As a product expert, you know how to design a product your customer wants. That might not be enough, If you are seeking FDA approvals or clearances, you must follow a very specific set of rules, called design controls. Design controls requirements vary based on your specific product and the regions in which you intend to market your product. Putting design controls in place during the design process is one of those critical steps. Not putting those controls in place will cost you precious time.

It is not uncommon to underestimate the time and cost of building a compliant business and manufacture a compliant product. Once you have implemented design controls, and advanced in the design and development process to the point where you receive FDA approval or clearance, the design transfer must be executed. It’s important that you are ready to launch. It will take time to onboard and hire your team. It will take time to get the marketing ready to launch, and to build the relationships that you will need to sell. It will also take time to scale up  manufacturing and purchasing operations. Get your funding as early as possible so are ready to perform design transfer and launch when the approval comes through. You will need a team in place prepared to market, sell, deliver, manage quality and invoice.

Many founders believe that doctors have the sole authority to make the decisions about what products they will use. As a result of that belief, they focus their energy on reaching and getting buy-in from surgeons or doctors and wait for them to make it happen. While that may work with surgeons who have their own practice and do outpatient surgeries at a surgery center, that is not how it works in a hospital. Doctors are one set of people who influence a decision to buy at a hospital or in a hospital system. 

The buying process of a hospital is complex with many different departments involved in the decision. Not understanding that the buying process can extend the sales cycle or undermine the sale altogether. The first thing to understand is that all purchases in a hospital must be budgeted. All MedTech purchases in a hospital must also be approved by the quality team including risk managers and the purchasing team. Many hospitals require that all vendors go through a pre-approval process and a purchase can’t be made until that is done. If it touches technology in any way, it must also be approved by the IT department. And legal must review contracts before they are signed. It is likely that technicians, nurses, and doctors who will interact with the device will also have a stake in the decision. If the product is going to have a large impact on the hospital or is fixing a problem that has had public scrutiny, the CEO and board may also have to approve the purchase. Understand how the buying decision is going to be made and make sure you cover all your bases. If purchasing, IT or Quality nix the project, the deal won’t close. 

Hospitals have very strict budgeting processes and timelines. The budgets are typically determined once a year and approved by the board. Revising that budget after the cycle is complete is possible, but very difficult. Typically, only an emergency will get funded outside the normal cycle. Before an item goes into the budget, it must either represent a problem the hospital has decided needs to be fixed and may not yet have a solution for, or it is an item that a purchase request has been made and it must go through a series of approvals before it can be considered for budgeting. Find out what that process is and how long it will take for that budget cycle to be completed. Budget cycles can postpone purchase by months or even years. Don’t be over optimistic about how quickly you will be able to sell to a hospital. Plan a year to 18 months for anything that is a large investment. 

• Read6 Surprises that Could Sink Your Medical Device Launch

• Watch Launching a Medical Device? Don’t make these 5 Big Mistakes Webinar

• Watch 6 Surprises that Could Sink Your Medical Device Launch

• Register for the Successful Medical Device Launch  Webinar 

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.

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. 

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. 

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.

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.

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

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

• Read Launching a Medical Device? Don’t make these 5 Big Mistakes Article

• Watch Launching a Medical Device? Don’t make these 5 Big Mistakes Webinar

• Watch 6 Surprises that Could Sink Your Medical Device Launch

• Register for the Successful Medical Device Launch  Webinar