So, you finally got your medical device project started but you just can’t seem to cross the finish line. From failing prototypes, failing mechanical tests, going over budget, to slipping timelines… your medical device development firm is failing you. If you are an OEM, you start to wonder why you didn’t do this project in-house to begin with. If you are an individual or small company maybe that wasn’t an option. Below are 7 signs that you need to cut ties with your outside development firm and find a new one.
- They don’t understand your vision. The key indicator here is that you spend too much time re-explaining things to the engineer. Whether that is the surgical technique, branding, or the ultimate cohesive functionality you need in the final system. Everything may have started out great in the beginning but projects can drift away from their original vision. Be ready to cut ties and move on to a development company that keeps your vision in focus throughout the entire project.
- The quality of the work output is poor. Product development is a process and not every design will work perfectly, especially in the beginning. How good is the firm at identifying and fixing problems? If they are responsive that makes a big difference. But having fewer problems is even better. While the owners or managers of many development firms may have medical device experience the actual work is often handed off to junior level engineers that may not. This results in a disconnect between the quality of work you are paying for and what you get in the end. Attention to detail is critical.
- There are no clear deliverables or they are not being met. I hear on a regular basis from new clients that deliverables are either completely ignored or never clearly defined at the beginning of a project. A clearly defined scope of deliverables keeps everyone on target and the development team accountable.
- They are not available to meet during the times you need. This one I see as more of an issue for the individual inventor. But we all know that the operating room is not 9-5 and surgical schedules can be unpredictable. The need to be flexible with meeting times is the only way to keep projects on track. An engineer should be available in the evening and on weekends – 24/7. Meetings should utilize technology such as web-based screen sharing and video conferencing. Your time is valuable and a partner respects that time.
- They did not help you budget for the entire project. Too many times most of the project budget is used up in the beginning on patenting and prototypes. By the time you make it to the final development phases funds are starting to dry up or are no longer available. The project starts to stall and there are little repercussions for the firm. Don’t let the firm drag the project out. It is better to move on and engage a firm with better planning and a financial strategy to see it though its final phases.
- They are not willing to take an equity position in the project for reduced fees. The best thing you can do is align the interest of both parties to make the project successful. Many companies are not able to reduce their fees due to large overhead costs. If you like the idea of reducing fees, look for a small to mid-size firm with low overhead that can provide flexible fee arrangements.
- They have trouble getting manufacturing quotes and acceptable lead times. With our booming economy it is not unheard of for manufacturers to quote 16-18 weeks for production lead times. Or for them to no-quote “small” jobs. You want a partner that has strategic relationships that can deliver prototypes and production quantities in more reasonable lead times of 4-12 weeks.
There are certainly other areas that an outside firm can let you down such as poor quality documentation or over-billing but I felt this list was enough to make my point. Sometimes you have to know when to move on.
Lawrence Binder – Chairman – Binder Biomedical, Inc – www.bindermed.com
This information is for reference only and not to be considered legal advice. We recommend that you work with an attorney when making important legal decisions.