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Oct 25, 2016

5 Best Practices for Developing Products Within a Highly Regulated Environment

Developing a new device is not as easy 
as it used to be.  You must understand
the entire product development 
process to be successful

by Tom KraMer

President & CEO

Kablooe Design



Do you have a great idea for a new medical device?  It's not as easy to get a product to market as it used to be. Following these five design research steps may successfully bring your device to market.

You Must Think About How Devices Get Purchased


Medical device technology today is fascinating. 3D printing tissue, robotic surgeons, and laser procedures are fabulous technologies that we all get excited about.

All too often however, medical device developers become so enthralled with their technology that they forget to think about how their device will be purchased. Who will make a purchasing decision, and what will the process be? It is good to know the answers to these questions if you want your device to even have a remote shot at success these days.


If you want the device to get purchased and used, you need to know what is going on inside the head of the people who will decide to purchase your device or reject it.  Fortunately, today that can easily be done.  We have accessible guidelines that, if we are smart, we can use to accomplish our goal.

Buying Decisions Are Not Easy Anymore


In the past, a doctor could get a device from a company rep and try it out. If he or she liked it, they could tell the hospital to buy that device, and voila, the rep had a new account and a trip to Cozumel planned for this year’s vacation.


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Committees and Panels


Now it works differently. If you want your device to be used in a hospital, that hospital needs to decide that your device is the best one for them to be using, and a lot of factors go into that decision. Most of them have a group called a “Value Analysis Committee” that evaluates new devices before making decisions to purchase. There are also “Health Economics and Outcomes Review” panels that perform a similar function. Fortunately we do not have to rely on fortune telling to guess what these groups will be using as criteria for making their decisions.

Five Areas of Focus


These groups divide their decision-making criteria into five major buckets. Their interpretation of how well the device fulfills these criteria is the key to their decision. These buckets are: Disease Burden, Unmet Need, Clinical Value, Economic Value, and Patient Adherence. Most criteria that the analysis groups use fall into one of these buckets.

Accounting for these five items is not as easy as it may seem. Each of these buckets has many subcategories of things to be considered in that bucket. For instance, when thinking about clinical value, evaluators may be focusing on things like how the device may improve usage for not only the physician, but the techs, nurses and patients. They will certainly be looking at the effectiveness but they will also be considering the long-term safety and evaluating how it may improve health-related quality of life. The evidence-based data is important, but the outcomes have to show more than patient success---they also have to show the device’s effectiveness in procedure time and efficiency as well. The fact that it may be an innovative product may play well in the clinical value arena too, if the hospital or clinic is fostering a reputation for providing cutting edge services.

The time to consider all of these decision-making criteria is at the start of the development process, before you even have a device solution that solves a need. This sounds like a formidable task… how can a development team consider all of these things before actually developing the device?

Design Research


Design research plays the major role in making this possible. Design research is simply gathering all the data you will need in order to make informed decisions about the device that will fulfill the need you are solving.  This includes usability research and human factors research. It also includes many kinds of market, intellectual property, demographic and financial research as well.

Five Steps to Take in Design Research

There are five critical steps  to focus on in design research that will help you gather the right data to form a good set of design, customer, and product requirements. This is the single most important thing you can do to set yourself up for success to design a device that will be purchased.

1.  Find the needs surrounding the need. Most people identify a need they are trying to fulfill with the creation of their new device. This is good practice. But there are big needs and then there are lots of little needs surrounding that need. “A better way for surgeons to remove calcification from mitral valve leaflets.” That is a great need. It requires some clarification around what ‘better’ actually means, but you get the point. It is a big, broad need. But many developers stop there and begin to create concepts from ideas. Resist the urge to do this. Instead, continue to dig in. Do ethnographies. Find out what is important to the surgeons, techs, nurses, buyers and patients. What little things make the procedure difficult, time consuming, or go off track?

These pain points can be turned into ‘little needs’ that surround the big need, and having your device solve these problems will go a long way in promoting clinical value and patient adherence… two of the buckets that the committees are looking at.

2Analyze competitive devices. I’m not talking just about function, price and sales… everyone does those. Dig deeper. Were there competitor recalls? If so, why? Is there information about their devices in the adverse events database? What are users saying about their devices on blogs and forums? What are some of the factors behind their high or low sales? Are there any lawsuits? How do they sell against each other? 

Finding answers to these questions can reveal factors that have led to failures. Identifying these pain points and turning them into design criteria for your device will help you succeed where others have failed.

3.  Make smart design inputs. All of the design research activities we have been talking about here are meant to give us a list good list of criteria to design to, which we call ‘design inputs’ in the med device world. Making them smart means to make sure you create inputs that address as many of the items in the committee buckets as possible. 

Knowing you need to do this at the start of a project means that you will be asking the right questions during research, and getting answers in those strategic areas.

4.  Know where your code is going. We have reimbursement codes for medical devices and sometimes they change. Are there any indications you can uncover that may hint at whether or not your code will change? Will it go lower? If so, will your device need to change with it? 

Looking at factors like the current and past prices of competitive devices, the functionality their devices are providing, and whether or not there is a ‘race to the bottom’ situation occurring in pricing are all good design research activities that will help you get a better handle on your coding situation.

5.  Know where your design is going.  Being able to design your device for long-term future use may be important. There are many design nuances that can make this possible, but you have to know where you want the design to go in the future. Will future changes or improvements put the device under another code? Will future improvements change the location of the procedure? Improving your device later so it interprets data instead of the physician will put you under another reimbursement code. The same applies to printed records vs. digital records, or diagnosing conditions instead of monitoring them. Moving your procedure from the OR to the clinician's office will put you under another reimbursement code as well. 

Discovering your desires for future enhancements during your design research will help prepare you to plan your designs to solve these issues without putting your coding situation at risk.

Knowing how to take these approaches in your early design research is the key to successful purchasing experiences with your product when it is launched. If you execute these steps, you will find that user adoption and the competitive advantage of your device will be surprisingly strong.

It may be hard and take some time to implement these tasks on the front end of your development project but the dividends will pay long-term results.



Tom KraMer is a Medical Devices Group Advisory Board member and medical device design company founder. Tom is passionate about making ideas become reality. You can find him at KablooeDesign helping his customers develop the latest and greatest products or speaking at various industry events on the topic of innovation and optimizing the product development process. Contact him at 763-785-9595 or ideas@kablooe.com.



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