It’s Not Me, It’s You (Medtech Edition)It’s Not Me, It’s You (Medtech Edition)

As 2024 draws to a close and budgets are developed for next year, it is time to look at your projects past and present.  What’s going right?  What’s going wrong?  Do you have the time and capability to fix it? Is it time to bring in…gulp…contractors?

Deciding that you need to bring in outside help on your project is a tough decision.  It can feel like an admission of guilt or make you feel incompetent.  It can seem like it is the more expensive option.  I get it, having been on both sides of that relationship. 

You must make the right decision for the project, and that can mean bringing in highly paid outside experts to fill gaps in your team or outsource work entirely. Having an expensive contractor working fast is often cheaper than having a low-salary employee work past due dates.  Below are five tips to get the most out of this process, so that you and your company not only succeed but thrive. 

Acknowledge What You Don’t Know

You cannot know everything.  You and your team might have been designing advanced catheters for 20 years, but if you are struggling to get this one out the door, there is a reason why.  If you are over budget and late, it’s past the time to admit that you don’t know everything.  Admit that there is a deficit. There is nothing wrong with that.  We aren’t omniscient beings; we are humans with limited experience and knowledge.  It often makes more financial sense to hire experience than try to develop it on your own.  Figure out what you don’t know and look for experts in that field before it is too late.

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Get Them Involved Early

Don’t wait.  As a contractor, there is no worse place to start a project than after the fire has been burning for months.  Consultants need time to get up to speed, even if they are experts.  They don’t know your company or your new product idea. Sometimes this can take hours, days, or months depending on the complexity of the situation.  Ask them how much time they need and give them a little extra. 

Furthermore, many companies fail to have a smooth pathway for hiring outside experts. Oftentimes, internal roadblocks like overly burdensome approval processes, unfriendly management, or lengthy payment terms can prevent hiring top talent who simply do not have the patience or cashflow to wait.  If possible, lean out the pathway to bring in contractors and avoid unnecessary delays or push away the expert you need.  If that isn’t possible, work with your contractors to help them navigate your organization quickly.  They are experts in their field, not in your company’s operating procedures. 

Related:What Were the Big Trends in Contract Manufacturing in 2024?

Think Through Your Needs

If you do not know what you want, how do you expect anyone else to get it? Make sure requirements and deliverables are carefully and thoroughly considered, written down, and reviewed.  Provide this list to your potential contract partner prior to asking for their quote.  Point out any TBD’s.  A complete list of needs and wants leads to a more accurate quote for work, acts as a guide throughout the project that limits scope creep, and aids in reviews to ensure needs are met.  Not to mention, Regulatory Bodies ask for it too. Save yourself the headache and write down your requirements.

Treat It Like a Partnership

Your contractors work with you, not for you. They are a legally separate entity from your organization and are allowed to work differently than your group.  Realize that they bring something to the table and that working together leads to synergistic and compounding effects.

Also, like any partnership, communication is key.  Yelling and name-calling are simply unprofessional.  Likewise, don’t say that everything is fine when it is not.  Keeping concerns to yourself only leads to hurt feelings and costly delays when it finally comes out.  Keep your cool and talk it out.  A good contractor will listen to your concerns and adjust.  Provide positive input often for when the times get tough.  Is it easier to hear criticism from someone who notices the good too, or who only calls when you are messing up?

Related:Questions to Ask a Prospective Contract Manufacturer for Your Medical Device

Smiling and nodding, or conversely yelling and berating, aren’t helpful. 

Understand The Process

Design is iterative.  This means that every step is not forward.  Some steps are backward, while others might be sideways or uphill.  You must try things to see what works.  Even seemingly simple problems can sometimes require multiple failures before you land on that great idea.  Your contract partner is intimately familiar with this process and should provide data to help you make an informed decision about your project.  If data is scarce or if your partner is not willing to share, it is time to push back.  However, if data shows your idea will not work, it is time to rethink your requirements.  Trust in physics, and the process.

Conclusion

Contract design and manufacturing are not predictable. When creating something for the first time, there is a learning curve for everyone involved, from client to designer to assembler.  Realize what you do not or cannot do and bring in the experts, but first write down all your requirements.  Communicate with your partner at least once a week. By reframing your relationship with contractors and consultants as a long-term partnership, transitions to manufacturing will become smoother over time.  Issues will arise and mistakes will be made. Retain that learning by keeping the team intact and building on that body of knowledge. This will demonstrate that you trust your team too and that you are all in it for the long haul.  If the same mistakes keep repeating, it might be time for a change of process or partner. In the meantime, trust the experts.