs, quality control, manufacturing expertise, and even their legal and marketing knowledge. Allowing for our tremendously fast growth was the lack of regulation by FDA. Initially MPD converted the engineering documentation from automotive type standards to medical standards very quickly.

Just to show you how medical protocol has changed, in the early 90s a surgeon in Florida asked to us to take the standard automotive air chisel (used for chiseling off rusted nuts and cutting exhaust system components) and turn it into a medical instrument to drive femoral stem implants into the tibia. We designed and manufactured it and then tested it on a piece of oak. I then flew down to Florida to watch its evaluation by the surgeon that requested the tool. To my great surprise we went straight into the operating room where the orthopedic surgeon tested the air chisel on a patient during his operation. No ISO 13485 or 9000 or Design History Files, or Master Device History existed in those days in the instrument community. Unfortunately in the mid 90s a change in management forced a number of the key original team to leave MPD; simultaneously, Snap-on Tools was going through some difficult times

 

In 1994, Guy Bradshaw, who started as a metallurgical  technician at Snap-on Tools and worked his way from jack-of-all-trades at MPD to become the West Coast Sales Manager. He left MPD and with Dick Beere started Beere Medical. From humble beginnings the company grew rapidly. A number of MPD employees left MPD and went to work for Beere Medical. At Beere, the silicone instrument handle was developed which replaced Ultem and the other handle materials being used. During this time the implant companies continued to request the adaption of automotive tools for medical uses. Designs for ratchets, sockets, different forms of cutters, pliers and locking pliers were converted from their automotive predecessors.  New combinations of tool functions were developed, such as the inclusion of a ratchet and a torque limiting mechanism in one single instrument. In 2002 Dick Beere decided to semi-retire. This resulted in Beere Medical being sold to Teleflex. After a short time Guy left Teleflex to enjoy the American dream. At Teleflex a complete kit was designed for cervical and lumbar screw/fastener extraction. This was a take -off of similar automotive kits that were one the initial automotive tool products that launched Snap-on Tools in 19XX. Now adopted by the automotive industry, silicone handles began to appear in both industries on more tools and even in various colors.  As always, custom instruments were developed to meet many needs, such as the growing area of medical spinal implants.

 

In 2006 Guy Bradshaw decided to start his own medical instrument company specializing in orthopedic and spine instruments. As before when numerous MPD employees left to follow Guy to Beere Medical, again many employees left Teleflex and headed to Bradshaw Medical (BMI). At Bradshaw a decision was made to put in extra effort to design the best mechanisms, handles and devices possible. Taking the lessons from his former experiences, Guy embarked upon building a company that he felt must follow his belief that customer service is at the core of every great business.

Guy’s new company took on many new challenges.  He improved the accuracy of torque limiting devices from the current industry standards down to +/- 5% over their service life. When the spinal industry moved to CoCr material and up to 6.35mm diameter in rod design, BMI designed a table top rod cutter to handle this new size and material. BMI is pursuing the industries’ move to dual color silicone handles.  Another recent trend has been to develop and make the instruments as compact as possible, thus reducing size and weight, and BMI will help lead the way.

 

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