6 Surprises to Avoid that Could Sink Your Medical Device Launch

Liz Heiman
13.05.22 04:33 PM Comment(s)

6 Surprises to Avoid that Could Sink Your Medical Device Launch

Even if you do everything right there are still surprises that could slow or halt your launch. It’s hard to be prepared for the unexpected, so it’s a good idea to have a Plan B. 

Surprise 1:  Your contract manufacturer goes out of business.

Often companies negotiate with one manufacturer in preparation for their launch. If you aren’t careful about the manufacturer you select, they may not be there when you are ready to start production. While some of that is out of your control, there are some things you can do to prevent a surprise like that. First, research your partner. Don’t look for the cheapest option. Find one that has a solid track-record, is financially sound and has procedures in place to minimize chance of failure. You should probably also have a plan B. Research more than one company and have one ready to engage if the first should fail.

Surprise 2:  Your raw materials are stuck at port for who knows how long.

There is not much you can do if your product or raw materials are stuck in the ports. It could happen for any number of reasons. There may be customs issues that you didn’t prepare for. Make sure both your provider and shipping company have filled out all the appropriate paperwork. You may also find that other factors like natural disasters or shipping backlogs can hold up delivery. Once it is held up, there isn’t a lot you can do, so be prepared. Put padding in your delivery dates so your clients have reasonable expectations. 

Surprise 3:  Material cost go up 50% since the last quote.

The US has had stable pricing for many years. Inflation is on the rise.  Exchange rates with our primary trading partners don’t fluctuate significantly, but things can change. We learned a lot about surprises during the pandemic, but natural disasters, wars and acts of terrorism as well as fuel costs can change prices unexpectedly. 

Surprise 4:  Hospitals postpone purchases due to economic or environmental emergencies.

Hospitals are pretty good at making plans and budgets and sticking to them, but sometimes even the best laid plans get abandoned. Natural disasters are a common reason for budget changes. A good example of that was when hurricane Sandy flooded NYC. Almost every hospital in the city had to buy new emergency generators and repair and redesign hospitals in preparation for future flooding. All non-critical purchases got postponed while the hospital dealt with the emergency and the aftermath. Natural disasters are increasingly common events. Now, we are learning that pandemics may become more common events as well. Target a variety of hospital types and locations. The more diverse the hospitals you sell to, the better your odds.

Surprise 5:  Critical internal team members leave.

Start-ups often count on the team they create to be loyal to the cause. While you may believe your team is loyal, anything can happen, so be prepared. It is important that you have documentation and redundancy built into your systems. If your only seller leaves with all the information about your customers, you will have a problem. Keep a CRM, review the funnel regularly and make sure more than one person has a relationship at every important account. The same is true of every part of the delivery team. Does anyone else know how the computer system works? The warehouse? Shipping? Whatever it is, have a backup plan for every member of your team whether they leave or get sick or go on vacation.

Surprise 6:  You invested too early on technology that you didn’t need or can’t use effectively.

You thought you followed all the rules and did it right, but ….

The technology stack used to support quality and operations is important.  Automating important but mundane activities is also important.  But the urgent and important goals for a start-up Med Tech company are:

  • Funding
  • Design and Development 
  • Reimbursement
  • Quality Management System Design
  • Market
  • Regulatory Submission

Without funding, a good to better product design and development system, having a product that is reimbursable and that meets an underserved clinical need are the must haves  for pre revenue start-ups. The technology required to effectively accomplish this depends largely on the complexity of the product under development.   

Make Sure You have a Successful Launch

Having a great idea and a skilled engineering team is important, but not sufficient. Learn more about launching successfully:

Need help launching your medical device? 

​Schedule a 30-minute Med Tech Launch Consultation

Schedule a Med Tech Launch Consult

For more great articles, sign up for our newsletter!


Liz Heiman