Medical Device Product Development Blog – Forma Medical Device Design Medical Device Industrial Design and Product Development Fri, 17 Jul 2020 14:01:08 +0000 en-US hourly 1 Face Mask Innovators Fri, 17 Jul 2020 14:00:42 +0000

face maskFace mask innovators need to step up their game. It looks like COVID-19 is going to be with us for a while. Rather than a temporary inconvenience, the wearing of face masks is becoming part of the new normal. An opportunity for better design has arisen because current masks fail in so many ways:

Where current face masks fail

They’re uncomfortable, especially when they’re worn for long periods. They’re hot, they restrict breathing, they smell, they hurt your face, they hurt your ears. If you wear eyeglasses, it’s difficult to get a fit that won’t cause your breath to fog them up. Masks are not exactly a fashion statement. They call attention to themselves and to the wearer in the most obvious way.

Although better than nothing, current masks are not very effective. They are meant more to protect others from the germs you might be carrying. They’re not meant to protect you from the germs of others. For that you need a respirator, not a face mask. Respirators, if properly fit to form a seal, can block most viral organisms. Masks, on the other hand, are made from materials that are too porous to effectively block the coronavirus. Their loose fit also significantly reduces their effectiveness. They can’t prevent the virus from infiltrating the body through the eyes.

Attempts at better face mask design since the advent of COVID-19

A number of new mask designs have been rushed to market, with more on the way. So far they’ve either focused on filtering systems priced beyond the reach of most people,  or they’ve been solutions focused on style but with all the same functional drawbacks.

What’s needed

What’s really needed is for face mask innovators to entire re-imagine the problem the use of face masks is trying to solve. Face mask design is the way it is because, one, we’ve been reacting to a crisis. Naturally, the tendency is to grasp the first solution that is workable. Almost all solutions in such a scenario will take existing design as the jumping off point. Little consideration will be given to novel solutions, and that is what we’ve seen so far in the COVID pandemic. Also, the hope that the virus could be contained and we would soon be back to conducting our lives as we used to, meant that delving deeply into mask redesign would yield a questionable payoff. Why waste the energy and resources on what could essentially be a very temporary problem?

Now that mask wearing threatens to be a longer term prospect, there is incentive to give mask design more serious thought. Here are some approaches that could be used for achieving meaningful innovation in mask design:

  • Focus on the real problem that needs to be solved: how to prevent a person from being infected with the coronavirus and, if they are infected but are asymptomatic, how to prevent them from infecting others. A mask is just one solution. How else might you look at this problem?
  • A mask is a blocking strategy. What other ways might the virus organisms be blocked?
  • Are there strategies other than blocking that can be used?
  • Fiber-based filtration systems are the norm. What other ways might the virus be blocked/trapped?
  • Is there a mechanism that kills the virus, or at least makes it inactive? How could it be deployed as an element of personal protective equipment?
  • Might there be a way to make a cloud of virus organisms visible so they could be avoided then captured? Could the organisms be detected in another way?

The coronavirus has caused massive disruption throughout the world. It has also created opportunity for smart design minds to tackle significant problems and find solutions that can actually save lives. Good luck.

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Good Design is Good Business Strategy Tue, 30 Jun 2020 16:21:36 +0000

White strategy board with chess figures on it. Plan of battle

Good design is good business strategy. Simply having stunning technology is not enough to achieve market success and sustained profitability. R&D might have developed a revolutionary innovation. But if you fail to package the innovation in a well-considered design that addresses both aesthetics and usability, you will leave a lot of money on the table.

Sure, revolutionary technology might be enough to make your product launch successful. But then what? Competitors will inevitably crop up. One of the ways they can take market share from you is by capitalizing on design deficiencies you might have allowed. If you invest the resources to achieve good design up front, you’ll remove a lever that others could use to take market share.

Did you know that the first MP3 player was a box marketed by Eiger Labs? (Right – never heard of them). The lion’s share of the market was taken by Apple years after the launch of the Eiger product, due in no small part to the iconic design of the iPod.

For medical devices, good industrial design is no less important than it is for consumer products. First, the design discipline brings expertise in usability. Failure to design for good usability has been shown to be a cause of medical error. Second, aesthetic design appeals to our emotions. How we make decisions is influenced by emotion to a much greater extent than most people realize. It is Industrial designers who bring an aesthetic sensitivity to the design of commercial products.

The bottom line is that innovative technology combined with good industrial design yields a product that will command the market not only from the outset but for years to follow. That is a profitable strategy.

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What Is Your Patent Worth? Tue, 16 Jun 2020 16:14:09 +0000

patentsYou might have a patent for a medical device, but is it really worth anything? If you focused on the wrong things when you had the patent application drafted, it might not be worth much.

At Forma, we are not patent attorneys. But we do work with clients to conceive and develop novel innovations. Sometimes our task is to develop ways to avoid infringement of established intellectual property. Sometimes the technology we are working to protect is entirely novel and new to the world. In still other cases, we’re asked to envision ways to extend patent claims in order to head off opportunities for competitors to develop workarounds.

Regardless of the specific concern – work around existing IP, extend existing IP, or develop strong IP for new technology – if the solutions don’t work within a business model they won’t have value. Jackie Hutter recommends focusing on the functionality that the innovation brings, rather than focusing on its implementation for a particular application.

Avoid common pitfalls!

Designing for a specific implementation is a trap that physician-inventors can fall into easily. It’s likely that they’ve come upon their innovation because they recognized a shortcoming of existing solutions in their specialty. As the example in Hutter’s post illustrates, failing to consider the innovation’s application to implementation in other specialties can reduce its value to the point that it isn’t economically viable. There either isn’t enough of a market or alternative means of accomplishing the functionality of the innovation weren’t explored.

Not all intellectual property has value. If you are hoping to profit by licensing or selling your innovative technology, be sure you’ve established there is a viable commercial opportunity before you invest the significant time resources it will take. Simply obtaining a patent will not bring value in and of itself.

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Designing Medical Products for Home-Based Care Wed, 20 May 2020 13:48:35 +0000

medical devices home-based careThe transition from hospital-based care to home-based care has been going on for some time.

The COVID-19 pandemic has sped that movement up considerably. As we continue to deal with the pandemic, medical products for home-based care will be increasingly needed.

In addition to products and devices aimed specifically at COVID, solutions to enhance the delivery of telemedicine in all areas will be needed. Devices to aid in remote examination, remote diagnostics and remote monitoring are some examples of what will be in demand. Med device company leaders would be wise to direct development efforts there. Certainly many other opportunities will become apparent as the adoption of telemedicine accelerates.

Designing devices intended to be used in the home, and largely by untrained care givers, requires a different approach than designing for use in hospitals/clinics by trained medical personnel. Designing for ease-of-use takes on even more importance for such products. Medical device companies that recognize this and incorporate it as an integral part of their product development strategy now will give them advantages as leading players while others try to catch up.

Some of the tenets of ease-of-use:

  • Use contrast to draw the users’ attention to areas where you intend interaction to take place. Color-coding of touch points works especially well in this regard.
  • Use grouping and framing to separate multiple visual cues into more quickly-grasped subsets.
  • Allow users to easily recover from mistakes (e.g., provide a “home” button).
  • Reduce visual complexity as much as practicable. Three to four pieces of information at a time is the limit users can deal with.
  • Provide feedback signals that let the user know they have completed an interaction task successfully.

Learn more about designing for ease-of-use in our whitepaper, Medical Device Design and Cognitive Psychology.

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How To Move Forward in the COVID-19 Environment Tue, 12 May 2020 15:42:48 +0000

How to move forward in the COVID-19 environment is a dilemma most companies are facing.

What should you be doing now to ensure revenue streams continue? How can you plan for the future, both for the next quarter moving forwardas well as for the next several years? These are daunting questions for any business, but they’re even more pressing during this time of crisis. Across the globe, this one question is keeping businessowners awake at night: “How does my brand move forward in the COVID-19 environment?”.

Luckily, Forma can help. Below is a list of actionable steps that you can begin taking immediately.

Concrete steps you can take now:

  • Survey your current and potential customers. What are their concerns now? What are their customers’ concerns? Determine what value you can provide that will help solve immediate problems.
  • Take steps to ensure the infrastructure you have for facilitating remote work is efficient and robust. Computing power and on-line collaboration tools. If there is anything you can do virtually, do it.
  • Shorten your time horizon. Plan for one to two quarters out, and be prepared to pivot.
  • At the same time, dedicate some resources to maintain your long-term view. Disruption creates significant opportunity if you can discern where it lies and prepare for it.
  • Secure your supply chain. Domestic sourcing will become valuable.
  • Staff wisely. You might be able to scale back in some areas, but you will regret losing capable staff simply because they are in the wrong functional area. Reassign and train.
  • On-line marketing has suddenly taken on a much greater role. Develop your capabilities in this sphere.
  • The tradeshow industry has been forced to go virtual. Traditional tradeshows might not return until a vaccine is available. By that time, virtual methods might be developed that we find are more effective and efficient at generating new customers and discovering new suppliers.

The good news for medical device companies is that their output is still vital, and there is and will be unprecedented demand for new technologies and solutions for the way we are having to live now and in the future.

  • The adoption of telemedicine technologies and methodologies is increasing at a much more rapid pace.
  • Data analysis has been big for several years, but has become even more important and useful now. Data analysis capability will be even more important in the future, especially as it can be harnessed to improve population health.
  • Population health in itself will become a focus of healthcare. Solutions for monitoring, tracking, predictive analysis – all will be in strong demand.
  • Rapid testing and point-of-care diagnostic devices will be in demand, not just for the coronavirus but in anticipation of other new pathogens as well.

If your company’s focus is on any of the above areas, now is the time to put investment dollars into research and development. If you’re not directly involved in those areas, can you develop a strategy to better position your organization to take advantage of the shift in demand?

If you’d like to have a conversation about how we can help elevate your business during this time of uncertainty, don’t hesitate to contact us.

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Alpha and Beta Prototypes – What’s the Difference? Thu, 30 Apr 2020 19:50:43 +0000

Alpha and Beta prototypes – what’s the difference?alpha and beta prototype device

If you’re confused by the terms “alpha and beta prototypes”, don’t feel bad. Many people are in that boat with you. Also, the terms hold different connotations for different industries (software vs hardware, for instance). Because my field is medical device design, I’ll be talking about hardware prototypes here.

The product development process happens in stages. First you have an idea. Then you develop that idea into a concept (or several different concepts) of what your idea might look like as a product.

Once you have a concept that you think will work, you’ll set about turning it into a working model. Your working model might be an interim step to proving your concept’s feasibility (you might have to build several in order to work out kinks), or it could be your actual feasibility prototype. A feasibility prototype is intended to prove that your concept can be made into something that works generally as you intend. It gives you confidence that your idea is sound and should be able to be made using technology and components that are readily available (whether your idea is commercially viable is a different question).

Achieving a feasibility prototype is your first major milestone. The next milestone is the alpha prototype. Between feasibility and alpha prototype is where the bulk of the product development effort will be. You’ll look for standard parts that you can use in your design, and you’ll design custom components if you can’t find them stock. A lot of problem solving, testing and iteration will happen here. The goal is to construct a model/prototype of your product that uses the parts that will be in the product you eventually sell to consumers. This is the alpha prototype.

The important thing to understand is that the alpha is still an approximation of what your product will become. Now you’ll refine the design with the objective of getting it to its final form that will be manufactured and sold. The alpha prototype has gotten you close, but there will still be changes and refinements that will need to be made. You’ll probably find suppliers that can offer a similar component to the one you used for your alpha prototype but with a better volume discount for commercial quantities. You’ll want to incorporate those parts in the design, and test to make sure the new parts haven’t introduced any unintended consequences. You might also need to make refinements to specific areas of the design. You might find components that have better performance characteristics than the ones you were able to find for the alpha build.

The beta prototype will be built incorporating all of the final changes and refinements. The beta will be as close to the commercial product as possible. Why won’t it be the commercial product? Because it won’t have been built using the actual manufacturing methods and tools that commercial volume production requires. In most cases, beta prototypes will have been hand-built, one by one. They’ll be close enough to the commercial product that they can be put through final testing. If the beta prototypes pass any remaining testing requirements and perform reliably, you’ll be ready to transfer your design to manufacturing. The dream you started with five paragraphs ago will have become a reality.

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Solving the Right Problem Tue, 28 Apr 2020 15:01:12 +0000

Solving the right problem is dependent on being able to separate symptom from disease.

solving the right problem

A symptom is but a manifestation of the true problem that lies beneath. Addressing the symptom rather than the problem is the grand flaw most of us make when we’re confronted with a difficult challenge, whether in business or in our personal relationships, or anywhere else in our sphere of living. Understanding why this is, and remaining aware of it, will help you develop the ability to dig below surfaces. Only by digging deeply will you be able to uncover the true problem you should be solving. Moreover, if you can uncover that problem, a solution often becomes clear.

So, what is it that prevents us from going beyond symptoms to where the true problem lies?

First, it’s the symptom that is painful and insistent, not the problem. The symptom hijacks your attention. Soothing the symptom becomes your overwhelming concern and distracts you from addressing what’s giving rise to the symptom in the first place.

Second, time is a bias. We want the pain gone quickly. Time spent investigating the symptom’s cause prolongs the pain we are experiencing from the symptom. Once we’ve eased the pain, finding its cause becomes less of a priority.

Third, mental concentration takes a lot of cognitive energy. We will choose to conserve cognitive energy whenever we can. Identifying and treating a symptom is cognitively efficient (if only in the short run). Delving to find underlying causes is cognitively taxing, and without strong intrinsic motivation we won’t do it.

There are various techniques/methods you can use to get to root causes. One technique that I find effective is Why/Because analysis (known in other forms as The 5 Whys, or 5Y) .

Let’s explore a simple scenario: you experience a significant drop in sales from one month to the next. The drop in sales is not the problem – it’s just a symptom. The thing that caused the drop in sales is the problem that needs to be uncovered, then fixed. The Why/Because exercise might go like this:

Why did sales decrease? Because a new competitor entered the territory. Why? Because they thought they could take some of the market from you. Why? Because they knew they could offer a better price. Why? Because your product is a commodity and your customers buy only on price; the new competitor’s larger size allowed them to secure a better price from the supplier. Why? Because they were able to take advantage of volume discounts that you could not.

So, the real problem here is that your competitor can offer a better price. That in itself suggests a number of possible solutions:

  1. Join in an association with others in your industry to secure volume discounts.
  2. Find a new supplier that will offer better pricing.
  3. Cut costs to maintain your profit margin at lower sales volumes.
  4. Institute a marketing initiative to persuade your customers that your product is worth a premium price.

Had you concentrated simply on boosting sales, you might have tried offering discounts or promotions. In essence, shooting in the dark. Perhaps your sales would have gone back up – soothing the symptom – but for how long? Without other changes, the discount strategy would not be sustainable. By searching for the root cause, you increase the chance that you’ll be able to find a solution that stops the problem from recurring – a structural, not a surface fix.

There are numerous methods that can bring you to the same place as Why/Because analysis. All provide a tool to help you dig deeply into a problem to find its root cause. Find the root cause and you’ll be solving the right problem. Otherwise, you’ll end up solving the same – wrong – problem, over and over again.

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Anticipating Necessary Medical Devices: Covid-19 Edition Tue, 14 Apr 2020 17:25:20 +0000

Anticipating necessary medical devices during periods crystal ballof uncertainty is a daunting task.

There’s a good chance you’ve been dealing with the immediate needs of responding to the coronavirus pandemic. And with all the uncertainty, you don’t know what to plan for.

When we come out of this crisis, it will be into a changed world. No one knows what that world will look like, but from the medical device/healthcare perspective, we can make some educated guesses.

What does the future look like?

The economy will open up gradually. Some social activities will resume, but not on a widespread basis until the infrastructure and means for extensive testing is in place. Even then, we’ll need a vaccine before we get back to anything close to the old normal. Because the incubation period is long, people will need to be tested multiple times. Right now, sample analysis is slow. What we need is an inexpensive rapid test that people can employ on a daily basis. Can you do anything to support that pipeline? You have opportunities then.

Also needed is a system for tracking individuals so that those that test positive can remain separate from those that test negative. Self-quarantining will need to take place. This raises all kinds of questions around privacy and personal freedom.

Beyond the current crisis, people will be concerned about the reoccurrence of Covid-19 in the relative short term, and the possibility that new pathogens could arise beyond that. There will be a lot of invention and innovation throughout the medical/healthcare industry because of those things. Even though the curve is being flattened, medical device companies that are anticipating necessary medical devices should focus their planning and future efforts on areas such as:

  • Diagnostic instruments, especially point-of-care
  • Sample collection devices and test kits/materials/methodologies
  • Devices for pulmonary therapy
  • PPE: masks, garments, eye protection
  • Decontamination systems
  • Rapid response and triage systems
  • Telemedicine solutions
  • Population health monitoring solutions

There are shortcomings in all of those areas — and more — that are ripe for remedy and innovation. If you’re interested in learning how Forma can help prepare you for this outcome, don’t hesitate to contact us.

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Covid-19: Crush the Curve Mon, 06 Apr 2020 16:38:56 +0000

crush the curveCovid-19: Crush the Curve: a summary from Ten Weeks to Crush the Curve, by Harvey V. Fineberg M.D., Ph.D. in the New England Journal of Medicine

  1. Establish a unified command: appoint a commander who reports directly to the President.
  2. Produce millions of diagnostic tests to test everyone with symptoms by mid-April.
  3. Supply all heath workers with adequate PPE (personal protective equipment). Additionally, Invoke the Defense Production Act to enlist capable companies in the US to manufacture gowns, masks, glove, face shields.
  4. Differentiate the population into five groups and treat accordingly: those infected; those with symptoms; those who have been exposed; those not known to have been exposed; those who have recovered.
  5. Inspire and mobilize the public: everyone wear a mask and stay home to the fullest extent possible.
  6. Learn while doing through real-time, fundamental research: for those who have recovered, is it safe for them to return to the workforce?

“If we take this concerted and determined approach and are guided by science, we can begin to revive businesses of all kinds, including airlines, hotels, restaurants, and entertainment venues. By putting cash in peoples’ pockets over the next couple of months, protecting small businesses, and releasing constraints on credit, the President, Congress, and the Federal Reserve will have positioned the economy to come roaring back — once the virus is out of the picture.”

Forma is dedicated to continual education of topics in life science, healthcare, and medical device design industries. If you have any questions and would like to get in touch with the experts at Forma, please contact us!

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Being Proactive During the Coronavirus Disruption Wed, 25 Mar 2020 15:41:54 +0000

Be proactive during the coronavirus disruption. No one knows how this is going to play out. Even so, this is not the time to wait and do nothing.coronavirus threatening world

The first priority should be coming together as a community to help slow the spread of the coronavirus and to do what we can to help those infected. Certainly those in the medical device design field have skills and expertise that can be applied. 3D printing of ventilator parts is one example of how companies are stepping up to help. In what other ways can we, as a profession, help?

Most of the needs right now are immediate – or at least, short term. Getting tests into the field, ramping up production of ventilators and N95 masks, tracking and monitoring those infected, getting gloves, eye protection and other personal protection equipment to health care workers on the front lines. Companies that can do so should be retooling their lines to help increase capacity.

Even if you can’t help with immediate needs, you can still develop a strategy and prepare for what might happen after the crisis has been contained. The world has changed.

Get your shop in order. Do you have systems and processes you’ve been wanting to fix or update but have been too busy to get to? Now is the time to do all that housekeeping so your operations are streamlined when you gear up again.

Stay in front of your customers. Maintain your on-line presence by developing and posting new content that your customers will find valuable. Point them to resources they can use to further their businesses when we get back to some semblance of normal.

Develop new capabilities. Is your website static? Video is a compelling medium you should be implementing on your website. Learn how to harness video to help move your customers through the buyers’ journey.

Can you help the community in any way? Do you have an expertise that can help in this fight? Use it.

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