The Facts:
Pressure against the skin from prolonged periods of non-movement can result in lesions on the skin of various degrees of severity (4 stages) termed pressure ulcers. These skin lesions are painful, can significantly increase the risk of serious infection, and could result in death. Pressure ulcers can occur in patients that are in wheelchairs or are confined to a bed, but can also occur during short-term hospital stays after surgery.

Prevention of pressure ulcer formation is a major concern in patient care. In Canada, the prevalence of pressure ulcers is estimated to be up to 30% in some long-term care settings, 25% in some acute care settings, and 15% in some community care settings. It is anticipated that the incidence of pressure ulcers will dramatically increase with the aging population, suggesting a sustained need for pressure ulcer prevention in the future. Legislation in the United States has proclaimed pressure ulcers as “Never Events” and removed the treatment of pressure ulcers from Medicaid and Medicare, leaving the hospitals responsible for the costs.

The total cost for 3 months of care of a person with a fairly serious (Stage III) pressure ulcer was estimated to be $27,500 and the total cost of pressure ulcers for the health care system in Canada is approximately $2.1 billion annually. The annual cost to healthcare institutions in the US is approximated at $12 billion.

The Bottom Line:
The potential to spare individuals from additional medical complications, to reduce health care and legal costs by managing the problem of pressure ulcers through prevention is substantial.

References:
Woodbury, M. G. & Houghton, P. E. (2004). Prevalence of pressure ulcers in Canadian healthcare settings. Ostomy Wound Manage 50
Toronto Health Economics and Technology Assessment Collaborative. (2008). The cost-effectiveness of prevention strategies for pressure ulcers in long-term care homes in Ontario: Projections of the Ontario Pressure Ulcer Model.
Teague and Mahoney (2011). Early Prevention of Pressure Ulcers Among Elderly Patients Admitted Through Emergency Departments: A Cost-effectiveness Analysis. Annals of Emergency Medicine 58.
Bergstrom N, B. M. (1994). Treatment of Pressure Ulcers. Clinical Practice Guideline Number 14. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service.
Berlowitz, D., Lukas, C. Preventing pressure ulcers in hospitals. Agency for Healthcare Research and Quality. http://www.ahrq.gov

Product Testing and Iteration

If you haven’t done so, take a minute to read Building a Clinical Evidence Package: Parts 1 and 2 first, as this post builds directly on them.

For all of you who have read Lean Startup, you know about the MVP. The MVP, or minimum viable product, is “a version of a new product which allows a team to collect the maximum amount of validated learning about customers with the least effort”. The entire point of this concept is to get a prototype out, make and test assumptions with your target market, and iterate the product based on those experiences, all in the shortest amount of time with the least risk possible. After all, in our case, who better to refine a product for wheelchair users than actual wheelchair users in the community? This falls under the umbrella of the emerging field of “Human Factors Engineering”. While I won’t talk much about Human Factors Engineering here, there are many great concepts that can be used in product development, like “user-centred design”. More information can be found at the Centre for Global eHealth Innovation, one of the organizations at the forefront of this discipline: http://ehealthinnovation.org/

Depending on what your device does and the type of regulatory classification it falls under, you may not be able to do this at all, or you may require authorization from Health Canada or the FDA. For example, you clearly can’t produce a minimum viable product and beta test a remotely monitored pacemaker without authorization, even though it may fall into the classification of a mobile medical application. Not only is it invasive, but it would be unethical to give patients devices that are unfinished and have the potential to do substantial harm to a patient.

With all of that out of the way, if you have a device that would benefit from this type of testing, how do you go about doing it? First, lay out your business plan and highlight key touch points, and then target those touch points for feedback. For a quick example of this, let’s think about the steps you would take if you wanted to purchase a coffee from Starbucks:

  • You decide you want a coffee
  • You walk or drive down to Starbucks, order a coffee, and pay for it yourself
  • You drink the coffee and go about your day

In this case, all 3 touch points are performed by one person: you want it, you pay for it, you drink it. However, in healthcare, this is rarely the case.

Business Model

Let’s use wheelchair users who wish to purchase the SensiMAT for Wheelchairs as an example. Regardless of their location in the community, these wheelchair users all have occupational or physical therapists. The therapist is the authorizer, someone who recommends physiotherapy/assistive devices and begins the reimbursement process. If the SensiMAT for Wheelchairs is recommended by the therapist, the wheelchair user will then order it from our website. Reimbursement can come in several forms and if it is secured, then the payer can become the government, the insurer, the patient, or a combination of those 3.

What key points do we take from this?

  • We definitely need feedback from wheelchair users, as they will be the ones using the device
  • We also need feedback from the authorizer, in this case the therapist, as they operate in the key role of recommending the device
  • We need feedback from a reimbursement agency, as they will support the device financially
  • ALL of their feedback matters, because if just one of the three is unhappy, the product falls apart

That being said: go out there and find as many therapists and as many wheelchair users you possibly can and get their feedback. Do it any way you can: tap into your network, go to conferences, visit where patients or users with your particular target health state congregate, talk to special interest groups. Once you get feedback, package it and pull out main themes, and use this information to guide product development. Many of these testers will be your first customers and they may be willing to pay for a product that is not even necessarily finished. They can be good sources of word-of-mouth and networking opportunities. Finally, some agencies will require some kind of authorizer or patient demand as a requirement for reimbursement, and what better way to create buy-in than directly involving them in product development.

Why bother with all of this? Quite simply, it ensures that you aren’t throwing massive amounts of time and money into creating a product that nobody wants. Just remember that when you target specific patients or users for mobile medical applications, they can have extremely specific needs that you would have never been able to anticipate on your own. This method provides real and actionable feedback that reduces your product risk – directly from sources that matter most, and that’s powerful.

If you haven’t done so, take a minute to read Part 1 first, as this post builds directly on that.

The first level of scientific and clinical development for a new product is simply a basic review of the published literature in your target field. For companies that want to take an exhaustive deep-dive, a full systematic review is usually the next step. The systematic review is essentially the scientific version of a market assessment. This means that you will comb as much published scientific literature that you can, looking for any devices or applications that fall into your space, and create a document that gives a “lay of the land” for your particular target area. Seems simple, right? Unless you have experience performing systematic reviews, this will not be an easy task. For example, if this was done professionally (ie. sponsored by a big pharma company) it would cost $20,000+ and take a minimum of 6-8 months from start-to-finish. We recommend that you bring someone onto the team that has a background in masters-level or higher academic publications, or has worked in medical communications for a pharma or med device company. The reason for this is because there is a massive amount of protocol to follow to ensure that your work is scientifically credible, especially if it is your goal to publish this review. It also gives the review an “arms length” editor to mitigate any potential bias.

There are many different options, formats, and tactics to consider when creating a review, each of which brings their own pros and cons:

  • First and foremost: will you want to publish this review to add to the scientific landscape?
  • Which is more appropriate: a narrative review, a systematic review, or a meta-analysis?
  • What resources do you have to pull onto the project that can increase the transparency, accuracy, and credibility of the publication?
  • Will the literature search be performed by a medical librarian or information specialist?
  • Do you have a key opinion leader from the space who can oversee and act as the senior author?
  • If a meta-analysis is chosen, will you have a statistician to ensure the statistics are correct?
  • Finally, once published, what resources will you use to ensure that this publication is seen by as many people in the space as possible?
  • Which journals do you target for publication?
  • Will you have evidence rankings, and how will these rankings be made as transparent as possible?

Regardless of whether you chose to publish this information or not, this review should be used as a precursor for product development (or at least run in parallel). Key learnings that are made in the process of creating this review should be used to iterate the product and ensure that you are creating a value proposition not just from a market standpoint, but from a scientific standpoint as well.

This review also helps you be as thorough as possible when searching for competing products. There are several products that may have been created and patented in academia, that were never actually commercialized. This review not only helps to ensure that you are not retreading what has already been created, but to avoid legal headaches around intellectual property. If you do discover that your idea for a product has already been created, it may open up avenues for your company to either license the product or collaborate clinically with an academic party who has no interest in commercialization. Finally, it serves as a vehicle to access key opinion leaders in your target field and seek their input and advice regarding product design. This way, the product is designed around what best addresses unmet patient needs, directly from leaders in the field.

In our previous post titled “Mobile Medical Applications: Classification and Revenue Models”, we discussed several different approaches you can take to positioning your mobile app. We believe that medical apps will slowly begin creeping towards higher regulation and will therefore require more clinical data to prove that it provides value for a patient.

Many people who are getting into the mobile medical app space will have experience in the tech sector and little-to-no experience in the medical device sector. They may find themselves asking why they should even bother with clinical evidence. Make it. Ship it. Done deal, right? Well, when your app moves higher on the regulatory scale, it begins to have less in common with a mobile app and more in common with a medical device. If your business model includes selling into healthcare institutions, gaining buy-in from health professionals, or securing reimbursement, you will need to treat it like a medical device. That being said, if we need to prove that a technology provides patient value, HOW do we do that? The answer is that there needs to be a focus on both scientific and clinical development, in parallel with product development.

As this is a complex topic, this will be the first in a series of posts titled “Building a Clinical Evidence Package”. We will discuss a high-level overview of scientific and clinical strategy, and then take a deep dive into each topic.

Publication Opportunity Flow Diagram.ai

This figure gives an overview of the entire scientific and clinical development process. The product and business development paths have been simplified to show only the relevant actions necessary to work in conjunction with scientific and clinical development. All companies do some form of identifying a business case or writing a business plan before they mindlessly create a product, but we would encourage those in the healthcare space to do two of these: one from the market aspect and one from the scientific aspect. The scientific aspect begins with some form of literature review to get an exhaustive picture of what the landscape looks like in your target health state (ie. diabetes, obesity, arthritis etc.) and what kind of products or services are being created for these health states. This will be used in combination with your business case to create a prototype. This prototype will be refined through beta testing and more specifically, human factors testing, to create a commercially viable product. Depending on what type of device you are creating, the sales cycle may actually begin now. However, for more complex business models the sales cycle may require clinical testing or health technology assessment as a prerequisite. Once the device is out on the market, data collection and analysis can be used for post-market evaluation.

At many points in this process, the opportunity for publications will arise. Publications are the de-facto method of getting your product into the knowledge landscape for your target health state. These publications can be used for marketing, sales, and gaining buy-in from key opinion leaders.

In the next few blog posts, we will tackle each of these scientific and clinical development milestones in more depth.

As a start-up, dealing with law firms can be a “delicate” process. When an hour of time spent chatting up an associate can cost $600, it can be difficult to justify. However, as a device and medical IT start-up it is essential to have an intellectual property strategy.

The first thing people usually think of with respect to patents is that they create barriers to market entry. True, the patent can protect the firm from another “genius” coming up with the same brilliant idea. However, it is very expensive to enforce and prove infringement in court. As a start-up you cannot afford to spend valuable time in court and are basically left with one option – threaten legal action.

From a start-up perspective, it is far more important to have a patent strategy for the following reasons:
- Strengthen your pitch and signal to potential investors that you are committed to the idea
- Build a patent portfolio to increase the valuation of the firm and make yourself a favourable acquisition target
- Open up opportunities for licensing

Once you’ve decided to file an application, you are faced with various options: pursue a Canadian patent, a US patent, or enter countries through the patent cooperation treaty (PCT). Entry into the US and Canada is far more cost-effective compared to entering countries through the PCT, but you are left exposed in other large potential markets.

In order to minimize the up-front expenditure and secure the earliest possible patent priority date, you can put together most of the provisional application yourself. Once submitted, you would have one year of time to convert the provisional into a complete patent application. The provisional application describes the system, potential use cases, and is backed up with diagrams and illustrations. Before submission, it is crucial that a lawyer adds a list of claims, as well as review the use cases.

By writing most of the provisional application yourself, you are able to get the PCT application submitted for ~$10k. If you can establish a strong relationship with a law firm, you may be able to split and backload most of the payment, decreasing your up-front expenditure. Within the year, it is critical to address the go-to-market strategy and asses if there are markets you would like to enter outside North America. This is particularly important since the PCT application will be independently reviewed by each country you enter, along with an associated cost of filing. For example, filing in Japan may cost around $14k, Brazil approximately $7 and Australia around $6k.

When thinking about patents:
- Figure out your go-to-market strategy and size of the market in the countries you would like to enter. PCT applications can get expensive and you want to make a conscious decision on where you want to enter
- Be mindful of dates – date of first disclosure, filing date, conversion of provisional application to full application, country entry dates
- Use a law firm that deals with start-ups! Negotiate a payment schedule that best aligns with your financial standing
- Seek out grant funding that may cover IP expenditures

Disclaimer
I am not a lawyer (seriously). The blog post is based on our own experience. Seek professional legal advice with respect to your business.

Patient Journey Diagram Just Wheelchairs

In the last blog post where I talked about business models I mentioned that higher device classification, and ergo the increase in clinical evidence that comes with it, can lead to more sophisticated business models. These sophisticated business models are both a blessing and a curse. In most industries, the person who uses the product is also the person who decides to buy the product, and is usually the one who pays for the product. In healthcare, this is not the case. The person who benefits from the “product” (the patient) is different than the person who authorizes the “purchase” (the doctor or other healthcare worker) and is different from the person who pays (the payer). Furthermore, these business models are not only complicated, but may differ wildly from country-to-country, or even province-to-province. Understanding this specific relationship is instrumental in developing a business model in healthcare, especially one that involves reimbursement.

There are several different paths that you can take to have your product reimbursed, ranging from public or private payers, government programs, social assistance, charitable organizations and non-profits. The reimbursement strategy you chose will depend on the type of device you are creating. For companies creating mobility devices, the best fit is the Ontario Assistive Devices Program (ADP).  If accepted, ADP pays 75% of the price towards the purchase of mobility and positioning devices for people who have chronic physical disability and meet the ADP criteria (see ADP website for latest criteria). Examples of the type of mobility devices ADP covers are power wheelchairs, crutches, power dynamic tilt devices etc. There are many small requirements that need to be met for ADP to consider listing the product, but the major requirements are:

  • Devices must undergo a technical and clinical evaluation at a designated testing centre prior to inclusion in the program
  • Statements from ten (10) authorizers from seven (7) different locations are required, indicating their support for having the product listed in the ADP product manual

One of the major drawbacks is that ADP currently does not list digital health devices or mobile medical applications as mobility devices. This may prove to be a bump in the road for companies who are trying to gain reimbursement for their device to help lower the cost for patients. However, if significant patient benefit can be shown through clinical testing and if the necessary support from front-line healthcare workers (for example occupational and physical therapists) is secured, it may be possible.

In our last post we discussed which applications fall under FDA regulation and this post will go more in depth on the consequences of that regulation. In the iPhone app store there are tons of health-related apps, but it is extremely rare to see an app that has actual clinical research done to prove it can impact patients. As mentioned previously, there are increased costs, lengthy approval processes, increased liability and possibly clinical testing needed to be classified as a mobile medical application. Due to these drawbacks, companies are often wary of navigating the FDA. As a result of this, the majority of applications on the market are purposely crippled to avoid regulation. Many apps that could be extremely beneficial to patients may need to remove beneficial features, or abandon the app altogether, just to avoid the FDA headache.

I am selecting a few examples of apps for diabetes, since it is a hot-topic and already has a handful of apps on the market. Typing “diabetes” into the app store gives us 563 results, the majority of which are digital diabetes logbooks. These logbooks rely on manual input of data by the patient and are used simply to keep track of their diabetes. Since there is no direct connection to a medical device or advice being given, these can be unregulated. There are some more advanced apps that connect directly to a glucometer and even some that can give advice based on a treatment algorithm. These more advanced apps must be regulated by the FDA, because as soon as they connect to a regulated medical device, they now become “mobile medical applications”.

Regulation Flow Diagram.ai

It is important to note that the line between regulated and unregulated is fairly black and white: if it connects to a medical device, it now becomes a medical mobile application. The split between Class 1 and Class 2 is much more of a grey area, as certain features may push the application either way. It is important to note that there are also Class 3 medical devices, but I will not be covering those here.

Now this is where it becomes interesting: depending on where you lie on the spectrum, you can take advantage of different revenue models. Although this is not an exhaustive list, these are the typical revenue models that I would expect from each section:

- Unregulated: Typically sold in the app store for free or a small charge; Models that are variations on this, like freemium or built-in microtransactions

- Class 1: Typically the same as unregulated; May provide value-add to certain glucose monitoring systems and may be of buyout interest to pharmaceutical or digital healthcare companies, as glucometers are all essentially the same; Gives the ability to be marketed as a mobile medical application, but it is unclear whether patients understand or care about this

- Class 2: Can have the same as unregulated and Class 1, but opens up the door to more sophisticated revenue models involving reimbursement from private or public payers; May provide the ability for physician prescription once it becomes more prevalent

Personally, I believe that the way of the future will be to push apps towards the higher end of the regulatory spectrum, providing clinical value for patients and widening the gap between a mobile medical application and the common health and fitness app. Yes, this will cost more and take longer, but truly drives value to the patient. As a diabetic, what would you rather have?

A) An app that that requires you to manually input your diabetic information for storage

B) An app that automatically connects to your glucometer, for seamless data transfer and storage

C) An app that your doctor has prescribed to you, has evidence of improving treatment outcomes in diabetic patients does everything from B, and is “smart”: can give you advice on how to adjust your treatment based on pattern recognition and can notify your physician when abnormalities are detected

I think the choice is quite clear.

Follow

Get every new post delivered to your Inbox.