Showing posts with label biomedical engineering. Show all posts
Showing posts with label biomedical engineering. Show all posts

Sunday, August 23, 2015

Get the Most out of Your Medical Device Contract Manufacturer

Contract manufacturing is a term that has been around for decades in the medical device industry. However, medtech companies are increasingly calling these service providers to assume more responsibilities, including design and development. Whether because of pricing pressures, government regulations, or rapidly evolving manufacturing techniques, manufacturers are offering a wider menu and forming business partnerships with medical device companies.
However, every type of outsourcing has its difficulties. There are some tricks to get the most out of it, though.
1. Clearly define roles, responsibilities, and expectations: “For example, what kind of support is the contract manufacturer willing to provide in the early stages? Who will assemble the prototype within each phase? Who will do the testing?”
2. Constant vigilance will minimize surprises: “A lack of communication will inevitably lead to nasty surprises, but “over communicating”—too many e-mails or too many meetings—can negatively affect productivity.”
3. Truly understand the level of each partner’s expertise: “Hope for the best, but plan for the worst.”
4. Fool me once…: “Learn from past mistakes, which often are due to putting off “trivial” issues early on in the process that then turn into much larger problems later on.”
If you are having issues with your medical device contract manufacturer; you are interested in arranging a business partnership or curious to learn more about medical device contract manufacturing, drop us a line! Biokyra is a Biomedical Engineering Company that develops minimally invasive medical devices, from the idea/need to the pre-series production. Our goal is to make your idea become an innovative and successful product. Therefore, we provide feasibility analysis, materials research, validation tests, and many other services.


Sunday, June 28, 2015

Medical Devices: From Concept to Launch

Integrated Technologies Ltd (ITL) - a global medical device product development, product design and contract manufacturing service company - has recently published an infographic that displays the entire product development cycle, from concept to commercialization and product launch.



Source: qmed.com - Infographic: The Journey from Idea to Commercialization


The infographic intends to show the development steps of a product, within a contract manufacturing company. But the process can also be replicated at large medical device companies that manufacture their products by themselves. At the bottom, one can see the early stages: idea, market research, business plan, funding round. Then comes the fun part for medical engineers: product development, product design, clinical trials. When the product is ready to be launched, marketing and sales have to do their part: commercialization.

As for post-market, Integrated Technologies Ltd listed steps such as after-sales support, obsolescence mitigation, further product development and manage regulatory change (especially true for medical devices!). The infographic also shows stages of the development of a product range, entering new markets/countries, IPO or technology transfer.

As a Brazilian-based biomedical engineering company that provides services from the idea to the pre-series production, Biokyra works to support all the stages of the project and minimize the risks of it. Our goal is to make your idea become an innovative and successful product.