Top Consulting Companies for Medical Devices: How To Choose

Author: Trinity M Consulting, LLC. | | Categories: 510 K Submission , 510 K Write Up , Clinical Research Consulting Services , EU MDR , EU MDR Guidance , EU MDR Support , Medical Device Consulting Firm , Medical Writing Services , Project Management , Project Management Consulting Services , Regulatory Affairs Consulting Services , Regulatory Consultants , Regulatory Consulting Company , Regulatory Contractors , Regulatory Strategy , Talent Recruitment Consulting Services

Blog by Trinity M Consulting LLC

Are you wondering how you can choose between the top consulting companies for medical devices? Read on and learn more here.

Medical device companies don't often have all the in-house personnel needed to complete all the technical functions at hand. Regulations also force companies to seek specialized knowledge to get their devices cleared by the FDA. This is one reason why many organizations choose to hire consultants.

Other companies also hire consultants to help write business plans or gap analyses for FDA approval. Companies on a tight budget may also not be able to offer attractive contracts to industry specialists. So, they may opt to reach out to specialists at the top consulting companies for specific projects.

Whatever the reason, all medical device companies need a consultant at some point. Unfortunately, not all consultants deliver what they promise. Many businesses have lost an FDA approval or business contract after hiring the wrong consultant company.

The same lack of expertise that forced them to look for specialized help also makes it hard for a company to identify qualified companies. So, what is the best way to find and hire a great consultant or consulting company? And which are the best medical consulting companies in the market?

Keep reading for more information on the top consulting companies for medical devices. You'll also learn how to choose the right consulting company for your organization.

Who Are the Top Consulting Companies?

Medical device companies face a lot of challenges to stay afloat in the current business environment. For instance, there is a lot of competition to release innovative products. At the same time, regulatory bodies are becoming tougher on companies. So meeting FDA standards before product release can be very costly both in time and money.

Manufacturers have learned that they can save a lot of time, money, and legal hassle by hiring consultants to assist with some of their processes. Consultant companies can conduct market research, test products, assist with certification, etc. Below are some of the best medical consulting firms in the market.

1. The Weinberg Group

The Weinberg Group specializes in pre-clinical and pre-regulatory consulting services. If you are seeking FDA approval for medical devices, this is one company you should lookup.

Their services include medical device submissions and setting up meetings with the regulatory authority. Their clientele has been American companies but they don't typically take on global customers.

2. 510KFDA

510KFDA is one of the most experienced consultancy firms when it comes to US FDA petitions. The company is more than 30 years old and has helped many companies get their products cleared for public use. Some medical devices cleared include x-radiation generators, 3d printing devices, and dental imaging products.

3. Excelerant Consulting

Excelerant Consulting is a multifaceted firm whose mission is to improve patient outcomes by bringing to market innovative medical devices and services. The company provides a wide range of consultancy services needed by most medical devices companies. The services include product and service positioning, contract negotiations, sales modeling, and commercializing medical devices and services.

Their client base includes firms from many different fields. For instance, they work with pharmaceuticals, biotechnology firms, and healthcare service companies. To accomplish their deliverables, the company has a team of experienced healthcare specialists, each an expert in their field.

4. Cavendish Scott

Most manufacturing companies pursue the coveted ISO certification as it provides social proof of quality products and services. But obtaining and keeping an ISO certification is not a walk in the park. Most companies need expert help to go through the process successfully.

This is where Cavendish Scott comes in. They are an ISO management system consulting, auditing, and training firm with years of experience in the management standard. The company isn’t just about getting the paperwork.

Cavendish Scott works with organizations to come up with systems that meet specific client needs. They do their best to use the simplest systems with straightforward documentation. This ensures that organizations maintain whatever standards they set to achieve ISO certification.

Once hired, Cavendish Scott consultants provide hands-on training and familiarization. If ISO certification is your goal, Cavendish Scott should be one of the consultants you interview.

5. Globizz

Globizz Corporation has established itself as one of the main FDA consulting firms targeting Japanese businesses in the US. It was one of the first Japanese-English bilingual consulting firms in the market. Many Japanese companies that are new to the US struggle with FDA 510(k) regulations and this is where Globizz comes in.

Their specializations are food, cosmetics, medical devices, drugs, and animal foods. So if you are a Japanese company seeking FDA medical device registration this may be the consultant company for you.

6. Ingenarious Consultants

If you are still in the early stage of product design, you could save a lot of time and money by conducting a feasibility study on your product. Ingenarious Consultants is one of the best consultancy companies for experts at early-stage design feasibility.

They use a phased approach to product development whereby more resources are provided at each stage of a product's design. Their process helps to bring your product from conception to clinical studies with the adequate amount of resources needed.

7. Intrinsik

Intrinsik is one of the most recognized consultancy firms in the field of drug development. The consultancy firm has years of experience and a team of experts that provide regulatory and scientific advice. Clients hire the firm to get the most efficient ways to develop and register human health products and drugs.

The company has helped to bring countless products to market. Some examples include small molecules, natural health products, medical devices, cosmetics, food additives, etc.

How to Choose the Right Medical Consultant?

Now that you know the top consulting companies for medical devices how can you choose the right one for you? Below are some of the important considerations you should make.

Define Your Project

The first step you must take if you want to choose the right consultant for your medical devices company is to define your project. Here are some questions to ask to make sure your defining process is thorough:

  • Why do you need to hire a consultant?
  • What tasks must they do?
  • What is the timeline of your project?
  • How will you divide project tasks and responsibilities between your consultant and your in-house team?

The project scope and consultant role and responsibilities should be written down in a project brief. You can share this with interested consultant companies. Many projects fail not because of an unqualified consultant but because of unclear goals. Usually, the issue is that the project scope or consultant role was not clearly defined.

You must also establish a budget for the consultancy position. While cost should not be the deciding factor of who you hire, your decision must still make business sense. Ultimately, your budget will determine the size and caliber of consultancy company you can hire.

Make Some Comparisons

Before you choose a consultant, it's a must to receive proposals from at least three companies. But if your project is large or complex you may need to get bids from at least 5 companies. Give all the companies the same project brief and deliverables.

You can then ask for their proposal on how they would approach your project. These proposals will give you an idea of whether the consultants understand the scope of work. Additionally, they can act as a guideline for drafting your consultancy agreement.

Look out for consultants that mention specific project management software that they will use to keep track of your project. Consultants or firms that don’t have a way to track project progress are either amateurs or unprofessional. If your medical device company is contracting services for a large project, then it’s a good idea to hire one of the top consulting companies.

The size of the consulting company hired should ideally match the size of your project. Also, consider hiring a locally based company as they would charge less for travel and accommodation. Hiring a consultant from overseas or out of state could be quite expensive if they must fly frequently to your location.

But if the project can happen remotely then distance may not have to be a consideration. In this case, you'll need to consider what tools you would need for remote communication and accountability.

Interview the Applicants

Before settling on a consultant, you should take the time to interview each consultant or company that applies for the role. Interviews will give the applicants a chance to sell you their approach to accomplishing your project goals. You'll also get a chance to assess the attitudes and personalities of each applicant.

It's essential that any consultant you hire gels well with your in-house team. You should not consider applicants that are condescending or rude. You also want to hire someone that listens to you and your team so watch out for applicants that talk more than listen.

Top consulting companies will thoroughly research your company before they show up for an interview. So, any consultant that is ignorant about your company or asks basic questions that a Google search could answer is questionable. Instead, serious contenders will ask project-specific questions and want to find out more about the project team.

If you're hiring a whole team rather than one consultant, try and interview each member of the team. At the least, you should get copies of each of their CVs and ask everything you need to learn more about them.

You will need to have a selection or tendering panel to decide which consultant to hire. This will help remove individual bias and increase the chances of hiring the best company for your project. Someone in the panel should be a technical expert in the project field. This will enable you to challenge the skills and expertise of the consultant you are interviewing.

Create some objective selection criteria that each member of the panel can use to score the top consulting companies. For instance, the companies could get points for the cost of services, quality of their business proposal, their project management systems, etc.

Check References

One thing to not forget to do is to ask for and check the references of the consultant. All top consulting companies list previous clients on their websites. Individual consultants will have a list of past clients that they can share with you.

Ensure that someone from your team calls the references to find out how well the consultant performed on their projects. You're bound to receive feedback that will confirm if the consultant is the right one for your project. Make sure to also do a Google search to see if any negative reviews come up online.

Put a Contract in Place

Once you choose a consultant you must get them to sign a consultancy agreement that protects your interests. For instance, consultancy payments could be tied to meeting project milestones, timelines, and deliverables. You could also reserve the right to terminate the contract in cases where the consultancy company misrepresented itself during the bidding process.

The contract should also clearly specify what the work conditions will be and any benefits the consultant would get. Ask your legal team to come up with a contract. Make sure it prevents loss of time and money to a bad consultant.

Choose the Right Consultant for Your Medical Devices Company

Many companies do not have the full range of in-house skills required to achieve their business goals. This is why many opt to hire one of the top consulting companies to bridge any gaps that show up. But hiring the right consultant is key to the success of your medical devices company.

Not only are consultant services expensive but the cost implications of a failed project can be very high. So, all care must be taken when choosing a consultant. If you do make the right choice, your consultant can be a great long-term business partner that helps grow your company.

If you're interested in working with a consultant, contact us for a free consult call!



READ MORE BLOG ARTICLES