Malcolm Wootton BSc MBA Make sure they know exactly what it's supposed to do, when and by how much. Rather than what everyone thinks or assumed it must do.

Craig Scherer When identifying and prioritizing user needs, understand that your users (stakeholders) can demonstrate an endless set of what may seem like conflicting user needs. For example, your device might have application to the ICU used by experienced clinicians but the same product may be used by untrained caregivers in the home. Confirm the right user need mix and priority with appropriate and iterative formative evaluations. These evaluations help achieve the FDA required safety and effectiveness levels, but can also bring important market differenciators like "desireability" into the mix.

If we're taking about a truly novel medical device, not a "me too", then unless it's someone in a well resourced company, I would ask how far is that person willing to go to get their device commercialised? Starting from scratch with something "patently" new is a massive undertaking - I know from personal experience!! It affects family life, work, friends, finances ... What would they put on the line?

Don't let the cart for the device be an afterthought

how many lives it is going to affect positively...

Start with the patient experience first, then simplify the Technicians interface, nailing those two priorities will quickly ensure your technology becomes their process.

work with the customers for better understanding of their requirements.

Hubert Martens Mine would be: start with the customer, truly understand the customer needs and continuously work with key customers during development. Make fast prototype iterations and evaluate with users to learn fast. Have a vision and dare to focus on your unique and differentiating benefits and don't try to chase each and every possible feature.

Hubert Martens Iterate with the customer. That is: start with the customer, truly understand the customer needs, and then work with a few key customers; design and build prototypes, test and iterate prototypes with users to learn fast. Show customers that their feedback matters and improves the product. Have a vision and dare to hold on to that: don't try to chase each and every possible feature but focus on your real differentiator and unique benefit.

Tony Butterfield Make sure you have market before wasting you're money

Tony Butterfield Please note both above comments seem simple enough but are both sometimes overlooked! There's no point spending money on a product that hasn't a firm market, with good revenue. Secondly if you infringe on someone's patent, no product, and if serious enough hello court case!

Charles Smith My tip would be - "Medical Devices should be useful, safe, reliable, testable and cost effective to manufacture".

Charles Smith To be useful, safe, reliable, testable and easy to use.

Julie Omohundro No...start with the customer and work FORWARD! That's where you start with design controls, and you go forward from there, not backwards.

medical device should fulfill the patient need , otherwise he wl throw your device and continue his activities same as before..

Robert Poyser Start with what a customer needs & CAN'T GET.... better versions of existing product doesn't always sell, as people are comfortable with what they know despite it's imperfections.

Sarah Nourse ensuring its "dumny proof". in a world where we are constantly multitasking, accidents happen. mistakes happen. A device that gives a greater margin to accommodate for that is better for the user and the patient. I read an article yesterday that they are considering nurses to be allowed to do highly complex testing. If we continue to intertwine specialties like that, without proper education, we better have the devices to compensate.

Medical device should be comfortable for the patients, "think always about what should be the best for the patients", I believe that this is the first issue at the moment that you design a medical device.

Use data to make every decision. Patient data, market data, testing data - and if I have a chance at a second one it would be make sure you are clear who the stakeholders in the market are that will use, recommend, get value from and promote you device or block its adoption.

Identify the need, research the market, nail the specification, use a good engineering team (Sorry, that's four - it's a complicated world.....)

make it affordable

Carl Lincoln Some great comments coming in already, thanks everyone. Julie, that's a very good point!

Collate information with everyone involved for it's life time use, patients, clinicians, therapists, carers etc.
A medical device is never just about one person. Think about all that will come into contact with it.

Jeff Wippel To avoid the obvious, consider the end user in comfort and durability that's been said above. My one point would be "Make it Cost Effective".

Jeff Wippel sorry hit post by accident Considering cost to the end user while ensuring its comfort and longevity is to me the end goal. Give patients something they want and that they can afford. Doing this should make the designer consider the whole team meaning making it manufacturable and sellable. My two cents.

Think of the Engineer who is going to have to maintain and repair the instrument. Smart design will cut down on repair times and will significantly reduce downtime.

I would suggest to start by a functional analysis in order to list all functions and requirements following by a brainstorming.

Great point as we head to redesign ours!

In an advanced age of technology today we always compare the newer ideas with existing technology and try to improvise and make advancements in the newer devices. I think especially with respect to medical devices, concentration not only on devices for a specific cause but also equally or more efficient multipurpose devices must be thought of and ventured in future designs of medical devices.

Make sure the user requirement specification (URS) is completed before attempting any design.

Work with your manufacturing engineers to make sure it is manufacturable.

Ricardo Faria If it is something new, innovative than it can't be tested nor you will get data from your potential market. If it is a improvement than do it be the need definition from the potential market. Here I agree with you. Do it backwards.

Follow the legal process and documentation for designing a safe medical device in the U.S.

No matter how good your idea is, if you don't follow the legal process, and clearly document your work, all the profits earned will be wiped clean through audits.

Research the process before spending any development dollars, so you know exactly what you are getting yourself involved in.

Learn as much as possible through interviews and observation about what is already in the space and identify the unmet needs (and sometimes unspoken) of those throughout the lifecycle of the product. Only through listening and learning can we spark the ideas for innovations that will truly impact the use for all from patient to caregiver to service technicians and beyond. Those sparks can be used to talk to decision makers about what will sell and the design and production team about feasibility to find the gems.

As a designer, and manufacture I look at the competitions pros and cons and improve functionality and decrease cost to the customer. Don't complicate the process.

A VOC is very important but don't forget about international standards. Use a QFD to link these requirements together and display them in order of importance. Also the Dfmea and Pfmea stages are critical to product and process manufacturing.

Solve a clinical problem. Ensure that it is easy to use for the average user. Design with future cost scenarios in mind.

Identify the unmet need in your best markets and develop a strategic competitive edge to beat your competitor and use well respected users to develop a white paper that will lead to a peer review article that hopefully supports your competitive edge and supports the claims you make that satisfies or is the best product or service to satisfy the unmet need.

Start with the market intelligence, competitors activities and their strength and weaknesses of the product comparing and analysis in promotional material to get the maximum market share from the market, and with this process we move into the market to grab the maximum sales accordingly.

It needs to be easy to reproduce in each campaign. from my experience, a lot of devices (especially when considering a human) are extremely hard to replicate in each batch. The ability to replicate/reproduce/stay consistent with no deviation has a lot to do with the cost the the manufacturer and also the costs on the end user.

Always put the patient in center and work strategic with FMEA, throughout the project. Insight-Ideation-Implementation.

Protect your invention legally.

Steve Corwin Why should anyone pay for this?

My advice is 'Simple, simple, simple'.

Michael Abrams Start to consider that (secure and reliable) wireless connectivity must now be included as a primary design element in medical devices where appropriate, or Connected Health - the term for IoT in medicine, cannot happen. Stop putting Bluetooth in everything; it's failed as an MBAN.

Annika Fahlén Make sure that you have performed the best pre-study ever and by that have a complete and clear PRS to start with. Then the rest is easy.

Start with the problem, not the customer. The customer does not always understand his own needs. remember henry fords cutomers, they wanted better horses!

1. Always start with the end user in mind.
2. Use the proper tools such as QFD, dFMEA, UMFMEA to ensure that the risk to patients and related users are minimized.
3. Make sure the solution is a simple one. Complexity increases uncertainties. Simplicity is the key to a great design

Fail early, iterate quickly and often, stay laser-focused on the milestone in front of you

As an innovation consultant, I would recommend discovering who the device USER truly is - patient (eg child), caregiver (eg parent), nurse, doctor, etc...

If it is anything less than simple do not develop

Premkumar Menon The one you are asked to design or designing - is there a requirement for that in the market ? If no then why do you want to design it, If yes how is it going to benefit the the person who is going to use it?

how Icould be able to marketing my device?? can any one give answar???

Jeff McGovern I agree with Michael on wireless connectivity. It is a basic requirement now in Healthcare. For my suggestion, go back to the original purpose of the item. Make it to do the basics first and foremost. An IV pump, for example, has to have certain features to be acceptable to FDA. So build it first to accomplish basic infusion. Doesn't have to be the most accurate. Add in FDA minimum requirements. Project cost to create/design/produce. Where is this cost-wise? This is assuming you are making a product for basic infusion.
The point I am making are that products are often started with this whole range of features built in, difficult and expensive to produce and maintain. Most clinicians want simple and reliable. Supply chain wants inexpensive. Possible to have both.

Amy Butler, MBA consider the person that is going to have to use it. adoption of a new device will not be successful if they don't like or use the product. how will it fit in with their current responsibilities and processes.

I would say that one should write down the CTQs (critical to quality) with some defined numbers, evaluate against "customer need", rank them and use it as User specs, and the whole design cycle has to be benchmarked against CTQs

Girish Srinivasan, PhD Since the request is for a design, assuming that the problem to be solved and the target market is already determined, my first thought would definitely be to start a dialog with the customer to understand the requirements and gaps. I see that this has already been mentioned here.

My input would be to create an architecture that is well structured to suit the requirement. Create layers by distinctly identifying the purpose and function for each.

Stay simple. Only put features that will come from users (patient, implanters,...). Don't let your engineers taking control over the requirements, features. Don't take risk with features that are not 100% under control (ask for evidence i.e. demo). Drive your project in order to permanently trying to reduce your risks (mitigation, actions, evidence).

Always ask the technician for advice ;)

COGS, make sure any design decision can be Manufactured within reasonable cost of Goods at the time of marketing the product to a price level customers can afford / are willing to Pay and still generating high margin for you.

Sean Harz Take the time to research and rationalize your supply chain early. What "works" in your design now can have massive down stream commercial impact.

Shreyans Mehta Intended use satisfied & Potential reduction in cost..!!

When designing a medical brace several factors come into play. I primarily work with bracing or what you would call an orthosis. The very first thing that I consider is activity level. Believe it or not, most patients won't tell you your design is failing them, they just put the device on the shelf

First and foremost you gotta figure out the customer experience; the customer use and acceptance of your device will be based on the daily tasks the device will help them accomplish, it's about quality of life. If the design of your device is able you to fulfill what the user end wants and needs in an affordable, innovative, user friendly and customer centric product you will most definitely have a successful product design!

Keep it simple and problem solving.

Be aware of the regulations - you can't CE-mark a non-compliant device.

Carl Lincoln This group never ceases to amaze, thank you so much everyone! Some time this week I'm going to get to work on my article so I'll be sure to post a link when it's done.

Design it to pass EMC and electrical safety testing on the first pass.

Jon Lant Focus on unmet need and enhancing the user experience. If you achieve this you'll rarely hear the words 'it costs more'.

I would say to keep an open mind as to the technology to use, rather than shoe horn an idea into a technology that is not fit for purpose. Remember limitations as far as Sensitivity and Specificity goes.

TRACEABILITY will be the key, from final product to its user requirements.

If what you are going to accomplish is really worth your time and effort, then the very first thing is to write down everything you know about the process, and the outcome to be realized. Nothing cursory, no bullet points, everything in detail down to the last iota, as though someone without any further input, would have all that is needed to accomplish the task on their own. Beyond directions, you will need to make your writing compelling to fuel their unfailing passion. Then hone it over and over, until you own every aspect of it, including the inspiration to continue, because if you don’t know all of the minutia, every person you talk to will have an off-the-cuff comment for improvement. That ends at best in your defending your assertions or a conversation of unwanted collaboration. Best of luck and may the wind be at your back!

Make it as easy to use as possible.

The "obvious" best solution is not always the best. Sometimes you have to blend in a second row idea to achieve the perfect product

I would start with the patient experience and work backwards.

Find a BMET once it's complete, hand it to them , and ask them nicely to fix your mistakes...😂

Antonin Cuc Dear friends, there are possible to project, to built, to manage..perfect closed repeatable production system - for example for group of standard orthopaedic Tasks - substitution THA - hip, knie, reoperation THA-Hip, kniem skeletal griddles...with extrremly perfect Technical Qualitym safety, lower cost, computer aided Design CAD/CAM for preliminarary mandatory Plan surgery in 3D, perfect processsing, perfect functional testing assembled THA...perfect postoperational RTG imaging, perfect Health surveillance, insurance, perfect postoperastional Physioterpy, locomoition abaility testing, long usage of patient implanting...with minimum growing entropy - minimum Patient riks! it is all ideas by my Utility model 21532 Czech Republic you should worldwide desimenation 500 x such closed systems in the whole world as Group Medical Devices! Common with me, I am able to be Author of physlosophy of project!

I'll would say mimesis and natural adaptation form will be a must have.

Simulate - that way you can test the design without going anywhere near a patient and figure out the safety factors with zero risk.

Bill Paine Consider letting some children review your UI and apply their KISS suggestions.

Make the use of the device intuitive

HwanJong Lee build a perfect R&D team.

HwanJong Lee build a wonderful r&d team

Understand the difference between Design Verification and Design Validation before you "get going".

Julie Omohundro OK, not being cranky here, just puzzled. Why do people think that, when you start with the patient/user/customer, the direction that you are going from there is backwards? Does this have something to do with the concept of reverse engineering?

Only one tip?? It would have to be, "make sure you completely follow and manage an FDA-accepted design process starting with documenting customer requirements through to verification and validation testing - with no shortcuts!"

Vasuki B K I guess I would start with the type of users (it could be patients or doctors or surgeons or technicians) and the medical field that we are trying to address. If it is an invitro, or invivo, if it a diagnostic device or a monitoring device, our approach would be much different, depending on one of these that we would be addressing. The basic design, usability and safety would all be at different levels for different applications...

John G. Caruso Never forget the three "someones". Someone has to manufacture it, someone has to maintain it, and most importantly, someone has to use it.

From my side: every time I start with the service engineer and with the end-users ... The first condition for IVD device / equipment is to be user friendly. The second one is to be implemented (inside) a self-check and a qc management.

Steve Sanghvi Easy to service!

Steve Sanghvi User experience is one of the most important aspect of the design

Understand USER NEEDS, and keep in mind that there are many users (not just end-users), and many users disagree. Get one aspect of this wrong, and the consequences go on and on....

Customer/user needs yes but more broadly 'what is the clinical need'? What is the problem to be solved? If that question is answered it will encompass the user needs including clinicians and patients. Seen lots of wonderful products with cool technology but no real clinical utility or solving a true clinical need.

Julie Omohundro This is a truly great collection of design tips. Is it just me, or does the industry not actually follow most of them most of the time?

Quantity in customer data to make informed priorities in final solution features - may exclude some users and include others - and that is pure math where to lay the cut.

I would suggest that you discuss the design with the people who are responsible for cleaning and disinfection, together with end-users; objections can be explained and/or corrected. Might lead to respect and understanding between the (very) different disciplines within the hospital. Ánd a product that is easily accepted..

Agreed - design it from
Outside looking in

Carl Lincoln @Julie O. For me, the idea comes from a Value Chain Management idea - i.e. that traditionally companies were product-led rather than market-led. This means that they would develop something and then use advertising to create the demand. Starting with marketing is effectively starting from the other end of the process, doing your research first and designing to meet the demands that already exist.

It's probably quite outdated now.

Know your customers' needs

Human engineering. Iso would come at manufacturing stage.

3 R's: risk management, regulatory requirements and reliability - ensure done and met well.

Only 1 tip? It would be: make sure that you understand yourself what it is you ask others to do. In most cases people think they understand, but it turns out, it was only half of the content. It could start with defining a proper problem description.
Very interesting to read how other people see this!

Definitely human factors, design to make it as hard as possible to use incorrectly.

Designing with Customer requirements in Mind is always good along with getting feedback from the customer at different milestones during development of a product.

Ee Bin Liew guess I jumped in late.. there's more to saying 'start with the customer" .. the customer is also yourself. yes, you! oftentimes it's always about others, other populations, users, people. but if your medical device was indeed created, and it's inserted in the clinical workflow, would you use it? would you pay for its service? that's a 'free' question to answer, and if you can get past yourself, then you can move to the next step.

Cheers. Ee Bin

1a) How are you going to sell it? 1b) Who is going to pay for it?

Santiago Ruiz-Valdepeñas Think about the product strategically: What the key differentiator is, how existing product lines may support device development in terms of expertise, integration or image (and vice versa), and how it will open new avenues for the business or strengthen priority or prospective areas.

This will get you internal buy-in, resources and motivation, and help you see the bigger picture for product development when something goes wrong or specifications have to change.

It needs to add value to an existing product, procedure, or service. There are enough "me too" products out there. Create something different.

Fred Zinos Is there a predicate device already in the market?

Art Pichierri Keep it low tech, high usage, niche' market vertical, disposable, non-sterile, Class III, non-patient item, make it absolutely perfect.

Dave Ask Something different and unique ( i mean innovative) which cannot be copied, easy to use, long life of the instrument.

it will really fulfill an unmet need from the user,? whoever it would be? who pays?

Wes Moncus To the extent possible, I would recommend co-development of the product with the customer. This provides clear understanding by both parties of what the design requirements are, what testing is required, expected costs, lead times, design for manufacturability issues, and mostly, you have the most important thing, at least one customer.

Most of the time customers, don't really know very clear there needs, especially physicians. But Patients, caregiver probably understand in a better way what can help them and what they are willing to pay for it.
Latin America still needs help in rural medicine : handle chronic disease, early diagnosis especially in oncology . I agree on co-development.

Robert Betz Starting with satisfying a patient need is good. If it is a medical device to be sold in the USA, the next step should be a conversation with FDA.

In my past we were successful by starting a voice of customer assessment and convert that into a list of customer requrements. then have R&D translate that into functional spec of what they could provide and on top of that what other features or capabilities that customers are not aware of. then a negotiation occurs where there are mismatches and confirmed with customers. in parallel how will it be verified and validated, sample availability, collaborations needed? Then and only then do we start development.

Identify top five new features/benefits for product/device. Helps to contain scope and cost of project.

Antonin Cuc Dear friends! I have had perfect experiences from the research main industrial production automatic systems "CAD, CAPP, CAM" . We should predicted the social Need full automatic repeated systems as substitution for indidivual desemination Numeric controlled individual Machines - as a Group integration multilateral Machines from full automatisation Designing products, full automatisation Processing Planning, full automatisation realisation Tasks in extremal short production Time, without mistakes in design, in technology, in measurement and automatic controlling Technical quality, perfect controlling Inputs/Outputs, including safety clever transport, It is trivial to design the industrial Computer Planning for patient with THA with individual Design of private implants for private Hip bones in geometry 3 D for Orthopadic Clinic with production 1500 prime surgery THA yearly! It should be trivial for 5 technical experts with Medical 2 MD as supervision.

Ankita Srivastava How can you reduce the cost drastically, so much so that it is affordable to patient. Keep in mind what is affordable to an average person's paying capacity (think of Medicare and Medicaid as patients not as a rich govt. capable of paying hundreds and thousands of dollars).

Ask the customer exactly what they need and why, what are the features they could not do without? Would this new product get then to move away from what they already use, and why, why not? ensure they get just that... and quickly. Then ensure there experience is backed up with service.

Karen Koenes Think of medical device packaging early in the design process. A lot of companies like CleanCut Technologies, can do 3D models to help in the process.

Ilsa Webeck I agree with many of the comments already posted. It is really about understanding the user need, whether they know what it is yet or not, and designing/creating a way to address that need. Too many products are developed because they are "cool" but struggle to meet a real need.

Chander Bhushan Sharma ' Finding a better product as alternate to existing medical device with value addition" Type writer - computer , Paper book - Kindle book & Kodak film roll- digital Camera etc

I would most certainly be talking about connectivity and how mobile technologies can be used to improve the cost effectiveness of developing such a device and also the user experience in terms of using a smartphone as a control interface for the actual device. This can also help to improve the portability of the device and also open up new data capture and date sharing / analysis opportunities.

Chander Bhushan Sharma Create an alternate to existing medical device " which can simply the procedure and add value to the experience of the users"

Risk management is crucial ,threat or opportunity are all considered.

Make sure to find a marketer/salesman who is familiar with selling a medical device. An effective device, affordable, and easy to use ---aimed at the home Users....is Not enough! You must find a ...salesman who can actually find potential Users and make the sale.

Julie Omohundro Chuck, I must say, I might be inclined to choose someone who has never sold a medical device, but very knowledgeable about the users, over someone who has sold a million medical devices to another type of user and knows nothing of the users of your device.

Having worked in many start-up organizations, I would look at the competition and weigh in on the needs of the end-users to design the medical device to be user-friendly and practical. That should be the focus to be successful.

Solve a problem, support overcome a challenge

Design a device which is most ergonomics for its application.

Robert Christensen Be sure it works

Mikel Condie Curry Work with the disease community FIRST before development even starts. Those that will be using the device as patients often times know more about what is needed than the designer or clinician.

Be sure to give some time to your scientists and engineers to engage in creative, perhaps even risky, thinking and designs. Break-through innovations often result by accident.

Ken Powell Carl-I would encourage you to extensively validate the problem you are attempting to solve with your device, which has a direct relationship to customer needs, use and value. If you don't ask the right questions, you most likely will not discover the correct answers regarding needs use and value. An example that immediately comes to mind were the hundreds of designers of sharps safety devices. They would present their design as a solution to all needlestick injuries for all sharps when in fact a hypodermic syringe, blood collection device, catheter, dental syringe, scalpel, all have sharps associated with them but are very different in terms of user technique. It may sound self-evident, but it took decades from the time the first needle safety devices were introduced until the became mainstream products supported by domestic and international regulations. Seat belts in autos are a great consumer example of the challenges. Lee Icocca introduced them in the Ford Falcon around 1964.

Always start by determining the risk should the device fail and how the outcome of the procedure would be effected then do the R&D so that the risk factor is taken care off.

Andrew Wilson From a marketing perspective, utilize the opportunity to get in front of thousands of doctors who can take your product to the consumers. Speak about your product at these conferences and allow users to test the device - if it is a wearable.
www.medtechimpact.com

Mark Proulx, CQA, cSSBB One tip: "Ensure that all of your essential requirements have been met in design and are validated...but, uh, be sure that you've documented ALL of your requirements..."

As a designer, the most important thing when you start to design a medical device is to know perfectly who is gonna be the final consumer, either a professional or a patient. If it’s a patient it’s crucial to understand and study the pathology.

As a Medical Product Design Specialist- The one tip would be, " Keep the design simple based on best practices (MUST) and you can integrate technologies as applicable (INNOVATIVE)".

Vasuki B K I would say, I wouldn't just design, 'I would live in it'

Ask yourself "Who do I want to satisfy?"

Human Factors! The way to identify, process and finalize design thinking. Task analysis of the process as a whole and the implementations of current design thinking.Regulatory standards are always in the background throughout.

The key factor so often lacking in the build process irrespective of what the product may be, is functionality!! It doesn't matter how good the thing flashes, bangs a drum or prints out report after report if it needs the user to jump through hoops backwards to get to the end result then it's no good. If it leaves the end user frustrated or annoyed then it's no good. I have seen it so many times.

At Costello Design we have designed medical devices for the end user and medical devices for the medical practitioner. There is a different list of constraints and variables depending on what group is your target. In either case, having an approachable aesthetic design is most important.
www.costellodesign.com

Validation as Ken mentioned is definitely important. Yet it's critical that we transition our mindsets from a supply push paradigm to a demand pull model. One solution to one clinician or department will not lead to full-scale-commercial adoption. That said, the one valuable tip for entrepreneurs is to know the market and the associated clinical needs. You need to assess the market first: Are there similar solutions in place elsewhere? What are the common gaps? How to improve upon or replace outdated solutions? How can you coordinate consumer demand to strategic planning? How can consumer needs be matched with project development?

As a Biomedical Technician. I would start with the end user, but in doing so I would also keep in mind that technicians would have to service this, so in addition to making it end user friendly, patient safe it should also be Biomed friendly to allow technicians to keep it in tip top shape.

Ronda Cobb, BSME As a business coach to the industry, I would ask that you consider the consequences of its' cost vs. reimbursement potential so the fitter/practitioner/dispensing agent will be properly reimbursed and therefore the patient will be able to enjoy the fruits of your labors. Also, it must have a medical necessity if it is to succeed in the marketplace of today's insurance carriers scrutinizing every device sold to their customers.

Raneem Al-Abwi what jobs should it do, and how should it be better than old version or better than other products? What a new application

Imagine that it is going into the worst possible user's hands. Once it is approved, control of who can use it is minimal. I prefer to have less experienced physicians on Medical Advisory Boards for this reason. It is much easier and cheaper to fix the risks early in the design, verses using only the best and finding out that the "not so great" can't use it successfully.

Marco Farina, Ph.D. from a technological point of view: 1st of all the power supply.
from a business point of view: who is going to pay it? insurance reimbursement in USA and State health system in Europe (mostly in Italy, France, Germany)

Health Tech Solution Ltd My focus would be on what are the essential requirements for the customer and what would add value in terms of efficiency, effectiveness and patient safety. Look forward to seeing the final publication.

How bout following a company and seeing the mistakes they made lawsuits due to faulty design errors and improving them can help start a company

Raneem Al-Abwi I am just an undergraduate biomedical Engineer, but I would say what services can this device do better than the old version of it, or than other products? How can it do a service,that no one has done a product that can do that with remarkable design specifications ? A new idea, a unique idea.

Shreyans Mehta I would Say that "Practical Handle on Design Controls Ensures a Quality Product that Safely and Effectively Meets a Real Market Need"

Carl Lincoln, how about "Start with intended impact and work backwards" ? One needs to clearly see a direct line connection between the device one is building and the impact one seeks to make with it.

Jon Lant Focus on the unmet need and optimise your device accordingly. Price becomes irrelevant if you get this bit right Carl.

I agree with Jon Lant's comment, to focus on the unmet need, although price is never irrelevant, even in medicine. If an insurance carrier doesn't see a cost/benefit ratio they like, procedures with your device won't be covered, and your market is effectively dead. And I suggest you make sure you are aware of the intellectual property landscape in your industry. Medical device companies are protective of their work.

When we designed and developed the Bebionic Hand - the need was very clear. The one tip I'd give is : take time to get the absolute and accurate specification that the end user needs - before you start designing.

Keep it simple. Get to market , update and improve

Heather Campbell Take time in the beginning to set the product requirements correctly, ensuring that all market , manufacturing, regulatory, clinical, and quality requirements are met. Then make sure that your R&D can design it (feasibility), and that your organization is committed to supporting it (think cost & schedule constraints).

How simple can you deliver the product from the demand perspective, without doing it the exact way that you are 'told' it has to be done. Innovate the solution from the minds of today's demand and requirements; not yesterday's.

Before you design , think and find out ... "Why should the end user use it? , What will it do better than what has been done as yet? How will it make life better for User and Patient? Is it Value for money? " ... basically as a user it should be able to answer a basic question "Why should , I buy it?" ....... Any invention has to answer this basic question first. Rest is just manufacturing , marketing and sales management ..

My Take would be, "Start with the medical condition and not the customer, and come up with not one but multiple devices keeping in mind the cost factor. If the device is monitoring more parameters the cost is more, less parameter monitoring less cost. That ways the customer gets to choose what he wants and how much he spends. The company gets to cater to a wider customer base.

I acted as a patient and researched in stores and online as patient and the result was outstanding; I invented Smart Swab ( www.smartswab.com)

My simple one liner would be - "Research, research, and then more research". This ensures that you fully understand your customer and their wants and needs, what problem are you trying to solve, how big is the market, is it a global product design or a niche one, what is the likely cost/margin, what is the competition etc - do all this before you start to design it. Once you have a working concept then commence testing, trials, professional and end user feedback, gather all data then start again as very rarely will you get it right first time.

Do all the ground work before you even start to design something. The research aspect covers all areas and is vitally important in any design process.

I'd suggest, whatever the "solution(s)" is/are, do your risk management thoroughly with people who understand the environment it will be in. Three times in my career I've seen products launch just to be recalled a month later because risk management was glossed over. And the fatal failure mode of each was plainly obvious.

1st tip in designing a medical device is - follow the design control requirements for the country you want to sell in (means you'll cover all bases concerning design - User Needs/Planning etc). Bonus 2nd tip - never every presume anything and write everything down.

If I had to designing and marketing medical device just one tip, it would be portative heart rate triggered transcutaneous auricular vagus nerve stimulation device for effective myocardial workload modulation.
Transcutaneous Vagus Nerve Stimulation (VNS) technology uses the fact that the auricular branch of the vagus nerve supplies the skin of the concha in the human ear. This allows for transcutaneous electrical stimulation of the nerve fibers in this area. Intensity, pulse duration and frequency of the VNS stimulation have been optimized to induce signals in thick-myelinated fibres - the starting point to activate a complex cerebral network, corresponding closely to that targeted by invasive vagus nerve stimulation (VNS).
In order to effective modulation (reduction) myocardial workload, heart rate triggered VNS must be performed at 200-250 ms after the R-wave with the 100-125 ms bipolar impulse package:
http://link.springer.com/chapter/10.1007/978-3-642-34197-7_25

Maurizio Colombo Be sure to include regulatory and applicable standards requirements right from the very beginning of device design.

Jon Lant Apply our Pilot 4D process to ensure you capture the full scope of opportunity for your device. The need could be greater than you first believe. The most successful innovations in our opinion are those that reflect input from a professional team. http://www.originltd.com/hp3/pilot

Karen Koenes Plan the packaging design early! Even if the device is still in concept stage, companies such as CleanCut Technologies can create exceptionally accurate 3D device models to begin creating your packaging. www.cleancuttek.com

Cinde Waller I am "the patient" who invented as I healed. It must ALWAYS begin with the patient then on to R&D with patient input. Patients are the basis for invention.