What’s holding you back from adding the Medical Device Industry to Your Marketing Plan?
Why Implement ISO 13485 when IATF 16949 certified?
There are four very good reasons to Implement ISO 13485:2016 “Medical Devices – Quality management systems – Requirements for regulatory purposes” when you are already IATF 16949:2015 “Automotive Quality Management System Standard”.
- Increased profitability
- Market diversification
- Economic Stability
- Increase asset utilization
Wouldn’t you like to add a zero right before the decimal point on your company’s profitability number? Wouldn’t it be nice to go from $1 million in profit to $10 million? That has been the experience of more than one automotive supplier who implemented ISO 13485 and entered the medical device market.
The vast majority of automotive suppliers are for profit companies. The automotive industry is well known for limiting the supplier profitability and forever driving down the costs from their suppliers. In some cases, the automotive companies refuses to cover the cost of research and development overhead but demands new concepts be given to them first.
Medical device manufacturers put safety and performance first and have not implemented the Lopez concept of cost management. They understand there is a cost to meeting regulatory requirements and do not quibble or ask for detailed break outs of materials, labor and overhead. They are price conscious but are a very different customer than the automotive industry.
Finding new sales is always difficult. Thousands of books have been written about how to increase market share. The question is do you what to fight for a small percentage of a low profit business or diversify and enter a high profitability market that limits suppliers due to regulation? ISO 13485 can be implemented prior to having any medical device customers. With this certification, your organization can enter a totally new market and increase your sales volumes.
The automotive industry is subject to the ebb and flow of the economy. A new vehicle is something consumers will delay purchasing when the economy is low. Hospitalization and medical testing will occur without relation to the economy. Medical device manufacturing is a stable steady demand industry independent of economic cycles.
Increased Asset Utilization
Do you have plant capacity? Do you have equipment standing idle? It can be put to work generating an increase in sales and profit without creating conflict with your current customer base. Unless you are running 24/7, it makes sense to find business for idle assets. The medical device market could be the place to find new business.
Implementing ISO 13485 while IATF 16949 is a Win-Win
There is no conflict between IATF 16949 and ISO 13485. ISO 13485 requires additional conditions and processes, but in no way is in opposes IATF 16949 requirements. Your organization can maintain its current customer base and certification while adding a certification that opens new markets, increases profitability, provides greater economic stability and utilizes idle plant capacity. The medical device industry gets a supplier accustomed to being responsive and innovative. That’s a win-win.
If you want to know how to make this happen, call or email me. Technacon Company is here for you. Give us a call today at +1 (708) 814-3685 or email us at Technacon1986@sbcglobal.net.
Technacon Company – Experts in ISO Implementation:
- Full-Service International Standards Implementation
- Customized Training/Documentation
- 20+ Years of Experience
- ISO 9001
- ISO 13485
- ISO 14001
- ISO 17100