What is medical device prototyping?

Medical device prototyping is a process, which involves an engineering team, and designers to address product purpose and human factors in a functional, proof of concept model which defines future medical devices. How much time or money you put in this process depends on the prototype’s purpose. Do we build it to check basic functionalities or do you need a fully functional prototype, beautifully polished to attract investors?

I think it would be wise to consider this matter before starting the prototyping stage. The initial definition of done will save a lot of money, time and stress on the part of both the contractor and the product owner.

Well, regardless of the level of “done” most projects move through four stages:

1. Alpha Prototyping
2. Beta Prototyping
3. Pilot Prototyping
4. Final Product

I’ll describe them later and focus on the results of each stage.

How does medical prototyping improve manufacturing?

Product manufacturing doesn’t forgive mistakes. Producing a big volume of units also means huge expenses. You wouldn’t want to get stuck with product development because you made mistakes in product design? Prototyping helps you to address not only product requirements, human factors, and legal but also business expectations and this means there is a narrow margin for mistakes. Prototyping is a tool to limit the risk you undertake with a new endeavor. That’s why prototyping is divided into stages which allow engineers and designers to split a big project into smaller chunks that are deliverable and impact one another.

Stages of medical device prototyping

1. Alpha 

Everything “Alpha” in engineering is associated (mostly in software-related fields) with something underdeveloped and unstable. When creating a physical device “Alpha” means a non-functional piece that tests the dimensions of the product design. Because we work on a device, design dimensions must answer the intended purpose of the device. On the other hand, we have a possibility to evaluate the interface and it complies with the end-user needs.

2. Beta

One leap ahead of Alpha, Beta prototypes are usually more advanced. Testing methods applied at this stage seek for strengths and weaknesses in mechanical parts or electronic components. This allows the rethinking and replacement of non-compliant elements and showcases this “error” to project members and stakeholders.

3. Pilot

When we plan to introduce a medical innovation that has no reference on the market yet, or the literature doesn’t reveal enough facts or scientific evidence, pilot prototypes are indispensable for clinical trials or introducing a small batch for the test. In some cases, we can see at this stage a product that soon could be available for customers, yet still, final polishing is required to manufacture on a scale.

4. Final Product

The most anticipated stage opens the door for mass production. Mind that you’re at a project stage when further modification would be even more expensive, sometimes unfeasible to implement and from a medical certification point of view, even inadvisable.

Benefits of medical device prototyping

The product development process with the prototyping stage is more likely to become successful and allow to gently step into full-scale production. Our experience gave us an insight into the benefits that you can get when working with a prototyping expert: 

Design refinement – which is the ability to improve the final product design when it’s essential. To make that more agile, it’s better to test and look for design flaws on a 3D-printed model, instead of a more expensive sophisticated prototype.

Materials build the first impression of a product. You should test your sketch or computer model in real conditions to check how chosen materials look and perform together.

Tough conditions mean tough testing. Your prototype must assure mechanical reliability and design will meet even the most extreme forms of use in the planned spectrum.

Prototype for manufacturing validates the process of production. Well, we need to test it, right? Manufacturing processes should be as smooth as possible to deliver a quality product and simplify scale to production.

Regulatory compliance and device safety – imagine a medical device, which is harmful to the patient or medical staff. One of the prototyping goals is to build a medical device as secure as possible. Legal compliance and device certification allow avoiding potentially dangerous products available on the market.

Cutting production expenses is possible however sooner modifications are implemented, the better. There is no such thing as a perfect product from the very beginning. You can modify design, materials, or manufacturing processes because the prototyping stage is for.  On the other hand, you minimize the risk of product recalls which usually lead to legal or financial problems.

Prototyping stage summary

I think the most impactful result which comes from prototyping is making a future innovation visible. Our imagination works differently so it is very easy to talk about something and everyone could imagine a different result. Prototyping is a remedy for misconceptions between designers, engineers and investors. Without a prototype that we can see, touch, and use it would be difficult to speed up the time to market and determine the final output.

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If an innovator desires to contribute to the healthcare industry, it requires a solid medical device startup business plan and services of medical device consulting firms at all medical device development lifecycle stages. It requires knowledge and highly valuable data to develop a concept into a functional medical device that can meet or exceed the target market expectations. The innovator should also have a successful medical commercialization, exit strategy and a network of potential distributors, for example, medical supply wholesalers like Direct Medical Supplies Australia. From the voice of the customer analysis and medical device business startup plan to commercialization strategy, consulting firms’ contribution is critical to the medical device company success. 

Starting a medical device company requires: 

1. Adhere to Regulatory Compliance :

As medical devices are used to deliver effective and accurate patient care, the medical device industry is highly regulated. Each country has its own regulatory body. Medical devices in the U.S. are subjected to FDA regulations and international regulatory bodies. The medical device company has to adhere to all the regulations to develop and market innovative healthcare technology. A startup may not be familiar with regulatory compliance. For this reason, the startups rely on medical device regulatory & compliance consulting firms. These firms help in managing medical device compliance risks. 

Note: A medical device startup has to work with different consulting firms. Medical device regulatory & compliance consulting firms ensure that the company follows all the regulations. Another type of consulting firm offers a full suite of strategic medical device consulting services, including:

• Voice of the customer analysis 
• Market analysis 
• Value analysis 
• Key opinion leader identification 
• Risk analysis 
• Competitive analysis 
• Positioning analysis 
• Financial valuation 
• Exit strategy 
• Business plan 
• Portfolio analysis 

Note: Strategy Inc. is not involved in regulatory consulting 

2. Apply for Intellectual Property :

Once the startup has an innovative idea, it should protect IP rights to get a competitive advantage in the target market. The company should get intellectual property rights to protect the ideas, logos, brand name, methods, and phrases. IP rights keep competitors from using the company’s medical device idea.

3. Market Analysis :

Market analysis is critical for target market identification and successful medical device commercialization. This analysis determines market size in terms of disease incidence and prevalence and procedure volume. Medical device consulting firms use primary sources for research and analysis. Other sources include market share statistics, reports, published literature, and secondary resources. Consultants customize the market analysis to define the medical device market and opportunities through: 

• Scope and drivers identification 
• Revenue driving market trends identification 
• Target customer profile identification for the selected clinical area 
• Current and emerging treatment modalities delineation 
• Competitive technology advantages and limitations identification 
• Projected barriers and market adoption threat identification     

4. Product Idea Comparison :

A medical device and wearable therapeutics startup requires a realistic approach to launch the medical device in the target market. Medical device consulting firms conduct a competitive analysis to compare the technology under consideration for development with the on-market and pipeline medical devices. The medical device startup can identify the value proposition of its idea.

Now that you’ve figured out how to start a medical device startup, you need to really ensure that you have the best people in your company to carry out the operations. Have you thought about coaching and mentoring programs that will be good for their productivity and well-being? There you go! In addition, you need to pay your employees properly and provide them with the pay stubs. If you need to make pay stubs, be sure to check out the pay stub generator.

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