A leg up.Click image to enlargeby Tim wilson

Prescriptions for success in medical manufacturing


The Canadian manufacturing landscape is changing, and many metalworking shops are eyeing the growing medical market as a source of long-term opportunity. But this industry has unique requirements, and that can be daunting for a shop that has served industries with fewer regulations and shorter turnaround times. Shop Metalworking Technology reached out to the experts for advice on how to get into this market, and how to succeed.

Go ISO. It costs money to get ISO certification, but there is a close affinity between ISO 13485 and FDA requirements. "FDA manufacturing practices do not always require ISO certification," says Jon Winer, CEO of Tollos, a Barrie, ON-based manufacturer of patient handling and care products. "However, testing labs for safety as well as some manufacturing have very similar practices." Going ISO then gets you closer to FDA approval, and access to the lucrative supply chain into the US.

Look to America. Given the time and money required to get started in medical manufacturing, it only makes sense to set your sights on the US market. Obamacare has delivered some uncertainty, but that should clear in the next year. "We sell to the US market, which is suffering from the effects of Obamacare, as hospitals are worried they will get less reimbursement," says Winer. "That said, 90% of our business is in the US – it represents a much larger market opportunity."

Find transferable skills. If the medical industry is new to you, it makes sense to look internally for transferable skills. If you don't have them, go out and get them. "We have two former Magna executives working for us," says Winer. "The automotive sector was having difficulties, and we have now picked up expertise in plant management, mechanical skills like tool and die, as well as electronics."

Learn the business. To succeed in the medical industry, you have to know how the business works. This, according to Rob Henderson, President and CEO of Biotalent, is one of the industry's biggest challenges. "The problem is that people don't know the business of science, the regulatory issues. Many people also lack the skills required when looking for industry specific financing." Getting the qualified business development, financing, and leadership skills are a must if metalworking companies are to succeed in the medical sector.

Get some partners, and show value. To participate in the medical manufacturing market, you can't go it alone. "In order to continue to build on successes, Canada's device manufacturers need to continue to work with industry partners and government," says Brian Lewis, President & CEO of MEDEC, which represents medical technology companies in Canada. Lewis says that those companies that partner to add value will have a better chance of succeeding. "It's important to show that innovative medical devices can improve patient outcomes, while reducing costs to the overall health care system at the same time."

And to do that, says Lewis, manufacturers had better be ready to show the value of their technology. SMT

Top ten Canadian medical device exports, 2012Click image to enlargeMedical device market data
From 2007 to 2012, Canadian medical device exports increased from $1.7 billion to $1.8 billion. Canada's largest trading partner for medical devices is the US. In 2012, Canada's medical device exports to the US were $1.2 billion, or 64.7% of Canada's total medical device exports. In 2012, Germany (4.5% of total), China (3.1%) and France (2.7%) constituted the next three leading destinations for Canada's medical device exports. In 2012, China (7.0% of total), Germany (6.3%) and Mexico (4.7%) constituted the next three leading sources of Canada's medical device imports after the US.

Top ten medical device markets  by sales revenue, 2012Click image to enlargeTim Wilson is a contributing editor. This email address is being protected from spambots. You need JavaScript enabled to view it.

Where challenges meet opportunity

by Tim Wilson

Only shops with rapid response to this sector’s challenging demands will succeed

Medical device manufacturing is one of the most exciting industrial sectors in Canada, but also one of the most challenging–specifically given the complexity of the regulatory environment.

Heinman introduces two new First VMCs 

COVID-19 has not stopped Heinman and First to continue to forge forward.

An old warrior steps aside: New CMM helps manufacturer eliminate bottlenecks

by Andrew Brooks

The Problem: Sourcing parts for an aging CMM

The Solution: Bring a new CMM on board

Double column machining centre for press dies

The new MCR-S double column machining centre (DCMC) from Okuma America Corp., roughs and finishes press dies in one setup.

The Impact of Alignment on Your Steel Turning Process

by Rolf Olofsson

What do an ancient Roman war strategy and ISO P steel turning grades have in common, and how can this help increase your machine shop’s output? Here, Rolf Olofsson, product manager at Sandvik Coromant explores how the coating and substrate of carbide grades can make a huge difference in the efficiency and productivity of steel turning processes.

$40 B US industrial robotics market by 2020

The global industrial robotics market is expected to exceed USD 40 billion by 2020, according to a new study by Grand View Research, Inc.

Volkswagone eliminates aerosol leakage with leak-proof chucks

Volkswagon's Salzgitter, Germany plant had a problem with its Minimum Quantity Lubrication and dry processing operations.

Unique machining concept: Multi-task turning

Mazak's Orbitec 20 is a unique machine originally developed as a customized solution for a customer application.

The Smarter Factory

by Noelle Stapinsky

Canada’s job shops are expanding with increased automation, putting them on the path to a fully autonomous future

Turn Right

by Kip Hanson

Breaking with tradition in turning operations can bring big benefits 

Green Manufacturing About Dollars and Sense

by Michael Ouellette

When it comes to greening your job shop, thinking small can pay big dividends

Fabricating: Punching Up

by Andrew Brooks

Bayview Metals relies on Wilson Tool for more than quality and price

6 Tips on Extending Life of Consumables

by Phil Parker

Longer consumable life can result in significant cost savings

Customize measurement configurations

Dual optical systems and touch-probe capability help the AVX550 Multi-Sensor Vision System from L.S. Starrett Co., measure parts with a diverse range of feature sizes and geometries.

Laser leap

by Mary Scianna

The Problem: Meet demands for higher quality, faster delivery

The Solution: Purchase a 4 kW CO2 laser cutting machine

Alberta fabricator invests in laser cutting technology to meet customer demands for higher quality

Stay In Touch

twitter facebook linkedIn