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Making the Case to Decision-Makers

Making the case for a healthcare innovation
Product Evaluation
Chapter 1

How to get in front of the right person at the right time

Every successful organization, from a small grassroots group to a global corporation, has a way for ideas to percolate through the system and find their way to the top decision-makers. Human ingenuity can come from anywhere, including cost-saving ideas (the matchbox), ways to attract new demographics (Flamin' Hot Cheetos), retain current customers (Starbucks), and of course, launch completely new products (PlayStation). From our last section, we know that hospitals and healthcare systems allocate their budgets in advance, with limited protocols for integrating innovations. How can the individual with an idea get that innovation in front of the right people at the right time, and of course, in the right way? 

Common to many innovation stories is how much the individual had to persist (and argue, and come back with more data, and remind, and present, and on and on)  before their idea is accepted. It's extremely hard to introduce a change to a system, especially one that has tried-and-true protocols and seems successful enough (just ask Ignaz Semmelweis). But that doesn't mean it isn't the better or right thing - sometimes even the critical thing - to do. So, how do we handle it when it is necessary? One approach to introducing change to an organization is the "diffusion of innovations" theory, which emphasizes that change takes time and tends to progress through the system slowly, from early adopters to laggards. When it comes to an innovation in healthcare, consider this theory on the following scales:

  1. The adoption of an innovation on a national scale, from early adopting systems to finally achieving Standard of Care. An example of this is the use of electronic health records.
  2. The adoption of an innovation at a system-wide level, requiring multiple steps up the corporate ladder. An example at this scale would be the adoption of preventive biocidal materials in patient rooms to reduce hospital-associated infections.
  3. The adoption of an innovation that requires personal buy-in by each staff member. The best example of this scale is hand hygiene, which must be adopted and re-adopted by every staff member into perpetuity.

The largest scale of adoption, #1 above, is typically handled by many cooperating organizations and agencies, often involving policy changes, professional organizations, and data reporting. The smallest scale, #3, is an every-day experience at every hospital, where changes in protocols, organization, and products require staff to be trained, supported, and encouraged to adopt the new approach. In the middle is the scale where an individual with an idea - something they came up with, or a product they encountered - wants to bring the innovation to their facility, but requires buy-in from corporate leaders and department supervisors.

Chapter 2

What data is needed

The first step in making a case for a healthcare innovation is collecting the data that supports it. This data includes evidence the the innovation works, that it is needed at your facility, that it would work at your facility, and that it has definite potential to improve patient outcomes and/or financial outcomes. In this section,  we will look at credible sources for that data, and how to make sure you are getting data free from conflict of interest.

Data about need at your facility

You may hear about an amazing healthcare innovation and want to bring it to your facility. But just like a shopper thinking to themself "Do I really need this?" as they look over an item, the first step is to focus your attention to your facility and confirm that the problem solved by the innovation is one faced by your hospital. You will want to collect data from your facility that would answer that question. In the case of an infection control product to reduce hospital-associated infections (HAIs) you will want to collect data about HAI rates, where infections tend to start, what patients are most vulnerable, and if you can get it, the financial impact of those infections. You will need to involve your colleagues in this data search to get the best results, talking with those colleagues about how you can try to pinpoint the source of the infection rates. For example, you may learn that there is significant turnover in environmental services personnel, or that your facility has trouble maintaining high hand hygiene compliance. You will then be able to answer with confidence that yes, you need this product, or that no, maybe you need to find a different solution. If you determine that you do need a solution to an HAI issue, then you need to evaluate the product you have in mind.

Efficacy data

The gold standard of efficacy data is publication in a peer-reviewed, well-established journal. While some online/independent journals have begun to enter the academic sphere, the journals with the highest quality vetting and editing process remain those affiliated with professional organizations or academic institutions. Emory University has an excellent way to evaluate academic journals here. If you don't recognize the name of the journal where you have found some data for the product, you'll need to take some extra steps to confirm it is unbiased and reliable. Keep in mind that individuals who want to publish their data want to publish in the top journals of their field - that's where they will get the most readers, leading to greater citations of their work, and (let's be honest) the most recognition. If they have chosen a journal that is not indexed in major libraries, with a small readership, and dubious vetting/editing procedures, that means that their research is most likely not up to snuff. Similarly, be sure you are not just reading the white papers released by the product manufacturer or published by individuals who have been paid by the manufacturer (including payment by receiving free products). Remember, white papers are essentially "salespeople on paper," and the goal is to present you with only the most attractive data points.

Efficacy data + facility data

Next, you bring it all together by looking at the efficacy data and your facility data and using as many data points as possible to see if the product meets the needs and context of your facility. If you are considering an infection prevention program that requires extensive staff time or a different IT infrastructure, you may decide that this product, while excellent, will not be feasible at your facility. You will want to identify the must-haves for the product to work as expected and decide whether it is reasonable for your facility. In some cases, the problem may be so significant that making some structural or staffing changes will be worthwhile. To demonstrate the need for those kinds of systemic changes, you will want to have strong data to support short- and long-term outcomes, both in terms of patient health and financial health.

Return on investment data

You've vetted the product, assessed the likelihood that it would work at your facility, and now have to collect the data that demonstrates that its adoption will lead to positive patient outcomes that won't negatively impact the financial health of the facility. The way to express this kind of business case is through return on investment, which means, you will need to collect financial data. In the case of HAIs, you will have already collected data on incidence rates. Now you need to supplement that data with information about how HAIs impact length of stay and readmissions, two data points that influence the facility finances in terms of Medicare reimbursements, reputation, and federal penalties. You will need to try to get data on how much your facility is spending on treating HAIs, and if that data is not available, collect academic research that provides reasonable estimates that you can use instead. (AHRQ has an excellent meta-analysis with HAI cost estimates.) When using outside data, be sure to use the most conservative estimate, or the lowest number in a range, as this will demonstrate good faith to your audience while also showing a minimum ROI, a baseline from where your facility can only do better, but not worse, than what was estimated. Ultimately, you will want to have a document that estimates the number of lives the innovation could save (QALYs or DALYs), and the amount of money saved or not spent, if cost-neutral. 

If you collect this kind of quality data before making a case for a healthcare innovation, you will gain the confidence that your idea can be supported by rational, concrete numbers that have been vetted by numerous experts in the field. This confidence will not only make it easier to approach the "powers that be" at your facility, it will also motivate you to be creative and persistent in your quest to bring the innovation to your facility. 

Chapter 3

Assessing risk

Assessing the potential risks and benefits is an important step  before proposing a new product or program for your facility. You need to anticipate all the possible things that could go wrong alongside the things you believe will go right. In this section, we will examine what types of risks to identify and how they might impact your facility.

What constitutes a risk? 

In healthcare, a risk would entail any change that deviates from the current standard of care that could have negative effects on patient outcomes - but risk can be so much more. For each of the types of risks listed below, you will want to ask yourself what specific things could go wrong, looking closely at the impact on partners, infrastructure, staff, community, and finances. 

  • Medical Risks: In what ways could this product/program impact delivery of care? What are all the possible health risks associated with this product? If used incorrectly, could it harm patients or staff?
    • Example: A new pharmaceutical item has the potential for abuse/misuse.
  • Operational Risks: How could this product/program interrupt daily operations? What impact would it have on the administration of the facility, including staff time and training? 
    • Example: A new product requires shutting down an area of the hospital as it is installed. 
  • Regulatory Risks: Does this product/program open the facility up to possible lapses in meeting regulatory requirements? If all the regulatory bodies are not accounted for, what could happen to the facility?
    • Example: Installation of a new product will temporarily cut off water supply to certain area of the facility.
  • Financial Risks: Does this investment have the potential to result in financial loss (directly or indirectly)? If funds are provided for the product/program, will other services not receive funds?
    • Example: An innovation requires ongoing costs, some of which may not be anticipated.
  • Strategic Risks: Does the product/program align with the long-term vision of the facility, or could it slow progress in one or more areas?
    • Example: Investment in an outpatient surgical area in the hospital when the strategic goals include moving outpatient services to a satellite location within 5 years.
  • Political Risks: If you invest in a new product/program, which affiliations will be impacted?
    • Example: Your new products affects a long-standing contract with a large vendor, or your new program requires a certification all your affiliated facilities will have to complete in order to continue your relationship.

Risk analysis

Of course, a risk you need to consider is "What do I risk if I do not adopt this new product/program?" You need to have data that backs up a confident belief that your facility will be better off with the new product/program that it is without it.

A tried-and-true way to anticipate risks is to complete a SWOT analysis. Your team can organize risk assessment by identifying the strengths, weaknesses, opportunities and threats of the proposed product/program, gaining a clearer picture of not only what could go wrong, but how many of those threats can be mitigated before they become a problem. A great break down of a healthcare-oriented SWOT analysis can be found here.

Chapter 4

The business case

After you make the case for the healthcare innovation in terms of patient and facility benefits, anticipating possible risks, and demonstrating efficacy, the final step is to put all that data into financial terms. To calculate return on investment, you will need to determine, to the best degree possible, the costs of implementation, the potential costs of not implementing, and make connections to the facility and/or system plan for the future. Let's see how you can use resources to help accomplish these tasks.

First, it's important to know that a business case, even a return on investment, does not need to show profit by the facility. Of course, some business cases will have increased revenue as a goal, but not every healthcare innovation requires it. Because patient lives are at stake, healthcare innovations can often require increased costs, while still demonstrating a positive return on investment in terms of lives saved or quality of life preserved. (For more on this, see this section.)

Now let's look at what you do need to demonstrate in your business case. If your innovation does not increase revenues, it should either reduce costs, address a healthcare imperative, or provide a strategic advantage to your facility. It is a rare (but not impossible) situation when adopting an innovation can do all of these things. Let's unpack those terms. 

Reduce costs

Healthcare cost reduction comes by preventing unnecessary spending or finding ways to accomplish the same care with lower costs. The key here is being cost-effective, such as bundling services or supplies, increasing efficiency, and value-based care. Some preventive programs, such as disease screening and care for chronic conditions, can also reduce care by keeping patients healthier. Preventing hospital-associated infections is a huge way to reduce unnecessary costs (costs that are also not reimbursable by Medicare), so an investment in preventive biocidal surfaces that kill bacteria can have long-term cost reduction ability.

Address a healthcare imperative

While addressing every illness, disease or injury more effectively is the goal of the healthcare industry, there are imperatives that are causing the most harm now or that are needlessly draining funds due to poor logistics or planning. Solving these imperatives come as a greater priority than others, so innovations that address them would have a greater, more immediate, return on investment. For example, if a hospital sees increased need for diabetes care in their community and do not have the infrastructure to meet those needs, they may see sicker patients as a result. Investing in an expansion of preventive care would address this need and have long-term benefits.

Provide a strategic advantage

Hospitals, like any other industry, are affected by competition. A hospital that does not stay up-to-date with technology, innovations and improvements will suffer in an environment where patients have a choice in their care. More than just marketing gimmicks, these updates help a facility position itself favorably in the market through better patient outcomes. Examples of the innovations that can provide a strategic advantage are specialized services, seamless integration between services, partnerships, reputation, and ease of access. Investments in these areas can lead to sustainable growth and long-term financial stability. 

Innovations in infection prevention

The hard part is certainly getting your business case to demonstrate how your innovation meets one or more of these requirements, so now we will look at some of the data sets you will probably need for a healthcare innovation, in this case, to reduce hospital-associated infections.

  • Your facility's infection rates
    You will want to get the most up-to-date infection rates as well as historical data to show trends. You can use publicly-available data such as that from Hospital Compare or Leapfrog Group, but those will only include the infections tracked by state and federal agencies. 
  • Your facility's cost per infection
    This might be difficult to secure, especially if your facility does not track that data point specifically. You can also use estimates provided by the Healthcare Cost and Utilization Project or peer-reviewed research studies such as this one.
  • The cost of implementing the innovation
    This includes initial costs, ongoing costs, anticipated costs (such as for repairs or supplies), and training as well as staff time, physical space or infrastructure changes required, marketing and educational outreach, and any other possible cost in both actual cash and time. Your vendor can help you generate this list of possible costs, but you should also reach out to facilities that have already adopted the innovation to find even more.
  • The potential costs if you do not invest
    Your business case should show the kinds of costs anticipated if no change is made, that is, if you remain as you are right now. You should also show alternatives to your chosen innovation and demonstrate how your choice compares favorably. 
  • Other financial benefits of the innovation
    When making the business case, use conservative estimates for both the possible costs and the benefits. Demonstrate the financial benefits, but also include nonfinancial (or indirectly financial) benefits such as patient satisfaction, since they can lead to direct financial benefits such as increased market share.

One example of the rare innovation that checks all of the boxes is a Preventive|Biocidal Surface. Presenting its full business case is equally important but the diligence reveals powerful support for its implementation. (See blog post here).

Creating a business case for a healthcare innovation is a long process, best accomplished by a team that can divide up the research and analysis. In some facilities, a special committee is assembled for just these situations, while others have a standing product-review committee with rotating membership. However, at times, it will come down to the one person who is "on fire," driven to bring the innovation to their facility and taking a leadership as well as motivational role. If you are that person, our hat is off to you.